Datasets:

eu_regulatory_ir

like 2

31993L0041

1993

COUNCIL DIRECTIVE 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology 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the opinion of the Economic and Social Committee (3), Whereas the provisions of Directive 87/22/EEC (4) have now been superseded by the provisions of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) and by Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations (6); Whereas provision has been made in Directive 93/39/EEC (7) for the continued management of marketing authorizations which have been granted by Member States following the opinion of the Committee for Proprietary Medicinal Products given in accordance with Directive 87/22/EEC; Whereas, furthermore, provision has been made in Directive 93/40/EEC (8) for the continued management of marketing authorization which have been granted by Member States following the opinion of the Committee for Veterinary Medicinal Products given in accordance with Directive 87/22/EEC; Whereas Directive 87/22/EEC should therefore be repealed; Whereas in the interests of legal certainty, provision should be made for the continued examination of applications for marketing authorization which have been referred to the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products in accordance with Directive 87/22/EEC before 1 January 1995, Article 1 With effect from 1 January 1995, Directive 87/22/EEC is hereby repealed. Article 2 Applications for marketing authorizations which have been referred to the Committee for Proprietary Medicinal Products or to the Committee for Veterinary Medicinal Products before 1 January 1995 in accordance with Article 2 of Directive 87/22/EEC and in respect of which the Committee concerned has not given an opinion by 1 January 1995 shall be considered in accordance with Regulation (EEC) No 2309/93. Article 3 Member States shall take all appropriate measures to comply with this Directive with effect from 1 January 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 This Directive is addressed to the Member States.

31993L0029

1993

Council Directive 93/29/EEC of 14 June 1993 on the identification of controls, tell-tales and indicators for two-or three-wheel motor vehicles Having regard to the Treaty establishing the European Economic Community and in particular Article 100a thereof, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles (1), Having regard to the proposal from the Commission (2), In cooperation with the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas the measures required for that purpose need to be adopted; Whereas, with regard to their controls, tell-tales and indicators, in each Member State two- or three-wheel motor vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas, as a result of their differences, such provisions constitute a barrier to trade within the Community; Whereas these obstacles to the operation of the internal market may be removed if the same requirements are adopted by all Member States in place of their national rules; Whereas it is necessary to draw up harmonized requirements concerning the identification of controls, tell-tales and indicators for two- or three-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle; Whereas, given the scale and impact of the action proposed in the sector in question, the Community measures covered by this Directive are necessary, indeed essential, to achieve the aim in view, which is to establish Community vehicle type-approval; whereas that aim cannot be adequately achieved by the Member States individually; Whereas in order to facilitate access to the markets of non-Community countries it would seem necessary to establish equivalence between the requirements of this Directive and those of Regulation No 60 of the United Nations Economic Commission for Europe, Article 1 This Directive applies to the identification of controls, tell-tales and indicators for all types of vehicle as defined in Article 1 of Directive 92/61/EEC. Article 2 The procedure for the granting of component type-approval in respect of the identification of controls, telltales and indicators for a type of two- or three-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Chapters II and III of Directive 92/61/EEC. Article 3 In accordance with the provisions of Article 11 of Directive 92/61/EEC, equivalence between the requirements laid down in this Directive and those laid down in UN/ECE Regulation No 60 (E/ECE/TRANS/505 - Add. 59) is hereby acknowledged. The authorities of the Member States which grant component type-approval shall accept approvals granted in accordance with the requirements of the abovementioned Regulation No 60 as well as component type-approval marks as an alternative to the corresponding approvals granted in accordance with the requirements of this Directive. Article 4 This Directive may be amended in accordance with Article 13 of Directive 70/156/EEC (5) in order to: - take into account any amendments to the ECE Regulation referred to in Article 3, - adapt the Annex to technical progress. Article 5 1. Member States shall adopt and publish the provisions necessary to comply with this Directive not later than 14 December 1994. They shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not, for reasons connected with the identification of controls, tell-tales and indicators, prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply the provisions referred to in the first subparagraph as from 14 June 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive is addressed to the Member States.

31993L0031

1993

Council Directive 93/31/EEC of 14 June 1993 on stands for two-wheel motor vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof; Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles (1), Having regard to the proposal from the Commission (2), In cooperation with the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas the measures required for that purpose need to be adopted; Whereas, with regard to their stands, in each Member State two-wheel motor vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas, as a result of their differences, such provisions constitute a barrier to trade within the Community; Whereas these obstacles to the operation of the internal market may be removed if the same requirements are adopted by all Member States in place of their national rules;. Whereas it is necessary to draw up harmonized requirements relating to stands for two-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle; Whereas, given the scale and impact of the action proposed in the sector in question, the Community measures covered by this Directive are necessary, indeed essential, to achieve the aim in view, which is to establish Community vehicle type-approval; whereas that aim cannot be adequately achieved by the Member States individually, Article 1 This Directive and its Annex apply to stands for all types of two-wheel vehicle as defined in Article 1 of Directive 92/61/EEC. Article 2 The procedure for the granting of component type-approval in respect of the stand for a type of two-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Chapters II and III of Directive 92/61/EEC. Article 3 Any amendments necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC (5). Article 4 1. Member States shall adopt and publish the provisions necessary to comply with this Directive not later than 14 December 1994. They shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not, for reasons connected with stands, prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply the provisions referred to in the first subparagraph as from 14 June 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive is addressed to the Member States.

31993L0033

1993

Council Directive 93/33/EEC of 14 June 1993 on protective devices intended to prevent the unauthorized use of two- or three-wheel motor vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles (1), Having regard to the proposal from the Commission (2), In cooperation with the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas measures necessary to that end should be adopted; Whereas, with regard to their protective devices intended to prevent unauthorized use, in each Member State two- or three-wheel motor vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas, as a result of their differences, such provisions constitute a barrier to trade within the Community; Whereas those obstacles to the establishment and operation of the internal market may be removed if the same requirements are adopted by all Member States in place of their national rules; Whereas it is necessary to draw up harmonized requirements concerning the protective devices intended to prevent the unauthorized use of two- or three-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle; Whereas, given the scale and impact of the action proposed in the sector in question, the Community measures covered by this Directive are necessary, indeed essential, to achieve the aim in view, which is to establish Community vehicle type-approval; whereas that aim cannot be adequately achieved by the Member States individually; Whereas in order to facilitate access to the markets of non-Community countries it would seem necessary to establish equivalence between the requirements of this Directive and those of Regulation No 62 of the United Nations Economic Commission for Europe, Article 1 This Directive and its Annexes apply to the protective devices intended to prevent the unauthorized use of all types of vehicle as defined in Article 1 of Directive 92/61/EEC. Article 2 The procedure for the granting of component type-approval in respect of the protective device intended to prevent the unauthorized use of a type of two- or three-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Chapters II and III of Directive 92/61/EEC. Article 3 In accordance with Article 11 of Directive 92/61/EEC, equivalence between the requirements laid down in this Directive and those laid down in United Nations ECE Regulation No 62 (E/ECE/TRANS/505 - Add. 61 / Amend. 1) is hereby acknowledged. The authorities of the Member States which grant component type-approval shall accept approvals granted in accordance with the requirements of the abovementioned Regulation No 62 as well as component type-approval marks as an alternative to the corresponding approvals granted in accordance with this Directive. Article 4 This Directive may be amended in accordance with Article 13 of Directive 70/156/EEC (5) in order to: - take into account any amendments to the United Nations ECE Regulation referred to in Article 3, - adapt the Annexes to technical progress. Article 5 1. Member States shall adopt and publish the provisions necessary to comply with this Directive not later than 14 December 1994. They shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not, for reasons connected with the protective device intended to prevent unauthorized use, prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply the provisions referred to in the first subparagraph as from 14 June 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 6 This Directive is addressed to the Member States.

31993L0044

1993

Council Directive 93/44/EEC of 14 June 1993 amending Directive 89/392/EEC on the approximation of the laws of the Member States relating to machinery 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 lifting persons entails specific hazards for the persons lifted; whereas those hazards are not covered by the essential health and safety requirements laid down by Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (4); Whereas, for the type of machinery in question, there is no reason to provide for different conformity assessment modules from those initially provided for in Directive 89/392/EEC for machinery in general; Whereas additional essential health and safety requirements to cover the risks run by lifted persons can be laid down by means of an amendment to Directive 89/392/EEC; whereas this amendment can be used to advantage to correct certain imperfections in the said Directive; Whereas it is also necessary to deal with safety components which are placed on the market separately and the safety function of which is declared by the manufacturer or his authorized representative established in the Community; Whereas the dates of implementation laid down in this Directive shall not alter the dates of implementation of Directive 89/392/EEC and Directive 91/368/EEC, which amended it, Article 1 Directive 89/392/EEC is hereby amended as follows: 1. Article 1 shall be amended as follows: (a) the following subparagraph shall be added to paragraph 1: 'It shall also apply to safety components placed on the market separately.'; (b) the following subparagraph shall be added to paragraph 2: 'For the purposes of this Directive, safety components means a component, provided that it is not interchangeable equipment, which the manufacturer or his authorized representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.'; (c) paragraph 3 shall be amended as follows: (i) the following indent shall be deleted: '- lifting equipment designed and constructed for raising and/or moving persons with or without loads, except for industrial trucks with elevating operation position,'; (ii) the following indent: '- cableways for the public or private transposition of persons,' shall be replaced by: '- cableways, including funicular railways, for the public or private transportation of persons,'; (iii) the following indents shall be added: '- lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at a angle of more than 15 degrees to the horizontal and designed for the transport of: - persons, - persons and goods, - goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside, - means of transport of persons using rack and pinion rail mounted vehicles, - mine winding gear, - theatre elevators, - construction site hoists intended for lifting persons or persons and goods.'; (d) paragraph 4 shall be replaced by the following: '4. Where, for machinery or safety components, 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 or safety components and of such risks on the implementation of these specific Directives.' 2. Article 2 shall be replaced by the following: 'Article 2 1. Member States shall take all appropriate measures to ensure that machinery or safety components covered by this Directive may be replaced on the market and put into service only if they do not endanger the health or safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for their intended purpose. 2. 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 machinery or safety components in question, provided that this does not mean that the machinery or safety components are 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 or safety components which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such machinery or safety components do not conform and that they are not for sale until they have 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.'; 3. Article 3 shall be replaced by the following: 'Article 3 Machinery and safety components covered by this Directive shall satisfy the essential health and safety requirements set out in Annex I.'; 4. Article 4 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: '1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery and safety components which comply with this Directive.'; (b) the following paragraph shall be added: '3. Member States may not prohibit, restrict or impede the placing on the market of safety components as defined in Article 1 (2) where they are accompanied by an EC declaration of conformity by the manufacturer or his authorized representative established in the Community as referred to in Annex II, point C.'; 5. Article 5 (1) and (2) shall be replaced by the following: '1. Member States shall regard the following as conforming to all the provisions of this Directive, including the procedures for checking the conformity provided for in Chapter II: - machinery bearing the CE marking and accompanied by the EC declaration of conformity referred to in Annex II.A., - safety components accompanied by the EC declaration of conformity referred to in Annex II.C. 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 or safety components 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.'; 6. Article 7 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: '1. Where a Member State ascertains that - machinery bearing the CE marking, or - safety components accompanied by the EC declaration of conformity, used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof. The Member States shall immediately inform the Commission of any such measure, indicating the reason 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.'; (b) paragraph 3 shall be replaced by the following: '3. Where: - machinery which does not comply bears the CE marking, - a safety component which does not comply is accompanied by an EC declaration of conformity, the competent Member State shall take appropriate action against whomsoever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.'; 7. Article 8 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: '1. The manufacturer or his authorized representative established in the Community must, in order to certify that machinery and safety components are in conformity with this Directive, draw up for all machinery or safety component manufactured an EC declaration of conformity based on the model given in Annex II, A or C as appropriate. In addition, for machinery alone, the manufacturer or his authorized representatives established in the Community must affix to the machine the CE marking referred to in Article 10.'; (b) the following paragraph shall be inserted: '4a. Safety components shall be subject to the certification procedures applicable to machinery pursuant to paragraphs 2, 3 and 4. Furthermore, during EC type-examination, the notified body shall verify the suitability of the safety component for fulfilling the safety functions declared by the manufacturer.'; (c) paragraph 6 shall be replaced by the following: '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 or safety component on the market in the Community. The same obligations shall apply to any person assembling machinery or parts thereof or safety components of various origins or constructing machinery or safety components for his own use.'; 8. Article 9 (1) shall be replaced by the following: '1. Each Member State shall notify the Commission and the other Member States of the bodies responsible for carrying out the certification procedures referred to in Article 8. The Commission shall publish a list of those bodies in the Official Journal of the European Communities for information and shall ensure that the list is kept up to date.'; 9. Article 11 shall be replaced by the following: 'Article 11 Any decision taken pursuant to this Directive which restricts the placing on the market and putting into service of machinery or a safety component 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.'; 10. Annex I shall be amended as follows: (a) the title shall be replaced by the following: 'ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINERY AND SAFETY COMPONENTS'; (b) the following shall be added after this title: 'For the purposes of this Annex, 'machinery' means either 'machinery' or 'safety component' as defined in Article 1 (2).'; (c) the preliminary observations shall be supplemented by the following: '3. The essential health and safety requirements have been grouped according to the hazards which they cover. Machinery presents a series of hazards which may be indicated under more than one heading in this Annex. The manufacturer is under an obligation to assess the hazards in order to identify all those which apply to his machine; he must then design and construct it taking account of his assessment.'; (d) in Section 1.2.4, the last paragraph concerning the emergency stop shall be replaced by the following: 'Once active operation of the emergency stop control has ceased following a stop command, that command must be sustained by engagement of the emergency stop device until that engagement is specifically overridden; it must not be possible to engage the device without triggering a stop command; it must be possible to disengage the device only by an appropriate operation, and disengaging the device must not restart the machinery but only permit restarting.'; (e) the following sections shall be added: '1.5.14. Risk of being trapped in a machine Machinery must be designed, constructed or fitted with a means of preventing an exposed person from being enclosed within it or, if that is impossible, with a means of summoning help.' 1.5.15. Risk of slipping, tripping or falling Parts of the machinery where persons are liable to move about or stand must be designed and constructed to prevent persons slipping, tripping or falling on or off these parts.'; (f) the second paragraph of Section 1.6.2 shall be deleted; (g) the first indent of Section 1.7.4 (a) shall be replaced by the following: '- a repeat of the information with which the machinery is marked, except the serial number (see 1.7.3) together with any appropriate additional information to facilitate maintenance (e.g. addresses of the importer, repairers etc.),'; (h) Section 1.7.4 (b) shall be replaced by the following: 'The constructions must be drawn up in one of the Community languages by the manufacturer or his authorized representative established in the Community. On being put into service, all machinery must be accompanied by a translation of the instructions in the language or languages of the country in which the machinery is to be used and by the instructions in the original language. This translation must be done either by the manufacturer or his authorized representative established in the Community or by the person introducing the machinery into the language area in question. By way of derogation from this requirement, the maintenance instructions for use by specialized personnel employed by the manufacturer or his authorized representative established in the Community may be drawn up in only one of the Community languages understood by that personnel.'; (i) Section 1.7.4 (d) shall be replaced by the following: 'Any literature describing the machinery must not contradict the instructions as regards safety aspects. The technical documentation describing the machinery must give information regarding the airborne noise emissions referred to in (f) and, in the case of hand-held and/or hand-guided machinery, information regarding vibration as referred to in 2.2.'; (j) the title of Section 2 shall be replaced by the following: 'ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY'; (k) in Sections 2.1, 2.2 and 2.3, the following words shall be deleted: 'In addition to the essential health and safety requirements set out in 1 above,'; (l) in Section 3, the first paragraph shall be replaced by the following: 'Machinery presenting hazards due to mobility must be designed and constructed to meet the requirements set out below.'; (m) in Section 4, the first paragraph shall be replaced by the following: 'Machinery presenting hazards due to lifting operations - mainly hazards of load falls and collisions or hazards of tipping caused by a lifting operation - must be designed and constructed to meet the requirements set out below.'; (n) the following paragraph shall be added to Section 4.2.3: 'Machinery serving specific levels at which operators can gain access to the load platform in order to stack or secure the load must be designed and constructed to prevent uncontrolled movement of the load platform, in particular while being loaded or unloaded.'; (o) the title of Section 5 shall be replaced by the following: 'ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY INTENDED FOR UNDERGROUND WORK'; (p) the first paragraph of Section 5 shall be replaced by the following: 'Machinery intended for underground work must be designed and constructed to meet the requirements set out below.'; (q) Section 6 in the Annex to this Directive shall be added; 11. Annex II shall be amended as follows: (a) the title of point A shall be replaced by the following: 'Contents of the EC declaration of conformity for machinery (1)'. (b) the first footnote shall be replaced by the following: '(1) This declaration must be drawn up in the same language as the original instructions (see Annex I, Section 1.7.4 (b)) and must be either typewritten or handwritten in block capitals. It must be accompanied by a translation in one of the official languages of the country in which the machinery is to be used. This translation must be done in accordance with the same conditions as for the translation of the instructions.'; (c) the following point shall be added: 'C. Contents of the EC declaration of conformity for safety components placed on the market separately (1). The EC declaration of conformity must contain the following particulars: - name and address of the manufacturer or his authorized representative established in the Community (2), - description of the safety component (4), - safety function fulfilled by the safety component, if not obvious from the description, - where appropriate, the name and address of the notified body and the number of the EC type-examination certificate, - where appropriate, the name and address of the notified body to which the file was forwarded in accordance with the first indent of Article 8 (2) (c), - where appropriate, the name and address of the notified body which carried out the verification referred to in the second indent of Article 8 (2) (c), - where appropriate, a reference to the harmonized standards, - where appropriate, the national technical standards and specifications used, - identification of the person empowered to sign on behalf of the manufacturer or his authorized representative established in the Community.'; (d) the following footnote 4 shall be added: '(4) Description of the safety component (make, type, serial number, if any, etc.).'; 12. Annex IV shall be amended as follows: (a) the title shall be replaced by the following: TYPES OF MACHINERY AND SAFETY COMPONENTS FOR WHICH THE PROCEDURE REFERRED TO IN ARTICLE 8 (2) (b) AND (c) MUST BE APPLIED'; (b) the following subtitle shall be inserted after the title: 'A. Machinery'; (c) Section 1 shall be replaced by the following: '1. Circular saws (single or multi-blade) for working with wood and analogous materials or for working with meat and analogous materials. 1.1. Sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed. 1.2. Sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage. 1.3. Sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading. 1.4. Sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloading.'; (d) Section 4 shall be replaced by the following: '4. Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials.'; (e) Section 5 shall be replaced by the following: '5. Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials.'; (f) Section 7 shall be replaced by the following: '7. Hand-fed vertical spindle moulding machines for working with wood and analogous materials.'; (g) the following shall be added to Section A: '16. Devices for the lifting of persons involving a risk of falling from a vertical height of more than three metres. 17. Machines for the manufacture of pyrotechnics.'; (h) the following section shall be added: 'B. Safety components 1. Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.). 2. Logic units which ensure the safety functions of bi-manual controls. 3. Automatic movable screens to protect the presses referred to in 9, 10 and 11. 4. Roll-over protection structures (ROPS). 5. Fallings-object protective structures (FOPS).'; 13. the following shall be added after the title in Annex V: 'For the purposes of this Annex, 'machinery' means either 'machinery' or 'safety component' as defined in Article 1 (2).'; 14. the following shall be added after the title in Annex VI: 'For the purposes of this Annex, 'machinery' means either 'machinery' or 'safety component' as defined in Article 1 (2).'; 15. the following shall be added after the title in Annex VII: 'For the purposes of this Annex, 'machinery' means either 'machinery' or 'safety component' as defined in Article 1 (2).' Article 2 1. Before 1 July 1994 Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Member States shall apply these provisions with effect from 1 January 1995. 2. By way of derogation from the third subparagraph of paragraph 1, Member States shall apply the laws, regulations and administrative provisions necessary to comply with the provisions listed below as from 1 July 1994: - Article 1 (10) excluding (a), (b) and (q), - Article 1 (11) (a) and (b), - Article 1 (12) (c), (d), (e) and (f). 3. However, until 31 December 1996 Member States may allow the placing on the market and putting into service of safety components and of machinery for the lifting or moving of persons which conform with the national provisions in force in their territories as at the date of adoption of this Directive. 4. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0032

1993

Council Directive 93/32/EEC of 14 June 1993 on passenger hand-holds on two-wheel motor vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles (1), Having regard to the proposal from the Commission (2), In cooperation with the European Parliament (3) Having regard to the opinion of the Economic and Social Committee (4), Whereas the internal market comprises and area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas the measures required for that purpose need to be adopted; Whereas, with regard to their passenger hand-holds, in each Member State two-wheel motor vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas, as a result of their differences, such provisions constitute a barrier to trade within the Community; Whereas these obstacles to the operation of the internal market may be removed if the same requirements are adopted by all Member States in place of their national rules; Whereas it is necessary to draw up harmonized requirements concerning passenger hand-holds on two-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle; Whereas, given the scale and impact of the action proposed in the sector in question, the Community measures covered by this Directive are necessary, indeed essential, to achieve the aim in view, which is to establish Community vehicle type-approval; whereas that aim cannot be adequately achieved by the Member States individually, Article 1 This Directive and its Annex apply to passenger hand-holds of all types of two-wheel vehicles as defined in Article 1 of Council Directive 92/61/EEC. Article 2 The procedure for the granting of component type-approval in respect of passenger hand-holds on a type of two-wheel motor vehicle and the conditions governing the free movement of said vehicles shall be as laid down in Chapters II and III of Directive 92/61/EEC. Article 3 Any amendments necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC (5). Article 4 1. Member States shall adopt and publish the provisions necessary to comply with this Directive not later than 14 December 1993. They shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not, for reasons connected with the passenger hand-holds, prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply the provisions referred to in the first subparagraph as from 14 June 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Artikel 5 This Directive is addressed to the Member States.

31993L0045

1993

Commission Directive 93/45/EEC of 17 June 1993 concerning the manufacture of nectars without the addition of sugars or honey Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 75/726/EEC of 17 November 1975 on the approximation of the laws of the Member States concerning fruit juices and certain similar products (1), as last amended by Directive 89/394/EEC (2). and in particular Article 1 (7) (b) thereof, which provides that in the case of certain fruits whose juice has a high natural sugar content, nectar may be produced from them without the addition of sugars, Whereas the fruits listed in points II and III of the Annex to Directive 75/726/EEC, and apricots, can have a naturally high sugar content and thus fall into the category in question; Whereas, therefore, when the conditions are met, it is appropriate to authorize the production of nectars without the addition of sugars or honey; Whereas, in view of the scope and effects of the action envisaged, the Community measures laid down by this Directive are not only necessary but also indispensable to the achievement of the objectives set; whereas these objectives cannot be achieved by the Member States individually; whereas, moreover, such Community level objectives are already set out in Directive 75/726/EEC; Whereas the list laid down by this Directive is in accordance with the opinion of the Standing Committee for Foodstuffs, Article 1 The fruits set out in points II and III of the Annex to Directive 75/726/EEC, and apricots, can be used, individually or mixed together, to manufacture nectars without the addition of sugars or honey where their naturally high sugar content so warrants. Article 2 1. Member States shall take the necessary legislative, regulatory and administrative measures to comply with this Directive no later than 31 December 1993. They shall forthwith inform the Commission thereof. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0047

1993

Sixteenth Commission Directive 93/47/EEC of 22 June 1993 adapting to technical progress Annexes II, III, V, VI and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 92/86/EEC (2), and in particular Article 8 (2) thereof, Whereas, on the basis of the available information, on the one hand an ultraviolet filter may be definitively permitted and on the other hand certain provisionally permitted substances, preservatives and ultraviolet filters must be definitively prohibited or permitted for a further specified period; Whereas, in order to protect public health, it is necessary to prohibit the use of 4-amino-2-nitrophenol; Whereas, on the basis of the latest scientific and technical research, the use of strontium peroxide and phenolphthalein may be permitted subject to certain restrictions and the obligatory inclusion of health warnings on the label; Whereas, on the basis of the latest scientific and technical research, 3-midazol-4-ylacrylic acid and its ethyl ester, may be used as an ultraviolet filter up to 30 July 1994 in cosmetic products subject to certain restrictions and conditions; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector, Article 1 Directive 76/768/EEC is hereby amended as follows: 1. in Annex II, the following number is added: '412. 4-Amino-2-nitrophenol'; 2. in Annex III, Part 1: (a) to reference numbers 8, 9 and 10 in paragraph (b) of column (f) the sentence: 'Wear suitable gloves' should be added; (b) to reference number 12 in column (f) the sentence: '(a) Wear suitable gloves' should be added; 3. in Annex III, Part 2, the following reference numbers are added: /* Tables: see OJ */ conditions laid down in Annex III, Part 2, reference number 1, . . .'; 5. in Annex VI, Part 2, '30 June 1993' in reference numbers 2, 15, 16, 21, 26, 27, 28, 29, 30 is replaced by '30 June 1994'; 6. in Annex VII, Part 1: (a) the following reference number is added: 7. in Annex VII, Part 2: (a) the following number is added: (c) '30 June 1993' in reference numbers 2, 5, 6, 12, 13, 17, 24, 25, 26, 28, 29, 32 is replaced by '30 June 1994'. Article 2 1. Regardless of the dates mentioned in Article 1, Member States shall take all the necessary measures to ensure that as from 1 July 1994 for the substances mentioned in Article 1, neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances mentioned in Article 1 shall not be sold or otherwise supplied to the final consumer after 30 June 1995 if they do not comply with the requirements of this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 30 June 1994. They shall forthwith inform the Commission thereof. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 3. 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.

31993L0049

1993

Commission Directive 93/49/EEC of 23 June 1993 setting out the schedule indicating the conditions to be met by ornamental plant propagating material and ornamental plants pursuant to Council Directive 91/682/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 91/682/EEC of 19 december 1991 on the marketing of ornamental plant propagating material and ornamental plants(1) , and in particular Article 4 thereof, Whereas, in applying the provisions of this Directive, it is appropriate to take into account the production cycles of the various materials; Whereas, the conditions laid down in this Directive must be regarded as the minimum standard acceptable at this stage taking into account the current production conditions in the Community; whereas they will progressively be developed and refined, in order ultimately to achieve high standards of improved quality; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for propagating Materials and Ornamental Plants, Article 1 1. This Directive establishes the schedules referred to in Article 4 of Directive 91/682/EEC including the requirements as to labelling referred to in the third paragraph of Article 11 of that Directive. 2. The schedule applies to the growing crop and ornamental propagating material (including rootstocks), and ornamental plants derived therefrom, of all the genera and species referred to in Annex to Directive 91/682/EEC, and to rootstocks of other genera and species referred to in Article 4 (2), irrespective of the propagation system applied, those items being hereinafter referred to as 'the material'. 3. The provisions of this Directive shall apply progressively, account being taken of the production cycles of the material referred to in paragraph 2. Article 2 The material shall, where applicable, comply with the relevant plant health conditions laid down in Council Directive 77/93/EEC(2) . Article 3 1. Without prejudice to the provisions of Article 2, the material must, at least on visual inspection, be substantially free from any harmful organisms and diseases impairing quality, or any signs or symptoms thereof, which reduce the usefulness of the propagating material or ornamental plants and in particular be free from those organisms and diseases listed in the Annex hereto in respect of the genus or species concerned. 2. Any material showing visible signs or symptoms of the harmful organisms or diseases referred to in paragraph 1 at the stage of the growing crop shall be properly treated immediately upon appearance or, where appropriate, shall be removed. 3. In the case of citrus material the following requirements shall also be met: (i) it shall be derived from initial material which has been checked and found to show no symptoms of the relevant viruses, virus-like organisms or diseases listed in the Annex hereto; (ii) it shall have been checked and found to be substantially free of such viruses, virus-like organisms or diseases since the beginning of the last cycle of vegetation; and (iii) in the case of grafting, it shall have been grafted onto rootstocks other than those susceptible to viroids. 4. In the case of flower bulbs the following requirement shall also be met: - the propagating material shall be derived directly from material which, at the stage of the growing crop, has been checked and found to be substantially free from any harmful organisms and diseases, signs or symptoms thereof referred to in paragraph 1 and in particular from those listed in the Annex hereto. Article 4 1. The material shall have adequate identity and purity relative to the genus or species in question, or where appropriate, group of plants, and, where marketed or intended to be marketed with a reference to the variety pursuant to Article 9 (1) of Directive 91/682/EEC, shall also have identity and purity as to variety. 2. In the case of commonly known varieties referred to in the first indent of Article 9 (2) of Directive 91/682/EEC the official denomination of the variety shall be used by the supplier. 3. In the case of varieties which are already the subject of an application for plant breeders' rights or an official registration referred to in the first indent of Article 9 (2) of Directive 91/682/EEC, the breeders' reference or proposed name must be used until the authorization is granted. 4. In the case of varieties entered on lists kept by suppliers pursuant to the second indent of Article 9 (2) of Directive 91/682/EEC, the requirement referred to in paragraph 1 in respect of variety shall be based on the detailed descriptions given in the lists kept by suppliers. Article 5 1. The material shall be substantially free from any defects likely to impair their quality as propagating or as planting material. 2. The vigour and dimensions of the material shall be satisfactory in respect of its usefulness as propagating material and ornamental plants. Furthermore, an appropriate balance shall be assured between the roots, stems and leaves. 3. In the case of seeds, in addition to the requirements in paragraph 1, the germination capacity shall be satisfactory. Article 6 1. The supplier's document referred to in Article 11 of Directive 91/682/EEC shall be of suitable material which has not previously been used and shall be printed in at least one of the official languages of the Community. It shall contain the following information headings: (i) indication 'EEC quality'; (ii) indication of EEC Member State code; (iii) indication of responsible official body or its distinguishing code; (iv) registration or accreditation number; (v) name of supplier; (vi) individual serial, week or batch number; (vii) date of issue of the supplier's documents; (viii) botanical name; (ix) denomination of the variety, where appropriate. In the case of rootstock, denomination of the variety of its designation; (x) denomination of the group of plants, where appropriate; (xi) quantity; (xii) in the case of imports from third countries pursuant to Article 16 (2) of Directive 91/682/EEC, the name of the country of harvesting. 2. In the case where the material is accompanied by a plant passport in accordance with Commission Directive 92/105/EEC(3) the plant passport may, if the supplier so wishes, constitute the supplier's document referred to in paragraph 1. Nonetheless, the indication 'EEC quality' and an indication as to the responsible official body under Directive 91/682/EEC must be given and a reference to the denomination of the variety, rootstock or group of plants. In the case of imports from third countries pursuant to Article 16 (2) of Directive 91/682/EEC, the name of the country of harvesting must also be given. This information may be on the same document as the plant passport but clearly separated. Article 7 This Directive is without prejudice to the provisions laid down in Council Regulation (EEC) No 315/68(4) . Article 8 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 9 This Directive is addressed to the Member States.

31993L0048

1993

COMMISSION DIRECTIVE 93/48/EEC of 23 June 1993 setting out the schedule indicating the conditions to be met by fruit plant propagating material and fruit plants intended for fruit production, pursuant to Council Directive 92/34/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (1), and in particular Article 4 thereof, Whereas, in applying the provisions of this Directive, it is appropriate to take into account the production cycles of the various materials; Whereas, pursuant to point (i) of Article 11 of Directive 92/34/EEC, requirements as to the supplier's document accompanying CAC propagating material and fruit plants shall be laid down in the schedule established pursuant to Article 4; Whereas a system of certification for such material has (as far as certain species are concerned) been developed or is in the course of development at an international level by the European Plant Protection Organization (EPPO); Whereas the conditions laid down in this Directive must be regarded as the minimum standard acceptable at this stage taking into account the current production conditions in the Community; whereas they will progressively be developed and refined in order ultimately to achieve high standards of quality; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Plants of Fruit Genera and Species, Article 1 1. This Directive establishes the schedule referred to in Article 4 of Directive 92/34/EEC, and sets out requirements as to labelling and sealing referred to in Article 11 of that Directive. 2. The schedule applies to the growing crop and propagating material (including rootstocks), and fruit plants derived therefrom, of all the genera and species referred to in Annex II to Directive 92/34/EEC, and to rootstocks of other genera and species referred to in point (iii) of Article 4(1) thereof, irrespective of the propagation system applied, those items being hereinafter referred to as ‘the material’. 3. The provisions of this Directive shall apply progressively, account being taken of the production cycles of the material referred to in paragraph 2. Article 2 The material shall, where applicable, comply with the relevant plant health conditions laid down in Council Directive 77/93/EEC (2). Article 3 1. Without prejudice to the provisions of Article 2, in the case of CAC material the material must, at least on visual inspection, be substantially free from any harmful organisms and diseases impairing quality, or any signs or symptoms thereof, which reduce the usefulness of the propagating material or fruit plants and in particular be free from those organisms and diseases listed in the Annex hereto in respect of the genus or species concerned. 2. Any material showing visible signs or symptoms of the harmful organisms or diseases referred to in paragraph 1 at the stage of the growing crop shall be properly treated immediately upon their appearance or, where appropriate, shall be removed. 3. In the case of citrus material the following requirements shall also be met: (i) it shall be derived from initial material which: — has been checked and found to show no symptoms of the relevant viruses, virus-like organisms or diseases listed in the Annex hereto, — has been tested individually using appropriate methods for the detection of such viruses, virus-like organisms or diseases and has been found to be free from them; (ii) it shall have been checked and found to be substantially free of such viruses, virus-like organisms or diseases since the beginning of the last cycle of vegetation; and (iii) in the case of grafting, it shall have been grafted onto rootstocks other than those susceptible to viroids. Article 4 1. CAC material shall have adequate identity and purity relative to the genus or species in question and also, without prejudice to the second sentence of Article 9 (1) of Directive 92/34/EEC, have identity and purity as to variety. 2. In the case of commonly known varieties referred to in point (i) of Article 9 (2) of Directive 92/34/EEC, the official denomination of the variety shall be used by the supplier. 3. In the case of varieties which are already the subject of an application for plants breeders' rights or an official registration referred to in point (i) of Article 9 (2) of Directive 92/34/EEC, the breeders' reference or proposed name must be used until the authorization is granted. 4. In the case of varieties entered on lists kept by suppliers pursuant to point (ii) of Article 9 (2) of Directive 92/34/EEC, the requirement referred to in paragraph 1 hereof in respect of variety shall be based on the detailed descriptions given in the lists kept by suppliers. Article 5 CAC material shall be substantially free from any defects likely to impair its quality as propagating material or as fruit plants. Article 6 In the case of pre-basic, basic and certified material, the requirements set out in Articles 3, 4 (1) and 5 hereof are applicable in so far as the certification schemes referred to in Article 7 hereof do not impose more stringent conditions. Article 7 Pending the establishment of a Community certification scheme, pre-basic, basic and certified material shall satisfy the conditions for each respective category as laid down in national schemes of certification provided that they comply, as far as possible, with existing international schemes of certification. Article 8 1. The supplier's document in respect of CAC material referred to in Article 11 (i) of Directive 92/34/EEC shall be of suitable material which has not previously been used and shall be printed in at least one of the official languages of the Community. It shall contain the following information headings: (i) indication ‘EEC quality’; (ii) indication of EEC Member State code; (iii) indication of responsible official body or its distinguishing code; (iv) registration or accreditation number; (v) name of supplier; (vi) individual serial, week or batch number; (vii) date of issue of the supplier's document; (viii) botanical name; (ix) denomination of the variety: in the case of rootstock, denomination of the variety or its designation; (x) quantity; (xi) category; (xii) in the case of imports from third countries pursuant to Article 16 (2) of Directive 92/34/EEC, the name of the country of harvesting. 2. Where material is accompanied by a plant passport in accordance with Commission Directive 92/105/EEC (3), the plant passport may, if the supplier so wishes, constitute the supplier's document referred to in paragraph 1. Nonetheless, the indication ‘EEC quality’ and an indication as to the responsible official body under Directive 92/34/EEC must be given, and also a reference to the denomination of the variety or rootstock and category. In the case of imports from third countries pursuant to Article 16 (2) of Directive 92/34/EEC, the name of the country of harvesting must also be given. This information may be on the same document as the plant passport but must be clearly separated. Article 9 1. The labelling and sealing requirements of the material qualified as pre-basic, basic or certified pursuant to point (ii) of Article 11 of Directive 92/34/EEC, are those laid down in the national schemes of certification referred to in Article 7 hereof. 2. Member States shall nonetheless ensure that where such an official label does not include all the information laid down in Article 8 (1) hereof, with the exception of headings (iv), (v) and (vii), that information shall be added. Furthermore, an indication as to whether the material is ‘virus-free’ or ‘virus-tested’ shall also be given. Article 10 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 11 This Directive is addressed to the Member States.

31993L0054

1993

Council Directive 93/54/EEC of 24 June 1993 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and 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 accordance with Article 28 of Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (4), it is necessary to review the list of diseases set out in Annex A to the said Directive; whereas this review must take into account both the Commission report on the experience gained and the opinion of the Scientific Veterinary Committee; Whereas, following the opinion of the Scientific Veterinary Committee, the list of diseases must be amended in order to take account of the latest epidemiological findings and of the experience gained; Whereas the situation with regard do diseases which are exotic to the Community needs to be reviewed and whereas current epidemiological data indicate that the susceptibility of certain species to certain diseases which are endemic to the Community and the classification of those diseases in lists II or III of Annex A to Directive 91/67/EEC must be reconsidered; Whereas it is necessary to clarify certain requirements laid down in Directive 91/67/EEC, in particular those concerning the procedure for the approval of zones and concerning the conditions governing the placing on the market of aquaculture animals not belonging to the susceptible species, Article 1 Directive 91/67/EEC is hereby amended as follows: 1. in Article 3 (a) paragraph 1 (c) shall be replaced by the following: '(c) they must not come from a farm which is subject to a prohibition for animal health reasons and must not have been in contact with animals from such a farm, and in particular from a farm which is subject to control measures in the context of Commission Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases (*); (*) OJ No L 175, 19. 7. 1993, p. 23.' (b) the following paragraph shall be added: '4. This Article shall apply without prejudice to the provisions of Directive 93/53/EEC with regard to the control of certain fish diseases, in particular the diseases in list I'; 2. in Article 5 (1), the introductory words shall be replaced by the following: '1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved zone, Member States shall submit to the Commission:'; 3. Article 5 (2) shall be replaced by the following: '2. The Commission shall scrutinize the information referred to in paragraph 1. The Commission shall use such information as a basis for approving zones in accordance with the procedure laid down in Article 26. If, in accordance with Annex B under I.D.5, II.D or III.D.5, the approval of a zone is withdrawn by the official service, the Commission shall revoke the decision concerning its approval. Re-approval of the zone concerned shall occur in accordance with the procedure laid down in Article 26.'; 4. in Article 6 (1), the introductory words shall be replaced by the following: '1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved farm situated in a non-approved zone, Member States shall submit to the Commission:'; 5. in Article 7 (1), the introductory words shall be replaced by the following: '1. The placing on the market of live fish belonging to the susceptible species referred to in Annex A, column 2, list II, their eggs or gametes, shall be subject to the following additional guarantees:'; 6. in Article 8 (1), the introductory words shall be replaced by the following: '1. The placing on the market of live molluscs referred to in Annex A, column 2, list II, shall be subject to the following additional guarantees:'; 7. in Article 9, the first sentence of point 1 shall be replaced by the following: '1. Fish susceptible to the diseases referred to in Annex A, column 1, list II, must be slaughtered and eviscerated prior to dispatch.'; 8. in Article 9, the first sentence of point 2 shall be replaced by the following: '2. Live molluscs susceptible to the diseases referred to in Annex A, column 1, list II, must be delivered either for direct human consumption or to the preserving industry; they shall not be relaid unless:'; 9. Article 14 shall be replaced by the following: 'Article 14 1. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III, established in accordance with Articles 12 and 13, the placing on the market of live farmed fish not belonging to the susceptible species referred to in Annex A, column 2, list II, as well as their eggs and gametes shall be subject to the following additional requirements: (a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status, from an approved farm in a non-approved zone or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. However, pending the outcome of the review provided for in Article 28, Member States may, under the procedure laid down in Article 26, request a derogation from the preceding subparagraph, in particular so as to prohibit the introduction into an approved zone of fish referred to in this paragraph originating in an approved farm situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. In order to ensure uniform compliance with that provision, appropriate conditions and measures shall be fixed under the same procedure. Pending those decisions, the relevant national rules shall continue to apply subject to compliance with the general provisions of the Treaty; (b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone, from a farm of the same health status or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters. 2. The requirements laid down in paragraph 1 shall apply to the placing on the market of farmed molluscs not belonging to the susceptible species referred to in Annex A, column 2, list II. 3. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III established in accordance with Articles 12 and 13, the placing on the market of wild fish, molluscs or crustaceans, their eggs or gametes, shall be subject to the following additional requirements: (a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status; (b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone; (c) where such animals are fished in the deep sea and are to be used for breeding in approved zones and approved farms, they must be placed in quarantine under the supervision of the official service in suitable facilities and under appropriate conditions to be determined in accordance with the procedure laid down in Article 26. 4. The requirements laid down in paragraphs 1, 2 and 3 shall not apply where practical experience and/or scientific evidence has shown that there is no passive transmission of the disease when acquacultre animals, their eggs and gametes, not belonging to the susceptible species referred to in Annex A, column 2, list II, are moved from a non-approved zone to an approved zone. In accordance with the procedure laid down in Article 26, the Commission shall establish the list of aquaculture animals to which the derogation referred to in the first subparagraph shall apply and, where necessary, shall amend that list in the light of scientific and technological developments. The special conditions for placing such animals on the market, including the model of the accompanying document required, shall be established and amended according to the same procedure. 5. This Article shall not apply to ornamental tropical fish kept permanently in aquariums.'; 10. the following paragraph shall be added to Article 19: '4. If by 1 January 1994 no decision has been taken with regard to the drawing up of the list referred to in paragraph 1, the requisite transitional measures may be adopted, in accordance with the procedure laid down in Article 26, for a period of three years.'; 11. the following paragraph shall be added to Article 20: '3. Pending establishment of the import conditions provided for in this Directive, Member States shall ensure that imports of aquaculture animals and products from third countries are subject to conditions at least equivalent to those applying to the production and placing on the market of Community products.'; 12. Article 24 shall be replaced by the following: 'Article 24 If an infectious or contagious disease of aquaculture animals, likely to endanger the health of livestock in a Member State breaks out or spreads in a third country or if any other animal health reason so justifies, the rules, procedures and measures laid down in Article 19 of Directive 90/675/EEC shall apply as regards aquaculture products and those laid down in Article 18 of Directive 91/496/EEC shall apply as regards aquaculture animals.'; 13. Annex A shall be replaced by the following: 'ANNEX A LIESTED DISEASES/PATHOGENS OF FISH, MOLLUSCS AND CRUSTACEA 1 2 Disease/pathogen Susceptible species LIST I Fish Infectious salmon aneamia (ISA) Atlantic salmon (Salmo salar) LIST II Fish Viral haemorrhagic septicaemia (VHS) Salmonid species, Grayling (Thymallus thymallus); Whitefish (Coregonus spp.); Pike (Esox lucius); Turbot (Scophthalmus maximus); Infectious haematopoietic necrosis (IHN) Salmonid species Pike fry (Esox lucius) Molluscs Bonamia ostreae Flat oyster (Ostrea edulis) Marteilla refringens Flat oyster (Ostrea edulis) 1 2 Disease/pathogen Susceptible species LIST III Fish Infectious pancreatic necrosis (IPN) Spring viraemia of carp (SVC) Bacterial kidney disease (BKD) (Renibacterium salmonidarum) Furunculosis (Aeromonas salmonicida) (Enteric redmouth disease) (ERM) (Yersinia ruckeri) Gyrodactylus salaris To be specified in the programme referred to in Articles 12 and 13'Crustaceans Crayfish plague (Aphanomyces astaci)' 14. References to 'list I' of Annex A shall be deleted from Annexes B, C and D. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994; they shall notify the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0052

1993

Council Directive 93/52/EEC of 24 June 1993 amending Directive 89/556/EEC on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof; Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas Article 1 of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (3) excluded embryos derived by certain techniques from the scope of the said Directive; whereas embryos which are to be subjected to techniques which involve the penetration of the zona pellucida may be traded or imported as long as they meet the requirements of the said Directive before recourse is had to these techniques, with certain additional safeguards; whereas embryos derived by in vitro fertilization may also be traded or imported, with appropriate safeguards; Whereas the additional safeguards require amendments to the Annexes, which, under Article 16 of Directive 89/556/EEC, come within the competence of the Commission; Whereas other amendments should be made to the Directive to clarify the status of semen used for fertilization of ova and to take account of the new foot-and-mouth disease policy in the Community, Article 1 Directive 89/556/EEC is hereby amended as follows: 1. Article 1 (2) shall be replaced by the following: '2. This Directive shall not apply to embryos derived by transfer of nuclei.'; 2. the following shall be added to Article 2: '(g) "embryo production team " means an officially approved embryo collection team for in vitro fertilization in accordance with the conditions laid down in the relevant Annex.'; 3. the first subparagraph of Article 3 (a) shall be replaced by the following: '(a) they must have been conceived as a result of artificial insemination or in vitro fertilization with semen from a donor sire standing at a semen collection centre approved by the competent authority for the collection, processing and storage of semen or by semen imported in accordance with Directive 88/407/EEC (*). (*) OJ No L 194, 22. 7. 1988, p. 10. Directive as last amended by Directive 90/425/EEC (OJ No L 224, 18. 8. 1990, p. 29).'; 4. Article 4 shall be deleted; 5. the following paragraph shall be inserted in Article 5: '2a. Approval of an embryo production team for embryos derived by in vitro fertilization shall be granted only where the provisions of the relevant Annex to this Directive are observed and where the embryo production team is able to satisfy the other relevant provisions of this Directive and in particular the provisions of paragraphs 1 and 2 of this Article, which shall apply mutatis mutandis.'; 6. Article 9 (3) shall be replaced by the following: '3. In laying down animal health provisions concerning foot-and-mouth disease in accordance with paragraph 1, it must be taken into account that: - only frozen embryos may be imported from third countries where vaccination against foot-and-mouth disease is practised. The embryos must be stored under approved conditions for a minimum of 30 days before consignment, - donor animals must come from a holding in which no animal has been vaccinated against foot-and-mouth disease during the 30 days prior to collection, and which is not subject to any prohibition or quarantine measures.'; 7. Articles 11, 12 and 13 shall be replaced by the following: 'Article 11 The principles and rules laid down by Directive 90/675/EEC (*) shall apply, in particular as regards the organization of the checks to be carried out by Member States and the follow-up to those checks as well as the safeguard measures to be implemented. (*) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Regulation (EEC) No 1601/92 (OJ No L 173, 27. 6. 1992, p. 13).' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such references shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0053

1993

Council Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases 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 fish are listed in Annex II to the Treaty; whereas the marketing of fish constitutes an important source of revenue for the aquaculture sector; Whereas it is necessary to establish at Community level the control measures to be taken in the event of outbreaks of disease, in order to ensure rational development of the aquaculture sector and to contribute to the protection of animal health in the Community; Whereas it is necessary, for diseases to be covered, to refer to the lists laid down in Annex A to Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (4); Whereas an outbreak of such diseases can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce severely the profitability of aquaculture; Whereas control measures must be taken as soon as the presence of such a disease is suspected so that immediate and effective action can be implemented as soon as its presence is confirmed; Whereas such measures must be aimed at preventing the spread of the disease, in particular by carefully controlling movements of fish and products liable to spread the infection; Whereas the prevention of diseases in the Community must normally be based on a non-vaccination policy; Whereas a thorough epizootiological investigation is essential to prevent any spread of the diseases; whereas the Member States must establish special units for that purpose; Whereas, in order to ensure an effective system of control, diagnosis of the diseases must be harmonized and carried out under the auspices of responsible laboratories, the coordination of which may be carried out by a reference laboratory designated by the Community; Whereas, in order to ensure uniform implementation of this Directive, a Community inspection procedure should be established; Whereas common measures for the control of the diseases form a minimum basis for maintaining a uniform standard of animal health; Whereas Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (5), and in particular Article 5 thereof, applies in the event of an outbreak of one of the diseases listed in Annex A to Directive 91/67/EEC; Whereas the Commission should be entrusted with the task of adopting the necessary implementing measures; whereas, for that purpose, a procedure should be established to bring about close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, CHAPTER I General provisions Article 1 This Directive defines the minimum Community measures for the control of the fish diseases referred to in Annex A, lists I and II, to Directive 91/67/EEC. Article 2 For the purposes of this Directive, the definitions laid down in Article 2 of Directive 91/67/EEC shall apply as necessary. In addition, the following definitions shall apply: 1. list I diseases: fish diseases referred to in Annex A, list I, to Directive 91/67/EEC; 2. list II diseases: fish diseases referred to in Annex A, list II, to Directive 91/67/EEC; 3. fish suspected of being infected: fish showing clinical signs or post-mortem lesions or dubious reactions in laboratory tests giving rise to reasonable suspicion of the presence of a list I or list II disease; 4. infected fish: fish in which the presence of a list I or list II disease has been officially confirmed as the result of a laboratory examination or, in the case of ISA, as the result of a clinical examination and a post-mortem examination; 5. farm suspected of being infected: farm containing fish suspected of being infected; 6. infected farm: farm containing infected fish; also farm which has been evacuated but not yet disinfected. Article 3 Member States shall ensure that all farms rearing or keeping fish susceptible to list I or list II diseases: 1. are registered by the official service; this registration must be kept constantly up to date; 2. keep a record of: (a) live fish, eggs and gametes entering the farm, containing all information relating to their delivery, their number or weight, their size, their source and their suppliers; (b) live fish, eggs and gametes leaving the farm, containing all information relating to their dispatch, their number or weight, their size and destination; (c) observed mortality. This record, which shall be open to scrutiny by the official service whenever the latter so requests, must be regularly updated and shall be kept for four years. Article 4 Member States shall ensure that it is compulsory for the suspected presence of any of the list I and list II diseases to be notified as soon as possible to the official service. CHAPTER II Control measures for list I diseases Article 5 1. When fish on a farm are suspected of being infected with a list I disease, Member States shall ensure that the official service immediately activates official investigation arrangements to confirm or rule out the presence of the disease, including clinical examination; in particular, it must take, or have taken, the samples necessary for laboratory examination. 2. As soon as the suspected presence of the disease is notified, the official service shall have the farm placed under official surveillance and shall in particular require that: (a) an official census be made of all species and categories of fish and that, in respect of each of these, the number of fish already dead, infected or suspected of being infected or contaminated be recorded; the census must be kept up to date by the owner or keeper to take account of the increase in the population or new mortality observed during the period of suspected infection; the information in the census must be produced on request and may be checked at each inspection; (b) no fish, whether alive or dead, or eggs or gametes enter or leave the farm without the authorization of the official service; (c) the disposal of dead fish or their offal be carried out under the supervision of the official service; (d) the entry or exit of feedingstuffs, utensils, objects or other substances such as waste, liable to transmit disease be subject, if necessary, to authorization by the official service, which shall lay down the conditions required to prevent the spread of the pathogen; (e) the movement of persons to or from the farm be made subject to authorization by the official service; (f) the entry or exit of vehicles to or from the farm be made subject to authorization by the official service, which shall lay down the conditions required to prevent the spread of the pathogen; (g) appropriate means of disinfection be used at the entrances end exits of the farm; (h) an epizootic investigation be carried out in accordance with Article 8 (1); (i) all of the farms situated in the same water catchment area or coastal area be placed under official surveillance, and no fish, eggs or gametes leave these farms without the authorization of the official service; in the case of extensive water catchment areas or coastal areas, the official service may decide to limit this measure to a less extensive area close to the farm suspected of being infected, if it considers that this area affords maximum guarantees for the prevention of the spread of the disease; if necessary, the official services of neighbouring Member States or third countries must be informed of the suspected case; in that event, the official services of the Member States involved shall take appropriate action to apply the measures laid down in this Article. Where necessary, specific measures may be taken in accordance with the procedure laid down in Article 19. 3. Until such time as the official measures laid down in paragraph 2 are enforced, the owner or keeper of any fish in which disease is suspected shall take every appropriate measure to ensure compliance with paragraph 2, except for (h) and (i) thereof. 4. The measures referred to in paragraph 2 shall not be withdrawn until the suspicion of disease has been officially ruled out. Article 6 As soon as the presence of a list I disease has been officially confirmed, Member States shall ensure that the official service orders that, in addition to the measures listed in Article 5 (2), of the following measures be applied: (a) in an infected farm: - all fish must be immediately withdrawn, - in the case of inland farms all pools must be drained for the purposes of cleaning and disinfection, - all eggs and gametes, dead fish and fish showing clinical signs of disease shall be regarded as high-risk material and must be destroyed under the supervision of the official service, in accordance with Directive 90/667/EEC (6), - all live fish shall either be killed and destroyed under the supervision of the official service in accordance with Directive 90/667/EEC, or else, in the case of fish which have reached commercial size and show no clinical sign of disease, be slaughtered under the supervision of the official service for marketing or processing for human consumption. In the latter case, the official service shall ensure that the fish are immediately slaughtered and gutted, that these operations are carried out in conditions such as to prevent the spread of pathogens, that the fish waste and offal are regarded as high-risk material and are submitted to a treatment to destroy pathogens in accordance with Directive 90/667/EEC and that the used water is submitted to a treatment which inactivates any pathogens it may contain; - after removal of the fish, eggs and gametes, ponds, equipment and any material liable to be contaminated must be cleaned and disinfected as soon as possible following the instructions established by the official service in such a way as to eliminate any risk of the agent of the disease spreading or surviving. The procedures for cleaning and disinfecting an infected farm shall be determined in accordance with the procedure laid down in Article 19, - any substances which might be contaminated, referred to in Article 5 (2) (d), must be destroyed or treated in such a way as to ensure the destruction of any pathogen present, - an epizootic investigation must be carried out in accordance with Article 8 (1) and the provisions of Article 8 (4) must be applied; this investigation must include the taking of samples for laboratory examination; (b) all farms situated in the water catchment area or in the coastal zone in which the infected farm is situated shall undergo health inspections; if these inspections reveal positive cases, the measures provided for under (a) of this paragraph shall be applied; (c) the repopulation of the farm shall be authorized by the official service following satisfactory inspection of the cleaning and disinfection operations and at the end of a period deemed adequate by the official service to ensure eradication of the pathogen, and of other possible infections in the same water catchment area; (d) it application of the measures laid down under (a), (b), (c) and (d) of Article 5 (2) requires the cooperation of the official services of other Member States, the official services of the Member States concerned shall collaborate to ensure compliance with the measures laid down in this Article. Where necessary, appropriate additional measures shall be adopted in accordance with the procedure laid down in Article 19. Article 7 Where fish from the wild and not belonging to any farm or fish in lakes, ponds or other installations intended for angling or holding ornamental fish are infected or suspected of being infected, Member States shall ensure that appropriate measures are taken. Member States shall inform the Commission and the other Member States, in the Standing Veterinary Committee, of the measures they have taken. Article 8 1. The epizootic investigation shall deal with: - the likely length of time during which the disease may have existed on the farm before being notified or suspected, - the possible origin of the disease on the farm and the identification of other farms on which there are eggs and gametes and fish of susceptible species which may have become infected; - the movement of fish, eggs or gametes, vehicles or substances and persons likely to have carried the agent of the disease to or from the farms in question, - the possible existence of carriers of the disease, and their distribution. 2. If the epizootic investigation reveals that the disease could have been introduced from another water catchment area or another coastal area, or could have been transferred to another water catchment area or another coastal area as a result of a contact arising from the movement of fish, eggs or gametes, animals, vehicles or persons, or in any other way, the farms belonging to such water catchment areas and coastal areas shall be considered suspect and the measures laid down in Article 5 shall apply. If the presence of the disease is confirmed, the measures laid down in Article 6 shall apply. 3. If the epizootic investigation reveals that the cooperation of the official services of other Member States is required, the official services of the Member States concerned shall take all necessary measures to ensure compliance with the provisions of this Directive. 4. A crisis unit shall be established in order to provide full coordination of all measures necessary to ensure eradication of the disease as quickly as possible and for the purpose of carrying out the epizootic investigation. The general rules concerning national crisis units and the Community crisis units shall be laid down by the Council, acting by a qualified majority on a proposal from the Commission. 5. The Council, acting by a qualified majority on a proposal from the Commission drawn up on the basis of the opinion of the Scientific Veterinary Committee to take account, in particular, of scientific and technological developments, shall review the provisions of this Article before 31 December 1996. CHAPTER III Control measures for list II diseases Article 9 1. Where a list II disease is suspected and/or confirmed in an approved zone or on an approved farm situated in a non-approved zone, an epizootic investigation shall be carried out in accordance with Article 8. Member States wishing to regain their status defined in accordance with Directive 91/67/EEC must comply with the provisions of Annexes B and C to that Directive. 2. If the epizootic investigation reveals that the disease could have been introduced from an approved zone or from another approved farm, or could have been transferred to another approved farm as a result of the movement of fish, eggs or gametes, vehicles or persons, or in any other way, those zones or farms shall be considered suspect and the appropriate measures shall apply. 3. The official service may, however, authorize the fattening of fish to be slaughtered until they reach commercial size. Article 10 1. Where a non-approved farm situated in a non-approved zone contains fish suspected of being infected with a list II disease, Member States shall ensure that the official service: (a) immediately sets in motion official means of investigation to confirm or rule out the presence of the disease including, where necessary, the taking of samples for examination in an approved laboratory; (b) carries out or causes to be carried out an official census of the infected farms, this census being regularly updated; (c) places, or causes to be placed, the infected farms under official supervision, in order to ensure that, by way of derogation from Article 3 (1) (c) of Directive 91/67/EEC, the only movements authorized from infected farms are live fish or eggs or gametes intended either for other farms infected by the same disease or for slaughter for human consumption. 2. Member States may, for a fixed period, set up under the supervision of the official service an optional or compulsory programme for the eradication of list II diseases in non-approved farms or in non-approved zones. During this period, the introduction into a zone or farm subject to such a programme of live fish, eggs or gametes from infected farms or farms of unknown health status shall be forbidden. These programmes, which will be set up on the basis of general criteria to be determined before the date specified in Article 20 in accordance with the procedure laid down in Article 19, will be submitted to the Commission for scrutiny, and approved and where necessary amended in accordance with that same procedure. After the period referred to in the first subparagraph, Member States which have recourse to this procedure shall inform the Commission and the other Member States, within the Standing Veterinary Committee, of the results obtained. 3. By 31 December 1996, the Commission shall submit to the Council a report, drawn up after obtaining the opinion of the Scientific Veterinary Committee, taking into account experience gained and scientific and technical developments and accompanied, where appropriate, by proposals for a review of the provision of this Article, in particular with regard to the placing on the market of infected live fish, and their eggs or gametes, intended for farming or fattening, and with regard to the carrying out of an epizootiological investigation in non-approved zones where a disease is suspected on a non-approved farm. The Council shall act by a qualified majority on any such proposals and the latter shall be put forward taking into account the conclusions of the report. 4. Any detailed rules for implementing paragraphs 1 and 2 shall be adopted by the Commission, as and when required, in accordance with the procedure laid down in Article 19. CHAPTER IV Final provisions Article 11 1. Sampling and laboratory testing for the presence of list I and list II diseases shall be carried out using the methods established in accordance with Article 15 of Directive 91/67/EEC. 2. Testing for the presence of disease or pathogens shall be carried out by a laboratory approved by the official service. Laboratory testing shall, if necessary and especially on the first appearance of the disease, identify the type, sub-type or the variant of the relevant pathogen, which must be confirmed by the national reference laboratory and may be confirmed, if necessary, by the Community reference laboratory referred to in Article 13. Article 12 1. Member States shall ensure that in each Member State a national reference laboratory is designated, with facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type, sub-type and variant of the relevant pathogen and to confirm results obtained by regional diagnostic laboratories. 2. The national laboratories designated for the diseases in question shall be responsible for coordinating diagnostic standards and methods, and for the use of reagents. 3. The national laboratories designated for the diseases in question shall be responsible for coordinating the diagnostic standards and methods laid down by each laboratory for diagnosis of the disease in question within the Member State. To this end, they: (a) may provide diagnostic reagents to laboratories approved by the Member State; (b) shall control the quality of all diagnostic reagents used in the Member State; (c) shall periodically arrange comparative tests; (d) shall hold isolates of the pathogen of the disease from cases confirmed in the Member State; (e) shall ensure confirmation of positive results obtained in diagnostic laboratories approved by the Member State. 4. However, by way of derogation from paragraph 1, Member States which do not have a national laboratory competent as regards the disease in question may use the services of a national laboratory with competence in the matter in another Member State. 5. The list of national reference laboratories for fish diseases is set out in Annex A. 6. The national laboratories designated for the diseases referred to shall cooperate with the Community reference laboratory referred to in Article 13. 7. The detailed rules for implementing this Article shall be adopted by the Commission under the procedure laid down in Article 19. Article 13 1. The Community reference laboratory for fish diseases is indicated in Annex B. 2. Without prejudice to Decision 90/424/EEC, and in particular Article 28 thereof, the functions and duties of the laboratory referred to in paragraph 1 of this Article shall be those laid down in Annex C. Article 14 1. Vaccination against list II diseases in approved zones or in approved farms situated in non-approved zones, in zones or farms which have already begun the approval procedures laid down by Directive 91/67/EEC, and against list I diseases, shall be forbidden. 2. The Council, acting by a qualified majority on a proposal from the Commission, shall by 30 June 1996, review the provisions of this Article, in particular with regard to laying down specific conditions for the use of vaccines and to take account of developments in scientific and technological research into vaccination. Article 15 1. Each Member State shall draw up a contingency plan specifying how it will implement the measures laid down in this Directive in the event of an outbreak of a list I disease. This plan must allow access to facilities, equipment, personnel and all other appropriate structures necessary for the rapid and efficient eradication of the outbreak. 2. The general criteria to be applied for drawing up those plans are set out in Annex D. Member States may, however, confine themselves to the application of the criteria specific to the diseases concerned, where the general criteria have already been adopted in the context of the submission of plans relating to the application of measures for the control of another disease. The Commission may, in accordance with the procedure laid down in Article 19, amend or supplement those criteria, taking into account the specific nature of the disease. 3. Plans drawn up in accordance with the criteria set out in Annex D shall be submitted to the Commission no later than six month after the date on which this Directive is brought into effect. 4. The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required, in particular to ensure that they are compatible with the plans of the other Member States. The Commission shall approve the plans, amended if necessary, in accordance with the procedure laid down in Article 19. The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation. Article 16 Commission experts may, in collaboration with the competent authorities, and in so far as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do that, they may check a representative percentage of holdings to see whether the competent authorities are checking that these holdings are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. The detailed rules for implementing this Article shall be determined in accordance with the procedure laid down in Article 19. Article 17 The conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC. Article 18 Annexes B, C and D shall be amended, as and when required, by the Council acting by a qualified majority on a proposal from the Commission, in particular in order to take into account developments in research and in diagnostic procedures. Annex A may be amended as and when required in accordance with the procedure laid down in Article 19. Article 19 1. Where the procedure laid down in this Article is to be followed, the Chairman shall, without delay, refer the matter to the Standing Veterinary Committee, either on his own initiative or at the request of the representative of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 20 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. However, from the date laid down in paragraph 1, Member States may, subject to the general rules of the Treaty, maintain or apply in their territory stricter provisions than those laid down by this Directive. They shall notify the Commission of any such measure. 3. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 21 This Directive is addressed to the Member States.

31993L0050

1993

Commission Directive 93/50/EEC of 24 June 1993 specifying certain plants not listed in Annex V, part A to Council Directive 77/93/EEC, the producers of which, or the warehouses, dispatching centres in the production zones of such plants, shall be listed in an official register Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or to plant products and against their spread within the Community (1), as last amended by Directive 93/19/EEC (2), and in particular Article 6 (5), and Article 6 (7), fifth indent, Whereas, with a view to the production of certain products not listed in Annex V, part A to the said Directive, such as potatoes other than seed potatoes, or fruits of Citrus L., Fortunella Swingle, Poncirus Raf. and their hybrids, which are not infested or infected by harmful organisms referred to in Directive 77/93/EEC, and to adequate monitoring by Member States of that production, it is necessary to list the producers of the abovementioned products or where it is more convenient, the collective warehouses or dispatching centres in the production zones of these products in an official local, regional or national register; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Member States shall ensure that producers, or collective warehouses, or dispatching centres in the production zones of the products listed in the Annex to this Directive shall be listed in an official local, regional or national register. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on the date referred to in Article 3 (1) of Council Directive 91/683/EEC (3). They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31993L0051

1993

Commission Directive 93/51/EEC of 24 June 1993 establishing rules for movements of certain plants, plant products or other objects through a protected zone, and for movements of such plants, plant products or other objects originating in and moving within such a protected zone Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Directive 93/19/EEC (2), and in particular Article 6 (7) first and second indent, Whereas the application of the Community plant health regime to the Community as an area without internal frontiers, includes the recognition of 'protected zones' established for certain plants, plant products or other objects in respect of one or more harmful organisms; Whereas, under the provisions of Directive 77/93/EEC, with effect from 1 June 1993, plants, plant products or other objects listed in Annex V, part A, section II may not be introduced into a specified protected zone or move therein, unless a plant passport valid for that zone and officially issued in accordance with the provisions of Article 10 (1) of the said Directive is attached to them, to their packaging or to the vehicles transporting them; whereas these provisions shall not apply if certain guarantees in respect of the movement of plants, plant products or other objects through a protected zone established for the said plants, plant products or other objects in respect of one or more harmful organisms, are fulfilled; and whereas these provisions may be satisfied by less stringent conditions than those laid down in Article 6 (4) of the said Directive in respect of such plants, plant products or other objects originating in and moving within such a protected zone; Whereas, in the absence of generally accepted guarantees, these should be laid down, taking account of the typical conditions under which the said movements are carried out, such that adequate plant health security is ensured; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 1. Member States shall ensure that the conditions laid down in paragraph 2 are met, when plants, plant products or other objects listed in Annex V, part A, section II of Directive 77/93/EEC, originating outside a protected zone established for the said plants, plant products or other objects in respect of one or more harmful organisms pursuant to Article 2 (1) (h) of Directive 77/93/EEC, are moved through such zone for final destination outside the zone, and without a plant passport valid for that zone. 2. The following conditions shall be met: (a) the packaging used or, where appropriate, the vehicles transporting the plants, plant products or other objects referred to in paragraph 1, shall be clean and free from the relevant organisms referred to in paragraph 1, and of such a nature as to ensure that there is no risk of harmful organisms spreading; (b) immediately after packaging, the packaging or, where appropriate, the vehicles transporting the said plants, plant products or other objects shall be secured according to stringent plant health standards to ensure that there is no risk of harmful organisms spreading in the relevant protected zone and that the identity will remain unchanged and to the satisfaction of the responsible official bodies referred to in Directive 77/93/EEC, and remain secured during transportation through the relevant protected zone; (c) the plants, plant products or other objects referred to in paragraph 1, shall be accompanied by a document which is normally used for trade purposes, indicating that the said products originate outside the relevant protected zone and have a destination outside the relevant protected zone. 3. If during an official check, organized pursuant to Article 11 (7) of Directive 77/93/EEC, and carried out at a place within the relevant zone, it is found that the requirements laid down under Article 1 (2) are not met, the following official measures shall be taken immediately, as appropriate, and without prejudice to the measures to be taken if the plants, plant products or other objects do not meet the conditions laid down by Directive 77/93/EEC: - sealing of the packaging, - transportation, under official control, of the plants, plant products or other objects to a destination outside the relevant protected zone. Article 2 1. Member States shall lay down that less stringent conditions shall apply to those plants, plant products or other objects listed in Annex V, part A, section II of Directive 77/93/EEC originating in and moving within a protected zone established for the said plants, plant products or other objects in respect of one or more harmful organisms. 2. For the purpose of paragraph 1 the following less stringent condition may apply: the official examinations referred to in Article 6 (4) of the said Directive may be satisfied by the conditions laid down in the detailed rules for surveys in Commission Directive 92/70/EEC of 30 July 1992 for the purposes of the recognition of protected zones in the Community (3). Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on the date referred to in Article 3 (1) of Council Directive 91/683/EEC (4). They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 4 This Directive is addressed to the Member States.

31993L0055

1993

Commission Directive 93/55/EEC of 25 June 1993 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 93/27/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for the content of the Annexes to be regularly adapted to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3); Whereas the use of the gelling agent and thickener 'cassia gum' has been tested in certain Member States; whereas, on the basis of experience gained, it appears that this new use can be authorized throughout the Community; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 Annex I to Directive 70/524/EEC is hereby amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 30 June 1994 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0059

1993

Council Directive 93/59/EEC of 28 June 1993 amending 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 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 within the context of the internal market; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the first programme of action of the European Communities on protection of the environment, approved on 22 November 1973(4) , 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, approved on 7 February 1983(5) , provides for additional efforts to be made to reduce substantially the present level of emissions of pollutants from motor vehicles; Whereas Directive 70/220/EEC(6) is one of the separate directives of the EEC type-approval procedure which has been established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(7) ; Whereas Directive 70/220/EEC lays down the limit values for carbon monoxide and unburnt hydrocarbon emissions from the engines of such vehicles; whereas these limit values were first reduced by Directive 74/290/EEC(8) and supplemented, in accordance with Directive 77/102/EEC(9) by limit values for permissible emissions of nitrogen oxides; whereas the limit values for these three types of pollution were successively reduced by Directives 78/665/EEC(10) , 83/351/EEC(11) and 88/76/EEC(12) , limit values for particulate pollutant emissions from diesel engines were introduced by Directive 88/436/EEC(13) and more stringent European standards for the emissions of gaseous pollutants of cars below 1 400 cm3 by Directive 89/458/EEC(14) ; whereas these standards have been extended to all cars independently of their engine capacity on the basis of an improved European test procedure including an extra-urban driving cycle and requirements relating to the evaporative emissions and to the durability of emission-related vehicle components as well as more stringent particulate pollutant standards for cars equipped with diesel engines which were introduced by Directive 91/441/EEC; Whereas the stringent European standards apply only to passenger cars designed to carry no more than six occupants and having a maximum mass of not more than 2 500 kg; whereas the transitional provisions relating to the other vehicle categories covered by Directive 70/220/EEC, in particular to light commercial vehicles, provide for less stringent standards; Whereas the environmental impact of the more stringent standards would be greatly increased and speeded up if the Member States were to grant tax incentives for the purchase of new vehicles which comply in advance with the standards set out in this Directive; Whereas it is generally agreed that future transport developments in the Community will be accompanied by an increase in pollution of the environment; whereas hitherto official forecasts of increases in traffic density have been exceeded by actual developments; whereas, therefore, very stringent exhaust emission standards must be laid down for all motor vehicles; Whereas a special R & D effort to reduce air pollution from motor vehicles may be a decisive factor in improving the competitiveness of the European motor industry; Whereas the Commission has the task of regularly evaluating the latest scientific progress enabling the permitted limit values for air pollution from motor vehicles to be lowered and allowing the appropriate reduction measures to be proposed after consultation with the Motor Vehicle Emissions Group; Whereas in the next stage to reduce limit values for light commercial vehicles, and subject to appropriate technical evaluation, vehicle categories II and III could be amalgamated and specific limit values applying to the control of production conformity should be deleted; Whereas the work undertaken by the Commission in this field has shown that Community industry has available, or is currently perfecting, technologies which allow thevehicles concerned by this Directive to comply with standards which are as severe as those for passenger cars taking into account the specific conditions of such vehicles; whereas the proposed standard should be implemented as soon as possible in order to ensure the consistency of the measures taken by the Community against air pollution by road traffic, Article 1 Annexes I, III, IV, V and IX to Directive 70/220/EEC are hereby amended in accordance with the Annex to this Directive. Article 2 1. As from 1 October 1993 no Member State may, on grounds relating to air pollution by their emissions: - 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, or to grant national type-approval for a type of motor vehicle, or - prohibit the initial entry into service of motor vehicles, if emissions from that type of motor vehicle or from such vehicles meet the provisions of Directive 70/220/EEC, as amended by this Directive. 2. From 1 October 1993 Member States: - may no longer grant EEC type-approval or issue the document provided for in the last indent of Article 10 (1) of Directive 70/156/EEC for a type of motor vehicle, - must 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 1 October 1994 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 only in respect of motor vehicles which comply with this Directive. Such incentives must comply with the provisions of the Treaty and, in addition, must meet the following conditions: - they must apply all new vehicles which are offered for sale on the market of a Member State and which meet, in advance, the requirements of this Directive, - they shall cease upon the dates 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 of allow it to submit comments. Article 4 The Council, acting under the conditions laid down in the Treaty, shall decide before 31 December 1994, on a proposal which the Commission will submit before 31 December 1993 on a further reduction in limit values. The reduced limit values shall not apply until 1 January 1996 for new type-approvals of vehicles of category I and not until 1 January 1997 for vehicles of categories II and III as specified in the table in item 5.3.1.4 of Annex I to Directive 70/220/EEC, as amended by this Directive; they may serve as a basis for tax incentives as from the adoption of the new Directive. The increased limit values for control of production (as specified in the table under item 7.1.1 of Annex I) shall cease to apply from the dates of application of the reduced limit values laid down in the second paragraph. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 September 1993. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 6 This Directive is addressed to the Member States.

31993L0057

1993

Council Directive 93/57/EEC of 29 June 1993 amending the Annexes to Directives 86/362/EEC and 86/363/EEC on the fixing of maximum levels for pesticide residues in and on cereals and foodstuffs of animal origin respectively Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 11 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 11 thereof, Having regard to the proposal from the Commission, Whereas it appears desirable to update the nomenclature in Annex I to each of Directives 86/362/EEC and 86/363/EEC to conform with Commission Regulation (EEC) No 2587/91 (3); Whereas it also appears desirable to enlarge the scope of Annex I to Directive 86/362/EEC to include husked rice and semi-milled or wholly milled rice in addition to paddy or rough rice, since a significant proportion of rice is put into circulation as such; Whereas, in the light of technical and scientific progress and the requirements of public health and agriculture, it is now desirable to supplement Annex II to Directive 86/363/EEC in respect of the provisions for the establishment of maximum levels for birds' eggs and egg yolks and to establish levels for the pesticides therein listed; whereas, for clarity, it appears desirable to present a consolidated version of the said Annex; Whereas it is also desirable, on the same grounds, to amend Directives 86/362/EEC and 86/363/EEC by adding provisions relating to further pesticide residues for cereals and foodstuffs of animal origin, namely acephate, benomyl, carbendazim, chlorpyrifos, chlorpyrifos-methyl, chlorthalonil, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, mancozeb, maneb, methamidophos, metiram, permethrin, procymidone, propineb, thiophanate-methyl, vinclozolin, zineb; Whereas, however, available data are insufficient for certain pesticide-cereal/foodstuffs of animal origin combinations as appropriate; whereas a period of time, not exceeding four years, will be necessary to generate such data; whereas, therefore, maximum levels should be established on the basis of such data by 1 January 1998 at the latest; whereas failure to provide satisfactory data would normally result in the establishment of levels at the appropriate limit of determination; Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where possible, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable; Whereas the maximum residue levels established in the current Directive will have to be reviewed in the framework of the re-evaluations of active substances provided for in the work programme established in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (4), Article 1 Directive 86/362/EEC is hereby amended as follows: 1. Annex I shall be replaced by the following: /* Tables: see OJ */ /* Tables: see OJ */ Article 2 Directive 86/363/EEC is hereby amended as follows: 1. Annex I shall be replaced by the following: /* Tables: see OJ */ Part A, and shall be amended and re-presented as follows: /* Tables: see OJ */ 'PART B Pesticide residues Maximum levels in mg/kg (ppm) of meat, including fat, preparations of meat, offals and animal fats listed in Annex I under heading Nos ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602 for milk and milk products listed in Annex I under heading Nos 0401, 0402, 0405 00 and 0406 of shelled fresh eggs, for birds' eggs and egg yolks listed in Annex I under heading Nos 0407 00 and 0408 1. ACEPHATE 0,02* 0,02* 0,02* 2. BENOMYL 3. CARBENDAZIM 4. THIOPHONATE METHYL sum expressed as carbendazim 0,1* 0,1* 0,1* 5. CHLOROTHALONIL 0,01* 0,01* 0,01* 6. GLYPHOSATE 0,5 ex 0206 pig kidney 2 ex 0206 cattle, goat and sheep kidney 0,1* other products 0,1* 0,1* 7. IMAZALIL 0,02* 0,02* 0,02* 8. MANCOZEB 9. MANEB 10. METIRAM 11. PROPINEB 12. ZINEB sum expressed as CS2 0,05* 0,05* 0,05* 13. METHAMIDOPHOS 0,01* 0,01* 0,01* 14. IPRODIONE 15. PROCYMIDONE 16. VINCLOZOLIN (sum of compounds and all metabolites containing the 3,5-dichloroaniline moiety expressed as 3,5 dichloroaniline) 0,05* 0,05* 0,05* * Indicates lower limit of analytical determination.' Article 3 Member States shall bring into force, not later than 31 December 1993, the laws, regulations or administrative provisions necessary to comply with this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 This Directive is addressed to the Member States.

31993L0058

1993

Council Directive 93/58/EEC of 29 June 1993 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables and the Annex to Directive 90/642/EEC relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a first list of maximum levels Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 1 thereof, Having regard to the proposal from the Commission, Whereas the pesticides chlorbenzide and 1,1-dichloro-2,2-bis (4-ethyl-phenyl) ethane are no longer of economic importance; whereas their residues are unlikely to occur in foodstuffs; whereas it is therefore appropriate to delete them from Annex II to Directive 76/895/EEC; Whereas in order to establish mandatory maximum levels of pesticide residues at Community level it is necessary to transfer provisions from Directive 76/895/EEC to Directive 90/642/EEC relating to the pesticides amitrole, atrazine, binapacryl, bromophos-ethyl, captafol, DDT, dichlorprop, dinoseb, dioxathion, endrin, ethylene dibromide, fenchlorphos, heptachlor, maleic hydrazide, methyl bromide (except for certain products), paraquat, TEPP, 2,4,5-T and toxaphene; whereas certain of those provisions should be amended in the light of technical and scientific progress; Whereas it is necessary to amend the Annex to Directive 90/642/EEC, in order that sunflower seed and olives may be more appropriately described considering current trade practices, thereby facilitating control of pesticide residues therein; Whereas pesticide residues may arise in products of plant origin, including fruit and vegetables, as a result of current or previous agricultural practices; whereas, to establish maximum levels for present practices, it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials; whereas, however, available data are frequently insufficient in terms of current standards to establish maximum levels, whereas in the case of previous agricultural practices, appropriate monitoring data must be evaluated; Whereas satisfactory monitoring data exist in order to establish maximum pesticide residue levels in tea for aldrin, dieldrin, chlordane, DDT, endrin, heptachlor, HCH and HCB; Whereas, in the case of certain pesticides used in the production of tea, insufficient data exist under current standards to establish maximum residue levels; whereas Member States may therefore fix, whilst respecting Community law, maximum levels in order to allow sufficient time for the generation of the necessary data for a Community decision to be taken; whereas, in the case of the pesticides ethion, omethoate and dimethoate used in the production of tea, sufficient data only exist to establish on a temporary basis maximum residue levels; Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where possible, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable; Whereas it is now appropriate that maximum levels be fixed for certain pesticides in products of plant origin, namely acephate, benomyl, carbendazim, thiophanate-methyl, maneb, mancozeb, metiram, propineb, zineb, methamidophos, procymidone, chlorothalonil, chlorpyrifos, chlorpyrifos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin and vinclozolin; Whereas, however, available data are insufficient for certain pesticide-crop combinations; whereas a period of time, not exceeding four years, will be necessary to generate such data; whereas, therefore, maximum levels should be established on the basis of such data by 1 January 1998 at the latest; whereas failure to provide satisfactory data would normally result in the establishment of levels at the appropriate limit of determination; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme established in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), Article 1 Annex II to Directive 76/895/EEC is hereby amended as follows: 1. the entries relating to the following pesticide residues shall be deleted: amitrole atrazine binapacryl bromophos-ethyl captafol chlorbenside DDT (sum of DDT-, TDE- and DDE-isomers, expressed as DDT) dichlorprop 1,1-dichloro-2,2-bis (4-ethyl-phenyl-) ethane dinoseb dioxathion endrin ethylene dibromide fenchlorphos heptachlor maleic hydrazide paraquat TEPP toxaphene 2,4,5-T 2. for methyl bromide the entry in the third column entitled 'Maximum levels' shall read as follows: '0,1: Nuts, apricots, peaches, plums, figs and grapes'. Article 2 Directive 90/642/EEC is hereby amended as follows: 1. the former Annex becomes Annex I; 2. that part of the Annex relating to miscellaneous fruit and oil seeds shall be amended as follows: /* Tables: see OJ */ 4. the following Annex shall be added: 'ANNEX II Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Acephate Chlorothalonil Chlorpyrifos Chlorpyrifosmethyl Cypermethrin, including other mixtures of constituent isomers (sum of isomers) Deltamethrin Fenvalerate, including other mixtures of constituent isomers (sum of isomers) Glyphosate Imazalil Iprodione Permethrin (sum of isomers) 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts I) CITRUS FRUIT 1 0,01* 0,3 2 0,05* (c) 0,1* 5 0,5 Grapefruit (a) Lemons (c) Limes Mandarines (including clementines and similar hybrids) (c) Oranges (c) Pomelos Others 0,05* 0,02* II) TREE NUTS (shelled or unshelled) 0,02* 0,01* 0,05* 0,05* 0,05* 0,05* 0,05* 0,1* 0,02* 0,1 Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts (a) Macadamia Pecans Pine nuts Pistachios Walnuts Others 0,02* 0,05* III) POME FRUIT (a) (b) 0,5 0,5 1 0,1 1 0,1* 5 10 1 Apples Pears Quinces Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Acephate Chlorothalonil Chlorpyrifos Chlorpyrifosmethyl Cypermethrin, including other mixtures of constituent isomers (sum of isomers) Deltamethrin Fenvalerate, including other mixtures of constituent isomers (sum of isomers) Glyphosate Imazalil Iprodione Permethrin (sum of isomers) IV) STONE FRUIT 0,1 0,1* 0,02* 5 1 Apricots 0,02* (b) 2 (c) Cherries 0,02* (b) (c) 1 Peaches (including nectarines and similar hybrids) (a) (b) (c) (c) 2 (c) Plums (a) 0,2 1 Others 0,02* 0,01* 0,05* 0,05* 0,05* 0,05* V) BERRIES AND SMALL FRUIT Table and wine grapes 0,02* 0,5 0,2 0,5 0,1 1 0,1* 0,02* 10 1 Table grapes 1 Wine grapes (b) Strawberries (other than wild) 0,02* (b) 0,2 0,5* (c) 0,05* 0,05* 0,1* (a) 10 (c) Cane fruit (other than wild) 0,02* (b) (c) 0,05* 0,5 (c) 0,05* 0,1* 0,02* 5 (c) Blackberries Loganberries Raspberries Others Other small fruit and berries (other than wild) 0,02* 0,05* 0,05* 0,1* 0,02* Bilberries (c) 10 Cranberries 2 (c) Currants (red, black and white) (b) (c) (c) 0,2 10 (c) Gooseberries (b) (c) (c) 0,2 10 (c) Others 0,01* 0,05* 0,05* 0,05* 0,02* 0,05* Wild berries and wild fruit 0,02* 0,01* 0,05* 0,05* 2 0,05* 0,05* 0,1* 0,02* 0,02* 0,05* VI) MISCELLANEOUS FRUIT 0,02* 0,01* 0,05* 0,05* 0,05* Avocados Bananas (c) 2 (a) Dates * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Acephate Chlorothalonil Chlorpyrifos Chlorpyrifosmethyl Cypermethrin, including other mixtures of constituent isomers (sum of isomers) Deltamethrin Fenvalerate, including other mixtures of constituent isomers (sum of isomers) Glyphosate Imazalil Iprodione Permethrin (sum of isomers) Figs (c) Kiwi 2 (c) 5 1 Kumquats Litchis Mangoes Olives (c) 0,1* (d) (c) Passion fruit Pineapples Pomegranates Others 0,05* 0,05* 0,1* 0,02* 0,02* 0,05* 2. Vegetables, fresh or uncooked, frozen or dry I) ROOT AND TUBER VEGETABLES 0,02* 0,05* 0,05* 0,05* 0,1* 0,02* Beetroot (c) Carrots (b) 0,1 (a) Celeriac (b) (a) 0,1 Horseradish Jerusalem artichokes Parsnips (c) Parsley root Radishes (c) (a) 0,1 Salsify Sweet potatoes Swedes (c) (c) Turnips (c) (c) (c) Yams Others 0,01* 0,05* 0,05* 0,02* 0,05* II) BULB VEGETABLES 0,02* 0,05* 0,05* 0,1* 0,02* Garlic 0,5 0,1 0,1 5 Onions 0,5 (c) 0,1 0,1 5 (c) Shallots 0,5 0,1 0,1 5 (c) Springonions (b) (c) (a) (c) Others 0,01* 0,05 0,05* 0,05* 0,02* 0,05* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Acephate Chlorothalonil Chlorpyrifos Chlorpyrifosmethyl Cypermethrin, including other mixtures of constituent isomers (sum of isomers) Deltamethrin Fenvalerate, including other mixtures of constituent isomers (sum of isomers) Glyphosate Imazalil Iprodione Permethrin (sum of isomers) III) FRUITING VEGETABLES Solanacea 2 0,5 0,5 0,5 0,2 0,1* 5 0,5 Tomatoes 0,5 1 Peppers (a) 0,2 (a) Aubergines (a) Others 0,02* 0,05* 0,02* Cucurbits - edible peel 0,05* 0,05* 0,2 0,1 0,1* 0,2 2 0,1 Cucumbers (a) 1 0,2 Gherkins Courgettes Others 0,02* (b) 0,05* Cucurbits - inedible peel 0,02* (b) 0,05* 0,05* (c) 0,05* 0,1* 0,1 Melons 0,2 (a) (a) Squashes 0,5 Watermelons 0,5 Others 0,05* 0,02* 0,02* Sweet corn 0,02* 0,01* (c) 0,05* 0,05* (c) 0,05* 0,1* 0,02* 0,02* 0,1 IV) BRASSICA VEGETABLES Flowering brassica (a) (b) (c) 0,05* 0,5 0,1 1 0,1* 0,02* (a) Broccoli (c) Cauliflower 0,1 Others 0,05* Head brassica 2 (c) 0,05* 0,5 0,1 (c) 0,1* 0,02* (c) Brussels sprouts 0,5 (a) Head cabbage (b) 5 Others 0,01* 0,02* Leafy brassica (a) (b) (c) 0,05* 0,5 0,1* 0,02* (a) 1 Chinese cabbage 1 Kale (c) Others 0,05* Kohlrabi 0,02* 0,01* 0,05* 0,05* 0,2 0,05* (c) 0,1* 0,02* 0,1 0,05* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Acephate Chlorothalonil Chlorpyrifos Chlorpyrifosmethyl Cypermethrin, including other mixtures of constituent isomers (sum of isomers) Deltamethrin Fenvalerate, including other mixtures of constituent isomers (sum of isomers) Glyphosate Imazalil Iprodione Permethrin (sum of isomers) V) LEAF VEGETABLES AND FRESH HERBS Lettuce and similar 0,05* 2 0,5 0,05* 0,1* 0,02* 10 2 Cress Lamb's lettuce (c) Lettuce 1 (b) (c) Scarole (c) Others 0,02* 0,01* 0,05* Spinach and similar 0,02* 0,01* 0,05* 0,05* 0,5 0,5 0,05* 0,1* 0,02* 0,02* 1 Beet leaves (chord) Water cress 0,02* 0,01* 0,05* 0,05* 0,05* 0,05* 0,05* 0,1* 0,02* 0,02* 0,05* Witloof 0,02* 0,01* 0,05* 0,05* (c) (c) 0,05* 0,1* 0,02* 1 0,05* Herbs 0,02* (b) (c) 0,05* 2 0,5 0,05* 0,1* 0,02* 10 2 Chervil Chives Parsley Celery leaves Others VI) LEGUME VEGETABLES (fresh) (a) (c) 0,05* (c) 0,1* 0,02* (a) Beans (with pods) (b) 0,5 0,2 0,5 Beans (without pods) (b) (c) (c) 0,05* Peas (with pods) 2 (c) 0,1 0,1 Peas (without pods) (b) (c) 0,05* Others 0,01* 0,05* 0,05* 0,05* VII) STEM VEGETABLES (c) 0,05* 0,1* 0,02* Asparagus Cardoons Celery (b) (c) (a) 2 Fennel (c) (a) (c) Globe artichokes (a) (c) (c) (c) Leek (a) (b) 0,5 0,5 Rhubarb 2 Others 0,02* 0,01* 0,05* 0,05* 0,05* 0,02* 0,05* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Acephate Chlorothalonil Chlorpyrifos Chlorpyrifosmethyl Cypermethrin, including other mixtures of constituent isomers (sum of isomers) Deltamethrin Fenvalerate, including other mixtures of constituent isomers (sum of isomers) Glyphosate Imazalil Iprodione Permethrin (sum of isomers) VIII) FUNGI 0,02* 0,05* 0,05* 0,05* 0,05* 0,02* 0,02* 0,05* Cultivated mushrooms (b) 0,05* 0,1* Wild mushrooms 0,01* 1 50 3. Pulses 0,01* 0,05* 0,05* 1 (c) 0,02* 0,2 0,05* Beans (a) 0,05* (d) Lentils 0,02* (c) 0,1* Peas (a) (c) (d) Others 0,02* 0,05* 0,1* 4. Oil seeds 0,02* 0,01* 0,05* 0,1 0,02* Linseed 0,2 10 (a) Peanuts 0,1 Poppy seed 0,2 Sesame seed 0,2 Sunflower seed 0,2 (c) Rape seed (c) 0,2 0,1 10 0,5 0,1 Soya bean Mustard (d) (a) 0,1 Cotton seed 0,2 0,2 Others 0,05* 0,05* 0,05* 0,1* 0,02* 0,05* 5. Potatoes 0,02* 0,01* 0,05* 0,05* 0,05* 0,05* 0,1* 0,02* 0,05* Early potatoes 0,05* 0,02* Ware potatoes (c) 5 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,1* 0,1* 0,1* 0,1* (d) 5 (d) 0,1* 0,1* 0,1* (d) 7. Hops (dried), including hop pellets and unconcentrated powder (d) (d) (d) 0,1* 30 5 5 0,1* 0,1* 0,1* (d) * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Benomyl Carbendazim Thiophanate-Methyl (sum expressed as carbendazim) Maneb Mancozeb Metiram Probineb, Zineb (sum expressed as CS2) Methamidophos Procymidone Vinclozolin (sum of vinclozolins and all metabolites containing the 3,5 dicloroaniline moiety, expressed as vinclozolin) 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts (I) CITRUS FRUIT 5 0,2 0,02* 0,05* Grapefruit Lemons Limes Mandarines (including clementines and similar hybrids) Oranges 2 Pomelos Others (c) (II) TREE NUTS (shelled or unshelled) 0,1* 0,1* 0,01* 0,05* 0,05* Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (III) POME FRUIT 2 (c) (b) 1 Apples (a) Pears (a) Quinces Others 0,02* (IV) STONE FRUIT (b) (a) Apricots (d) 2 2 Cherries (d) 1 0,5 Peaches (including nectarines and similar hybrids) (d) 2 2 Plums (d) 1 (c) Others 0,1* 0,05* 0,05* (V) BERRIES AND SMALL FRUIT Table and wine grapes (d) 2 (b) 5 5 Table grapes Wine grapes Strawberries (other than wild) 2 (b) 5 5 Cane fruit (other than wild) (d) (c) 0,01* 5 Blackberries Dewberries Loganberries Raspberries 10 Others 0,02* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Benomyl Carbendazim Thiophanate-Methyl (sum expressed as carbendazim) Maneb Mancozeb Metiram Probineb, Zineb (sum expressed as CS2) Methamidophos Procymidone Vinclozolin (sum of vinclozolins and all metabolites containing the 3,5 dicloroaniline moiety, expressed as vinclozolin) Other small fruit and berries (other than wild) 0,01* 0,02* Bilberries (fruit of species vaccinium myrtyllus) Cranberries Currants (red, black and white) (d) (c) (c) Gooseberries (d) (c) Others 0,1* 0,05* 0,05* Wild berries and wild fruit 0,1* 0,05* 0,01* 0,02* 0,05* (VI) MISCELLANEOUS FRUIT Avocados 0,05* 0,01* 0,05* (except kiwi) Bananas 1 Dates Figs Kiwi 5 Kumquats Litchis Mangoes Olives (table consumption) (d) Olives (oil extraction) (d) Passion fruit Pineapples Pomegranates Others 0,1* 0,02* 2. Vegetables, fresh or uncooked, frozen or dry (I) ROOT AND TUBER VEGETABLES 0,01* 0,02* Beetroot (c) Carrots (d) (c) (c) Celeriac (d) 0,2 Horseradish (c) Jerusalem artichokes Parsnips (c) Parsley root Radishes (c) (c) Salsify (d) (c) Sweet potatoes Swedes (d) (c) Turnips (d) Yams Others 0,1* 0,05* 0,05* (II) BULB VEGETABLES 0,01* 1 Garlic 0,5 0,2 Onions (d) 0,5 0,2 Shallots 0,5 0,2 Spring onions (c) (a) Others 0,1* 0,05* 0,02* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Benomyl Carbendazim Thiophanate-Methyl (sum expressed as carbendazim) Maneb Mancozeb Metiram Probineb, Zineb (sum expressed as CS2) Methamidophos Procymidone Vinclozolin (sum of vinclozolins and all metabolites containing the 3,5 dicloroaniline moiety, expressed as vinclozolin) (III) FRUITING VEGETABLES Solanacea 2 3 Tomatoes (d) (c) 0,5 Peppers (d) (b) Aubergines 0,5 0,2 Others 0,1* 2 0,01* Cucurbits - edible peel 1 1 Cucumbers (d) 0,5 1 Gherkins (d) (c) Courgettes (c) Others 0,1* 0,05* 0,01* Cucurbits - inedible peel (c) 0,01* 1 1 Melons 0,5 Squashes 0,5 Watermelons Others 0,1* Sweet corn 0,1* 0,05* 0,01* 0,02* 0,05* (IV) BRASSICA VEGETABLES Flowering brassica (d) (c) (b) 0,02* 0,05* Broccoli Cauliflower Others Head brassica (c) 0,5 0,02* 0,05* Brussels sprouts (d) Head cabbage Others Leafy brassica 0,1* (c) (b) 0,02* Chinese cabbage 2 Kale Others 0,05* Kohlrabi 0,1* (c) 0,01* 0,02* 0,05* (V) LEAF VEGETABLES AND FRESH HERBS Lettuce and similar (d) 5 5 5 Cress Lamb's lettuce Lettuce 0,2 Scarole Others 0,01* Spinach and similar 0,1* 0,05* 0,01* 0,02* 0,05* Beet leaves (chord) Water cress (d) (c) 0,01* 0,02* 0,05* Witloof (d) 0,2 0,01* (a) 2 Herbs 0,1* 5 0,01* 0,02* 0,05* Chervil Chives Parsley Celery leaves Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Benomyl Carbendazim Thiophanate-Methyl (sum expressed as carbendazim) Maneb Mancozeb Metiram Probineb, Zineb (sum expressed as CS2) Methamidophos Procymidone Vinclozolin (sum of vinclozolins and all metabolites containing the 3,5 dicloroaniline moiety, expressed as vinclozolin) (VI) LEGUME VEGETABLES (fresh) (d) (c) (b) Beans (with pods) 2 2 Beans (without pods) (a) (c) Peas (with pods) (a) 2 Peas (without pods) (a) (c) Others 0,2* 0,05* (VII) STEM VEGETABLES 0,02* Asparagus Cardoons Celery (d) (c) (c) Fennel Globe artichokes (c) (b) Leek (c) (b) Rhubarb Others 0,1* 0,05* 0,01* 0,05* (VIII) FUNGI 0,05* 0,01* 0,02* 0,05* Cultivated mushrooms 1 Wild mushrooms 0,1* 3. Pulses (c) (a) (c) Beans (d) (b) Lentils 0,1* 0,01* Peas (d) (b) Others 0,1* 0,01* 4. Oil seeds Linseed Peanuts Poppy seed Sesame seed Sunflower seed (with shell) 1 Sunflower seed (without shell) Rape seed (c) 1 1 Soya bean 0,2 1 Mustard Cotton seed 0,1 Others 0,1* 0,1* 0,01* 0,05* 0,05* 5. Potatoes (d) 0,05* 0,01* 0,02* 0,05* Early potatoes Ware potatoes 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,1* 0,1* 0,1* 0,1* 0,1* 7. Hops (dried), including hop pellets and unconcentrated powder (d) 25 2 0,1* 40 * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) DDT (sum of p,p& prime;-DDT, o,p& prime;-DDT, p,p& prime;-DDE and p,p& prime;-TDE (DDD) expressed as DDT) 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts (I) CITRUS FRUIT 0,05* Grapefruit Lemons Limes Mandarines (including clementines and similar hybrids) Oranges Pomelos Others (II) TREE NUTS (shelled or unshelled) 0,05* Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (III) POME FRUIT 0,05* Apples Pears Quinces Others (IV) STONE FRUIT 0,05* Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (V) BERRIES AND SMALL FRUIT 0,05* Table and wine grapes Table grapes Wine grapes Strawberries (other than wild) Cane fruit (other than wild) Blackberries Dewberries Loganberries Raspberries Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) DDT (sum of p,p& prime;-DDT, o,p& prime;-DDT, p,p& prime;-DDE and p,p& prime;-TDE (DDD) expressed as DDT) Other small fruit and berries (other than wild) Bilberries (fruit of species vaccinium myrtyllus) Cranberries Currants (red, black and white) Gooseberries Others Wild berries and wild fruit (VI) MISCELLANEOUS FRUIT 0,05* Avocados Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives (table consumption) Olives (oil extraction) Passion fruit Pineapples Pomegranates Others 2. Vegetables, fresh or uncooked, frozen or dry (I) ROOT AND TUBER VEGETABLES 0,05* Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yams Others (II) BULB VEGETABLES 0,05* Garlic Onions Shallots Spring onions Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) DDT (sum of p,p& prime;-DDT, o,p& prime;-DDT, p,p& prime;-DDE and p,p& prime;-TDE (DDD) expressed as DDT) (III) FRUITING VEGETABLES 0,05* Solanacea Tomatoes Peppers Aubergines Others Cucurbits - edible peel Cucumbers Gherkins Courgettes Others Cucurbits - inedible peel Melons Squashes Watermelons Others Sweet corn(IV) BRASSICA VEGETABLES 0,05* Flowering brassica Broccoli Cauliflower Others Head brassica Brussels sprouts Head cabbage Others Leafy brassica Chinese cabbage Kale Others Kohlrabi (V) LEAF VEGETABLES AND FRESH HERBS 0,05* Lettuce and similar Cress Lamb's lettuce Lettuce Scarole Others Spinach and similar Beet leaves (chord) Water cress Witloof Herbs Chervil Chives Parsley Celery leaves Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) DDT (sum of p,p& prime;-DDT, o,p& prime;-DDT, p,p& prime;-DDE and p,p& prime;-TDE (DDD) expressed as DDT) (VI) LEGUME VEGETABLES (fresh) 0,05* Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (VII) STEM VEGETABLES 0,05* Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (VIII) FUNGI 0,05* Cultivated mushrooms Wild mushrooms 3. Pulses 0,05* Beans Lentils Peas Others 4. Oil seeds 0,05* Linseed Peanuts Poppy seed Sesame seed Sunflower seed (with shell) Sunflower seed (without shell) Rape seed Soya bean Mustard Cotton seed Others 5. Potatoes 0,05* Early potatoes Ware potatoes 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,2* 7. Hops (dried), including hop pellets and unconcentrated powder 0,05* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Aminotriazole (Amitrole) Atrazine Binapacryl Bromophos-ethyl Captafol Dichlorprop (including dichlorprop P) 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts (I) CITRUS FRUIT 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Grapefruit Lemons Limes Mandarines (including clementines and similar hybrids) Oranges Pomelos Others (II) TREE NUTS (shelled or unshelled) 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (III) POME FRUIT 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Apples Pears Quinces Others (IV) STONE FRUIT 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (V) BERRIES AND SMALL FRUIT 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Table and wine grapes Table grapes Wine grapes Strawberries (other than wild) Cane fruit Blackberries Dewberries Loganberries Raspberries Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Aminotriazole (Amitrole) Atrazine Binapacryl Bromophos-ethyl Captafol Dichlorprop (including dichlorprop P) Other small fruit and berries (other than wild) Bilberries (fruit of species vaccinium myrtyllus) Cranberries Currants (red, black and white) Gooseberries Others Wild berries and wild fruit (VI) MISCELLANEOUS FRUIT 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Avocados Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Pomegranates Others 2. Vegetables, fresh or uncooked, frozen or dry (I) ROOT AND TUBER VEGETABLES 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yams Others (II) BULB VEGETABLES 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Garlic Onions Shallots Spring onions Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Aminotriazole (Amitrole) Atrazine Binapacryl Bromophos-ethyl Captafol Dichlorprop (including dichlorprop P) (III) FRUITING VEGETABLES 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Solanacea Tomatoes Peppers Aubergines Others Cucurbits - edible peel Cucumbers Gherkins Courgettes Others Cucurbits - inedible peel Melons Squashes Watermelons Others Sweet corn(IV) BRASSICA VEGETABLES 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Flowering brassica Broccoli Cauliflower Others Head brassica Brussels sprouts Head cabbage Others Leafy brassica Chinese cabbage Kale Others Kohlrabi (V) LEAF VEGETABLES AND FRESH HERBS 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Lettuce and similar Cress Lamb's lettuce Lettuce Scarole Others Spinach and similar Beet leaves (chord) Water cress Witloof Herbs Chervil Chives Parsley Celery leaves Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Aminotriazole (Amitrole) Atrazine Binapacryl Bromophos-ethyl Captafol Dichlorprop (including dichlorprop P) (VI) LEGUME VEGETABLES (fresh) 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (VII) STEM VEGETABLES 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (VIII) FUNGI 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Cultivated mushrooms Wild mushrooms 3. Pulses 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Beans Lentils Peas Others 4. Oil seeds 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed Soya bean Mustard Cotton seed Others 5. Potatoes 0,05* 0,1* 0,05* 0,05* 0,02* 0,05* Early potatoes Ware potatoes 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,1* 0,1* 0,1* 0,1* 0,1* 0,1* 7. Hops (dried), including hop pellets and unconcentrated powder 0,1* 0,1* 0,1* 0,1* 0,1* 0,1* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Dinoseb Dioxathion Endrin 1,2-dibromo ethane (ethylene dibromide) Fenchlorphos (sum of fenchlorphos and fenchlorphos oxon expressed as fenchlorphos) 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts (I) CITRUS FRUIT 0,05* 0,05* 0,01* 0,01* 0,01* Grapefruit Lemons Limes Mandarines (including clementines and similar hybrids) Oranges Pomelos Others (II) TREE NUTS (shelled or unshelled) 0,05* 0,05* 0,01* 0,01* 0,01* Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (III) POME FRUIT 0,05* 0,05* 0,01* 0,01* 0,01* Apples Pears Quinces Others (IV) STONE FRUIT 0,05* 0,05* 0,01* 0,01* 0,01* Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (V) BERRIES AND SMALL FRUIT 0,05* 0,05* 0,01* 0,01* 0,01* Table and wine grapes Table grapes Wine grapes Strawberries (other than wild) Cane fruit Blackberries Dewberries Loganberries Raspberries Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Dinoseb Dioxathion Endrin 1,2-dibromo ethane (ethylene dibromide) Fenchlorphos (sum of fenchlorphos and fenchlorphos oxon expressed as fenchlorphos) Other small fruit and berries (other than wild) Bilberries (fruit of species vaccinium myrtyllus) Cranberries Currants (red, black and white) Gooseberries Others Wild berries and wild fruit (VI) MISCELLANEOUS FRUIT 0,05* 0,05* 0,01* 0,01* 0,01* Avocados Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Pomegranates Others 2. Vegetables, fresh or uncooked, frozen or dry (I) ROOT AND TUBER VEGETABLES 0,05* 0,05* 0,01* 0,01* 0,01* Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yams Others (II) BULB VEGETABLES 0,05* 0,05* 0,01* 0,01* 0,01* Garlic Onions Shallots Spring onions Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Dinoseb Dioxathion Endrin 1,2-dibromo ethane (ethylene dibromide) Fenchlorphos (sum of fenchlorphos and fenchlorphos oxon expressed as fenchlorphos) (III) FRUITING VEGETABLES 0,05* 0,05* 0,01* 0,01* 0,01* Solanacea Tomatoes Peppers Aubergines Others Cucurbits - edible peel Cucumbers Gherkins Courgettes Others Cucurbits - inedible peel Melons Squashes Watermelons Others Sweet corn(IV) BRASSICA VEGETABLES 0,05* 0,05* 0,01* 0,01* 0,01* Flowering brassica Broccoli Cauliflower Others Head brassica Brussels sprouts Head cabbage Others Leafy brassica Chinese cabbage Kale Others Kohlrabi (V) LEAF VEGETABLES AND FRESH HERBS 0,05* 0,05* 0,01* 0,01* 0,01* Lettuce and similar Cress Lamb's lettuce Lettuce Scarole Others Spinach and similar Beet leaves (chord) Water cress Witloof Herbs Chervil Chives Parsley Celery leaves Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Dinoseb Dioxathion Endrin 1,2-dibromo ethane (ethylene dibromide) Fenchlorphos (sum of fenchlorphos and fenchlorphos oxon expressed as fenchlorphos) (VI) LEGUME VEGETABLES (fresh) 0,05* 0,05* 0,01* 0,01* 0,01* Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (VII) STEM VEGETABLES 0,05* 0,05* 0,01* 0,01* 0,01* Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (VIII) FUNGI 0,05* 0,05* 0,01* 0,01* 0,01* Cultivated mushrooms Wild mushrooms 3. Pulses 0,05* 0,05* 0,01* 0,01* 0,01* Beans Lentils Peas Others 4. Oil seeds 0,05* 0,05* 0,01* 0,01* 0,01* Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed Soya bean Mustard Cotton seed Others 5. Potatoes 0,05* 0,05* 0,01* 0,01* 0,01* Early potatoes Ware potatoes 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,1* 0,1* 0,01* 0,1* 0,1* 7. Hops (dried), including hop pellets and unconcentrated powder 0,1* 0,1* 0,1* 0,01* 0,1* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Heptachlor (sum of heptachlor and heptachlor epoxide) Maleic hydrazide Methyl bromide Paraquat 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts (I) CITRUS FRUIT 0,01* 1* 0,05* 0,05* Grapefruit Lemons Limes Mandarines (including clementines and similar hybrids) Oranges Pomelos Others (II) TREE NUTS (shelled or unshelled) 0,01* 1* 0,05* Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (III) POME FRUIT 0,01* 1* 0,05* 0,05* Apples Pears Quinces Others (IV) STONE FRUIT 0,01* 1* 0,05* Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (V) BERRIES AND SMALL FRUIT 0,01* 1* 0,05* Table and wine grapes Table grapes Wine grapes Strawberries (other than wild) 0,05* Cane fruit (other than wild) 0,05* Blackberries Dewberries Loganberries Raspberries Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Heptachlor (sum of heptachlor and heptachlor epoxide) Maleic hydrazide Methyl bromide Paraquat Other small fruit and berries (other than wild) 0,05* Bilberries (fruit of species vaccinium myrtyllus) Cranberries Currants (red, black and white) Gooseberries Others Wild berries and wild fruit 0,05* (VI) MISCELLANEOUS FRUIT Avocados 0,01* 1* 0,05* (except figs) 0,05* Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Pomegranates Others 2. Vegetables, fresh or uncooked, frozen or dry (I) ROOT AND TUBER VEGETABLES 0,01* 1* 0,05* 0,05* Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yams Others (II) BULB VEGETABLES 0,01* 0,05* 0,05* Garlic Onions Shallots Spring onions 1* Others 10 * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Heptachlor (sum of heptachlor and heptachlor epoxide) Maleic hydrazide Methyl bromide Paraquat (III) FRUITING VEGETABLES 0,01* 1* 0,05* 0,05* Solanacea Tomatoes Peppers Aubergines Others Cucurbits - edible peel Cucumbers Gherkins Courgettes Others Cucurbits - inedible peel Melons Squashes Watermelons Others Sweet corn(IV) BRASSICA VEGETABLES 0,01* 1* 0,05* 0,05* Flowering brassica Broccoli Cauliflower Others Head brassica Brussels sprouts Head cabbage Others Leafy brassica Chinese cabbage Kale Others Kohlrabi (V) LEAF VEGETABLES AND FRESH HERBS 0,01* 1* 0,05* 0,05* Lettuce and similar Cress Lamb's lettuce Lettuce Scarole Others Spinach and similar Beet leaves (chord) Water cress Witloof Herbs Chervil Chives Parsley Celery leaves Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) Heptachlor (sum of heptachlor and heptachlor epoxide) Maleic hydrazide Methyl bromide Paraquat (VI) LEGUME VEGETABLES (fresh) 0,01* 1* 0,05* 0,05* Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (VII) STEM VEGETABLES 0,01* 1* 0,05* 0,05* Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (VIII) FUNGI 0,01* 1* 0,05* 0,05* Cultivated mushrooms Wild mushrooms 3. Pulses 0,01* 1* 0,05* Beans Lentils Peas Others 4. Oil seeds 0,01* 1* 0,1* 0,05* Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed Soya bean Mustard Cotton seed Others 5. Potatoes 0,01* 0,05* 0,05* Early potatoes 1* Ware potatoes 50 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,02* 1* 0,05* 0,1* 7. Hops (dried), including hop pellets and unconcentrated powder 0,01* 1* 0,05* 0,1* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) TEPP Camphechlor (Toxaphene) 2,4,5-T 1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts (I) CITRUS FRUIT 0,01* 0,1* 0,05* Grapefruit Lemons Limes Mandarines (including clementines and similar hybrids) Oranges Pomelos Others (II) TREE NUTS (shelled or unshelled) 0,01* 0,1* 0,05* Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (III) POME FRUIT 0,01* 0,1* 0,05* Apples Pears Quinces Others (IV) STONE FRUIT 0,01* 0,1* 0,05* Apricots Cherries Peaches (including nectarines and similar hybrids) Plums Others (V) BERRIES AND SMALL FRUIT 0,01* 0,1* 0,05* Table and wine grapes Table grapes Wine grapes Strawberries (other than wild) Cane fruit (other than wild) Blackberries Dewberries Loganberries Raspberries Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) TEPP Camphechlor (Toxaphene) 2,4,5-T Other small fruit and berries (other than wild) Bilberries (fruit of species vaccinium myrtyllus) Cranberries Currants (red, black and white) Gooseberries Others Wild berries and wild fruit (VI) MISCELLANEOUS FRUIT 0,01* 0,1* 0,05* Avocados Bananas Dates Figs Kiwi Kumquats Litchis Mangoes Olives Passion fruit Pineapples Pomegranates Others 2. Vegetables, fresh or uncooked, frozen or dry (I) ROOT AND TUBER VEGETABLES 0,01* 0,1* 0,05* Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root Radishes Salsify Sweet potatoes Swedes Turnips Yams Others (II) BULB VEGETABLES 0,01* 0,1* 0,05* Garlic Onions Shallots Spring onions Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) TEPP Camphechlor (Toxaphene) 2,4,5-T (III) FRUITING VEGETABLES 0,01* 0,1* 0,05* Solanacea Tomatoes Peppers Aubergines Others Cucurbits - edible peel Cucumbers Gherkins Courgettes Others Cucurbits - inedible peel Melons Squashes Watermelons Others Sweet corn(IV) BRASSICA VEGETABLES 0,01* 0,1* 0,05* Flowering brassica Broccoli Cauliflower Others Head brassica Brussels sprouts Head cabbage Others Leafy brassica Chinese cabbage Kale Others Kohlrabi (V) LEAF VEGETABLES AND FRESH HERBS 0,01* 0,1* 0,05* Lettuce and similar Cress Lamb's lettuce Lettuce Scarole Others Spinach and similar Beet leaves (chord) Water cress Witloof Herbs Chervil Chives Parsley Celery leaves Others * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.Groups and examples of individual products to which the MRLs apply Pesticide residues and maximum residue levels (mg/kg) TEPP Camphechlor (Toxaphene) 2,4,5-T (VI) LEGUME VEGETABLES (fresh) 0,01* 0,1* 0,05* Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Others (VII) STEM VEGETABLES 0,01* 0,1* 0,05* Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (VIII) FUNGI 0,01* 0,1* 0,05* Cultivated mushrooms Wild mushrooms 3. Pulses 0,01* 0,1* 0,05* Beans Lentils Peas Others 4. Oil seeds 0,01* 0,1* 0,05* Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed Soya bean Mustard Cotton seed Others 5. Potatoes 0,01* 0,1* 0,05* Early potatoes Ware potatoes 6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) 0,02* 0,1* 0,05* 7. Hops (dried), including hop pellets and unconcentrated powder 0,02* 0,1* 0,05* * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*. Pesticide residues and maximum residue levels specifically in respect of tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) Pesticide residues Maximum levels in mg/kg (ppm) 1. Aldrin 2. Dieldrin AA aa A aa a singly or combined expressed as dieldrin (HEOD) 0,02 3. Endosulfan (sum of alpha- and beta-isomers and of endosulfan sulphate, expressed as endosulfan) 30 4. Hexachlorocyclohexane (HCH) 4.1 alpha-isomer 4.2 beta-isomer AA A a (sum) 0,2 4.3 gamma-isomer (lindane) 0,2 5. Biphentrin (d) 6. Bromopropylate (d) 7. Cartap 20 8. Chlordane (sum of cis- and trans-isomers) 0,02* 9. Dichlorvos (d) 10. Dicofol (d) 11. Dimethoate 0,2 12. Omethoate 0,1 13. Ethion 2 14. Fenitrothion (d) 15. Flucythrinate (sum of isomers) (d) 16. Hexachlorobenzene (HCB) 0,01* 17. Malathion (sum of malathion and malaoxon expressed as malathion) (d) 18. Methidathion (d) 19. Monocrotophos (d) 20. Phoxim (d) 21. Profenophos (d) 22. Propargite (d) 23. Quinalphos (d) 24. Phosmet (sum of phosmet and phosmet oxon expressed as phosmet) (d) * Indicates lower limit of analytical determination. (a) (b) (c) (d) Should levels not be adopted by 1 January 1998, the following maximum levels shall apply as indicated thereafter: (a) 0,02* (b) 0,01* (c) 0,05* (d) 0,1*.' Article 3 Member States shall bring into force not later than 31 December 1993 the laws, regulations or administrative provisions necessary to comply with this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 This Directive is addressed to the Member States.

31993L0056

1993

Commission Directive 93/56/EEC of 29 June 1993 amending Council Directive 82/471/EEC concerning certain products used in animal nutrition Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (1), as last amended by Commission Directive 93/26/EEC (2), and in particular Article 6 thereof, Whereas Directive 82/471/EEC provides for the content of the Annexes to be regularly adapted to take account of advances in scientific and technical knowledge; Whereas the study of the non-protein nitrogenous compound 'ammonium sulfate' and of hydroxyanalogue of methionine and its calcium salt has permitted a beneficial effect in ruminants to be established; whereas authorization for the use of the products in question should therefore be extended to this category of animal; Whereas the measures provided for in this Directive are in accordance with the Standing Committee on Feedingstuffs, Article 1 The Annex to Directive 82/471/EEC is hereby amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with Article 1 by 30 June 1994 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0060

1993

Council Directive 93/60/EEC of 30 June 1993 amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species and extending it to cover fresh bovine semen 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 88/407/EEC(4) lays down the animal health requirements applicable to intra-Community trade in, and imports of, deep-frozen semen of domestic animals of the bovine species; Whereas Article 4 of the said Directive defined provisional measures for trade in semen from bulls which are seropositive for infectious bovine rhinotracheitis (IBR); whereas these requirements should be reviewed, on the basis of a report from the Commission; whereas this report indicates that it is necessary to phase out bulls which were seropositive or of unknown status prior to vaccination in the centre by 1998 and to maintain the possibility of vaccinating in a centre in the future; whereas it is necessary to amend the aforementioned Article 4 in this respect; Whereas routine foot-and-mouth disease vaccination has been discontinued in the Community as from August 1991; whereas, therefore, it is necessary to amend the provisions of Directive 88/407/EEC to take account of this change in policy; whereas this change also permits trade in fresh bovine semen to take place under harmonized rules; Whereas it is opportune to make further amendments to the said Directive to clarify certain issues and to take account of technical progress, particularly in respect of treatment of bulls against leptospirosis, and to align the rules with respect to brucellosis, tuberculosis and leucosis on those laid down in Directive 64/432/EEC(5) ; Whereas it is appropriate to provide for amendments to the Annexes under a procedure establishing close cooperation between Member States and the Commission within the Standing Veterinary Committee, Article 1 Directive 88/407/EEC is hereby amended as follows: 1. In the title and in Article 1, the words 'deep-frozen' shall be deleted. 2. Article 4 (1) shall be replaced by the following: '1. Without prejudice to paragraph 2, Member States shall authorize the admission of semen from bulls giving a negative reaction to the serum neutralization test or the Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis or showing a positive result after vaccination in accordance with this Directive. Member States may, until 31 December 1998, authorize the admission of semen of bulls giving a positive reaction to the serum neutralization test or the Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis and not having been vaccinated in accordance with this Directive. In that case, each consignment must pass an examination by inoculation into a live animal and/or virus isolation test. This requirement shall not apply in respect of the semen of animals which, prior to their first routine vaccination at the insemination centre, reacted negatively to the tests referred to in the first subparagraph. However, the semen of animals given emergency vaccinations following an outbreak of IBR must pass a virus isolation test. These examinations may, by bilateral agreement, be carried out either in the country of collection or in the country of destination. In that case, at least 10 % of each collection of semen (with a minimum of five straws) must be treated. Protocols for tests to be used in accordance with this Article shall be laid down in accordance with the procedure in Article 18'. 3. Article 4 (3) shall be replaced by the following: '3. Member States may not oppose the admission of semen from bulls vaccinated against foot-and-mouth disease. However, where the semen was obtained from a bull which had been vaccinated against foot-and-mouth disease during the 12 month period prior to collection, 5 % of the semen from each collection (with a minimum of five straws) intended for sending to another Member States shall be subjected, in a laboratory in the Member State of destination or in a laboratory designated by it, to a virus isolation test for foot-and-mouth disease, with negative results'. 4. Article 12 shall be replaced by the following: 'Article 12 The rules laid down in Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (*) shall apply in particular to the organization and follow-up of checks to be carried out by the Member States and the safeguard measures to be applied. (6) ()OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Regulation (EEC) No 1601/92 (OJ No L 173, 27. 6. 1992, p. 13.' 5. Articles 13 and 14 shall be deleted. 6. In Annex A, Chapter II, the following shall be added to point (f) (i): 'Deep-frozen embryos may also be stored in approved centres provide that: - such storage is authorized by the competent authority, - the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (*), - the embryos are stored in separate storage flasks in the premises for storing approved semen. (7) ()OJ No L 302, 19. 10. 1989, p. 1. Directive as amended by Directive 90/425/EEC (OJ No L 224, 18. 8. 1990, pl. 29).' 7. In Annex A, Chapter II, (f) (vii) shall be replaced by the following: '(vii) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal, the name of the centre and the serological status of the donor animal in respect of infectious bovine rhinotracheitis and infectious pustular vulvo-vaginitis, possibly in code, can be readily established; the characteristics and form of this marking will be established in accordance with the procedure laid down in Article 19.' 8. In Annex B, Chapter I, paragraph 1 (b) shall be replaced by the following: '(b) prior to their stay in the isolation accommodation described in (a), have belonged to a herd which is officially tuberculosis free and officially brucellosis free in accordance with Directive 64/432/EEC. The animals may not previously have been kept in one or more herds of a lower status.' 9. In Annex B, Chapter I, the first subparagraph of paragraph 1 (c) shall be replaced by the following: 'have come from a herd free of enzootic bovine leucosis as defined in Directive 64/432/EEC, or have been produced by dams which have been subjected, with negative results, to an Agar Gel immunodiffusion test, carried out in accordance with Annex G of Directive 64/432/EEC, after removal of the animals from their "dam" In the case of animals derived by embryo tansfer, 'dam' means the recipient of the embryo.' 10. In Annex B, Chapter I, paragraph 1 (d) (ii) shall be replaced by the following: '(ii) a serum agglutination test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC and showing a brucella count lower than 30 IU of agglutination per millilitre, or a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units).' 11. In Annex B, Chapter I, paragraph 1 (e) (i) shall be replaced by the following: '(i) a serum agglutination test complying with the procedure described in Annex C to Directive 64/432/EEC and showing a brucella count lower than 30 IU of agglutination per millilitre, or a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units).' 12. In Annex B, Chapter I, in the last sentence of paragraph 1 (e), the words 'and have treatment against leptospirosis comprising two injections of streptomycin at an interval of 14 days (25 mg per kilogram of live body weight)' shall be deleted. 13. The following paragraph shall be added to Annex B, Chapter I: '6. However, until 1 July 1995 the Member States may admit to approved semen collection centres animals of the bovine species originating in herds which are free of brucellosis. In that case, the animals must, during the aforementioned period, be subjected to a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units) as provided for in (d) (ii) and (e) (i).' 14. In Annex B, Chapter II, paragraph 1 (ii) shall be replaced by the following: '(ii) a serum agglutination test for brucellosis, carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC, giving a count lower than 30 IU of agglutination per millilitre, or a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units).' 15. In Annex B, Chapter II, paragraph 1 (iii) shall be replaced by the following: '(iii) a screening test for enzootic bovine leucosis, carried out in accordance with the procedure described in Annex G to Directive 64/432/EEC, with a negative result;' 16. In Annex B, Chapter II, paragraph 1 (iv) the words 'until 31 December 1992' shall be deleted. 17. In Annex B, Chapter II, paragraph 3 the third subparagraph shall be replaced by the following subparagraphs: 'These provisions shall not apply to sero-positive bulls which, prior to their first vaccination in accordance with this Directive at the insemination centre, gave a negative reaction to the serum neutralization test or the ELISA test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis. Sero-positive bulls referred to in the second subparagraph of Article 4 (1) must be isolated since their semen may be the subject of intra-Community trade in accordance with the provisions for trade in semen from such bulls.' 18. In Annex C, paragraph 1 (b) shall be replaced by the following: '(b) (i) have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection, or (ii) have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case 5 % (with a minimum of five straws) of each collection shall be submitted to virus isolation test for foot-and-mouth disease with negative results;'. 19. In Annex C, paragarph 1 (d) shall be replaced by the following: '(d) have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to the collection of the semen in the case of collections of fresh semen;'. 20. In Annex C, paragraph 1 (f) and (g) shall be replaced by the following: '(f) are kept in semen collection centres which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch and are situated in the centre of an area of 10 kilometres radius in which for at least 30 days there has been no case of foot-and-mouth disease; (g) have been kept in semen collection centres which, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, have been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E to Directive 64/432/EEC;'. 21. In Annex C, paragraph 3 (i) shall be replaced by the following: '(i) be stored in approved conditions for a minimum period of 30 days prior to dispatch. This requirement shall not apply to fresh semen;' 22. In Annex D (IV), paragraph 4 (iii), the word 'consignment' shall be replaced by the word 'collection'. 23. In Annex D (IV), paragraph 5 shall be replaced by: '5. the semen described above was collected from bulls: (i) which have not been vaccinated against foot-and-mouth disease within 12 months prior to collection (1); or (ii) which have been vaccinated against foot-and-mouth disease with 12 months prior to collection, in which case the semen comes from a collection in which 5 % of each collection intended for trade (with a minimum of 5 straws) has been subjected, with negative results, to a virus isolation test for foot-and-mouth disease in ..... laboratory (2);'. 24. In Annex D, IV the following shall be added: '6. the semen was stored in approved conditions for a minimum period of 30 days prior to dispatch (3).' 25. In Annex D, in footnote 2, the words 'the second subpararagraph of Article 4 (1)' shall be replaced by 'Article 4'. 26. In Annex D, the following shall be added as footnote 3: '(3) May be deleted for fresh semen.' Article 2 The Commission shall submit to the Council, before 1 January 1998, a report on this Directive, taking account of experience gained and technical and scientific developments, particularly in the fight against, and eradication of, diseases, together with any appropriate proposals. The Council shall act by a qualified majority on those proposals by 30 June 1998. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 1 July 1994. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be adopted by the Member States. 2. Member States shall inform the Commission of the text of the essential provisions of national law which they adopt in the area governed by this Directive. Article 4 This Directive is addressed to the Member States.

31993L0061

1993

COMMISSION DIRECTIVE 93/61/EEC of 2 July 1993 setting out the schedules indicating the conditions to be met by vegetable propagating and planting material, other than seed pursuant to Council Directive 92/33/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 92/33/EEC of 28 April 1992 on the marketing of vegetable propagating and planting material, other than seed (1), and in particular Article 4 thereof, Whereas, in applying the provisions of this Directive, it is appropriate to take into account the production cycles of the various materials; Whereas, the conditions laid down in this Directive may be regarded as the minimum standard acceptable at this stage, regard being had to the current production conditions in the Community; whereas they will progressively be developed and refined in order ultimately to achieve high standards of quality; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 1. This Directive establishes the schedules referred to in Article 4 of Directive 92/33/EEC and sets out requirements as to labelling referred to in Article 11 of that Directive. 2. The schedules apply to the growing crop and vegetable propagating material (including rootstock), and planting material derived therefrom, of all the genera and species referred to in Annex II to Directive 92/33/EEC, and to rootstocks of other genera and species referred to in Article 4 of that Directive, irrespective of the propagation system applied, the abovementioned items being hereinafter collectively referred to as ‘the material’. 3. The provisions of this Directive shall apply progressively, account being taken of the production cycles of the material referred to in paragraph 2. Article 2 The material shall, where applicable, comply with the relevant plant health conditions laid down in Council Directive 77/93/EEC (2). Article 3 1. Without prejudice to the provisions of Article 2, material must at least appear, on visual inspection, to be substantially free from harmful organisms and diseases liable to affect quality, or signs or symptoms thereof, which reduce the usefulness of the vegetable propagating and planting material, and in particular from those listed in the Annex hereto, in respect of the genus or species concerned. 2. Any material showing visible signs or symptoms of harmful organisms or diseases referred to in paragraph 1 at the stage of the growing crop shall be treated properly immediately upon their appearance or, where appropriate, shall be eliminated. 3. In the case of bulbs of shallots and garlic, the following requirements shall also be met: the propagating material shall be derived directly from material which, at the stage of the growing crop, has been checked and found to be substantially free from any harmful organisms and diseases, or signs or symptoms thereof, referred to in paragraph 1 and in particular from those listed in the Annex hereto. Article 4 The material shall have identity and purity in respect of genera or species and shall also have sufficient varietal identity and varietal purity. Article 5 1. The material shall be substantially free from defects likely to impair its quality as propagating or planting material. 2. The vigour and dimensions of the material shall be satisfactory in respect of its usefulness as vegetable propagating and planting material. Furthermore, an appropriate balance shall be assured between the roots, stems and leaves. Article 6 1. The supplier's document referred to in Article 11 of Directive 92/33/EEC shall be of suitable material which has not previously been used and shall be printed in at least one of the official languages of the Community. It shall contain the following information headings: (i) indication ‘EEC quality’ (ii) indication of EEC Member State code; (iii) indication of responsible official body or its distinguishing code; (iv) registration or accreditation number; (v) name of supplier; (vi) individual serial, week or batch number; (vii) date of issue of the supplier's document; (viii) reference number of seed lot in the case of young plants raised direct from seeds marketed pursuant to Council Directive 70/458/EEC (3). Alternatively this reference number shall be made available, on request, to the responsible official body; (ix) common name, or where the material is accompanied by a plant passport in accordance with Commission Directive 92/105/EEC (4), botanical name; (x) denomination of the variety. In the case of rootstock, denomination of the variety or its designation; (xi) quantity; (xii) in the case of imports from third countries pursuant to Article 16 (2) of Directive 92/33/EEC, the name of the country of harvesting. 2. Where the material is accompanied by a plant passport in accordance with Directive 92/105/EEC, the plant passport may, if the supplier so wishes, constitute the supplier's document referred to in paragraph 1. Nonetheless, the remark ‘EEC-quality’ and an indication as to the responsible official body under Directive 92/33/EEC must be given, together with a reference to the denomination of the variety. In the case of imports from third countries under Article 16 (2) of Directive 92/33/EEC, the name of the country of harvesting must also be given. This information may be on the same document as the plant passport but must be clearly separated. Article 7 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 8 This Directive is addressed to the Member States.

31993L0063

1993

Commission Directive 93/63/EEC of 5 July 1993 setting out the implementing measures concerning the supervision and monitoring of suppliers and establishments pursuant to Council Directive 91/682/EEC on the marketing of ornamental plant propagating material and ornamental plants Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 91/682/EEC of 19 December 1991 on the marketing of ornamental plant propagating material and ornamental plants(1) , and in particular Article 6 (4) thereof, Whereas it is appropriate to set out measures concerning the supervision of monitoring of all suppliers and their establishments, with the exception of those whose activity is confined to the placing on the market of ornamental plant propagating material and ornamental plants; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Ornamental Plants, Article 1 1. This Directive lays down implementing measures concerning the supervision and monitoring of suppliers and their establishments, other than those whose activity is confined to the placing on the market of ornamental propagating material and ornamental plants, pursuant to Article 6 (4) of Directive 91/682/EEC, in cases where the checks referred to in Article 5 (2) of the said Directive are carried out by the suppliers themselves or an accredited supplier. Article 2 The responsible official body shall carry out regularly, at least once a year at an appropriate time, supervision and monitoring of suppliers and their establishments in order to ensure continued compliance with the requirements laid down in Directive 91/682/EEC, and in particular with the principles set out in the first to fourth indents of Article 5 (2) thereof, account being taken of the particular nature of the activity or activities of the supplier. Article 3 As far as the identification of critical points in the production process referred to in the first indent of Article 5 (2) of Directive 91/682/EEC and the keeping of records referred to in the fourth indent of Article 5 (2) thereof are concerned, the responsible official body shall supervise and monitor the supplier to ensure that the supplier: (a) continues to take into account the following critical points, where appropriate: - the quality of propagating material and plants utilized to start the production process; - the sowing, pricking-out, potting-up, and planting of propagating material and plants, - compliance with the conditions laid down in Articles 3, 4 and 5 of Council Directive 77/93/EEC(2) , - the cultivation plan and method, - general crop care, - the multiplication operations, - the harvesting operations, - hygiene, - treatments, - packaging, - storage, - transport, - administration; (b) keeps records, with a view to having complete information available for the said responsible official bodies, on: (i) plants or other objects: - purchased for storage or planting on the premises, - under production, or - dispatched to others; and (ii) any chemical treatments which have been applied to the plants, and that he keeps related documents for at least one year; (c) is available personally or designates another person technically experienced in plant production and related plant-health matters, to liaise with the said responsible official bodies; (d) carries out visual inspections as necessary and at appropriate times in a manner accepted by the said responsible official bodies; (e) allows access by persons entitled to act for the said responsible official bodies, in particular for inspection and/or sampling purposes, and allows access to the records and related documents referred to in point (b); (f) otherwise cooperates with the said responsible official bodies. Article 4 As fas as the establishment and implementation of methods for monitoring and checking the critical points as referred to in the second indent of Article 5 (2) of Directive 91/682/EEC are concerned, the responsible official body shall supervise and monitor the supplier to ensure that, where apropriate, such methods continue to be carried out, giving particular attention to: (a) the availability and actual use of methods for checking each of the critical points mentioned in Article 3; (b) the reliability of those methods; (c) their suitability for an assessment of the content of the production and marketing arrangements, including the administrative aspects; and (d) the competence of the supplier's staff to carry out the checks. Article 5 As far as the taking of samples for analysis in an accredited laboratory as referred to in the third indent of Article 5 (2) of Directive 91/682/EEC is concerned, the responsible official body shall supervise and monitor the supplier to ensure, where appropriate, that: (a) samples are taken during the various stages of production at such intervals as are established by the responsible official body when the production methods were verified at the time of accreditation; (b) samples are taken in a technically correct manner and using a statistically reliable procedure, regard being had to the kind of analysis to be carried out; (c) the persons who take the samples are qualified to do so; and (d) the analysis of samples is carried out by a laboratory which is accredited for that purpose pursuant to Article 6 (2) of the said Directive. Article 6 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 7 This Directive is addressed to the Member States.

31993L0062

1993

COMMISSION DIRECTIVE 93/62/EEC of 5 July 1993 setting out the implementing measures concerning the supervision and monitoring of suppliers and establishments pursuant to Council Directive 92/33/EEC on the marketing of vegetable propagating and planting material, other than seed Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 92/33/EEC of 28 April 1992 on the marketing of vegetable propagating and planting material, other than seed (1), and in particular Article 6 (4) thereof, Whereas it is appropriate so set out measures concerning the supervision and monitoring of all suppliers and their establishments, with the exception of those whose activity is confined to the placing on the market of vegetable propagating and planting material; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Agricultural, Horticultural and Forestry Seeds and Plants, Article 1 1. This Directive lays down implementing measures concerning the supervision and monitoring of suppliers and their establishments, other than those whose activity is confined to the placing on the market of vegetable propagating and planting material, pursuant to Article 6 (4) of Directive 92/33/EEC, in cases where the checks referred to in Article 5 (2) of the said Directive are carried out by the suppliers themselves or an accredited supplier. Article 2 The responsible official body shall carry out regularly, at least once a year at an appropriate time, supervision and monitoring of suppliers and their establishments in order to ensure continued compliance with the requirements laid down in Directive 92/33/EEC, and in particular with the principles set out in the first to fourth indents of Article 5 (2) thereof, account being taken of the particular nature of the activity or activities of the supplier. Article 3 As far as the identification of critical points in the production process referred to in the first indent of Article 5 (2) of Directive 92/33/EEC and the keeping of records referred to in the fourth indent of Article 5 (2) thereof are concerned, the responsible official body shall supervise and monitor the supplier to ensure that the supplier: (a) continues to take into account the following critical points, where appropriate: — the quality of the vegetable propagating and planting material utilized to start the production process; — the sowing, pricking-out, potting-up, and planting of vegetable propagating and planting material, — compliance with the conditions laid down in Articles 3, 4 and 5 of Council Directive 77/93/EEC (2), — the cultivation plan and method, — general crop care, — the multiplication operations, — the harvesting operations, — hygiene, — treatments, — packaging, — storage, — transport, — administration; (b) keeps records, with a view to having complete information available for the said responsible official bodies, on: (i) plants or other objects: — purchased for storage or planting on the premises, — under production, or — dispatched to others; and (ii) any chemical treatments which have been applied to the plants, and that he keeps related documents for at least one year; (c) is available personally or designates another person technically experienced in plant production and related plant-health matters, to liaise with the said responsible official bodies; (d) carries out visual inspections as necessary and at appropriate times in a manner accepted by the said responsible official bodies; (e) allows access by persons entitled to act for the said responsible official bodies, in particular for inspection and/or sampling purposes, and allows access to the records and related documents referred to in point (b); (f) otherwise cooperates with the said responsible official bodies. Article 4 As fas as the establishment and implementation of methods for monitoring and checking the critical points as referred to in the second indent of Article 5 (2) of Directive 92/33/EEC are concerned, the responsible official body shall supervise and monitor the supplier to ensure that, where apropriate, such methods continue to be carried out, giving particular attention to: (a) the availability and actual use of methods for checking each of the critical points mentioned in Article 3; (b) the reliability of those methods; (c) their suitability for an assessment of the content of the production and marketing arrangements, including the administrative aspects; and (d) the competence of the supplier's staff to carry out the checks. Article 5 As far as the taking of samples for analysis in an accredited laboratory as referred to in the third indent of Article 5 (2) of Directive 92/33/EEC is concerned, the responsible official body shall supervise and monitor the supplier to ensure, where appropriate, that: (a) samples are taken during the various stages of production at such intervals as are established by the responsible official body when the production methods were verified at the time of accreditation; (b) samples are taken in a technically correct manner and using a statistically reliable procedure, regard being had to the kind of analysis to be carried out; (c) the persons who take the samples are qualified to do so; and (d) the analysis of samples is carried out by a laboratory which is accredited for that purpose pursuant to Article 6 (2) of the said Directive. Article 6 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 7 This Directive is addressed to the Member States.

31993L0064

1993

COMMISSION DIRECTIVE 93/64/EEC of 5 July 1993 setting out the implementing measures concerning the supervision and monitoring of suppliers and establishments pursuant to Council Directive 92/34/EEC on the marketing of fruit plant propagating material and fruit plants intended for fruit production Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 92/34/EEC of 29 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (1), and in particular Article 6 (4) thereof, Whereas it is appropriate to set out measures concerning the supervision and monitoring of all suppliers and their establishments, with the exception of those whose activity is confined to the placing on the market of propagating material and fruit plants; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee Propagating Material and Plants of Fruit Genera and Species, Article 1 1. This Directive lays down implementing measures concerning the supervision and monitoring of suppliers and their establishments, other than those whose activity is confined to the placing on the market of propagating material and fruit plants, pursuant to Article 6 (4) of Directive 92/34/EEC, in cases where the checks referred to in Article 5 (2) of the said Directive are carried out by the suppliers themselves or an accredited supplier. Article 2 The responsible official body shall carry out regularly, at least once a year at an appropriate time, supervision and monitoring of suppliers and their establishments in order to ensure continued compliance with the requirements laid down in Directive 92/34/EEC, and in particular, in respect of with the principles set out in the first to fourth indents of Article 5 (2) thereof, account being taken of the particular nature of the activity or activities of the supplier. Article 3 As far as the identification of critical points in the production process referred to in the first indent of Article 5 (2) of Directive 92/34/EEC and the keeping of records referred to in the fourth indent of Article 5 (2) thereof are concerned, the responsible official body shall supervise and monitor the supplier to ensure that the supplier: (a) continues to take into account the following critical points, where appropriate: — the quality of propagating material and fruit plants utilized to start the production process, — the sowing, pricking-out, potting-up, and planting of propagating material and fruit plants, — compliance with the conditions laid down in Articles 3, 4 and 5 of Council Directive 77/93/EEC (2), — the cultivation plan and method, — general crop care, — the multiplication operations, — the harvesting operations, — hygiene, — treatments, — packaging, — storage, — transport, — administration; (b) keeps records, with a view to having complete information available for the said responsible official bodies, on: (i) plants or other objects: — purchased for storage or planting on the premises, — under production, or — dispatched to others; and (ii) any chemical treatments which have been applied to the plants, and that he keeps related documents for at least one year; (c) is available personally or designates another person technically experienced in plant production and related plant-health matters, to liaise with the said responsible official bodies; (d) carries out visual inspections as necessary and at appropriate times in a manner accepted by the said responsible official bodies; (e) allows access by persons entitled to act for the said responsible official bodies, in particular for inspection and/or sampling purposes, and allows access to the records and related documents referred to in point (b); (f) otherwise cooperates with the said responsible official bodies. Article 4 As fas as the establishment and implementation of methods for monitoring and checking the critical points as referred to in the second indent of Article 5 (2) of Directive 92/34/EEC are concerned, the responsible official body shall supervise and monitor the supplier to ensure that, where appropriate, such methods continue to be carried out, giving particular attention to: (a) the availability and actual use of methods for checking each of the critical points mentioned in Article 3; (b) the reliability of those methods; (c) their suitability for an assessment of the content of the production and marketing arrangements, including the administrative aspects; and (d) the competence of the supplier's staff to carry out the checks. Article 5 As far as the taking of samples for analysis in an accredited laboratory as referred to in the third indent of Article 5 (2) of Directive 92/34/EEC is concerned, the responsible official body shall supervise and monitor the supplier to ensure, where appropriate, that: (a) samples are taken during the various stages of the production process and in conformity with the frequency as communicated to the responsible official body when the production methods were verified at the time of accreditation; (b) samples are taken in a technically correct manner and using a statistically reliable procedure, regard being had to the kind of analysis to be carried out; (c) the persons who take the samples are qualified to do so; and (d) the analysis of samples is carried out by a laboratory which is accredited for that purpose pursuant to Article 6 (2) of the said Directive. Article 6 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 7 This Directive is addressed to the Member States.

31993L0067

1993

Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of subtances notified in accordance with Council Directive 67/548/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967, on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as amended by Directive 93/21/EEC (2) and, in particular, Article 3 thereof, Whereas, in accordance with the provisions of Directive 67/548/EEC, any new substance placed on the market should be notified to the competent authorities to Member States by means of a notification containing certain information; Whereas Article 16 of Directive 67/548/EEC requires the competent authorities receiving notification of a new substance to carry out an assessment of its risks to man and the environment in accordance with general principles; Whereas, given that the responsibility for risk assessment lies with the Member States, it is, however, appropriate that general principles be adopted at Community level to avoid disparities between Member States which not only affect the functioning of the internal market but also do not guarantee the same level of protection of man and the environment thorughout the Community and whereas, therefore, Article 3 of Council Directive 67/548/EEC provides that the Commission shall lay down the general principles; Whereas the assessment of risks should be based on a comparison of the potential adverse effects of a substance with the reasonably foreseeable exposure of man and the environment to that substance; Whereas, having regard to its classification in accordance with Directive 67/548/EEC, the assessment of risks to man should take account of the physico-chemical and toxicological properties of a substance; Whereas, having regard to its classification in accordance with Directive 67/548/EEC, the assessment of risks to the environment should take account of the environmental effects of a substance; Whereas, where the assessment of risks indicates that a substance is of concern, the competent authority may acquire further information including the results of further tests to determine the substance's intrinsic hazardous properties in accordance with Council Directive 67/548/EEC; Whereas the results of a risk assessment should be the principal basis of decisions under appropriate legislation to reduce the risks arising from the placing of substances on the market; Whereas it is appropriate that, having carried out an assessment of risks, the competent authority may inform the notifier of a dangerous substance of its conclusions and that, further, the competent authority should forward a written report thereon to the Commission; Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (3); Whereas the provisions of this Directive shall be without prejudice to specific Community legislation concerning the safety and protection of health of workers at work, in particular 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 (4), which places an obligation on employers to evaluate the risks to the health and safety of workers arising from the use of new and existing chemical substances and, as necessary, to take measures to ensure an appropriate protection of workers; Whereas the measures set out in this Directive are in accordance with the opinion of the committee set up pursuant to Article 29 of Directive 67/548/EEC, Article 1 Objectives This Directive lays down general principles for the assessment of the risks posed by substances to man and the environment as required by Article 3 of Directive 67/548/EEC. Article 2 Definitions 1. The definitions contained in Article 2 of Directive 67/548/EEC are applicable to this Directive. 2. For the purposes of this Directive: (a) 'hazard identification' is the identification of the adverse effects which a substance has an inherent capacity to cause; (b) 'dose (concentration) - response (effect) assessment' is the estimation of the relationship between dose, or level of exposure to a substance, and the incidence and severity of an effect; (c) 'exposure assessment' is the determination of the emissions, pathways and rates of movement of a substance and its transformation or degradation in order to estimate the concentrations/doses to which human populations or environmental compartments are or may be exposed; (d) 'risk characterization' is the estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance, and may include 'risk estimation', i.e., the quantification of that likelihood; (e) 'recommendations for risk reduction' is the recommendation of measures which would enable the risks for man and/or the environment in connection with the marketing of the substance to be lessened. They may include: (i) modifications to the classification, packaging or labelling of the substance proposed by the notifier in the notification submitted in accordance with Article 7 (1), 8 (1) or 8 (2) of Directive 67/548/EEC; (ii) modifications to the safety data sheet proposed by the notifier in the notification submitted in accordance with Article 7 (1), 8 (1) or 8 (2) of Directive 67/548/EEC; (iii) modifications to the recommended methods and precautions or emergency measures, as set out in sections 2.3, 2.4 and 2.5 of Annex VIIA, VIIB or VIIC, proposed by the notifier in the technical dossier of the notification submitted in accordance with Article 7 (1), 8 (1) or 8 (2) of Directive 67/548/EEC; (iv) advice to the relevant control authorities that they should consider appropriate measures for the protection of man and/or the environment from the risks identified. Article 3 Principles of risk assessment 1. The risk assessment shall entail hazard identification and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterization. It shall normally be conducted in accordance with the procedures set out in Articles 4 and 5. 2. Notwithstanding paragraph 1, in relation to particular effects, such as ozone depletion, for which the procedures set out in Articles 4 and 5 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the competent authority shall include a full description and justification of such assessments in the written report submitted to the Commission in accordance with Article 7. 3. In conducting an exposure assessment, the competent authority shall take into account those human populations or environmental compartments for which exposure to the substance is reasonably foreseeable in the light of available information on the substance, with particular regard to storage, formulation into a preparation or other processing, use and disposal or recovery. 4. The risk assessment shall indicate one or more of the following conclusions: (i) The substance is of no immediate concern and need not be considered again until further information is made available in accordance with Article 7 (2), 8 (3), 8 (4) or 14 (1) of Directive 67/548/EEC. (ii) The substance is of concern and the competent authority shall decide what further information is required for revision of the assessment but shall defer a request for that information until the quantity placed on the market reaches the next tonnage threshold as indicated in Article 7 (2), 8 (3) or 8 (4) of Directive 67/548/EEC. (iii) The substance is of concern and further information shall be requested immediately. (iv) The substance is of concern and the competent authority shall immediately make recommendations for risk reduction. 5. When the risk assessment indicated that the conclusions at paragraph 4 (ii), (iii) or (iv) above apply, the notifier may be informed by the competent authority of its conclusions and be given the opportunity to comment on those conclusions and to provide additional information. The competent authority shall use any relevant information to revise the risk assessment before sending it to the Commission in accordance with Article 17 of Directive 67/548/EEC. 6. In making recommendations for risk reduction in relation to a substance, the competent authority shall take account of the possibility that reducing the exposure of certain human populations or environmental compartments may increase the exposure of other human populations or environmental compartments. Article 4 Risk assessment: human health 1. For each substance notified in accordance with Article 7 (1), Article 8 (1) or Article 8 (2) of Directive 67/548/EEC, the competent authority shall carry out a risk assessment, the first stage of which shall be hazard identification which shall address, as a minimum, the properties and potential adverse effects specified in Annexes IA and IIA. Having conducted the hazard identification, the competent authority shall proceed to the following sequence of actions which shall be carried out in accordance with the guidelines set out in Annexes IB and IIB: (a) (i) dose (concentration)-response (effect) assessment, where appropriate; (ii) exposure assessment for whichever of the human populations (i.e., workers, consumers and man exposed indirectly via the environment) is likely to be exposed to the substance; (b) risk characterization. 2. In derogations from paragraph 1: (i) if the test appropriate to hazard identification in relation to a particular effect or property has been conducted and the results have not led classification of the substance in accordance with Directive 67/548/EEC, the risk assessment in relation to that effect or property need not include the actions at paragraph 1 (a) and (b) and the conclusion at Article 3 (4) (i) shall apply, unless there are other reasonable grounds for concern; and (ii) if the test appropriate to hazard identification in relation to a particular effect or property has not yet been conducted, that effect or property shall not be considered in the risk assessment unless there are other reasonable grounds for concern. Article 5 Risk assessment: environment 1. For each substance notified in accordance with Article 7 (1), 8 (1) or 8 (2) of Directive 67/548/EEC, the competent authority shall carry out a risk assessment in relation to its environmental effects, the first stage of which shall be hazard identification. Having conducted the hazard identification, the competent authority shall proceed to the following sequence of actions which shall be carried out in accordance with the guidelines set out in Annex III: (a) (i) dose (concentration)-response (effect) assessment, where appropriate; (ii) exposure assessment for the environmental compartments (i.e. aquatic environment, terrestrial environment and air) likely to be exposed to the substance; (b) risk characterization. 2. In derogation from paragraph 1: (i) for substances notified in accordance with Article 7 (1) of Directive 67/548/EEC but not classified dangerous for the environment, the risk assessment need not include the actions at paragraph 1 (a) and (b) and the conclusion at Article 3 (4) (i) shall apply, unless there are other reasonable grounds for concern; and (ii) for substances notified in accordance with Article 8 (1) or 8 (2) of Directive 67/548/EEC, if there are insufficient data to determine whether classification as dangerous for the environment is appropriate, the hazard identification shall entail consideration of whether there are any reasonable grounds for concern in relation to environmental effects on the basis of other data, e.g. data on physico-chemical and toxic properties. Unless there are such reasonable grounds, the risk assessment need not include the actions at paragraph 1 (a) and (b) and the conclusion at Article 3 (4) (i) shall apply. Article 6 Risk assessment: conclusions 1. Having carried out a risk assessment in accordance with Articles 4 and 5 and in conformity with Annexes I, II and III, the competent authority shall determine, in conformity with Annex IV, which of the four conclusions of Article 3 (4) is/are applicable and take action as described in Article 3 (5) if appropriate. 2. Where additional information is received in accordance with Articles 7 (2), 8 (3), 8 (4), 14 (1) or 16 of Directive 67/548/EEC or otherwise, the risk assessment carried out in accordance with Articles 4 and 5 and in conformity with Annexes I, II and III shall be reviewed and, if necessary, revised. Article 7 Content of written report to the Commission 1. Having carried out the risk assessment in accordance with Articles 4 and 5 and made conclusions in accordance with Article 6, the competent authority shall prepare a written report containing at least the information set out at Annex V. That report shall be sent to the Commission in accordance with Article 17 of Directive 67/548/EEC. It shall be updated following any revision of the assessment in the light of additional information and the updated report shall be sent to the Commission. 2. When, in accordance with Article 18 of Directive 67/548/EEC, the competent authorities have reached agreement on the written report of the risk assessment or any revision thereof, a copy shall be made available to the notifier on request. Article 8 Final provisions 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 October 1993 and shall forthwith inform the Commission. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 9 This Directive is addressed to the Member States.

31993L0069

1993

Commission Directive 93/69/EEC of 23 July 1993 adapting to technical progress Council Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilizers Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (1), as last amended by Directive 89/530/EEC (2), and in particular Article 9 (1) thereof, Whereas Article 8a of the Treaty envisages an area without internal frontiers in which the free circulation of goods, persons, services and capital is assured; Whereas Directive 76/116/EEC laid down rules for the marketing of EEC fertilizers; Whereas new fertilizers need to be added to Annex I to Directive 76/116/EEC to enable them to be designated as 'EEC fertilizer'; whereas Council Directives 89/284/EEC (3) and 89/530/EEC supplementing and amending Directive 76/116/EEC both have specific Annexes which have not been incorporated into Annex I to Directive 76/116/EEC; whereas, therefore, it is necessary to restructure Annex I to Directive 76/116/EEC to make it clearer and easier to read and understand; Whereas, in view of the scope and effects of the proposed action, the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the stated objectives; whereas those objectives cannot be achieved by Member States individually, and furthermore their attainment at Community level is already provided for by Directive 76/116/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to Trade in Fertilizers, Article 1 Annex I to Directive 76/116/EEC shall be amended as follows: (a) the straight nitrogenous fertilizers listed in Annex I to this Directive shall be added to point 1 of Part A; (b) the compound fertilizers listed in Annex II to this Directive shall be added to Part B; (c) the fluid fertilizer listed in Annex III to this Directive shall be added to point 1 of Part C. Article 2 1. Annex I to Directive 89/284/EEC shall become Part D of Annex I to Directive 76/116/EEC and shall be entitled 'Secondary nutrient fertilizers'. 2. The fertilizer listed in Annex IV to this Directive shall be added to Part D of Annex I to Directive 76/116/EEC. Article 3 1. The Annex to Directive 89/530/EEC shall become Part E of Annex I to Directive 76/116/EEC and shall be entitled 'Trace element fertilizers'. 2. Chapter A in Part E of Annex I to Directive 76/116/EEC shall be replaced by Annex V to this Directive. Article 4 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 April 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall apply these provisions with effect from 1 May 1994. Article 5 This Directive is addressed to the Member States.

31993L0071

1993

Commission Directive 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC lay down the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary to indicate to applicants in Annexes II and III, as precisely as possible, the details of the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossiers; Whereas greater precision can be given at the present time to the general introductionary provisions to Annexes II and III and to the data requirements concerning efficacy testing provided for in Section 6 of Parts A and B of Annex III; Whereas the introductions to the Annexes II and III currently refer to the application of the principles of good laboratory practice (GLP) for any data requirements; whereas, however, the application of such principles is not considered to be appropriate for efficacy testing and for the testing of certain physico-chemical properties or other information which are not related to data on the properties and/or safety with respect to human or animal health or the environment; Whereas moreover it is necessary to provide for a temporary exemption of the application of these principles for certain data requirements to permit the laboratories concerned to adapt themselves to the requirements of GLP; Whereas the specific European and Mediterranean Plant Protection Organization (EPPO) guidelines constitute for the time being the best available basis for setting the minimum requirements to be applied in all Member States with regard to the guidelines used for efficacy testing, whereas it appears necessary however to proceed urgently to a detailed examination of these guidelines and to provide for higher standards in Directive 91/414/EEC in cases where certain guidelines would appear inadequate for efficacy testing; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 91/414/EEC is amended as follows: 1. the section headed 'Introduction' in Annex II is replaced by Annex I hereto; 2. the section headed 'Introduction' in Annex III is replaced by Annex II hereto, 3. Section 6 headed 'Efficacy data' in both Parts A and B of Annex III is replaced by Annex III hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within twelve months following notification thereof. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0070

1993

Eleventh Commission Directive 93/70/EEC of 28 July 1993 establishing Community analysis methods for official control of feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 2 thereof, Whereas Directive 70/373/EEC requires official controls on feedingstuffs for the purpose of checking compliance with requirements arising under quality and composition provisions laid down by law, regulation or administrative action, to be carried out using Community sampling and analysis methods; Whereas a Community analysis method for the additive halofuginone should be established for use in checking compliance with the conditions for its use in animal nutrition; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Member States shall require that analyses for halofuginone content for the purposes of official checks on feedingstuffs be made using the method described in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1994. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0072

1993

Commission Directive 93/72/EEC of 1 September 1993 adapting to technical progress for the nineteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 93/21/EEC (2), and in particular Articles 28 and 29 thereof, Whereas Annex I of Council Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance and whereas Council Directive 92/32/EEC (3) amended the provisions relating to the classification and labelling of dangerous substances; Whereas, therefore, it is necessary to revise the classification of certain substances in Annex I and, further, to include, where appropriate in Annex I, the EEC number; Whereas Germany requested a change in the labelling of a number of substances and notified the Commission accordingly under Article 23 of Directive 67/548/EEC as amended by Directive 79/831/EEC (4); Whereas examination of the list of dangerous substances in the said Annex I has shown that this list needs to be adapted in the light of present scientific and technical knowledge; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Annex I to Directive 67/548/EEC is replaced by Annex I to this Directive. Article 2 1. Not later than 1 July 1994 the Member States shall implement the laws, regulations and administrative provisions necessary to comply with this Directive. 2. Member States shall immediately inform the Commission thereof. 3. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0073

1993

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of 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 93/35/EEC (2), and in particular Article 8 (1) thereof, Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of ensuring that the conditions laid down by Community provisions concerning the composition of cosmetic products are satisfied; Whereas all the necessary methods of analysis should be laid down as quickly as possible; whereas four steps have already been taken by Commission Directive 80/1335/EEC (3), as amended by Directive 87/143/EEC (4), Commission Directive 82/434/EEC (5), as amended by Directive 90/207/EEC (6) and Commission Directives 83/514/EEC (7) and 85/490/EEC (8); whereas the identification and determination of silver nitrate, the identification and determination of silver nitrate, the identification and determination of selenium disulphide in anti-dandruff shampoos, the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes, the identification and determination of benzyl alcohol, the identification of zirconium, and the determination of zirconium, aluminium and chlorine in non-aerosol antiperspirants and the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine, constitute a fifth step; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation of Directive 76/768/EEC to technical progress, Article 1 Member States shall take all necessary steps to ensure that during official testing of cosmetic products, the: - identification and determination of silver nitrate, - identification and determination of selenium disulphide in anti-dandruff shampoos, - determination of soluble barium and soluble strontium in pigments in the form of salts or lakes, - identification and determination of benzyl alcohol, - identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol antiperspirants, - identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine, shall be carried out in accordance with the methods described in the Annex. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions needed to comply with this Directive no later than 30 September 1994. The shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States

31993L0074

1993

Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes 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 feedingstuffs intended for particular nutritional purposes are playing an increasing role in the diet of pet animals; whereas such products are also used in the rearing of productive livestock; Whereas, in some Member States, feedingstuffs covered by this Directive are already marketed in such a way as to draw the attention of users to their particular composition; Whereas a common definition should be laid down for the products concerned; whereas that definition must provide that products presented as intended to meet certain specific nutritional needs must have a specific composition and/or be manufactured using special methods; whereas it is essential to establish the principle that such feedingstuffs must be clearly distinguished, in their characteristics and purpose, from both ordinary feedingstufffs and medicated feedingstuffs; Whereas the composition and preparation of feedingsuffs intended for particular nutritional purposes must be specially designed to meet the particular nutritional needs of categories of pets or productive livestock whose process of assimilation, absorption or metabolism could briefly be impaired or is temporarily or irreversibly impaired; Whereas, when rules are being laid down for the marketing of feedingstuffs intended for particular nutritional purposes, care should be taken to ensure that such feedingstuffs have a beneficial effect on the animals which ingest them; whereas feedingstuffs must therefore always be of merchantable quality; whereas they must neither present a hazard for animal or human health or for the environment nor be marketed in a manner liable to mislead; Whereas this Directive applies without prejudice to other Community provisions on feedingstuffs, and particularly the rules applicable to compound feedingstuffs; Whereas the user of feedingstuffs intended for particular nutritional purposes needs to be provided with accurate and meaningful information; Whereas in order to distinguish between the feedingstuffs meeting the criteria laid down in this Directive and other feedingstuffs, a single qualifying expression, 'dietetic', must accompany the description of the feedingstuff; Whereas, as in the case of ordinary feedingstuffs, at least the levels of analytical constituents having a direct effect on the quality of the feedingstuff should be declared; whereas provision should be made for the declaration of certain additional analytical constituents which give the feedingstuff its dietetic properties; Whereas all producers of feedingstuffs intended for particular nutritional purposes must have the option of indicating on the label certain particulars useful to the user; Whereas it is not necessary for the supply of feedingstuffs intended for particular nutritional purposes to be subject to presentation of a veterinary prescription since these products contain no medicinal substances within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (4), but, to ensure the appropriate use of feedingstuffs with a very specific character, the user should be warned that it is desirable to seek a specialist's opinion before using them; Whereas, however, for feedingstuffs designed to satisfy the nutritional requirements of animals with irreversibly impaired processes of assimilation, absorption or metabolism or which are in a pathological state requiring medical supervision, the possibility should be provided of laying down additional labelling rules which provide that a recommendation shall be given to the user to request the prior opinion of a veterinarian instead of the general recommendation to consult a specialist; Whereas a positive list should also be drawn up at Community level of the intended uses of animal feedingstuffs for particular nutritional purposes, indicating their precise use, essential nutritional characteristics, compulsory or optional declarations and special labelling requirements; whereas, bearing in mind the importance of this list for the implementation of this Directive, such list should be adopted in good time; Whereas the marketing of feedingstuffs intended for particular nutritional purposes which satisfy the requirements of this Directive must not be subject to any restriction on grounds of content, methods of manufacture, presentation or labelling; Whereas, in cases where a product presents a hazard to animal or human health or the environment, provision should be made for any Member State to request that the Commission take the appropriate measures, on justified grounds; Whereas, for cases where the Council empowers the Commission to apply the rules laid down in respect of feedingstuffs intended for particular nutritional purposes, a procedure should be provided for close cooperation between the Member States and the Commission in the Standing Committee on Feedingstuffs set up by Council Decision 70/372/EEC (5); Whereas effective inspection of feedingstuffs intended for particular nutritional purposes must be ensured; whereas in certain circumstances the usual means at the disposal of the inspection services amy be insufficient to allow verification that a feedingstuff actually possesses the particular nutritional properties attributed to it; whereas it should therefore be provided that, where necessary, the person responsible for marketing the product should assist the inspection service in its duties, Article 1 1. This Directive concerns feedingstuffs intended for particular nutritional purposes. 2. Member Statets shall prescribe that feedingstuffs intended for particular nutritional purposes may be marketed only if they: - fulfil the conditions referred to in Article 3, - are labelled in accordance with the provisions laid down in Article 5, - their intended uses are included in the list drawn up pursuant to Article 6 and they fulfil the other provisions laid down in that list. Article 2 For the purposes of this Directive, the following definitions shall apply: (a) 'feedingstuffs' shall mean products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding; (b) 'compound feedingstuffs' shall mean mixtures of products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, or of organic or inorganic substances, whether or not containing additives, for oral animal feeding in the form of complete feedingstuffs or complementary feedingstuffs; (c) 'feedingstuffs intended for particular nutritional purposes' shall mean compound feedingstuffs which, by virtue of their particular composition or method of manufacture, can be clearly distinguished from both ordinary feedingstuffs and the products defined in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (6), and are presented as intended to meet specific nutritional requirements; (d) 'particular nutritional purpose' shall mean the purpose of satisfying the specific nutritional needs of certain pets or productive livestock whose process of assimilation, absorption or metabolism could be temporarily impaired or is temporarily or irreversibly impaired and are therefore able to derive benefit from ingestion of feedingstuffs appropriate to their condition. Article 3 The Member States shall require that the nature of composition of the feedingstuffs referred to in Article 1 (1) shall be such that the products are appropriate for their intended particular nutritional purpose. Article 4 This Directive shall apply, subject to the specific provisions laid down therein, without prejudice to the Community provisions on: (a) compound feedingstuffs; (b) additives used in feedingstuffs; (c) undesirable substances and products in animal nutrition; (d) certain products used in animal nutrition. Article 5 In addition to the labelling provisions in Article 5 of Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (7) the Member States shall require that: 1. the following additional indications appear in the space provided for the purpose on the packaging, on the container or on the label of the feedingstuffs referred to in Article 1 (1): (a) the qualifying expression 'dietetic' together with the description of the feedingstuff; (b) the precise use, i.e. the particular nutritional purpose; (c) the indication of the essential nutritional characteristics of the feedingstuffs; (d) the declarations prescribed in column 4 in the Annex concerning the particular nutritional purpose; (e) the recommended length of time for use of the feedingstuff. The indications referred to in points (a) to (e) must comply with the content of the list of intended uses in the Annex and the general provisions to be laid down in accordance with Article 6 (b); 2. indications other than those referred to in paragraph 1 may be supplied in the space provided for the purpose, in so far as they are covered by Article 6 (a); 3. without prejudice to Article 5e of Directive 79/373/EEC, the labelling of feedingstuffs as referred to in Article 1 (1) may make reference to a specific pathological condition in so far as that condition corresponds to the nutritional purpose laid down in the list of uses drawn up in accordance with Article 6 (a); 4. the label or the directions for use of the feedingstuffs referred to in Article 1 (1) must bear the indication 'It is recommended that a specialist's opinion be sought before use.' It may, however, be provided in the list of intended uses in the Annex that this declaration shall be replaced for specific dietetic feedingstuffs with a recommendation to request the prior opinion of a veterinarian; 5. the provisions of Article 5c (5) of Directive 79/373/EEC shall also apply to the feedingstuffs referred to in Article 1 (1) and intended for animals other than pets; 6. the labelling of the feedingstuffs referred to in Article 1 (1) may also highlight the presence or the low level of one or more analytical constituents which are essential for the description of the feedingstuff. In such cases, the minimum or maximum level of the analytical constituents expressed as percentage weight of the feedingstuff must be clearly indicated in the list of declared analytical constituents; 7. the qualifying expression 'dietitic' shall be reserved solely for feedingstuffs as referred to in Article 1 (1). Qualifying expressions other than 'dietitic' shall be prohibited in the labelling and presentation of these feedingstuffs; 8. Notwithstanding the provisions of Article 5c (3) of Directive 79/373/EEC, the declaration of ingredients may be made in the form of categories grouping several ingredients, even where the declaration of certain ingredients by their specific name is required to justify the nutritional characteristics of the feedingstuff. Article 6 Pursuant to the procedure laid down in Article 9: (a) a list of intended uses shall be established in accordance with the Annex not later than 30 June 1994. That list shall contain: - the indications referred to in Article 5 (1) (b), (c), (d) and (e), and - where appropriate, the indications referred to in Article 5 (2) and Article 5 (4), second subparagraph; (b) general provisions regarding the application of the indications referred to in (a), including applicable tolerances, may be established; (c) the measures adopted in accordance with (a) and (b) may be modified, following developments in scientific and technical knowledge. Article 7 The Member States shall ensure that feedingstuffs as referred to in Article 1 (1) are not, for reasons concerning the provisions of this Directive, subject to marketing restrictions other than those provided for in this Directive. Article 8 1. Where a Member State establishes that the use of a feedingstuff as referred to in Article 1 (1) or its use in the prescribed conditions presents a hazard for animal or human health or for the environment, it shall immediately inform the Commission, giving the reasons for its decision. 2. The Commission shall initiate as soon as possible the procedure laid down in Article 9 with a view to adopting any appropriate measures. Article 9 1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter to the Standing Committee on Feedingstuffs, 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 for 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 as provided 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, present to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission unless the Council has decided against those measures by a simple majority. Article 10 To allow effective official inspection of feedingstuffs as referred to in Article 1 (1), the following specific provisions shall apply: 1. 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; 2. where appropriate, the competent authority shall be empowered to require the person responsible for placing the product on the market to produce data and information establishing the feedingstuff's conformity with this Directive. If such data have been published in readily accessible form, a reference to the publication shall suffice. Article 11 The following Directives are hereby amended as specified: 1. the following shall be added to Article 1 (2) of Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (8): '(f) feedingstuffs for particular nutritional purposes'; 2. in Directive 79/373/EEC: (a) the following shall be added to Article 1 (2): '(h) feedingstuffs for particular nutritional purposes'; (b) the first indent of the second subparagraph of Article 5e shall be replaced by the following: '- 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 of this Directive or Article 5 (2) of Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (*); (*) OJ No L 237, 22. 9. 1993, p. 23.'; 3. the following shall be added to Article 1 (2) of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (9): '(f) feedingstuffs for particular nutritional purposes;'. Article 12 The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1995. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall include references to this Directive or shall accompany them with such references on their official publication. The Member States shall lay down the manner in which such references shall be made. Article 13 This Directive is addressed to the Member States.

31993L0076

1993

Council Directive 93/76/EEC of 13 September 1993 to limit carbon dioxide emissions by improving energy efficiency (SAVE) Having regard to the Treaty establishing the European Economic Community, and in particular Articles 130s and 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, by its resolution of 16 September 1986 (4), the Council set new Community energy policy objectives for 1995 and convergence of the policies of the Member States; Whereas the Council of Environment and Energy Ministers agreed at their meeting on 29 October 1990 that the Community and the Member States, assuming that other leading countries undertook similar commitments, and acknowledging the targets identified by a number of Member States for stabilizing or reducing emissions by different dates, were willing to take actions aimed at reaching stabilization of the total carbon dioxide emissions by the year 2000 at the 1990 level in the Community as a whole; whereas it was also agreed that Member States which start from relatively low levels of energy consumption and therefore low emissions measured on a per capita or other appropriate basis are entitled to have carbon dioxide targets and/or strategies corresponding to their economic and social development, while improving the energy efficiency of their economic activities; Whereas by Decision 91/565/EEC the Council adopted the SAVE programme aimed at promoting energy efficiency in the Community (5); Whereas Article 130r of the Treaty stipulates that the objective of action by the Community relating to the environment shall be to ensure a prudent and rational utilization of natural resources; whereas these natural resources include oil products, natural gas and solid fuels, which are essential sources of energy but also the leading sources of carbon dioxide emissions; Whereas, since the Treaty has not provided elsewhere the powers required to legislate on energy-related aspects of the programmes laid down in this Directive, recourse should be had also to Article 235 of the Treaty; Whereas the residential and tertiary sectors account for nearly 40 % of final energy consumption in the Community and are expanding, a trend which is bound to increase their energy consumption and hence also their carbon dioxide emissions; Whereas this Directive aims to preserve the quality of the environment and to ensure a prudent and rational utilization of natural resources, which are matters of non-exclusive Community competence; Whereas a collective effort by all Member States, implying measures at Community level, is necessary in order to limit carbon dioxide emissions and to promote the rational use of energy; Whereas the measures are to be determined according to the principle of subsidiarity by Member States on the basis of potential improvements in energy efficiency, cost effectiveness, technical feasibility and environmental impact; Whereas, by providing objective information on the energy characteristics of buildings, energy certification will help to improve transparency of the property market and to encourage investment in energy savings; Whereas the billing, to occupiers of buildings, of heating, air-conditioning and hot water costs calculated, in an appropriate proportion, on the basis of actual consumption will contribute towards energy saving in the residential sector; whereas it is desirable that occupants of such buildings should be enabled to regulate their own consumption of heat, cold and hot water; whereas the recommendations and resolutions adopted by the Council on the billing of heating and hot water costs (6) have been applied in only two Member States; whereas a significant proportion of heating, air-conditioning and hot water costs are still being billed on the basis of factors other than energy consumption; Whereas new methods of financial support are needed to promote investments in energy saving in the public sector; whereas, with that in mind, the Member States should permit and make full use of the possibilities offered by third-party financing; Whereas buildings will have an impact on long-term energy consumption; whereas new buildings should therefore be fitted with efficient thermal insulation tailored to the local climate; whereas this applies also to public authority buildings where the public authorities should set an example in taking environmental and energy considerations into account; Whereas regular maintenance of boilers contributes to maintaining their correct adjustment in accordance with the product specification and in that way to an optimal performance from an environmental and energy point of view; Whereas industry is generally willing to make more efficient use of energy to meet its own economic objectives; whereas energy audits in particular in undertakings with high energy consumption should be promoted to bring about significant improvements in energy efficiency in this sector; Whereas improving energy efficiency in all regions of the Community will strengthen economic and social cohesion in the Community, as provided for in Article 130a of the Treaty, Article 1 The purpose of this Directive is the attainment by Member States of the objective of limiting carbon dioxide emissions by improving energy efficiency, notably by means of drawing up and implementing programmes in the following fields: - energy certification of buildings, - the billing of heating, air-conditioning and hot water costs on the basis of actual consumption, - third-party financing for energy efficiency investments in the public sector, - thermal insulation of new buildings, - regular inspection of boilers, - energy audits of undertakings with high energy consumption. Programmes can include laws, regulations, economic and administrative instruments, information, education and voluntary agreements whose impact can be objectively assessed. Article 2 Member States shall draw up and implement programmes on the energy certification of buildings. Energy certification of buildings, which shall consist of a description of their energy characteristics, must provide information for prospective users concerning a building's energy efficiency. Whereas appropriate, certification may also include options for the improvement of these energy characteristics. Article 3 Member States shall draw up and implement programmes on the billing of heating, air-conditioning and hot water costs calculated, in an appropriate proportion, on the basis of actual consumption. These programmes shall enable the cost of these services to be apportioned among the users of all or part of a building on the basis of the specific quantities of heat, of cold and of hot water consumed by each occupier. This shall apply to buildings or parts of buildings supplied by a collective heating, air-conditioning or domestic hot water installation. Occupants of such buildings should be enabled to regulate their own consumption of heat, cold or hot water. Article 4 Member States shall draw up and implement programmes to permit third-party financing for energy efficiency investments in the public sector. For the purposes of this Directive, 'third-party financing' means the overall provision of auditing, installation, operation, maintenance and financing services for an energy efficiency investment, with recovery of the cost of these services being contingent, either wholly or in part, on the level of energy savings. Article 5 Member States shall draw up and implement programmes so that new buildings receive effective thermal insulation, taking a long-term view, on the basis of standards laid down by the Member States, taking account of climatic conditions or climatic areas and the intended use of the building. Article 6 Member States shall draw up and implement programmes on the regular inspection of heating installations of an effective rated output of more than 15 Kw with the aim of improving operating conditions from the point of view of energy consumption and of limiting carbon dioxide emissions. Article 7 Member States shall draw up and implement programmes with the aim of promoting the regular completion of energy audits of industrial undertakings with high energy consumption to improve their energy efficiency and limit emissions of carbon dioxide, and may make similar provisions for other undertakings with high energy consumption. Article 8 Member States shall determine the scope of the programmes referred to in Articles 1 to 7 on the basis of potential improvements in energy efficiency, cost-effectiveness, technical feasibility and environmental impact. Article 9 Member States shall report to the Commission every two years on the results of the measures taken to implement the programmes provided for in this Directive. In so doing, they shall inform the Commission of the choices they have made in their package of measures. In addition, they shall, on request, provide the Commission with justification for the content of the programmes, taking Article 8 into account. In considering Member States' reports, the Commission shall be assisted by the advisory committee referred to in Decision 91/565/EEC following the procedure referred to in Article 6 of that Decision. Article 10 1. Member States shall bring into force the laws, regulations and/or other measures as mentioned in Article 1 as necessary to comply with this Directive as soon as possible and not later than 31 December 1994. Member States are required to make all the necessary provisions to enable them to fulfil the objectives of this Directive. When Member States adopt laws or regulations for this purpose, such laws or regulations shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. This shall apply by analogy where the programmes are transposed in another form. 2. Member States shall communicate to the Commission the provisions of national law and/or other measures as mentioned in Article 1 which they adopt in the field covered by this Directive. Article 11 This Directive is addressed to the Member States.

31993L0075

1993

Council Directive 93/75/EEC of 13 September 1993 concerning minimum requirements for vessels bound for or leaving Community ports and carrying dangerous or polluting goods Having regard to the Treaty establishing the European Economic Community, and in particular Article 84 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the volume of dangerous or polluting goods carried by sea has been growing unabated, increasing the risk of serious accidents which continue to occur; Whereas it appears necessary to take all appropriate measures in order to avoid conditions likely to cause accidents of this type and to reduce the resulting damage when such accidents occur; whereas to that end minimum requirements must be observed by vessels bound for or leaving a Community port; Whereas better information could contribute to prevention and minimization of accidents; whereas better information will also enable the relevant authorities to take the necessary precautions with regard to vessels carrying dangerous or polluting goods bound for or leaving Community ports; Whereas, in accordance with the Solas and Marpol Conventions, information must be provided to the competent authorities about the nature and the location of the dangerous or polluting goods on board vessels; Whereas some regular scheduled services may be exempted from providing such information; Whereas, in order to reduce the accident risk, it is appropriate to stress certain navigation rules; Whereas IMO Resolution A 648 (16) 'urges Member Governments to ensure that ship reporting systems and reporting requirements comply as closely as possible with the general principles specified in its Annex'; Whereas to that end the competent authorities should, in case of an incident or circumstance at sea posing a threat to their coastline or to related interests, receive from the master of the vessel immediate information as regards the incident and the presence of dangerous or polluting goods on board so as to permit those authorities to take all necesary measures; Whereas, in addition, this Directive recalls what measures are available to Member States under international law; Whereas the Solas and Marpol Conventions oblige vessels to inform the other vessels and the coastal authorities of danger for the vessel itself, for other vessels and for maritime navigation, as well as of actual or probable unpermitted or abnormal discharge of polluting goods; whereas it seems appropriate that the relevant authorities shall, as necessary, broadcast the information made available to them; Whereas each Member State should make the necessary arrangements to use fully such information; Whereas such exchange of information imposes an appropriate cooperation between authorities from all over the Community, shippers, operators of vessels, masters and pilots; Whereas the implementation of the Directive may require some amendments which will be adopted by the Commission assisted by a committee or, in given circumtances, by the Council itself; Whereas the Commission should produce new proposals to complete the sytem laid down by this Directive; Whereas this Directive repeals Council Directive 79/116/EEC of 21 December 1978 concerning minimum requirements for certain tankers entering or leaving Community ports (4); Whereas this Directive does not affect the right of Member States to impose additional requirements in respect of vessels, Article 1 1. Member States take all necessary and appropriate measures to ensure that the masters or operators of vessels bound for or leaving a Community port and carrying dangerous or polluting goods in bulk or in packaged form, as well as shippers of such goods observe the minimum requirements addressed to them under this Directive. 2. This Directive shall not apply to: (a) warships and other official ships used for non-commercial purposes; (b) bunkers, stores and equipment for use on board ships. Article 2 For the purpose of this Directive: (a) 'operators' includes the owners, charterers, managers or agents of the vessel; (b) 'vessel' means any cargo vessel, oil, chemical or gas tanker or passenger vessel bound for or leaving a Community port and carrying dangerous or polluting goods in bulk or in packaged form; (c) 'dangerous goods' means goods classified in the IMDG Code, in Chapter 17 of the IBC Code and in Chapter 19 of the IGC Code; (d) 'polluting goods' means: - oils as defined in Marpol Annex 1, - noxious liquid substances as defined in Marpol Annex 2, - harmful substances as defined in Marpol Annex 3; (e) 'Marpol' means the International Convention for the prevention of pollution from ships, 1973 and its 1978 Protocol, as it is in force at the time of adoption of this Directive; (f) 'IMDG Code' means the International Maritime Dangerous Goods Code, as it is in force at the time of adoption of this Directive; (g) 'IBC Code' means the IMO International Code for construction and equipment of ships carrying dangerous chemicals in bulk, as it is in force at the time of adoption of this Directive; (h) 'IGC Code' means the IMO International Code for the construction and equipment of ships carrying liquefied gases in bulk, as it is in force at the time of adoption of this Directive; (i) 'IMO Resolution A 648 (16)' means the International Maritime Organization Resolution 648 (16) adopted by the Assembly at its sixteenth session on 19 October 1989 and entitled 'General principles for ship reporting systems and ship reporting requirements, including guidelines for reporting incidents involving dangerous goods, harmful substances and/or marine pollutants', as it is in force at the time of adoption of this Directive; (j) 'competent authorities' are the authorities and organizations designated by Member States in accordance with Article 3; (k) 'shipper' means any person by whom or in whose name or on whose behalf a contract of carriage of goods by sea has been concluded with a carrier. Article 3 Member States shall designate, and inform the Commission of, the competent authorities to which the information and notifications provided for in this Directive shall be addressed. The Commission shall publish the list of the competent authorities and their communication links designated by Member States. Article 4 No dangerous or polluting goods shall be offered for carriage or taken on board any vessel unless a declaration has been delivered to the master or operator containing the correct technical names of the dangerous or polluting goods, the United Nations (UN) numbers where they exist, the IMO hazard classes in accordance with the IMDG, IBC and IGC Codes, the quantities of such goods and, if in portable tanks or freight containers, their identification marks. It shall be the duty of the shipper to deliver to the master or operator the declaration required by this Directive and to ensure that the shipment offered for carriage is indeed the one declared in compliance with the first subparagraph. Article 5 1. Each Member State shall make the necessary arrangements to apply the requirements set out in the following paragraph to any vessel. 2. The operator of a vessel leaving a port in a Member State shall notify before departure of the vessel all information listed in Annex I to the competent authority of that Member State. 3. The operator of a vessel coming from a port located outside the Community and bound for a port located in the Community or an anchorage located in a Member State's territorial waters shall, as a condition for the entry into that port or anchorage, notify on departure from the loading port, all information listed in Annex I to the competent authority of the Member State in which the first port of destination or anchorage is located. 4. Member States may exempt regular scheduled services of less than one hour's crossing time from the application of paragraphs 2 and 3. The Commission may, on request from a Member State, agree to a reasonable extension of this period. In this case, the information in Annex I must at all times be made available by the operator upon request by the authorities of the Member States of departure or destination. 5. Vessels entering or leaving a port located in a Member State shall in accordance with the national regulations of that State: (a) make use of the service provided by the local vessel traffic service (VTS), where they exist; (b) make use of pilots. Article 6 1. Each Member State shall require that, in the case of an incident or circumstance at sea which poses a threat to its coastline or related interest, the master of the vessel concerned shall at least provide immediate information to the competent authority of the Member State concerned as to the particulars of the incident and the information in Annex I. The competent authority may consider that the obligation to report the information in Annex I is satisfied if the vessel indicates which competent authority within the Community is holding the information required by Article 5. 2. The notification provided for in paragraph 1 shall be effected in accordance with IMO Resolution A 648 (16) and shall be made at least in all circumstances set out in that Resolution. 3. Annex III sets out what measures are available to Member States under international law. Article 7 Articles 5 and 6 shall be without prejudice to existing requirements imposed as a result of international conventions or national port notification arrangements. Article 8 1. The master of the vessels shall complete truly and accurately a check list as reproduced in Annex II to this Directive and make it available to the pilot for his information and to the competent authority, if it so requests. 2. Pilots engaged in berthing, unberthing or manoeuvring vessels shall immediately inform the competent authority whenever they learn that there are deficiencies which may prejudice the safe navigation of the vessel. Article 9 The competent authority of the Member State concerned shall, as necessary, broadcast within the relevant areas any incident notified under Article 6 (1) and information with regard to any vessel which poses a threat to other shipping. Article 10 The competent authorities holding the information as notified in accordance with Articles 5 and 6 (1) shall make adequate arrangements to provide such information at any time upon request for safety reasons by the competent authority of another Member State. Any Member State the competent authorities of which have been informed, in accordance with this Directive or in some other way, of facts which involve or increase the risk for another Member State of a hazard being posed to certain maritime and coastal zones, shall take whatever measures are appropriate to inform the Member State concerned thereof as soon as possible. Each Member State shall make the necessary arrangements to use fully the reports which the vessels are obliged to transmit to them in the event of an incident which may cause very serious damage. Article 11 This Directive may be amended in accordance with the procedure laid down in Article 12 in order to: - apply, for the purposes of this Directive, subsequent amendments which have entered into force to the International Convention, Codes and Resolution referred to in Article 2 (e), (f), (g), (h) and (i), - adapt the implementation of this Directive in the light of scientific and technical progress, without broadening its scope. Article 12 1. The Commission shall be assisted by a committee composed of 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 accorance 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 eight weeks from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 13 1. The Commission shall submit a report to the Council by 31 December 1995, together with proposals as necessary, concerning the implementation of this Directive. 2. The Commission shall also, as soon as possible and in any case by 31 December 1993, produce new proposals for the introduction of a fuller reporting system for the Community. These proposals may cover vessels transiting along the coasts of Member States and include electronic data interchange systems between vessels and shore-based installations. Article 14 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive no later than 12 months after adoption of this Directive. They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States. 3. The obligations deriving from this Directive shall take effect 24 months after adoption of this Directive. 4. Member States shall communicate to the Commission, no later than 12 months after the adoption of this Directive, the texts of the basic provisions of national law which they adopt in the field governed by this Directive. In addition, these provisions shall be communicated via the national warning and information services to the maritime sector. Article 15 Directive 79/116/EEC shall be repealed 24 months after the adoption of this Directive. Article 16 This Directive is addressed to the Member States.

31993L0079

1993

COMMISSION DIRECTIVE 93/79/EEC of 21 September 1993 setting out additional implementing provisions for lists of varieties of fruit plant propagating material and fruit plants, as kept by suppliers under Council Directive 92/34/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (1), as amended by Commission Decision 93/401/EEC (2), and in particular Article 9 (6) thereof, Whereas a system of description of varieties already exists at an international level; whereas the International Union for the Protection of New Varieties of Plants (UPOV) has developed such a system; Whereas it is desirable to base the Community system on the experience gained at international level; Whereas suppliers whose activity is confined to the placing on the market of fruit plant propagating material and fruit plants should be subject to less onerous requirements; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Plants of Fruit Genera and Species, Article 1 This Directive establishes additional implementing provisions for lists of varieties of fruit plant propagating material and fruit plants as kept by suppliers pursuant to Article 9 (2) (ii) of Directive 92/34/EEC. Article 2 1. The lists kept by suppliers shall include the following: (i) the name of the variety, together with its commonly known synonyms, where appropriate; (ii) indications as to the maintenance of the variety and propagation system applied; (iii) description of the variety at least on the basis of the characteristics and their expressions as specified in the Annex hereto; (iv) if possible, indications as to how the variety differs from the other varieties most closely resembling it. 2. Subparagraphs (ii) and (iv) of paragraph 1 shall not apply to any supplier whose activity is confined to the placing on the market of fruit plant propagating material or fruit plants. Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive. Article 4 This Directive is addressed to the Member States.

31993L0078

1993

Commission Directive 93/78/EEC of 21 September 1993 setting out additional implementing provisions for lists of varieties of ornamental plant propagating material and ornamental plants, as kept by suppliers under Council Directive 91/682/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 91/682/EEC of 19 December 1991 on the marketing of ornamental plant propagating material and ornamental plants (1), as amended by Commission Decision 93/399/EEC (2), and in particular Article 9 (5) thereof, Whereas a system of description of varieties already exists at an international level; whereas the International Union for the Protection of New Varieties of Plants (UPOV) has developed such a system; Whereas it is desirable to base the Community system on the experience gained at international level; Whereas suppliers whose activity is confined to the placing on the market of propagating material and ornamental plants should be subject to less onerous requirements; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Propagating Material and Ornamental Plants, Article 1 This Directive establishes additional implementing provisions for lists of varieties of propagating material and ornamental plants, as kept by suppliers pursuant to the second indent of Article 9 (2) of Directive 91/682/EEC. Article 2 1. The lists kept by suppliers shall include the following: (i) the name of the variety, together with its commonly known synonyms, where appropriate; (ii) indications as to the maintenance of the variety and propagation system applied; (iii) description of the variety, at least on the basis of the characteristics and their expressions as specified in the Annex hereto; (iv) if possible, indications as to how the variety differs from the other varieties most closely resembling it. 2. Subparagraphs (ii) and (iv) of paragraph 1 shall not apply to any supplier whose activity is confined to the placing on the market of propagating material and ornamental plants. Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive. Article 4 This Directive is addressed to the Member States.

31993L0083

1993

COUNCIL DIRECTIVE 93/83/EEC of 27 September 1993 on the coordination of certain rules concerning copyright and rights related to copyright applicable to satellite broadcasting and cable retransmission Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57(2) and 66 thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), (1) Whereas the objectives of the Community as laid down in the Treaty include establishing an ever closer union among the peoples of Europe, fostering closer relations between the States belonging to the Community and ensuring the economic and social progress of the Community countries by common action to eliminate the barriers which divide Europe; (2) Whereas, to that end, the Treaty provides for the establishment of a common market and an area without internal frontiers; whereas measures to achieve this include the abolition of obstacles to the free movement of services and the institution of a system ensuring that competition in the common market is not distorted; whereas, to that end, the Council may adopt directives for the coordination of the provisions laid down by law, regulation or administrative action in Member States concerning the taking up and pursuit of activities as self-employed persons; (3) Whereas broadcasts transmitted across frontiers within the Community, in particular by satellite and cable, are one of the most important ways of pursuing these Community objectives, which are at the same time political, economic, social, cultural and legal; (4) Whereas the Council has already adopted 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 (4), which makes provision for the promotion of the distribution and production of European television programmes and for advertising and sponsorship, the protection of minors and the right of reply; (5) Whereas, however, the achievement of these objectives in respect of cross-border satellite broadcasting and the cable retransmission of programmes from other Member States is currently still obstructed by a series of differences between national rules of copyright and some degree of legal uncertainty; whereas this means that holders of rights are exposed to the threat of seeing their works exploited without payment of remuneration or that the individual holders of exclusive rights in various Member States block the exploitation of their rights; whereas the legal uncertainty in particular constitutes a direct obstacle in the free circulation of programmes within the Community; (6) Whereas a distinction is currently drawn for copyright purposes between communication to the public by direct satellite and communication to the public by communications satellite; whereas, since individual reception is possible and affordable nowadays with both types of satellite, there is no longer any justification for this differing legal treatment; (7) Whereas the free broadcasting of programmes is further impeded by the current legal uncertainty over whether broadcastsing by a satellite whose signals can be received directly affects the rights in the country of transmission only or in all countries of reception together; whereas, since communications satellites and direct satellites are treated alike for copyright purposes, this legal uncertainty now affects almost all programmes broadcast in the Community by satellite; (8) Whereas, furthermore, legal certainty, which is a prerequisite for the free movement of broadcasts within the Community, is missing where programmes transmitted across frontiers are fed into and retransmitted through cable networks; (9) Whereas the development of the acquisition of rights on a contractual basis by authorization is already making a vigorous contribution to the creation of the desired European audiovisual area; whereas the continuation of such contractual agreements should be ensured and their smooth application in practice should be promoted wherever possible; (10) Whereas at present cable operators in particular cannot be sure that they have actually acquired all the programme rights covered by such an agreement; (11) Whereas, lastly, parties in different Member States are not all similarly bound by obligations which prevent them from refusing without valid reason to negotiate on the acquisition of the rights necessary for cable distribution or allowing such negotiations to fail; (12) Whereas the legal framework for the creation of a single audiovisual area laid down in Directive 89/552/EEC must, therefore, be supplemented with reference to copyright; (13) Whereas, therefore, an end should be put to the differences of treatment of the transmission of programmes by communications satellite which exist in the Member States, so that the vital distinction throughout the Community becomes whether works and other protected subject matter are communicated to the public; whereas this will also ensure equal treatment of the suppliers of cross-border broadcasts, regardless of whether they use a direct broadcasting satellite or a communications satellite; (14) Whereas the legal uncertainty regarding the rights to be acquired which impedes cross-border satellite broadcasting should be overcome by defining the notion of communication to the public by satellite at a Community level; whereas this definition should at the same time specify where the act of communication takes place; whereas such a definition is necessary to avoid the cumulative application of several national laws to one single act of broadcasting; whereas communication to the public by satellite occurs only when, and in the Member State where, the programme-carrying signals are introduced under the control and responsibility of the broadcasting organization into an uninterrupted chain of communication leading to the satellite and down towards the earth; whereas normal technical procedures relating to the programme-carrying signals should not be considered as interruptions to the chain of broadcasting; (15) Whereas the acquisition on a contractual basis of exclusive broadcasting rights should comply with any legislation on copyright and rights related to copyright in the Member State in which communication to the public by satellite occurs; (16) Whereas the principle of contractual freedom on which this Directive is based will make it possible to continue limiting the exploitation of these rights, especially as far as certain technical means of transmission or certain language versions are concerned; (17) Whereas, in ariving at the amount of the payment to be made for the rights acquired, the parties should take account of all aspects of the broadcast, such as the actual audience, the potential audience and the language version; (18) Whereas the application of the country-of-origin principle contained in this Directive could pose a problem with regard to existing contracts; whereas this Directive should provide for a period of five years for existing contracts to be adapted, where necessary, in the light of the Directive; whereas the said country-of-origin principle should not, therefore, apply to existing contracts which expire before 1 January 2000; whereas if by that date parties still have an interest in the contract, the same parties should be entitled to renegotiate the conditions of the contract; (19) Whereas existing international co-production agreements must be interpreted in the light of the economic purpose and scope envisaged by the parties upon signature; whereas in the past international co-production agreements have often not expressly and specifically addressed communication to the public by satellite within the meaning of this Directive a particular form of exploitation; whereas the underlying philosophy of many existing international co-production agreements is that the rights in the co-production are exercised separately and independently by each co-producer, by dividing the exploitation rights between them along territorial lines; whereas, as a general rule, in the situation where a communication to the public by satellite authorized by one co-producer would prejudice the value of the exploitation rights of another co-producer, the interpretation of such an existing agreement would normally suggest that the latter co-producer would have to give his consent to the authorization, by the former co-producer, of the communication to the public by satellite; whereas the language exclusivity of the latter co-producer will be prejudiced where the language version or versions of the communication to the public, including where the version is dubbed or subtitled, coincide(s) with the language or the languages widely understood in the territory allotted by the agreement to the latter co-producer; whereas the notion of exclusivity should be understood in a wider sense where the communication to the public by satellite concerns a work which consists merely of images and contains no dialogue or subtitles; whereas a clear rule is necessary in cases where the international co-production agreement does not expressly regulate the division of rights in the specific case of communication to the public by satellite within the meaning of this Directive; (20) Whereas communications to the public by satellite from non-member countries will under certain conditions be deemed to occur within a Member State of the Community; (21) Whereas it is necessary to ensure that protection for authors, performers, producers of phonograms and broadcasting organizations is accorded in all Member States and that this protection is not subject to a statutory licence system; whereas only in this way is it possible to ensure that any difference in the level of protection within the common market will not create distortions of competition; (22) Whereas the advent of new technologies is likely to have an impact on both the quality and the quantity of the exploitation of works and other subject matter; (23) Whereas in the light of these developments the level of protection granted pursuant to this Directive to all rightholders in the areas covered by this Directive should remain under consideration; (24) Whereas the harmonization of legislation envisaged in this Directive entails the harmonization of the provisions ensuring a high level of protection of authors, performers, phonogram producers and broadcasting organizations; whereas this harmonization should not allow a broadcasting organization to take advantage of differences in levels of protection by relocating activities, to the detriment of audiovisual productions; (25) Wheres the protection provided for rights related to copyright should be aligned on that contained in Council Directive 92/100/EEC of 19 November 1992 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (5) for the purposes of communication to the public by satellite; whereas, in particular, this will ensure that peformers and phonogram producers are guaranteed an appropriate remuneration for the communication to the public by satellite of their performances or phonograms; (26) Whereas the provisions of Article 4 do not prevent Member States from extending the presumption set out in Article 2 (5) of Directive 92/100/EEC to the exclusive rights referred to in Article 4; whereas, furthermore, the provisions of Article 4 do not prevent Member States from providing for a rebut-table presumption of the authoriztion of exploitation in respect of the exclusive rights of performers referred to in that Article, in so far as such presumption is compatible with the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations; (27) Whereas the cable retransmission of programmes from other Member States is an act subject to copyright and, as the case may be, rights related to copyright; whereas the cable operator must, therefore, obtain the authorization from every holder of rights in each part of the programme retransmitted; whereas, pursuant to this Directive, the authorizations should be granted contractually unless a temporary exception is provided for in the case of existing legal licence schemes; (28) Whereas, in order to ensure that the smooth operation of contractual arrangements is not called into question by the intervention of outsiders holding rights in individual parts of the programme, provision should be made, through the obligation to have recourse to a collecting society, for the exclusive collective exercise of the authorization right to the extent that this is required by the special features of cable retransmission; whereas the authorization right as such remains intact and only the exercise of this right is regulated to some extent, so that the right to authorize a cable retransmission can still be assigned; whereas this Directive does not affect the exercise of moral rights; (29) Whereas the exemption provided for in Article 10 should not limit the choice of holders of rights to transfer their rights to a collecting society and thereby have a direct share in the remuneration paid by the cable distributor for cable retransmission; (30) Whereas contractual arrangements regarding the authorization of cable retransmission should be promoted by additional measures; whereas a party seeking the conclusion of a general contract should, for its part, be obliged to submit collective proposals for an agreement; whereas, furthermore, any party shall be entitled, at any moment, to call upon the assistance of impartial mediators whose task is to assist negotiations and who may submit proposals; whereas any such proposals and any opposition thereto should be served on the parties concerned in accordance with the applicable rules concerning the service of legal documents, in particular as set out in existing international conventions; whereas, finally, it is necessary to ensure that the negotiations are not blocked without valid justification or that individual holders are not prevented without valid justification from taking part in the negotiations; whereas none of these measures for the promotion of the acquisition of rights calls into question the contractual nature of the acquisition of cable retransmission rights; (31) Whereas for a transitional period Member States should be allowed to retain existing bodies with jurisdiction in their territory over cases where the right to retransmit a programme by cable to the public has been unreasonably refused or offered on unreasonable terms by a broadcasting organization; whereas it is understood that the right of parties concerned to be heard by the body should be guaranteed and that the existence of the body should not prevent the parties concerned from having normal access to the courts; (32) Whereas, however, Community rules are not needed to deal with all of those matters, the effects of which perhaps with some commercially insignificant exceptions, are felt only inside the borders of a single Member State; (33) Whereas minimum rules should be laid down in order to establish and guarantee free and uninterrupted cross-border broadcasting by satellite and simultaneous, unaltered cable retransmission of programmes broadcast from other Member States, on an essentially contractual basis; (34) Whereas this Directive should not prejudice further harmonization in the field of copyright and rights related to copyright and the collective administration of such rights; whereas the possibility for Member States to regulate the activities of collecting societies should not prejudice the freedom of contractual negotiation of the rights provided for in this Directive, on the understanding that such negotiation takes place within the framework of general or specific national rules with regard to competition law or the prevention of abuse of monopolies; (35) Whereas it should, therefore, be for the Member States to supplement the general provisions needed to achieve the objectives of this Directive by taking legislative and administrative measures in their domestic law, provided that these do not run counter to the objectives of this Directive and are compatible with Community law; (36) Whereas this Directive does not affect the applicability of the competition rules in Articles 85 and 86 of the Treaty, CHAPTER I DEFINITIONS Article 1 Definitions 1. For the purpose of this Directive, ‘satellite’ means any satellilte operating on frequency bands which, under telecommunications law, are reserved for the broadcast of signals for reception by the public or which are reserved for closed, point-to-point communication. In the latter case, however, the circumstances in which individual reception of the signals takes place must be comparable to those which apply in the first case. 2. (a) For the purpose of this Directive, ‘communication to the public by satellite’ means the act of introducing, under the control and responsibility of the broadcasting organization, the programme-carrying signals intended for reception by the public into an uninterrupted chain of communication leading to the satellite and down towards the earth. (b) The act of communication to the public by satellite occurs solely in the Member State where, under the control and responsibility of the broadcasting organization, the programme-carrying signals are introduced into an uninterrupted chain of communication leading to the satellite and down towards the earth. (c) If the programme-carrying signals are encrypted, then there is communication to the public by satellite on condition that the means for decrypting the broadcast are provided to the public by the broadcasting organization or with its consent. (d) Where an act of communication to the public by satellite occurs in a non-Community State which does not provide the level of protection provided for under Chapter II, (i) if the programme-carrying signals are transmitted to the satellite from an uplink situation situated in a Member State, that act of communication to the public by satellite shall be deemed to have occurred in that Member State and the rights provided for under Chapter II shall be exercisable against the person operating the uplink station; or (ii) if there is no use of an uplink station situated in a Member State but a broadcasting organization established in a Member State has commissioned the act of communication to the public by satellite, that act shall be deemed to have occured in the Member State in which the broadcasting organization has its principal establishment in the Community arid the rights provided for under Chapter II shall be exercisable against the broadcasting organization. 3. For the purposes of this Directive, ‘cable retransmission’ means the simultaneous, unaltered and unabridged retransmission by a cable or microwave system for reception by the public of an initial transmission from another Member State, by wire or over the air, including that by satellite, of television or radio programmes intended for reception by the public. 4. For the purposes of this Directive ‘collecting society’ means any organization which manages or administers copyright or rights related to copyright as its sole purpose or as one of its main purposes. 5. For the purposes of this Directive, the principal director of a cinematographic or audiovisual work shall be considered as its author or one of its authors. Member States may provide for others to be considered as its co-authors. CHAPTER II BROADCASTING OF PROGRAMMES BY SATELLITE Article 2 Broadcasting right Member States shall provide an exclusive right for the author to authorize the communication to the public by satellite of copyright works, subject to the provisions set out in this chapter. Article 3 Acquisition of broadcasting rights 1. Member States shall ensure that the authorization referred to in Article 2 may be acquired only be agreement. 2. A Member State may provide that a collective agreement between a collecting society and a broadcasting organization concerning a given category of works may be extended to rightholders of the same category who are not represented by the collecting society, provided that: — the communication to the public by satellite simulcasts a terrestrial broadcast by the same broadcaster, and — the unrepresented rightholder shall, at any time, have the possibility of excluding the extension of the collective agreement to his works and of exercising his rights either individually or collectively. 3. Paragraph 2 shall not apply to cinematographic works, including works created by a process analogous to cinematography. 4. Where the law of a Member State provides for the extension of a collective agreement in accordance with the provisions of paragraph 2, that Member States shall inform the Commission which broadcasting organizations are entitled to avail themselves of that law. The Commission shall publish this information in the Official Journal of the European Communities (C series). Article 4 Rights of performers, phonogram producers and broadcasting organizations 1. For the purposes of communication to the public by satellite, the rights of performers, phonogram producers and broadcasting organizations shall be protected in accordance with the provisions of Articles 6, 7, 8 and 10 of Directive 92/100/EEC. 2. For the purposes of paragraph 1, ‘broadcasting by wireless means’ in Directive 92/100/EEC shall be understood as including communication to the public by satellite. 3. With regard to the exercise of the rights referred to in paragraph 1, Articles 2 (7) and 12 of Directive 92/100/EEC shall apply. Article 5 Relation between copyright and related rights Protection of copyright-related rights under this Directive shall leave intact and shall in no way affect the protection of copyright. Article 6 Minimum protection 1. Member States may provide for more far-reaching protection for holders of rights related to copyright than that required by Article 8 of Directive 92/100/EEC. 2. In applying paragraph 1 Member States shall observe the definitions contained in Article 1 (1) and (2). Article 7 Transitional provisions 1. With regard to the application in time of the rights referred to in Article 4 (1) of this Directive, Article 13 (1), (2), (6) and (7) of Directive 92/100/EEC shall apply. Article 13 (4) and (5) of Directive 92/100/EEC shall apply mutatis mutandis. 2. Agreements concerning the exploitation of works and other protected subject matter which are in force on the date mentioned in Article 14 (1) shall be subject to the provisions of Articles 1 (2), 2 and 3 as from 1 January 2000 if they expire after that date. 3. When an international co-production agreement concluded before the date mentioned in Article 14 (1) between a co-producer from a Member State and one or more co-producers from other Member States or third countries expressly provides for a system of division of exploitation rights between the co-producers by geographical areas for all means of communication to the public, without distinguishing the arrangement applicable to communication to the public by satellite from the provisions applicable to the other means of communication, and where communication to the public by satellite of the co-production would prejudice the exclusivity, in particular the language exclusivity, of one of the co-producers or his assignees in a given territory, the authorization by one of the co-producers or his assignees for a communication to the public by satellite shall require the prior consent of the holder of that exclusivity, whether co-producer or assignee. CHAPTER III CABLE RETRANSMISSION Article 8 Cable retransmission right 1. Member States shall ensure that when programmes from other Member States are retransmitted by cable in their territory the applicable copyright and related rights are observed and that such retransmission takes place on the basis of individual or collective contractual agreements between copyright owners, holders of related rights and cable operators. 2. Notwithstanding paragraph 1, Member States may retain until 31 December 1997 such statutory licence systems which are in operation or expressly provided for by national law on 31 July 1991. Article 9 Exercise of the cable retransmission right 1. Member States shall ensure that the right of copyright owners and holders or related rights to grant or refuse authorization to a cable operator for a cable retransmission may be exercised only through a collecting society. 2. Where a rightholder has not transferred the management of his rights to a collecting society, the collecting society which manages rights of the same category shall be deemed to be mandated to manage his rights. Where more than one collecting society manages rights of that category, the rightholder shall be free to choose which of those collecting societies is deemed to be mandated to manage his rights. A rightholder referred to in this paragraph shall have the same rights and obligations resulting from the agreement between the cable operator and the collecting society which is deemed to be mandated to manage his rights as the rightholders who have mandated that collecting society and he shall be able to claim those rights within a period, to be fixed by the Member State concerned, which shall not be shorter than three years from the date of the cable retransmission which includes his work or other protected subject matter. 3. A Member State may provide that, when a right-holder authorizes the initial transmission within its territory of a work or other protected subject matter, he shall be deemed to have agreed not to exercise his cable retransmission rights on an individual basis but to exercise them in accordance with the provisions of this Directive. Article 10 Exercise of the cable retransmission right by broadcasting organizations Member States shall ensure that Article 9 does not apply to the rights exercised by a broadcasting organization in respect of its own transmission, irrespective of whether the rights concerned are its own or have been transferred to it by other copyright owners and/or holders of related rights. Article 11 Mediators 1. Where no agreement is concluded regarding authorization of the cable retransmission of a broadcast. Member States shall ensure that either party may call upon the assistance of one or more mediators. 2. The task of the mediators shall be to provide assistance with negotiation. They may also submit proposals to the parties. 3. It shall be assumed that all the parties accept a proposal as referred to in paragraph 2 if none of them expresses its opposition within a period of three months. Notice of the proposal and of any opposition thereto shall be served on the parties concerned in accordance with the applicable rules concerning the service of legal documents. 4. The mediators shall be so selected that their independence and impartiality are beyond reasonable doubt. Article 12 Prevention of the abuse of negotiating positions 1. Member States shall ensure by means of civil or administrative law, as appropriate, that the parties enter and conduct negotiations regarding authorization for cable retransmission in good faith and do not prevent or hinder negotiation without valid justification. 2. A Member State which, on the date mentioned in Article 14 (1), has a body with jurisdiction in its territory over cases where the right to retransmit a programme by cable to the public in that Member State has been unreasonably refused or offered on unreasonable terms by a broadcasting organization may retain that body. 3. Paragraph 2 shall apply for a transitional period of eight years from the date mentioned in Article 14 (1). CHAPTER IV GENERAL PROVISIONS Article 13 Collective administration of rights This Directive shall be without prejudice to the regulation of the activities of collecting societies by the Member States. Article 14 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1995. They shall immediately inform the Commission thereof. When Member States adopt these measures, the latter shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. 3. Not later than 1 January 2000, 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 audio and audiovisual sector. Article 15 This Directive is addressed to the Member States.

31993L0081

1993

Commission Directive 93/81/EEC of 29 September 1993 adapting Council Directive 70/156/EEC relating to the type-approval of 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 relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 92/53/EEC (2), and in particular Article 13 (2) thereof, Whereas Council Directive 88/77/EEC of 3 December 1987 relating to the measures to be taken against the emission of gaseous pollutants from diesel engines for use in vehicles (3), as amended by Directive 91/542/EEC (4), reduced levels of gaseous pollutants from diesel engines for new vehicles sold, registered or entered into service with effect from 1 October 1993; Whereas Article 8 (2) (b) of Directive 70/156/EEC provides for the possibility of Member States granting for a limited period and for small quantities a derogation for 'end-of-series' vehicles; Whereas this derogation is limited by virtue of Annex XII B to Directive 70/156/EEC to vehicles of category M1; Whereas it is forecast that the total market for heavy commercial vehicles in the Community for 1993 will be 13 % less than the number which was sold in 1992; whereas this represents a 25 % reduction in the number of sales over a four-year period; Whereas experience has shown that, as a consequence of the severe downturn in the Community market for vehicles powered by diesel engines covered by Directive 88/77/EEC, there is likely to be a certain number of vehicles type-approved to the previous version of the Directive which will not have been sold before 1 October 1993; Whereas, in the absence of a directive to amend Annex XII B, the manufacturers of such vehicles would be either left with unsaleable stocks of such vehicles or required to take uneconomic measures to satisfy the requirements of the Directive; Whereas such an outcome would cause an additional economic burden on the producers and threaten their ability to invest in future technologically advanced products at a time when the Community market for such vehicles is already in a severe downturn; Whereas a similar problem is likely to arise in the future with regard to diesel-engined light commercial vehicles due to the unfavourable evolution of this market; Whereas it is necessary, in order to remedy the uneconomic commercial effects referred to above, to amend Directive 70/156/EEC by extending the 'end-of-series' derogation so that it applies to all categories of vehicle and not just to vehicles of category M1; Whereas the maximum number of vehicles which may benefit from the 'end-of-series' limits may not exceed 10 % of the vehicles of the types concerned put into service in that Member State during the previous year; whereas the overall impact of this amendment on the environment will be slight and temporary; Whereas the operation of the provisions of Directive 70/156/EEC on 'end-of-series' limits should be further clarified in order to find a definitive solution adapted to the needs of all vehicle categories including multi-stage build vehicles; whereas the Commission will examine this problem by 31 March 1994 and will make appropriate proposals to the Member States by that date; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Section B of Annex XII to Directive 70/156/EEC shall be amended by the deletion of the words: 'In the case of category M1,'. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1993. They shall forthwith inform the Commission thereof. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 3. Member States shall communicate to the Commission the text 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.

31993L0085

1993

COUNCIL DIRECTIVE 93/85/EEC of 4 October 1993 on the control of potato ring rot 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 potato production occupies an important place in Community agriculture; whereas the potato yield is constantly threatened by harmful organisms; Whereas, through the protection of potato cultivation against such harmful organisms, not only should productive capacity be maintained but agricultural productivity should also be increased; Whereas protective measures to prevent the introduction of harmful organisms into the territory of a Member State would have only a limited effect were such organisms not controlled simultaneously and methodically throughout the Community and not prevented from spreading; Whereas one of the harmful organisms on potatoes is Clavibacter michiganensis (Smith) Davis et al. ssp. sepedonicus (Spieckermann et Kotthoff) Davis et al., the pathogenic agent of the potato ring rot disease; whereas this disease has occurred in some parts of the Community and some limited sources of infection still exist; Whereas there is a considerable risk to potato cultivation throughout the Community if effective measures are not taken to locate this disease and determine its distribution, to prevent it from occurring and spreading, and, if found, to prevent its spread and to control it with the aim of eradication; Whereas, in order to ensure this, certain measures must be taken within the Community; whereas Member States must, in addition, be able to take additional or stricter measures where necessary, provided that there is no hindrance to the movement of potatoes within the Community, except in so far as laid down in 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 (4); whereas such measures must be notified to the other Member States and to the Commission; Whereas Council Directive 80/665/EEC of 24 June 1980 on the control of potato ring rot (5), laid down minimum measures to be taken by the Member States against potato ring rot; Whereas, since then, there have been significant developments in the understanding of potato ring rot disease and the detection of the potato ring rot pathogen; Whereas the application of the Community plant health regime to the Community as an area without internal frontiers has called for the re-examination and revision of some provisions of Directive 80/665/EEC; Whereas, as a result of such re-examination, the provisions of Directive 80/665/EEC have been found insufficient, and further specification of measures is necessary; Whereas, in that situation, Directive 80/665/EEC should be repealed and the necessary measures adopted; Whereas the measures have to take into account, first, that the disease can remain latend and unobserved both in the growing crop and in stored tubers, and so can be effectively prevented only by production and use of seed potatoes free from infection and, secondly, that systematic official surveys are necessary to locate it; whereas spread of the pathogen within the growing crop is not the most important factor, but whereas the pathogen can exist through the winter in self-sown (volunteer) potato plants and these are the major source of infection being carried from one season to the next; whereas the pathogen is spread mainly by the contamination of potatoes through contact with infected potatoes and through contact with planting, harvesting and handling equipment or transport and storage containers which have become contaminated with the organism by previous contact with infected potatoes; whereas such contaminated objects can remain infectious for some time after such contamination; whereas spread of the pathogen can be reduced or prevented by disinfection of such objects; whereas any such contamination of seed potatoes poses a major risk for the spread of the pathogen; Whereas, for the determination of the details of such general measures, as well as for those stricter or additional measures taken by Member States to prevent the introduction of the pathogen into their territory, it is desirable for Member States to cooperate closely with the Commission within the Standing Committee of Plant Health (hereinafter referred to as ‘the Committee’), Article 1 The Directive concerns the measures to be taken within the Member States against Clavibacter michiganensis (Smith) Davis et al. ssp. sepedonicus (Spieckermann et Kotthoff) Davis et al., the cause of potato ring rot (hereinafter referred to as ‘the organism’), in order to: (a) locate it and determine its distribution; (b) prevent its occurrence and spread; and (c) if found, to prevent its spread and to control it with the aim of eradication. Article 2 1. Member States shall conduct systematic official surveys for the organism on tubers and, where appropriate, on plants of potato (Solanum tuberosum L.) originating in their territory, for the confirmation of absence of the organism. For these surveys, in the case of tubers samples of both seed and other potatoes shall be taken, preferably from lots in store and subjected to official or officially supervised laboratory testing using the method set out in Annex I for the detection and diagnosis of the organism. In addition, where appropriate, official or officially supervised visual inspection by cutting of tubers on other samples may be done. In the case of plants, these surveys shall be carried out according to appropriate methods and the samples shall be subjected to appropriate official or officially supervised testing. The number, origin, stratification and timing of collection of samples shall be decided by the responsible official bodies within the meaning of Directive 77/93/EEC based on sound scientific and statistical principles and the biology of the organism, and taking into account the particular potato production systems of the Member States concerned. The details thereof shall be submitted annually to the other Member States and the Commission, with a view to ensuring comparable levels of assurance between Member States for confirmation of the absence of the organism. 2. The results of the official surveys provided for in paragraph 1 shall be notified at least once a year to the other Member States and to the Commission. The details of this notification shall be confidential. They may be submitted to the Committee in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC. 3. The following provisions may be adopted in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC; — the details of surveys provided for in paragraph 1 above, to be carried out in accordance with sound scientific and statistical principles, — the details of the notification provided for in paragraph 2 above. 4. The following provisions shall be adopted in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC: — the appropriate method for the surveys and the testing provided for in the third subparagraph of paragraph 1 above. Article 3 Member States shall ensure that the suspected occurrence or confirmed presence of the organism, in potato plants and tubers or harvested, stored or marketed tubers in their territory shall be reported to their own responsible official bodies. Article 4 1. In cases of suspected occurrence, the responsible official bodies of the Member State in which these cases have been reported shall ensure completion of official or officially supervised laboratory testing, using the method set out in Annex I, and in accordance with the conditions specified in point 1 of Annex II, in order to confirm or refute the suspected occurrence. In the former case, the requirements laid down in point 2 of Annex II shall apply. 2. Pending the confirmation or refutation of the suspected occurrence under paragraph 1, in those cases of suspect occurrence where, either: (i) suspect diagnostic visual symptoms of the disease have been seen; or, (ii) a positive immunofluorescence test as specified in Annex I or other appropriate positive test has been identified, the responsible official bodies of the Member States shall: (a) prohibit the movement of all lots or consignments from which the samples have been taken, except under their control and provided that it has been established that there is no identifiable risk of the organism spreading; (b) take steps to trace the origin of the suspected occurrence; (c) introduce appropriate additional precautionary measures based on the level of estimated risk, in order to prevent any spread of the organism. These measures may include the official control of the movement of all other tubers or plants within or off premises associated with the suspected occurrence. 3. The following provision may be adopted in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC: — the measures referred to in paragraph 2 (c) above. 4. The following provision shall be adopted in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC: — the other appropriate test provided for in paragraph 2 (ii) above; Article 5 1. If official or officially supervised laboratory testing using the method set out in Annex I confirms the presence of the organism in a sample of tubers, plants, or parts of plants, the responsible official bodies of a Member State, having regard to sound scientific principles, the biology of the organism and the particular production, marketing and processing systems in that Member State shall: (a) designate as contaminated the tubers or plants, consignment and/or lot, and the machinery, vehicle, vessel, store, or units thereof, and any other objects including packaging material, from which the sample was taken, and, where appropriate, the place(s) of production and field(s) from which the tubers or plants were harvested; (b) determine, taking into account the provisions of point 1 of Annex III, the extent of probable contamination through pre- or post-harvest contact or through production link with the designated contamination; (c) demarcate a zone on the basis of the designation of contamination under (a), the determination of the extent of probable contamination under (b), and the possible spread of the organism, taking into account the provisions of point 2 of Annex III. 2. Member States shall immediately notify the other Member States and the Commission, in accordance with the provisions of point 3 of Annex III, of any contamination designated under paragraph 1 (a) and the details of the zone demarcation under paragraph 1 (c). The details of this notification shall be confidential. They may be submitted to the Committee in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC. 3. As a result of the notification under paragraph 2 and the elements mentioned therein, other Member States detailed in the notification shall, as appropriate, designate contamination, determine the extent of probable contamination and demarcate a zone, in accordance with paragraph 1 (a), (b) and (c) respectively. Article 6 Member States shall prescribe that where tubers or plants have been designated to be contaminated under Article 5 (1) (a), testing in accordance with Article 4 (1) shall be carried out on potato stocks which are clonally related to those involved in the contamination. The testing shall be carried out on as many such tubers or plants as are needed to determine the probable primary source of infection and the extent of the probable contamination, preferably in order of degree of risk. As a result of the testing, further designation of contamination, determination of the extent of probable contamination and demarcation of a zone shall be conducted, as appropriate, under Articles 5 (1) (a), (b) and (c) respectively. Article 7 1. Member States shall prescribe that tubers or plants, designated to be contaminated under Article 5 (1) (a) may not be planted and that, under the control of their responsible official bodies, they shall be: — destroyed, or — otherwise disposed of, subject to officially supervised measure(s), in accordance with the provisions of point 1 of Annex IV, provided that it is established that there is no identifiable risk of the organism spreading. 2. Member States shall prescribe that tubers or plants determined as probably contaminated under Article 5(1) (b) may not be planted and, without prejudice to the outcome of the testing referred to in Article 6 for clonally related stocks shall, under the control of their responsible official bodies, be put to appropriate use or disposal as specified in point 2 of Annex IV, in such a way that it is established that there is no identifiable risk of the organism spreading. 3. Member States shall prescribe that any machinery, vehicle, vessel, store, or units thereof, and any other objects including packaging material, designated as contaminated under Article 5 (1) (a) or determined as probably contaminated under Article 5(1) (b), shall either be destroyed or cleansed and disinfected using appropriate methods as specified in point 3 of Annex IV. After disinfection, any such objects shall no longer be considered contaminated. 4. Without prejudice to the measures implemented under paragraphs 1, 2 and 3, Member States shall prescribe that, in the zone demarcated under Article 5 (1) (c), a series of measures, as specified in point 4 of Annex IV, shall be implemented. Article 8 1. Member States shall prescribe that seed potatoes shall meet the requirements of Directive 77/93/EEC and shall derive in direct line from material obtained under an officially approved programme which has been found free of the organism in official or officially supervised testing using the method set out in Annex I. The aforesaid testing shall be carried out: — in cases where the contamination affects seed potato production, on the plants of the initial clonal selection, — in other cases, either on the plants of the initial clonal selection or on representative samples of the basic seed potatoes or earlier propagations. 2. The following provisions may be adopted in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC: — the detailed rules of application of the first indent of the second subparagraph of paragraph 1 of this Article, — the rules concerning the representative samples provided for in the second indent of the second subparagraph of paragraph 1 of this Article. Article 9 Member States shall ban the holding and handling of the organism. Article 10 Without prejudice to the provisions of Directive 77/93/EEC, Member States may authorize derogations from the measures referred to in Articles 6, 7 and 9 of this Directive for experimental or scientific purposes, and for work on varietal selection, provided that such derogations do not prejudice the control of the organism and create no risk of spread of the organism. Article 11 Member States may adopt such additional or stricter measures as may be required to combat the organism or to prevent it from spreading, in so far as they are in compliance with the provisons of Directive 77/93/EEC. The additional measures mentioned in the first subparagraph may include the prescription that only seed potatoes may be planted that are either officially certified or officially inspected to meet the required plant health standards. The latter may apply in particular in case farmers are authorized to use, on their own holding, seed potatoes which they have obtained from their own harvest and in other cases that own-produced seed potatoes are planted. The details of these measures shall be notified to the other Member States and to the Commission. Article 12 Amendments to the Annexes to this Directive, to be made in the light of developments in scientific or technical knowledge, shall be adopted in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC. Article 13 1. By 15 November 1993 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by Member States. Member States shall apply these provisions from 16 November 1993. 2. Member States shall immediately communicate to the Commission all provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 14 Directive 80/665/EEC is hereby repealed with effect from 16 November 1993. Article 15 This Directive is addressed to the Member States.

31993L0086

1993

COMMISSION DIRECTIVE 93/86/EEC of 4 October 1993 adapting to technical progress Council Directive 91/157/EEC on batteries and accumulators containing certain dangerous substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 75/442/EEC of 15 July 1975 on waste (1), as last amended by Directive 91/692/EEC (2), and in particular Article 18 thereof, Having regard to Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances (3) and in particular Article 10 thereof, Whereas detailed arrangements should be established for the making system provided for in Article 4 of Directive 91/157/EEC; Whereas appliances need not be marked, since Annex II to Directive 91/157/EEC provides for a special information system for appliances from which the consumer cannot easily remove the battery or accumulator; Whereas there is a need for a symbol clearly showing that batteries or accumulators covered by Directive 91/157/EEC should be collected separately from other household waste; Whereas the use of this symbol for batteries and accumulators covered by Directive 91/157/EEC must be protected; Whereas the measures provided for in this Directive are in accordance with the opinion delivered by the Committee for the Adaptation to Scientific and Technical Progress of Community Legislation on Waste, Article 1 1. This Directive establishes the detailed arrangements for the marking system envisaged in Article 4 of Directive 91/157/EEC on batteries and accumulators covered by that Direcctive and manufactured for sale in, imported into, the Community on or after 1 January 1994. 2. The batteries and accumulators referred to in paragraph 1 which are produced in, or imported into, the Community before 1 January 1994 may be marketed without the symbols provided for in Articles 2 and 3 until 31 December 1995. Article 2 The symbol indicating separate collection shall consist of one of the roll-out containers crossed through, as shown below: The decision on the choice of symbol to be used on batteries and accumulators covered by Directive 91/157/EEC shall be made by the person responsible for marking as described in Article 5 of this Directive. The use of the two symbols shall be considered equivalent throughout the Community. Member States shall inform the public of the meaning of both symbols and grant them equal status in their national provisions regarding batteries and accumulators covered by Directive 91/157/EEC. The use of either symbol shall not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Article 3 The symbol indicating the heavy-metal content shall consist of the chemical symbol for the metal concerned, Hg, Cd or Pb according to the type of battery or accumulator concerned, as described in Annex I to Directive 91/157/EEC. Article 4 1. The symbol described in Article 2 shall cover 3 % of the area of the largest side of the battery or accumulator, up to a maximum size of 5 x 5 cm. For cylindrical cells the symbol shall cover 3 % of half the surface area of the battery or accumulator and shall have a maximum size of 5 x 5 cm. Where the size of the battery or accumulator is such that the symbol would be smaller than 0,5 x 0,5 cm, the battery or accumulator need not be marked but a symbol measuring 1 x 1 cm shall be printed on the packaging. 2. The symbol referred to in Article 3 shall be printed beneath the symbol referred to in Article 2. It shall cover an area of at least one quarter the size of the symbol described in paragraph 1 of this Article. 3. The symbols shall be printed visibly, legibly and indelibly. Article 5 Member States shall take the necessary steps to ensure that the marking complies with the provisions of this Directive and is carried out by the manufacturer or his authorized representative established in the Member State concerned or else by the person responsible for placing the batteries or accumulators on the national market. Article 6 Member States shall adopt appropriate measures to ensure full implementation of all the provisions of this Directive, in particular as regards observance of the symbols referred to in Articles 2 and 3. Member States shall lay down the penalties to be applied in the event of an infringement of the measures adopted to comply with this Directive; such penalties must be effective, proportionate and deterrent in their effect. Article 7 Member States shall take the measures necessary to comply with this Directive no later than 31 December 1993. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 8 This Directive is addressed to the Member States.

31993L0096

1993

Council Directive 93/96/EEC of 29 October 1993 on the right of residence for students Having regard to the Treaty establishing the European Economic Community, and in particular the second paragraph of Article 7 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 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, as the Court of Justice has held, Articles 128 and 7 of the Treaty prohibit any discrimination between nationals of the Member States as regards access to vocational training in the Community; whereas access by a national of one Member State to vocational training in another Member State implies, for that national, a right of residence in that other Member State; Whereas, accordingly, in order to guarantee access to vocational training, the conditions likely to facilitate the effective exercise of that right of residence should be laid down; Whereas the right of residence for students forms part of a set of related measures designed to promote vocational training; Whereas beneficiaries of the right of residence must not become an unreasonable burden on the public finances of the host Member State; Whereas, in the present state of Community law, as established by the case law of the Court of Justice, assistance granted to students, does not fall within the scope of the Treaty within the meaning of Article 7 thereof; Whereas the right of residence can only be genuinely exercised if it is also granted to the spouse and their dependent children; Whereas the beneficiaries of this Directive should be covered by administrative arrangements similar to those laid down in particular in Council Directive 68/360/EEC of 15 October 1968 on the abolition of restrictions on movement and residence within the Community for workers of Member States and their families (4) and Council Directive 64/221/EEC of 25 February 1964 on the coordination of special measures concerning the movement and residence of foreign nationals which are justified on grounds of public policy, public security or public health (5); Whereas this Directive does not apply to students who enjoy the right of residence by virtue of the fact that they are or have been effectively engaged in economic activities or are members of the family of a migrant worker; Whereas, by its judgment of 7 July 1992 in Case C-295/90, the Court of Justice annulled Council Directive 90/366/EEC of 28 June 1990 on the right of residence for students (1), while maintaining the effects of the annulled Directive until the entry into force of a directive adopted on the appropriate legal basis; Whereas the effects of Directive 90/366/EEC should be maintained during the period up to 31 December 1993, the date by which Member States are to have adopted the laws, regulations and administrative provisions necessary to comply with this Directive, Article 1 In order to lay down conditions to facilitate the exercise of the right of residence and with a view to guaranteeing access to vocational training in a non-discriminatory manner for a national of a Member State who has been accepted to attend a vocational training course in another Member State, the Member States shall recognize the right of residence for any student who is a national of a Member State and who does not enjoy that right under other provisions of Community law, and for the student's spouse and their dependent children, where the student assures the relevant national authority, by means of a declaration or by such alternative means as the student may choose that are at least equivalent, that he has sufficient resources to avoid becoming a burden on the social assistance system of the host Member State during their period of residence, provided that the student is enrolled in a recognized educational establishment for the principal purpose of following a vocational training course there and that he is covered by sickness insurance in respect of all risks in the host Member State. Article 2 1. The right of residence shall be restricted to the duration of the course of studies in question. 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 Community', the validity of which may be limited to the duration of the course of studies or to one year where the course lasts longer; in the latter event it shall be renewable annually. 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 and 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, Articles 2 to 9 of Directive 64/221/EEC shall apply. Article 3 This Directive shall not establish any entitlement to the payment of maintenance grants by the host Member State on the part of students benefiting from the right of residence. Article 4 The right of residence shall remain for as long as beneficiaries of that right fulfil the conditions laid down in Article 1. Article 5 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. The Commission shall pay particular attention to any difficulties to which the implementation of Article 1 might give rise in the Member States; it shall, if appropriate, submit proposals to the Council with the aim of remedying such difficulties. Article 6 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1993. They shall forthwith inform the Commission thereof. For the period preceding that date, the effects of Directive 90/366/EEC shall be maintained. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such references shall be laid down by the Member States. Article 7 This Directive is addressed to the Member States.

31993L0098

1993

Council Directive 93/98/EEC of 29 October 1993 harmonizing the term of protection of copyright and certain related rights Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57 (2), 66 and 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), (1) Whereas the Berne Convention for the protection of literary and artistic works and the International Convention for the protection of performers, producers of phonograms and broadcasting organizations (Rome Convention) lay down only minimum terms of protection of the rights they refer to, leaving the Contracting States free to grant longer terms; whereas certain Member States have exercised this entitlement; whereas in addition certain Member States have not become party to the Rome Convention; (2) Whereas there are consequently differences between the national laws governing the terms of protection of copyright and related rights, which are liable to impede the free movement of goods and freedom to provide services, and to distort competition in the common market; whereas therefore with a view to the smooth operation of the internal market, the laws of the Member States should be harmonized so as to make terms of protection identical throughout the Community; (3) Whereas harmonization must cover not only the terms of protection as such, but also certain implementing arrangements such as the date from which each term of protection is calculated; (4) Whereas the provisions of this Directive do not affect the application by the Member States of the provisions of Article 14a (2) (b), (c) and (d) and (3) of the Berne Convention; (5) Whereas the minimum term of protection laid down by the Berne Convention, namely the life of the author and 50 years after his death, was intended to provide protection for the author and the first two generations of his descendants; whereas the average lifespan in the Community has grown longer, to the point where this term is no longer sufficient to cover two generations; (6) Whereas certain Member States have granted a term longer than 50 years after the death of the author in order to offset the effects of the world wars on the exploitation of authors' works; (7) Whereas for the protection of related rights certain Member States have introduced a term of 50 years after lawful publication or lawful communication to the public; (8) Whereas under the Community position adopted for the Uruguay Round negotiations under the General Agreement on Tariffs and Trade (GATT) the term of protection for producers of phonograms should be 50 years after first publication; (9) Whereas due regard for established rights is one of the general principles of law protected by the Community legal order; whereas, therefore, a harmonization of the terms of protection of copyright and related rights cannot have the effect of reducing the protection currently enjoyed by rightholders in the Community; whereas in order to keep the effects of transitional measures to a minimum and to allow the internal market to operate in practice, the harmonization of the term of protection should take place on a long term basis; (10) Whereas in its communication of 17 January 1991 'Follow-up to the Green Paper - Working programme of the Commission in the field of copyright and neighbouring rights' the Commission stresses the need to harmonize copyright and neighbouring rights at a high level of protection since these rights are fundamental to intellectual creation and stresses that their protection ensures the maintenance and development of creativity in the interest of authors, cultural industries, consumers and society as a whole; (11) Whereas in order to establish a high level of protection which at the same time meets the requirements of the internal market and the need to establish a legal environment conducive to the harmonious development of literary and artistic creation in the Community, the term of protection for copyright should be harmonized at 70 years after the death of the author or 70 years after the work is lawfully made available to the public, and for related rights at 50 years after the event which sets the term running; (12) Whereas collections are protected according to Article 2 (5) of the Berne Convention when, by reason of the selection and arrangement of their content, they constitute intellectual creations; whereas those works are protected as such, without prejudice to the copyright in each of the works forming part of such collections, whereas in consequence specific terms of protection may apply to works included in collections; (13) Whereas in all cases where one or more physical persons are identified as authors the term of protection should be calculated after their death; whereas the question of authorship in the whole or a part of a work is a question of fact which the national courts may have to decide; (14) Whereas terms of protection should be calculated from the first day of January of the year following the relevant event, as they are in the Berne and Rome Conventions; (15) Whereas Article 1 of Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs (4) provides that Member States are to protect computer programs, by copyright, as literary works within the meaning of the Berne Convention; whereas this Directive harmonizes the term of protection of literary works in the Community; whereas Article 8 of Directive 91/250/EEC, which merely makes provisional arrangements governing the term of protection of computer programs, should accordingly be repealed; (16) Whereas Articles 11 and 12 of Council Directive 92/100/EEC of 19 November 1992 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (5) make provision for minimum terms of protection only, subject to any further harmonization; whereas this Directive provides such further harmonization; whereas these Articles should accordingly be repealed; (17) Whereas the protection of photographs in the Member States is the subject of varying regimes; whereas in order to achieve a sufficient harmonization of the term of protection of photographic works, in particular of those which, due to their artistic or professional character, are of importance within the internal market, it is necessary to define the level of originality required in this Directive; whereas a photographic work within the meaning of the Berne Convention is to be considered original if it is the author's own intellectual creation reflecting his personality, no other criteria such as merit or purpose being taken into account; whereas the protection of other photographs should be left to national law; (18) Whereas, in order to avoid differences in the term of protection as regards related rights it is necessary to provide the same starting point for the calculation of the term throughout the Community; whereas the performance, fixation, transmission, lawful publication, and lawful communication to the public, that is to say the means of making a subject of a related right perceptible in all appropriate ways to persons in general, should be taken into account for the calculation of the term of protection regardless of the country where this performance, fixation, transmission, lawful publication, or lawful communication to the public takes place; (19) Whereas the rights of broadcasting organizations in their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite, should not be perpetual; whereas it is therefore necessary to have the term of protection running from the first transmission of a particular broadcast only; whereas this provision is understood to avoid a new term running in cases where a broadcast is identical to a previous one; (20) Whereas the Member States should remain free to maintain or introduce other rights related to copyright in particular in relation to the protection of critical and scientific publications; whereas, in order to ensure transparency at Community level, it is however necessary for Member States which introduce new related rights to notify the Commission; (21) Whereas it is useful to make clear that the harmonization brought about by this Directive does not apply to moral rights; (22) Whereas, for works whose country of origin within the meaning of the Berne Convention is a third country and whose author is not a Community national, comparison of terms of protection should be applied, provided that the term accorded in the Community does not exceed the term laid down in this Directive; (23) Whereas where a rightholder who is not a Community national qualifies for protection under an international agreement the term of protection of related rights should be the same as that laid down in this Directive, except that it should not exceed that fixed in the country of which the rightholder is a national; (24) Whereas comparison of terms should not result in Member States being brought into conflict with their international obligations; (25) Whereas, for the smooth functioning of the internal market this Directive should be applied as from 1 July 1995; (26) Whereas Member States should remain free to adopt provisions on the interpretation, adaptation and further execution of contracts on the exploitation of protected works and other subject matter which were concluded before the extension of the term of protection resulting from this Directive; (27) Whereas respect of acquired rights and legitimate expectations is part of the Community legal order; whereas Member States may provide in particular that in certain circumstances the copyright and related rights which are revived pursuant to this Directive may not give rise to payments by persons who undertook in good faith the exploitation of the works at the time when such works lay within the public domain, Article 1 Duration of authors' rights 1. The rights of an author of a literary or artistic work within the meaning of Article 2 of the Berne Convention shall run for the life of the author and for 70 years after his death, irrespective of the date when the work is lawfully made available to the public. 2. In the case of a work of joint authorship the term referred to in paragraph 1 shall be calculated from the death of the last surviving author. 3. In the case of anonymous or pseudonymous works, the term of protection shall run for seventy years after the work is lawfully made available to the public. However, when the pseudonym adopted by the author leaves no doubt as to his identity, or if the author discloses his identity during the period referred to in the first sentence, the term of protection applicable shall be that laid down in paragraph 1. 4. Where a Member State provides for particular provisions on copyright in respect of collective works or for a legal person to be designated as the rightholder, the term of protection shall be calculated according to the provisions of paragraph 3, except if the natural persons who have created the work as such are identified as such in the versions of the work which are made available to the public. This paragraph is without prejudice to the rights of identified authors whose identifiable contributions are included in such works, to which contributions paragraph 1 or 2 shall apply. 5. Where a work is published in volumes, parts, instalments, issues or episodes and the term of protection runs from the time when the work was lawfully made available to the public, the term of protection shall run for each such item separately. 6. In the case of works for which the term of protection is not calculated from the death of the author or authors and which have not been lawfully made available to the public within seventy years from their creation, the protection shall terminate. Article 2 Cinematographic or audiovisual works 1. The principal director of a cinematographic or audiovisual work shall be considered as its author or one of its authors. Member States shall be free to designate other co-authors. 2. The term of protection of cinematographic or audiovisual works shall expire 70 years after the death of the last of the following persons to survive, whether or not these persons are designated as co-authors: the principal director, the author of the screenplay, the author of the dialogue and the composer of music specifically created for use in the cinematographic or audiovisual work. Article 3 Duration of related rights 1. The rights of performers shall expire 50 years after the date of the performance. However, if a fixation of the performance is lawfully published or lawfully communicated to the public within this period, the rights shall expire 50 years from the date of the first such publication or the first such communication to the public, whichever is the earlier. 2. The rights of producers of phonograms shall expire 50 years after the fixation is made. However, if the phonogram is lawfully published or lawfully communicated to the public during this period, the rights shall expire 50 years from the date of the first such publication or the first such communication to the public, whichever is the earlier. 3. The rights of producers of the first fixation of a film shall expire 50 years after the fixation is made. However, if the film is lawfully published or lawfully communicated to the public during this period, the rights shall expire 50 years from the date of the first such publication or the first such communication to the public, whichever is the earlier. The term 'film' shall designate a cinematographic or audiovisual work or moving images, whether or not accompanied by sound. 4. The rights of broadcasting organizations shall expire 50 years after the first transmission of a broadcast, whether this broadcast is transmitted by wire or over the air, including by cable or satellite. Article 4 Protection of previously unpublished works Any person who, after the expiry of copyright protection, for the first time lawfully publishes or lawfully communicates to the public a previously unpublished work, shall benefit from a protection equivalent to the economic rights of the author. The term of protection of such rights shall be 25 years from the time when the work was first lawfully published or lawfully communicated to the public. Article 5 Critical and scientific publications Member States may protect critical and scientific publications of works which have come into the public domain. The maximum term of protection of such rights shall be 30 years from the time when the publication was first lawfully published. Article 6 Protection of photographs Photographs which are original in the sense that they are the author's own intellectual creation shall be protected in accordance with Article 1. No other criteria shall be applied to determine their eligibility for protection. Member States may provide for the protection of other photographs. Article 7 Protection vis-à-vis third countries 1. Where the country of origin of a work, within the meaning of the Berne Convention, is a third country, and the author of the work is not a Community national, the term of protection granted by the Member States shall expire on the date of expiry of the protection granted in the country of origin of the work, but may not exceed the term laid down in Article 1. 2. The terms of protection laid down in Article 3 shall also apply in the case of rightholders who are not Community nationals, provided Member States grant them protection. However, without prejudice to the international obligations of the Member States, the term of protection granted by Member States shall expire no later than the date of expiry of the protection granted in the country of which the rightholder is a national and may not exceed the term laid down in Article 3. 3. Member States which, at the date of adoption of this Directive, in particular pursuant to their international obligations, granted a longer term of protection than that which would result from the provisions, referred to in paragraphs 1 and 2 may maintain this protection until the conclusion of international agreements on the term of protection by copyright or related rights. Article 8 Calculation of terms The terms laid down in this Directive are calculated from the first day of January of the year following the event which gives rise to them. Article 9 Moral rights This Directive shall be without prejudice to the provisions of the Member States regulating moral rights. Article 10 Application in time 1. Where a term of protection, which is longer than the corresponding term provided for by this Directive, is already running in a Member State on the date referred to in Article 13 (1), this Directive shall not have the effect of shortening that term of protection in that Member State. 2. The terms of protection provided for in this Directive shall apply to all works and subject matter which are protected in at least one Member State, on the date referred to in Article 13 (1), pursuant to national provisions on copyright or related rights or which meet the criteria for protection under Directive 92/100/EEC. 3. This Directive shall be without prejudice to any acts of exploitation performed before the date referred to in Article 13 (1). Member States shall adopt the necessary provisions to protect in particular acquired rights of third parties. 4. Member States need not apply the provisions of Article 2 (1) to cinematographic or audiovisual works created before 1 July 1994. 5. Member States may determine the date as from which Article 2 (1) shall apply, provided that date is no later than 1 July 1997. Article 11 Technical adaptation 1. Article 8 of Directive 91/250/EEC is hereby repealed. 2. Articles 11 and 12 of Directive 92/100/EEC are hereby repealed. Article 12 Notification procedure Member States shall immediately notify the Commission of any governmental plan to grant new related rights, including the basic reasons for their introduction and the term of protection envisaged. Article 13 General provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 1 to 11 of this Directive before 1 July 1995. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. 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. 2. Member States shall apply Article 12 from the date of notification of this Directive. Article 14 This Directive is addressed to the Member States.

31993L0091

1993

Commission Directive 93/91/EEC of 29 October 1993 adapting to technical progress Council Directive 78/316/EEC relating to the interior fittings of motor vehicles (identification of controls, tell-tales and indicators) 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 92/53/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 78/316/EEC of 21 December 1977 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (identification of controls, tell-tales and indicators) (3), and in particular Article 4 thereof, Whereas Directive 78/316/EEC is one of the separate directives of the EEC type-approval procedure which has been established by Council Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units shall apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas 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 (4), as last amended by Directive 91/663/EEC (5), established the symbol used to identify the control of headlamp-levelling devices, and this identification shall be maintained; Whereas practical experience has shown that some requirements need to amended or clarified, in particular by using new symbols which are now internationally recognized and standardized by the International Organization for Standardization (ISO), and by deleting certain symbols which are no longer used; whereas account should be taken of the new identification techniques which should enter into widespread use, consisting of the use of words or abbreviations instead of symbols for controls, tell-tales and indicators; whereas specific requirements will have to be introduced when more detailed knowledge is available to enable designs based on these new identification techniques to be made; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation on Technical Progress established by Directive 70/156/EEC, Article 1 1. Article 1 of Directive 78/316/EEC shall be amended to read at the end: ' . . . rails and of agricultural and forestry tractors and all mobile machinery.' 2. The list of Annexes and Annexes I, II, III and IV to Directive 78/316/EEC shall be amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 April 1994 Member States may not, on grounds relating to interior fittings (identification of controls, tell-tales and indicators): - refuse, in respect of a type of motor vehicle, to grant EEC type-approval, or to grant national type-approval, or - prohibit the registration, sale or entry into service of vehicles if the interior fittings (identification of controls, tell-tales and indicators) comply with the requirements of Directive 78/316/EEC as amended by this Directive. 2. With effect from 1 October 1995 the Member States: - shall no longer grant EEC type-approval for a type of vehicle, - may refuse to grant national type-approval for a type of vehicle, and - may refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC on grounds relating to interior fittings (identification of controls, tell-tales and indicators) if the requirements of Directive 78/316/EEC, as amended by this Directive, are not fulfilled. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 March 1994. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States.

31993L0095

1993

Council Directive 93/95/EEC of 29 October 1993 amending Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE) 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 to establish the internal market in personal protective equipment (PPE) have to be adopted pursuant to Directive 89/686/EEC (4); Whereas Article 5 (3) of that Directive states that PPE for which harmonized standards are not available may continue on a transitional basis, until 31 December 1992, to be subject to national arrangements already in force on the date of adoption of the Directive; Whereas it emerges from information received from the Member States and the trade that the transitional period is too short to enable the Directive to be properly applied; Whereas the harmonized standards will make a significant contribution towards facilitating the placing on the market and the free movement of personal protective equipment; Whereas, however, some of the harmonized standards will not be available on the date of application of Directive 89/686; whereas, therefore, the establishment and uniformity of a single market in these products cannot be ensured; Whereas the introduction of a new system of control and certification and the establishment of the provisions and mechanisms needed for the proper functioning of the Directive are not sufficiently advanced; Whereas the absence of harmonized standards could lead to a situation in which an adequate degree of protection and conformity control as regards helmets for users of two-wheeled motor vehicles was no longer ensured; whereas the protection of persons in the event of an accident might thus be jeopardized; whereas, in order to avoid a deterioration in safety and control such helmets should be excluded from the scope of Directive 89/686/EEC pending the introduction of specific requirements for such helmets, Article 1 Directive 89/686/EEC is hereby amended as follows: 1. Article 5 (3) shall be deleted; 2. the last indent of Article 8 (4) (a) shall be deleted; 3. Article 16 shall be replaced by the following: 'Article 16 1. Before 31 December 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply the measures in question with effect from 1 July 1992. 2. Furthermore, Member States shall allow, for the period until 30 June 1995, the placing on the market and putting into service on PPE in conformity with the national regulations in force in their territory on 30 June 1992. 3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.'; 4. the following item 5 shall be added to Annex I: '5. Helmets and visors intended for users of two- or three-wheeled motor vehicles'. Article 2 1. Within three months of adoption of this Directive, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with it. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0090

1993

Commission Directive 93/90/EEC of 29 October 1993 concerning the list of substances referred to in Article 13 (1) (5th indent) of Council Directive 67/548/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 93/72/EEC (2), and in particular Article 13 (1) thereof, Whereas the fifth indent of Article 13 (1) of Directive 67/548/EEC exempts from certain of the provisions of the said Directive, particularly those provisions concerning notification, those substances for exclusive use in other product sectors for which Community notification or approval procedures exist and for which the requirements for data submission are equivalent to those laid down in Directive 67/548/EEC; whereas, therefore, the Commission is required to establish a list of such Community legislation; Whereas, at present, there is only one piece of Community legislation which comes within the terms of the said fifth indent of Article 13 (1); whereas, however, the list will be re-examined periodically and, as necessary, revised; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 The list of Community legislation concerning products sectors for which Community notification or approval procedures exist and for which the requirements for data submission for the categories of substances identified in the list, are equivalent to those laid down in Directive 67/548/EEC is contained in the Annex to this Directive. Article 2 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 October 1993 and shall immediately inform the Commission thereof. 2. When the Member States adopt these provisions these shall contain a reference to the present directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be determined by the Member States. Article 3 This Directive is addressed to the Member States.

31993L0097

1993

Council Directive 93/97/EEC of 29 October 1993 supplementing Directive 91/263/EEC in respect of satellite earth station 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), (1) Whereas the Commission has issued a Green Paper on a common approach in the field of satellite communications in the Community proposing the introduction of mutual recognition of type approval for satellite earth station equipment as one of the major preconditions for, inter alia, a Community-wide market for satellite earth station equipment; (2) Whereas the Council resolution of 19 December 1991 on the development of a common market for satellite communications services and equipment (4) considers as one of the major goals in satellite telecommunications policy the harmonization and liberalization of appropriate satellite earth station equipment, subject, in particular, to conditions necessary for compliance with essential requirements; (3) Whereas that resolution notes with interest the intention of the Commission to propose measures for the approximation of the laws of the Member States concerning the appropriate satellite earth station equipment, including the mutual recognition of their conformity, in line with the principles already established in Directive 91/263/EEC (5); (4) Whereas the goal of an advanced, open Community-wide market for satellite earth station equipment requires effective and efficient harmonized procedures for certification, testing, marking, quality assurance and product surveillance; whereas the alternative to Community legislation is an analogous system of provisions negotiated between Member States, which would involve obvious difficulties because of the number of organisms which would be involved in multiple bilateral negotiations; whereas this is not practicable, rapid or efficient; whereas therefore the objectives of the proposed action cannot be sufficiently achieved by the Member States; whereas on the contrary the form of a Community directive has repeatedly shown itself, in the sector of telecommunications among others, as a practicable, rapid and efficient means; whereas the objective of the action under consideration can therefore be better achieved at Community level; (5) Whereas Community law in its present form provides, notwithstanding 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 legislations relating to the marketing of products, must be accepted in so far as such requirements can be recognized as being necessary to satisfy essential requirements; whereas, therefore, the harmonization of laws in this case must be limited only to those requirements necessary to satisfy the essential requirements relating to satellite earth station equipment; whereas these requirements must replace the relevant national requirements because they are essential; (6) Whereas 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) and 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 (7), are applicable, inter alia, to the fields of telecommunications and information technology; (7) Whereas Directive 73/23/EEC in general also covers safety of persons; (8) Whereas Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (8) sets out harmonized procedures for the protection of apparatus by electromagnetic disturbances and defines the protection requirements and inspection procedures relating thereto; whereas the general requirements of that Directive also apply to satellite earth station equipment; whereas electromagnetic compatibility requirements are covered by this Directive in so far as they are specific to satellite earth station equipment; (9) Whereas Decision 87/95/EEC (9) sets out the measures to be implemented for the promotion of standardization in Europe and the preparation and implementation of standards in the field of information technology and telecommunications; (10) Whereas bearing in mind the essential requirements, it is desirable in order to help manufacturers to prove conformity with these essential requirements, to have standards harmonized at European level to safeguard the general interest in the design and manufacture of satellite earth station equipment and allow checks on conformity with these essential requirements; 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), the European Committee for Electrotechnical Standardization (Cenelec) and the European Telecommunications Standards Institute (ETSI) are the bodies recognized as competent to adopt harmonized standards; (11) Whereas the proposals for common technical regulations are, as a general rule, drawn up on the basis of harmonized standards, and, in order to ensure appropriate technical coordination on a broad European basis, of additional consultations, in particular with the Telecommunications Regulations Application Committee (TRAC); (12) Whereas Directive 91/263/EEC introduced the full mutual recognition of type approval for telecommunications terminal equipment and established the Approvals Committee for Terminal Equipment (ACTE) composed of representatives of the Member States and chaired by the representative of the Commission to assist the Commission in executing the tasks entrusted to it by that Directive; (13) Whereas Directive 91/263/EEC does not explicitly apply to satellite earth station equipment; (14) Whereas it is therefore necessary to extend to satelitte earth station equipment the principles already established in that Directive in relation to telecommunications terminal equipment; (15) Whereas the scope of this Directive must be based on a general definition of the term 'satellite earth station equipment' so as to allow the technical development of products; whereas the scope excludes purpose-built satellite earth station equipment intended for use as part of the public terrestrial telecommunications network; whereas this is intended to exclude, inter alia, gateway satellite earth stations for major trunking applications within the context of the infrastructure provision (such as large size diameter stations) and satellite tracking and control earth stations; (16) Whereas this Directive does not affect current special or exclusive rights concerning satellite communications which may in accordance with Community law, be retained by the Member States; (17) Whereas satellite earth station equipment is configured, as far as its interface to the space-based system is concerned, either for the transmission of radio communications signals or for both the transmission and reception of radio-communications signals, or for the reception-only of radio-communications signals; (18) Whereas satellite earth station equipment is, as far as the terrestrial interface is concerned, either intended for, or not intended for terrestrial connection to the public telecommunications network; (19) Whereas orbits (such as the geo-stationary orbit, low earth orbits and elliptical orbits) are paths in space described by satellites or other space-based systems, and are limited, nature-given resources; (20) Whereas orbital resources are used in conjunction with the radio frequency spectrum which is also a limited, nature-given resource; whereas transmitting satellite earth station equipment makes use of both these resources; (21) Whereas the effective use of orbital resources in conjunction with the radio frequency spectrum and avoidance of harmful interference between space-based and terrestrial communications systems and other technical systems is of importance for the development of European satellite communications; whereas the International Telecommunications Union (ITU) establishes criteria for effective use of orbital resources as well as for radio-coordination to enable space and terrestrial systems to co-exist without undue interference; (22) Whereas harmonizing conditions for the placing on the market of satellite earth station equipment will create the conditions for an open and unified market and further will achieve an effective use of orbital resources and the radio frequency spectrum and facilitate avoidance of harmful interference between space-based and terrestrial communications systems and other technical systems; (23) Whereas in respect of the essential requirements related to effective use of orbital resources and the radio frequency spectrum, and avoiding harmful interference with space-based and terrestrial communications systems and other technical systems, it is in general not possible to comply with such requirements other than by the application of special technical solutions; whereas common technical regulations are therefore necessary; (24) Whereas the parameters for the use of the frequency spectrum by transmitters are covered by the essential requirements in Article 4 (c) and (e) of Directive 91/263/EEC, with the test methods and the limit values being specifed in conjunction with the technical features of the specific equipment; (25) Whereas satellite earth station equipment, capable of being used for transmission or for transmission and reception of radio-communications signals, may be subject to licensing terms, in addition to the provisions of this Directive; (26) Whereas satellite earth station equipment, only capable of being used for reception of radio-communications signals, shall not be subject to licensing terms but only to the provisions of this Directive unless they are intended for terrestrial connection to the public telecommunications network, as proposed in the Green Paper on satellite communications in the European Community; whereas the use of such satellite earth station equipment must be in conformity with national regulations, compatible with Community law; (27) Whereas real, comparable access to third country markets, in particular the United States of America and Japan, for European manufacturers should preferably be achieved through multilateral negotiations within the GATT, although bilateral talks between the Community and third countries may also contribute to this process; (28) Whereas representatives of the telecommunication organizations, users, consumers, manufacturers, service providers and the trade unions should have the right to be consulted; (29) Whereas the addressees of any decision taken under this Directive must be informed of the reasons for such a decision and the means of appeal open to them; (30) Whereas transitional arrangements are required in order that the manufacturers have the necessary time to adapt the design and production of satellite earth station equipment to the common technical regulations; whereas in order to have the necessary flexibility the transition arrangements must be worked out on a case-by-case basis; whereas the common technical regulations shall lay down the necessary transition arrangements; (31) Whereas ACTE has to play an important role in the application of this Directive; whereas it should work in close cooperation with relevant committees dealing with licence procedures for satellite network and services, CHAPTER I Scope, placing on the market and free circulation Article 1 1. This Directive shall apply to satellite earth station equipment as defined in paragraph 2. 2. For the purpose of this Directive: - the definitions given in Directive 91/263/EEC shall apply, where relevant, - satellite earth station equipment means equipment which is capable of being used either for transmission only, or for transmission and reception (transmit-receive), or for reception only (receive-only), of radio-communication signals by means of satellites or other space-based systems, but excluding purpose-built satellite earth station equipment intended for use as part of the public telecommunications network of a Member State, - terrestrial connection to the public telecommunications network means any connection to the public telecommunications network which does not include a space segment. 3. The manufacturer of supplier of satellite earth station equipment shall declare if the equipment is either intended for, or not intended for terrestrial connection to the public telecommunications network. Article 2 1. Member States shall take all appropriate measures to ensure that receive-only satellite earth station equipment not intended for terrestrial connection to the public telecommunications network may be placed on the market and put into service and used on their territory, in conformity with national law compatible with Community law, only if it complies with the requirements of this Directive when it is properly installed and maintained and used for its intended purposes. Such use must be in conformity with any national law, compatible with Community law, which restricts the use to the reception of services intended for that user. 2. Member States shall take all appropriate measures to ensure that other satellite earth station equipment may be placed on the market only if it complies with the requirements of this Directive when it is properly installed and maintained and used for its intended purposes. The use of such equipment may be subject to licensing terms in conformity with Community law. 3. Member States shall also take all appropriate measures to ensure that satellite earth station equipment which is not intended for terrestrial connection to the public telecommunications network is not permitted to be connected to the public telecommunications network. 4. Member States shall also take all appropriate measures to ensure that satellite earth station equipment which is not intended for terrestrial connection to the public telecommunications network is disconnected from the public telecommunications network. Member States shall moreover take all appropriate measures, according to their national laws, to prevent terrestrial connection to the public telecommunications network of such equipment. Article 3 Member States shall not impede the free circulation and the placing on the market of satellite earth station equipment conforming to the provisions of this Directive. Article 4 1. Satellite earth station equipment shall satisfy the same essential requirements as those set out in Article 4 of Directive 91/263/EEC. 2. For the purpose of this Directive, as well as Directive 91/263/EEC, the essential requirements of Article 4 (a) of Directive 91/263/EEC shall imply the safety of persons in the same way as in Directive 73/23/EEC. 3. In the context of transmit or transmit-receive satellite earth station equipment, the essential requirement set out in Article 4 (e) of Directive 91/263/EEC concerning effective use of the radio frequency spectrum shall include the effective use of orbital resources and the avoidance of harmful interference between space-based and terrestrial communications systems and other technical systems. 4. In the context of satellite earth station equipment, electromagnetic compatibility requirements in so far as they are specific to satellite earth station equipment shall be subject to the essential requirement set out in Article 4 (c) of Directive 91/263/EEC. 5. Satellite earth station equipment shall satisfy the essential requirement set out in Article 4 (f) of Directive 91/263/EEC, regarding the interworking of satellite earth station equipment with the public telecommunications network. 6. Satellite earth station equipment shall satisfy the essential requirement set out in Article 4 (g) of Directive 91/263/EEC regarding the interworking of satellite earth station equipment via the public telecommunications network in justified cases. Cases where satellite earth station equipment is capable of supporting and intended to support a service for which the Council has decided that there should be Community-wide availability are considered as justified cases and the requirements concerning this interworking shall be determined in accordance with the procedure laid down in Article 16 of this Directive. 7. Notwithstanding paragraphs 1, 5 and 6 of this Article, satellite earth station equipment which is not intended for connection to the public telecommunications network shall not be required to satisfy the essential requirements set out in Article 4 (b), (d), (f) and (g) of Directive 91/263/EEC. Article 5 1. Member States shall presume compliance with the essential requirements referred to in Article 4 (a) and (b) of Directive 91/263/EEC in respect of satellite earth station equipment which is in conformity with the national standards implementing the relevant harmonized standards, the references of which have been published in the Official Journal of the European Communities. Member States shall publish the references of such national standards. 2. The Commission shall, in accordance with the procedure laid down in Article 16 of this Directive, adopt: - as a first step, the measures identifying the type of satellite earth station equipment for which a common technical regulation is required, as well as the associated scope statement for that regulation, with a view to its transmission to the relevant standardization bodies, - as a second step, once they have been prepared by the relevant standardization bodies, the corresponding harmonized standards, or parts thereof, implementing the essential requirements referred to in Article 4 (2) to (5), which shall be transformed into common technical regulations, compliance with which shall be mandatory and the reference of which shall be published in the Official Journal of the European Communities. Article 6 Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 of this Directive exceed or do not entirely meet the relevant essential requirements referred to in Article 4 of this Directive, the same enquiry and notification procedures shall apply as those set out in Article 7 of Directive 91/263/EEC. Article 7 1. Where a Member State finds that satellite earth station equipment bearing the marking under the provisions laid down in Chapter III does not comply with the relevant essential requirements when properly used in accordance with the purpose intended by the manufacturer, the same measures, information and consultation procedures shall apply as those set out in Article 8 (1) (2) and (4) of Directive 91/263/EEC. 2. Where satellite earth station equipment which does not comply with the relevant essential requirements bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking. The same notification procedures shall apply as those set out in Article 8 (3) and (4) of Directive 91/263/EEC. CHAPTER II Conformity assessment Article 8 1. All transmit or transmit receive satellite earth station equipment shall, according to the choice of the manufacture or his authorized representative established within the Community, be subject to all the provisions of Article 9 (1) and (2) of Directive 91/263/EEC concerning conformity assessment. 2. The same procedures regarding language requirements shall apply as those set out in Article 9 (3) of Directive 91/263/EEC. 3. Article 10 (5) of Directive 89/336/EEC shall not apply to equipment falling within the scope of this Directive or of Directive 91/263/EEC. Article 9 Receive-only satellite earth station equipment, which is intended for terrestrial connection to the public telecommunications network, shall, as far as its terrestrial interface is concerned, be subject to the provisions of Article 8 (1) concerning conformity assessment while, as far as other elements are concerned, they shall be subject either to the provisions of Article 8 (1) or to the Community internal production control procedures set out in the Annex, as far the requirements of this Directive are concerned. Article 10 Receive-only satellite earth station equipment which is not intended for terrestrial connection to the public telecommunications network shall be subject either to the provisions of Article 8 (1) or to the Community internal production control procedures set out in the Annex as far the requirements of this Directive are concerned. Article 11 In addition to the provisions of Articles 8, 9 and 10 of this Directive satellite earth station equipment which is not intended for connection to the public telecommunications network shall be accompanied by a manufacturer's or supplier's declaration made and transmitted in accordance with the same procedures as those set out in Article 2 and Annex VIII to Directive 91/263/EEC, except that the declaration shall make a reference to this Directive instead of Directive 91/263/EEC. Article 12 In relation to satellite earth station equipment, the same procedures for notified bodies and test laboratories shall apply as those set out in Article 10 and Annex V to Directive 91/263/EEC. CHAPTER III CE marking of conformity and inscriptions Article 13 1. The marking of satellite earth station equipment complying with this Directive shall consist of the CE marking consisting of the symbol 'CE', followed by the identifying symbol of the notified body responsible and, where relevant, a symbol indicating that the equipment is intended and is suitable to be connected through a terrestrial connection to the public telecommunications network. The 'CE' symbol and these two other symbols shall be the same as those shown in Annex VI to Directive 91/263/EEC. 2. The affixing of marks which are likely to be confused with the CE marking referred to in paragraph 1 above shall be prohibited. 3. Satellite earth station equipment shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer and/or supplier responsible for placing it on the market. 4. Notwithstanding paragraph 1, the marking of receive-only satellite earth station equipment which is not intended for terrestrial connection to the public telecommunications network and which has been subject to the Community internal production control procedure set out in the Annex as far as the requirements of this Directive are concerned, shall consist of the CE marking, consisting of the symbol 'CE'. Article 14 Where it is established that the marking referred to in Article 13 (1) of this Directive has been affixed to satellite earth station equipment which: - does not conform to an approved type, or - conforms to an approved type which does not meet the essential requirements applicable to it, or or where the manufacturer has failed to fulfil his obligations under the relevant Community declaration of conformity, the same procedures shall apply as those set out in Article 12 of Directive 91/263/EEC. CHAPTER IV Committee Procedures Article 15 1. The Approvals Committee for Terminal Equipment (hereinafter referred to as 'the Committee') set up under Article 13 (1) of Directive 91/263/EEC shall assist the Commission in implementing this Directive. 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. The Commission shall inform the Committee of the manner in which its opinion has been taken into account. 3. The Commission will periodically consult the representatives of the telecommunications organizations, users, consumers, manufacturers, service providers and trade unions and will inform the Committee of the outcome of such consultations, with a view to taking due account of the outcome. Article 16 1. Notwithstanding Article 15 (1) and (2), the procedure laid down in the following paragraphs shall apply for matters covered by Articles 4 (6) and 5 (2). 2. The representative of the Commission shall submit to the Committee set up under Article 14 a draft of the measures to be taken as referred to in Articles 4 (6) and 5 (2). 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 from the date referred to it, the Council has not acted, the proposed measures shall be adopted by the Commission. CHAPTER V Final and transitional provisions Article 17 1. The Commission shall report on the implementation of this Directive at the same time and in the same manner as provided for in Article 15 of Directive 91/263/EEC. 2. The Commission shall, when submitting those draft measures referred to in Article 5 (2) of this Directive dealing with common technical regulations, ensure that transition arrangements, where appropriate, form part of the draft measures. Article 18 1. Member States shall take the measures necessary to comply with this Directive no later than 1 May 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall inform the Commission of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 19 This Directive is addressed to the Member States.

31993L0101

1993

Commission Directive 93/101/EC of 11 November 1993 adapting to technical progress for the 20th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 93/72/EEC (2), and in particular Article 28 thereof, Whereas Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance; whereas it is necessary to add to this list a number of substances notified to the Commission in accordance with the abovementioned Directive; 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 Directive for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 The entries in the Annex to this Directive are included for the first time in Annex I to Directive 67/548/EEC. Article 2 1. Not later than 1 January 1995 the Member States shall implement the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0102

1993

Commission Directive 93/102/EC of 16 November 1993 amending Directive 79/112/EEC 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 Having regard to the Treaty establishing the European Community, Having regard to Council Directive 79/112/EEC 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 (1), as last amended by Commission Directive 91/72/EEC (2), and in particular Article 6 (5) (b) thereof, first and second indent, Whereas, according to the scope and effects of the proposed action, the Community measures envisaged by this Regulation are not only necessary but also indispensable for the attainment of the stated objectives; whereas these objectives cannot be achieved by Member States individually, and that furthermore their attainment at Community level is already provided for by Directive 79/112/EEC; Whereas, without detracting from consumer information, additions should be made to the list of ingredients in Annex I to Directive 79/112/EEC for which the category rather than the specific name may be stated; Whereas Annex I to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (3) contains a list of the categories of food additives to which the Directive applies; Whereas this list includes categories which do not appear, or which appear in a different form, in the list given in Annex II to Directive 79/112/EEC; Whereas, in order that the various Community provisions may concord, the Directive 79/112/EEC list should be brought into line with the list approved by the Council within the framework of Directive 89/107/EEC provided that this meets a need for better information for consumers; Whereas the measures laid down by this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Annex I to Directive 79/112/EEC is hereby replaced by Annex I to this Directive. Article 2 Annex II to Directive 79/112/EEC is hereby replaced by Annex II to this Directive. Article 3 Member States shall, if appropriate, amend their laws, regulations and administrative provisions so that they comply with this Directive by 31 December 1994. The measures concerned must: - permit trade in products complying with this Directive by no later than 1 January 1995, - prohibit trade in products not complying with this Directive with effect from 30 June 1996. They shall immediately inform the Commission thereof. When Member States adopt these provisions, the latter shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 The present Directive enters into effect on the third day following its publication in the Official Journal of the European Communities.

31993L0104

1993

Council Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organization of working time Having regard to the Treaty establishing the European Community, and in particular Article 118a 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 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 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 provisions 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(4) are fully applicable to the areas covered by this Directive without prejudice to more stringent and/or specific provisions contained therein; Whereas the Community Charter of the Fundamental Social Rights of Workers, adopted at the meeting of the European Council held at Strasbourg on 9 December 1989 by the Heads of State or of Government of 11 Member States, and in particular points 7, first subparagraph, 8 and 19, first subparagraph, thereof, declared that: '7. The completion of the internal market must lead to an improvement in the living and working conditions of workers in the European Community. This process must result from an approximation of these conditions while the improvement is being maintained, as regards in particular the duration and organization of working time and forms of employment other than open-ended contracts, such as fixed-term contracts, part-time working, temporary work and seasonal work. 8. Every worker in the European Community shall have a right to a weekly rest period and to annual paid leave, the duration of which must be progressively harmonized in accordance with national practices. 19. Every worker must enjoy satisfactory health and safety conditions in his working environment. Appropriate measures must be taken in order to achieve further harmonization of conditions in this area while maintaining the improvements made.'; Whereas the improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations; Whereas this Directive is a practical contribution towards creating the social dimension of the internal market; Whereas laying down minimum requirements with regard to the organization of working time is likely to improve the working conditions of workers in the Community; Whereas, in order to ensure the safety and health of Community workers, the latter must be granted minimum daily, weekly and annual periods of rest and adequate breaks; whereas it is also necessary in this context to place a maximum limit on weekly working hours; Whereas account should be taken of the principles of the International Labour Organization with regard to the organization of working time, including those relating to night work; Whereas, with respect to the weekly rest period, due account should be taken of the diversity of cultural, ethnic, religious and other factors in the Member States; whereas, in particular, it is ultimately for each Member State to decide whether Sunday should be included in the weekly rest period, and if so to what extent; Whereas research has shown that the human body is more sensitive at night to environmental disturbances and also to certain burdensome forms of work organization and that long periods of night work can be detrimental to the health of workers and can endanger safety at the workplace; Whereas there is a need to limit the duration of periods of night work, including overtime, and to provide for employers who regularly use night workers to bring this information to the attention of the competent authorities if they so request; Whereas it is important that night workers should be entitled to a free health assessment prior to their assignment and thereafter at regular intervals and that whenever possible they should be transferred to day work for which they are suited if they suffer from health problems; Whereas the situation of night and shift workers requires that the level of safety and health protection should be adapted to the nature of their work and that the organization and functioning of protection and prevention services and resources should be efficient; Whereas specific working conditions may have detrimental effects on the safety and health of workers; whereas the organization of work according to a certain pattern must take account of the general principle of adapting work to the worker; Whereas, given the specific nature of the work concerned, it may be necessary to adopt separate measures with regard to the organization of working time in certain sectors or activities which are excluded from the scope of this Directive; Whereas, in view of the question likely to be raised by the organization of working time within an undertaking, it appears desirable to provide for flexibility in the application of certain provisions of this Directive, whilst ensuring compliance with the principles of protecting the safety and health of workers; Whereas it is necessary to provide that certain provisions may be subject to derogations implemented, according to the case, by the Member States or the two sides of industry; whereas, as a general rule, in the event of a derogation, the workers concerned must be given equivalent compensatory rest periods, SECTION I SCOPE AND DEFINITIONS Article 1 Purpose and scope 1. This Directive lays down minimum safety and health requirements for the organization of working time. 2. This Directive applies to: (a) minimum periods of daily rest, weekly rest and annual leave, to breaks and maximum weekly working time; and (b) certain aspects of night work, shift work and patterns of work. 3. This Directive shall apply to all sectors of activity, both public and private, within the meaning of Article 2 of Directive 89/391/EEC, without prejudice to Article 17 of this Directive, with the exception of air, rail, road, sea, inland waterway and lake transport, sea fishing, other work at sea and the activities of doctors in training; 4. The provisions of Directive 89/391/EEC are fully applicable to the matters referred to in paragraph 2, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. working time shall mean any period during which the worker is working, at the employer's disposal and carrying out his activity or duties, in accordance with national laws and/or practice; 2. rest period shall mean any period which is not working time; 3. night time shall mean any period of not less than seven hours, as defined by national law, and which must include in any case the period between midnight and 5 a. m.; 4. night worker shall mean: (a) on the one hand, any worker, who, during night time, works at least three hours of his daily working time as a normal course; and (b) on the other hand, any worker who is likely during night time to work a certain proportion of his annual working time, as defined at the choice of the Member State concerned: (i) by national legislation, following consultation with the two sides of industry; or (ii) by collective agreements or agreements concluded between the two sides of industry at national or regional level; 5. shift work shall mean any method of organizing work in shifts whereby workers succeed each other at the same work stations according to a certain pattern, including a rotating pattern, and which may be continuous or discontinuous, entailing the need for workers to work at different times over a given period of days or weeks; 6. shift worker shall mean any worker whose work schedule is part of shift work. SECTION II MINIMUM REST PERIODS - OTHER ASPECTS OF THE ORGANIZATION OF WORKING TIME Article 3 Daily rest Member States shall take the measures necessary to ensure that every worker is entitled to a minimum daily rest period of 11 consecutive hours per 24-hour period. Article 4 Breaks Member States shall take the measures necessary to ensure that, where the working day is longer than six hours, every worker is entitled to a rest break, the details of which, including duration and the terms on which it is granted, shall be laid down in collective agreements or agreements between the two sides of industry or, failing that, by national legislation. Article 5 Weekly rest period Member States shall take the measures necessary to ensure that, per each seven-day period, every worker is entitled to a minimum uninterrupted rest period of 24 hours plus the 11 hours' daily rest referred to in Article 3. The minimum rest period referred to in the first subparagraph shall in principle include Sunday. If objective, technical or work organization conditions so justify, a minimum rest period of 24 hours may be applied. Article 6 Maximum weekly working time Member States shall take the measures necessary to ensure that, in keeping with the need to protect the safety and health of workers: 1. the period of weekly working time is limited by means of laws, regulations or administrative provisions or by collective agreements or agreements between the two sides of industry; 2. the average working time for each seven-day period, including overtime, does not exceed 48 hours. Article 7 Annual leave 1. Member States shall take the measures necessary to ensure that every worker is entitled to paid annual leave of at least four weeks in accordance with the conditions for entitlement to, and granting of, such leave laid down by national legislation and/or practice. 2. The minimum period of paid annual leave may not be replaced by an allowance in lieu, except where the employment relationship is terminated. SECTION III NIGHT WORK - SHIFT WORK - PATTERNS OF WORK Article 8 Length of night work Member States shall take the measures necessary to ensure that: 1. normal hours of work for night workers do not exceed an average of eight hours in any 24-hour period; 2. night workers whose work involves special hazards or heavy physical or mental strain do not work more than eight hours in any period of 24 hours during which they perform night work. For the purposes of the aforementioned, work involving special hazards or heavy physical or mental strain shall be defined by national legislation and/or practice or by collective agreements or agreements concluded between the two sides of industry, taking account of the specific effects and hazards of night work. Article 9 Health assessment and transfer of night workers to day work 1. Member States shall take the measures necessary to ensure that: (a) night workers are entitled to a free health assessment before their assignment and thereafter at regular intervals; (b) night workers suffering from health problems recognized as being connected with the fact that they perform night work are transferred whenever possible to day work to which they are suited. 2. The free health assessment referred to in paragraph 1 (a) must comply with medical confidentiality. 3. The free health assessment referred to in paragraph 1 (a) may be conducted within the national health system. Article 10 Guarantees for night-time working Member States may make the work of certain categories of night workers subject to certain guarantees, under conditions laid down by national legislation and/or practice, in the case of workers who incur risks to their safety or health linked to night-time working. Article 11 Notification of regular use of night workers Member States shall take the measures necessary to ensure that an employer who regularly uses night workers brings this information to the attention of the competent authorities if they so request. Article 12 Safety and health protection Member States shall take the measures necessary to ensure that: 1. night workers and shift workers have safety and health protection appropriate to the nature of their work; 2. appropriate protection and prevention services or facilities with regard to the safety and health of night workers and shift workers are equivalent to those applicable to other workers and are available at all times. Article 13 Pattern of work Member States shall take the measures necessary to ensure that an employer who intends to organize work according to a certain pattern takes account of the general principle of adapting work to the worker, with a view, in particular, to alleviating monotonous work and work at a predetermined work-rate, depending on the type of activity, and of safety and health requirements, especially as regards breaks during working time. SECTION IV MISCELLANEOUS PROVISIONS Article 14 More specific Community provisions The provisions of this Directive shall not apply where other Community instruments contain more specific requirements concerning certain occupations or occupational activities. Article 15 More favourable provisions This Directive shall not affect Member States' right to apply or introduce laws, regulations or administrative provisions more favourable to the protection of the safety and health of workers or to facilitate or permit the application of collective agreements or agreements concluded between the two sides of industry which are more favourable to the protection of the safety and health of workers. Article 16 Reference periods Member States may lay down: 1. for the application of Article 5 (weekly rest period), a reference period not exceeding 14 days; 2. for the application of Article 6 (maximum weekly working time), a reference period not exceeding four months. The periods of paid annual leave, granted in accordance with Article 7, and the periods of sick leave shall not be included or shall be neutral in the calculation of the average; 3. for the application of Article 8 (length of night work), a reference period defined after consultation of the two sides of industry or by collective agreements or agreements concluded between the two sides of industry at national or regional level. If the minimum weekly rest period of 24 hours required by Article 5 falls within that reference period, it shall not be included in the calculation of the average. Article 17 Derogations 1. With due regard for the general principles of the protection of the safety and health of workers, Member States may derogate from Article 3, 4, 5, 6, 8 or 16 when, on account of the specific characteristics of the activity concerned, the duration of the working time is not measured and/or predetermined or can be determined by the workers themselves, and particularly in the case of: (a) managing executives or other persons with autonomous decision-taking powers; (b) family workers; or (c) workers officiating at religious ceremonies in churches and religious communities. 2. Derogations may be adopted by means of laws, regulations or administrative provisions or by means of collective agreements or agreements between the two sides of industry provided that the workers concerned are afforded equivalent periods of compensatory rest or that, in exceptional cases in which it is not possible, for objective reasons, to grant such equivalent periods of compensatory rest, the workers concerned are afforded appropriate protection: 2.1. from Articles 3, 4, 5, 8 and 16: (a) in the case of activities where the worker's place of work and his place of residence are distant from one another or where the worker's different places of work are distant from one another; (b) in the case of security and surveillance activities requiring a permanent presence in order to protect property and persons, particularly security guards and caretakers or security firms; (c) in the case of activities involving the need for continuity of service or production, particularly: (i) services relating to the reception, treatment and/or care provided by hospitals or similar establishments, residential institutions and prisons; (ii) dock or airport workers; (iii) press, radio, television, cinematographic production, postal and telecommunications services, ambulance, fire and civil protection services; (iv) gas, water and electricity production, transmission and distribution, household refuse collection and incineration plants; (v) industries in which work cannot be interrupted on technical grounds; (vi) research and development activities; (vii) agriculture; (d) where there is a foreseeable surge of activity, particularly in: (i) agriculture; (ii) tourism; (iii) postal services; 2.2. from Articles 3, 4, 5, 8 and 16: (a) in the circumstances described in Article 5 (4) of Directive 89/391/EEC; (b) in cases of accident or imminent risk of accident; 2.3. from Articles 3 and 5: (a) in the case of shift work activities, each time the worker changes shift and cannot take daily and/or weekly rest periods between the end of one shift and the start of the next one; (b) in the case of activities involving periods of work split up over the day, particularly those of cleaning staff. 3. Derogations may be made from Articles 3, 4, 5, 8 and 16 by means of collective agreements or agreements concluded between the two sides of industry at national or regional level or, in conformity with the rules laid down by them, by means of collective agreements or agreements concluded between the two sides of industry at a lower level. Member States in which there is no statutory system ensuring the conclusion of collective agreements or agreements concluded between the two sides of industry at national or regional level, on the matters covered by this Directive, or those Member States in which there is a specific legislative framework for this purpose and within the limits thereof, may, in accordance with national legislation and/or practice, allow derogations from Articles 3, 4, 5, 8 and 16 by way of collective agreements or agreements concluded between the two sides of industry at the appropriate collective level. The derogations provided for in the first and second subparagraphs shall be allowed on condition that equivalent compensating rest periods are granted to the workers concerned or, in exceptional cases where it is not possible for objective reasons to grant such periods, the workers concerned are afforded appropriate protection. Member States may lay down rules: - for the application of this paragraph by the two sides of industry, and - for the extension of the provisions of collective agreements or agreements concluded in conformity with this paragraph to other workers in accordance with national legislation and/or practice. 4. The option to derogate from point 2 of Article 16, provided in paragraph 2, points 2.1. and 2.2. and in paragraph 3 of this Article, may not result in the establishment of a reference period exceeding six months. However, Member States shall have the option, subject to compliance with the general principles relating to the protection of the safety and health of workers, of allowing, for objective or technical reasons or reasons concerning the organization of work, collective agreements or agreements concluded between the two sides of industry to set reference periods in no event exceeding 12 months. Before the expiry of a period of seven years from the date referred to in Article 18 (1) (a), the Council shall, on the basis of a Commission proposal accompanied by an appraisal report, re-examine the provisions of this paragraph and decide what action to take. Article 18 Final provisions 1. (a) Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 23 November 1996, or shall ensure by that date that the two sides of industry establish the necessary measures by agreement, with Member States being obliged to take any necessary steps to enable them to guarantee at all times that the provisions laid down by this Directive are fulfilled. (b) (i) However, a Member State shall have the option not to apply Article 6, while respecting the general principles of the protection of the safety and health of workers, and provided it takes the necessary measures to ensure that: - no employer requires a worker to work more than 48 hours over a seven-day period, calculated as an average for the reference period referred to in point 2 of Article 16, unless he has first obtained the worker's agreement to perform such work, - no worker is subjected to any detriment by his employer because he is not willing to give his agreement to perform such work, - the employer keeps up-to-date records of all workers who carry out such work, - the records are placed at the disposal of the competent authorities, which may, for reasons connected with the safety and/or health of workers, prohibit or restrict the possibility of exceeding the maximum weekly working hours, - the employer provides the competent authorities at their request with information on cases in which agreement has been given by workers to perform work exceeding 48 hours over a period of seven days, calculated as an average for the reference period referred to in point 2 of Article 16. Before the expiry of a period of seven years from the date referred to in (a), the Council shall, on the basis of a Commission proposal accompanied by an appraisal report, re-examine the provisions of this point (i) and decide on what action to take. (ii) Similarly, Member States shall have the option, as regards the application of Article 7, of making use of a transitional period of not more than three years from the date referred to in (a), provided that during that transitional period: - every worker receives three weeks' paid annual leave in accordance with the conditions for the entitlement to, and granting of, such leave laid down by national legislation and/or practice, and - the three-week period of paid annual leave may not be replaced by an allowance in lieu, except where the employment relationship is terminated. (c) Member states shall forthwith inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member states. 3. Without prejudice to the right of Member States to develop, in the light of changing circumstances, different legislative, regulatory or contractual provisions in the field of working time, as long as the minimum requirements provided for in this Directive are complied with, implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to workers. 4. Member States shall communicate to the Commission the texts of the provisions of national law already adopted or being adopted in the field governed by this Directive. 5. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the viewpoints of the two sides of industry. 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. 6. Every five years the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of this Directive taking into account paragraphs 1, 2, 3, 4 and 5. Article 19 This Directive is addressed to the Member States.

31993L0103

1993

COUNCIL DIRECTIVE 93/103/EC of 23 November 1993 concerning the minimum safety and health requirements for work on board fishing vessels (thirteenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European 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, in its resolution of 21 December 1987 on safety, hygiene and health at work (4), the Council noted the Commission's intention of submitting to it minimum requirements concerning the organization of the safety and health of workers at work; Whereas occupational safety and health measures should be introduced as part of the various Community measures for the fisheries sector; Whereas compliance with the minimum requirements for ensuring a better level of safety and health on board fishing vessels is essential to ensure the safety and health of the workers concerned; Whereas, because of the specific and particularly difficult working and living conditions on board fishing vessels, the incidence of fatal accidents among workers engaged in sea fishing is very high; Whereas, on 15 April 1988, the European Parliament adopted a resolution recognizing the importance of the preventive aspects of safety at work on board fishing vessels; Whereas, for the safety and health of the workers concerned, prominence should be given to locating fishing vessels in an emergency, particularly through the use of new technologies; Whereas this Directive is an individual Directive within the meaning of Article 16 (1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5); whereas, therefore, the provisions thereof are fully applicable to work on board fishing vessels, without prejudice to more stringent and/or specific provisions contained in this Directive; Whereas the individual Directives already adopted in the field of safety and health at work apply, unless otherwise specified, to sea fishing; whereas, therefore, it may in some cases be necessary to specify the particular characteristics of this activity in order to ensure that the individual Directives are applied in the best way; Whereas Council Directive 92/29/EEC of 31 March 1992 on the minimum safety and health requirements for improved medical treatment on board vessels (6) is applicable in full to the sea fishing industry; Whereas this Directive constitutes concrete progress towards the achievement of the social dimension of the internal market, Article 1 Object 1. This Directive, which is the thirteenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum safety and health requirements applicable to work on board the vessels defined in Article 2. 2. The provisions of Directive 89/391/EEC are fully applicable to the field referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the following terms shall have the meanings hereby assigned to them: (a) fishing vessel: any vessel flying the flag of a Member State or registered under the plenary jurisdiction of a Member State used for commercial purposes either for catching or catching and processing fish or other living resources from the sea; (b) new fishing vessel: a fishing vessel with a length between perpendiculars of 15 metres or over and for which, on or after the date specified in the first subparagraph of Article 13 (1): (i) the building or major conversion contract is placed; or (ii) the building or major conversion contract has been placed before the date specified in the first subparagraph of Article 13 (1) and which is delivered three or more years after that date; or (iii) in the absence of a building contract: — the keel is laid, or — construction identifiable with a specific vessel begins, or — assembly has commenced, comprising at least 50 tonnes or 1 % of the estimated mass of all structural material, whichever is the lesser; (c) existing fishing vessel: any fishing vessel with a length between perpendiculars of 18 metres or over and which is not a new fishing vessel; (d) vessel: any new or existing fishing vessel; (e) worker: any person carrying out an occupation on board a vessel, including trainees and apprentices but excluding shore personnel carrying out work on board a vessel at the quayside and port pilots; (f) owner: the registered owner of a vessel, unless that vessel has been chartered by demise or is managed, either wholly or in part, by a natural or legal person other than the registered owner under the terms of a management agreement; in that case, the owner shall be construed as the demise charterer or natural or legal person managing the vessel, as appropriate; (g) skipper: the worker who, in accordance with national legislation and/or practice, commands the vessel or has responsibility for it. Article 3 General provisions 1. Member States shall take the measures necessary to see that: (a) owners ensure that their vessels are used without endangering the safety and health of workers, in particular in foreseeable meterological conditions, without prejudice to the skipper's responsibility; (b) account is taken of any hazards faced by the rest of the workers when Article 8 (4) of Directive 89/391/EEC is applied; (c) any occurrences at sea which affect or could affect the safety and health of the workers on board are described in a detailed report to be forwarded to the relevant competent authorities and are recorded carefully and in detail in the ship's log, where the national regulations or legislation in force require such a log to be kept on the type of vessel in question or, in the absence of such a log, in a document required for the purpose. 2. Member States shall take the measures necessary to ensure that, as regards compliance with this Directive, vessels are subject to regular checks by authorities specifically empowered to carry out such checks. Certain checks concerning compliance with this Directive may be carried out at sea. Article 4 New fishing vessels New fishing vessels must comply with the minimum safety and health requirements laid down in Annex I at the latest by the date referred to in the first subparagraph of Article 13 (1). Article 5 Existing fishing vessels Existing fishing vessels must comply with the minimum safety and health requirements laid down in Annex II within seven years of the date referred to in the first subparagraph of Article 13. (1). Article 6 Extensive repairs, conversions and alterations Where vessels undergo extensive repairs, conversions and alterations on or after the date specified in the first subparagraph of Article 13 (1), such extensive repairs, conversions and alterations must comply with the relevant minimum requirements laid down in Annex I. Article 7 Equipment and maintenance 1. For the protection of the safety and health of workers, Member States shall take the measures necessary to ensure that, without prejudice to the skipper's responsibility, owners: (a) ensure that the vessels and their fittings and equipment, particularly those referred to in Annexes I and II, are technically maintained, and that any defects found which are likely to affect the safety and health of workers are rectified as quickly as possible; (b) take measures to ensure that the vessels and all fittings and equipment are cleaned regularly in order to maintain an appropriate standard of hygiene; (c) keep on board the vessel an adequate quantity of suitable emergency and survival equipment in good working order; (d) take account of the minimum safety and health requirements concerning life-saving and survival equipment given in Annex III; (e) without prejudice to the provisions of Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (7), take account of the personal protective equipment specifications given in Annex IV to this Directive. 2. Member States shall take all necessary measures to ensure that, for the protection of the safety and health of workers, the owner supplies the skipper with the means needed to enable him to fulfil the obligations imposed upon him by this Directive, Article 8 Information for workers 1. Without prejudice to the provisions of Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all measures to be taken regarding safety and health on board vessels. 2. The information must be comprehensible to the workers concerned. Article 9 Training of workers 1. Without prejudice to Article 12 of Directive 89/39I/EEC, workers shall be given suitable training, in particular in the form of precise, comprehensible instructions, on safety and health on board vessels and on accident prevention in particular. 2. The training referred to in paragraph 1 shall cover in particular fire fighting, the use of life-saving and survival equipment and, for the workers concerned, the use of fishing gear and hauling equipment and the use of various types of signs including hand signals. Such training shall be subject to the necessary updating where this is required by changes in the activities on board. Article 10 Detailed training of persons likely to command a vessel Without prejudice to Article 5 (3) of Directive 92/29/EEC, any person likely to command a vessel shall be given detailed training on: (a) the prevention of occupational illness and accidents on board and the steps to be taken in event of accident; (b) stability and maintenance of the vessel under all foreseeable conditions of loading and during fishing operations; (c) radio navigation and communication, including procedures. Article 11 Consultation and participation of workers The consultation of workers and/or their representatives and their participation in discussions on the matters covered by this Directive and its Annexes shall take place in accordance with Article 11 of Directive 89/391/EEC. Article 12 Adaptation of the Annexes Purely technical adaptations of the Annexes to take account of: — the adoption of directives in the field of technical harmonization and standardization concerning certain aspects of safety and health on board vessels, and/or — technical progress, changes in the international regulations or specifications and new findings in the field of safety and health on board vessels, shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 13 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 23 November 1995, They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the provisions of 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 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 periodically submit to the European Parliament, the Council and the Economic and Social Committee a report on the implementation of this Directive, taking into account paragraphs 1, 2 and 3. Article 14 This Directive is addressed to the Member States.

31993L0105

1993

Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 93/72/EEC (2), and in particular Article 12 thereof, Whereas, in accordance with the provisions of Directive 67/548/EEC, any new substance placed on the market should be notified to the competent authorities of Member States by means of a notification containing certain information including a technical dossier; whereas Article 12 of the said Directive requires that specific provisions should be laid down concerning the technical dossiers for polymers; Whereas it is necessary that the technical dossier contains a test package for polymers which would supply the information necessary to evalute their foreseeable risks for man and the environment; Whereas it is appropriate in order to avoid unnecessary testing to group polymers into families and thereby to require testing only of representative members of a family; whereas such representative testing shall continue to assure a high level of protection; Whereas for some high molecular weight polymers, it is scientifically justifiable and appropriate to define a reduced test package (RTP); Whereas criteria need to be developed to define those polymers with high molecular weight for which a reduced test package is deemed to be sufficient; Whereas those criteria must ensure a high level of protection for man and the environment while ensuring that industry will continue to have the incentive to invest in continuing development of new and better polymers; Whereas considering the limited experience with notification of polymers and the incomplete knowledge of risks associated with those substances, the strict criteria for RTP polymers may need to be revised in the light of experience gained with such notifications made in accordance with the new specific requirements laid down in this Directive; Whereas the measures set out in this Directive are in accordance with the opinion of the Committee set up under Article 29 of Directive 67/548/EEC, Article 1 The Annex to this Directive shall be inserted in Annex VII to Directive 67/548/EEC in the form of Annex VII D. Article 2 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 December 1993 and shall forthwith inform the Commission. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0107

1993

Commission Directive 93/107/EC of 26 November 1993 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 93/55/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 91/248/EEC (3); Whereas the use of the coccidiostat 'Diclazuril' has been tested in certain Member States; whereas, on the basis of experience gained, it appears that this new use can be authorized throughout the Community; Whereas the use of certain colouring agents in feeds for ornamental fish has been tested in certain Member States; whereas this new use may be authorized provisionally at national level pending approval at Community level; Whereas the investigation of various additives currently listed in Annex II and therefore authorizable at national level has not yet been completed; whereas, therefore, the period of authorization of these substances should be extended for a specific period; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 30 November 1994 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0106

1993

Commission Directive 93/106/EEC of 29 November 1993 amending Directive 92/76/EEC recognizing protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 93/19/EEC (2), and in particular the first subparagraph of Article 2 (1) (h) thereof, Having regard to the requests made by Greece, France, Italy and Portugal, Whereas Member States may request the recognition as a protected zone, in particular, of a zone in which one or more harmful organisms referred to in the said Directive, which are established in one or more parts of the Community, are not endemic or established, despite conditions being favourable for them to establish themselves there; Whereas by Commission Directive 92/76/EEC (3) the Commission has recognized certain such protected zones; Whereas certain Member States have requested that certain zones be recognized as protected zones in respect of Citrus tristeza virus (European isolates); Whereas the abovementioned requests should be based on the grounds that the results of appropriate surveys, monitored by Commission experts, confirm that one or more of the harmful organisms, in respect of which the zone is to be recognized as a protected zone, are not endemic or established there; Whereas, however, the details of such surveys are not yet fully established at Community level; Whereas the recognition should be provisional only and based on the available information submitted by the Member State concerned; Whereas, based on recent new information by Italy, it appears that it is no longer appropriate to maintain the 'protected zones' recognized for Italy in respect of Dendroctonus micrans Kugelan, Ips amitinus Eichhof and Ips duplicatus Sahlbey because these organisms seem to be present locally; Whereas, based on recent new information submitted by the UK, it appears that the 'protected zones' recognized for the UK, in respect of Dendroctonus micans Kugelan, should be extended because a larger zone seems to be free from the harmful organism; 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 92/76/EEC is hereby amended as indicated in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on 15 December 1993. They shall forthwith inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.

31993L0109

1993

COUNCIL DIRECTIVE 93/109/EC of 6 December 1993 laying down detailed arrangements for the exercise of the right to vote and stand as a candidate in elections to the European Parliament for citizens of the Union residing in a Member State of which they are not nationals Having regard to the Treaty establishing the European Community, and in particular Article 8b (2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Whereas the Treaty on European Union marks a new stage in the process of creating an ever closer union among the peoples of Europe; whereas one of its tasks is to organize, in a manner demonstrating consistency and solidarity, relations between the peoples of the Member States; whereas its fundamental objectives include a strengthening of the protection of the rights and interests of the nationals of its Member States through the introduction of a citizenship of the Union; Whereas to that end Title II of the Treaty on European Union, amending the Treaty establishing the European Economic Community, with a view to establishing the European Community, introduces a citizenship of the Union for all nationals of the Member States and confers on such nationals on that basis a number of rights; Whereas the right to vote and to stand as a candidate in elections to the European Parliament in the Member State of residence, laid down in Article 8b (2) of the Treaty establishing the European Community, is an instance of the application of the principle of non-discrimination between nationals and non-nationals and a corollary of the right to move and reside freely enshrined in Article 8a of that Treaty; Whereas Article 8b (2) of the EC Treaty is concerned only with the possibility of exercising the right of vote and to stand as a candidate in elections to the European Parliament, without prejudice to Article 138 (3) of the EC Treaty, which provides for the establishment of a uniform procedure in all Member States for those elections; whereas it essentially seeks to abolish the nationality requirement which currently has to be satisfied in most Member States in order to exercise those rights; Whereas application of Article 8b (2) of the EC Treaty does not presuppose harmonization of Member States' electoral systems; whereas, moreover, to take account of the principle of proportionality set out in the third paragraph of Article 3b of the EC Treaty, the content of Community legislation in this sphere must not go beyond what is necessary to achieve the objective of Article 8b (2) of the EC Treaty; Whereas the purpose of Article 8b (2) of the EC Treaty is to ensure that all citizens of the Union, whether or not they are nationals of the Member State in which they reside, can exercise in that State their right to vote and to stand as a candidate in elections to the European Parliament under the same conditions; whereas the conditions applying to non-nationals, including those relating to period and proof of residence, should therefore be identical to those, if any, applying to nationals of the Member State concerned; Whereas Article 8b (2) of the EC Treaty provides for the right to vote and to stand as a candidate in elections to the European Parliament in the Member State of residence, without, nevertheless, substituting it for the right to vote and to stand as a candidate in the Member State of which the citizen is a national; whereas the freedom of citizens of the Union to choose the Member State in which to take part in European elections must be respected, while taking care to ensure that this freedom is not abused by people voting or standing as a candidate in more than one country; Whereas any derogation from the general rules of this Directive must be warranted, pursuant to Article 8b (2) of the EC Treaty, by problems specific to a Member State; whereas any derogation must, by its very nature, be subject to review; Whereas such specific problems may arise in a Member State in which the proportion of citizens of the Union of voting age, who reside in it but are not nationals of it, is very significantly above average; whereas derogations are warranted where such citizens form more than 20 % of the total electorate; whereas such derogations must be based on the criterion of period of residence; Whereas citizenship of the Union is intended to enable citizens of the Union to integrate better in their host country and that in this context, it is in accordance with the intentions of the authors of the Treaty to avoid any polarization between lists of national and non-national candidates; Whereas this risk of polarization concerns in particular a Member State in which the proportion of non-national citizens of the Union of voting age exceeds 20 % of the total number of citizens of the Union of voting age who reside there and that, therefore, it is important that this Member State may lay down, in compliance with Article 8b of the Treaty, specific provisions concerning the composition of lists of candidates; Whereas account must be taken of the fact that in certain Member States residents who are nationals of other Member States have the right to vote in elections to the national parliament and certain provisions of this Directive may consequently be dispensed with in those Member States, CHAPTER I GENERAL PROVISIONS Article 1 1. This Directive lays down the detailed arrangements whereby citizens of the Union residing in a Member State of which they are not nationals may exercise the right to vote and to stand as a candidate there in elections to the European Parliament. 2. Nothing in this Directive shall affect each Member State's provisions concerning the right to vote or to stand as a candidate of its nationals who reside outside its electoral territory. Article 2 For the purposes of this Directive: 1. ‘elections to the European Parliament’ means elections by direct universal suffrage to the European Parliament of representatives in accordance with the Act of 20 September 1976 (2); 2. ‘electoral territory’ means the territory of a Member State in which, in accordance with the above Act and, within that framework, in accordance with the electoral law of that Member State, members of the European Parliament are elected by the people of that Member State; 3. ‘Member State of residence’ means a Member State in which a citizen of the Union resides but of which he is not a national; 4. ‘home Member State’ means the Member State of which a citizen of the Union is a national; 5. ‘Community voter’ means any citizen of the Union who is entitled to vote in elections to the European Parliament in his Member State of residence in accordance with this Directive; 6. ‘Community national entitled to stand as a candidate’ means any citizen of the Union who has the right to stand as a candidate in elections to the European Parliament in his Member State of residence in accordance with this Directive; 7. ‘electoral roll’ means the official register of all voters entitled to vote in a given constituency or locality, drawn up and kept up to date by the competent authority under the electoral law of the Member State of residence, or the population register if it indicates eligibility to vote; 8. ‘reference date’ means the day or the days on which citizens of the Union must satisfy, under the law of the Member State of residence, the requirements for voting or for standing as a candidate in that State; 9. ‘formal declaration’ means a declaration by the person concerned, inaccuracy in which makes that person liable to penalties, in accordance with the national law applicable. Article 3 Any person who, on the reference date: (a) is a citizen of the Union within the meaning of the second subparagraph of Article 8 (1) of the Treaty; (b) is not a national of the Member State of residence, but satisfies the same conditions in respect of the right to vote and to stand as a candidate as that State imposes by law on its own nationals, shall have the right to vote and to stand as a candidate in elections to the European Parliament in the Member State of residence unless deprived of those rights pursuant to Articles 6 and 7. Where, in order to stand as a candidate, nationals of the Member State of residence must have been nationals for a certain minimum period, citizens of the Union shall be deemed to have met this condition when they have been nationals of a Member State for the same period. Article 4 1. Community voters shall exercise their right to vote either in the Member State of residence or in their home Member State. No person may vote more than once at the same election. 2. No person may stand as a candidate in more than one Member State at the same election. Article 5 If, in order to vote or to stand as candidates, nationals of the Member State or residence must have spent a certain minimum period as a resident in the electoral territory of that State, Community voters and Community nationals entitled to stand as candidates shall be deemed to have fulfilled that condition where they have resided for an equivalent period in other Member States. This provision shall apply without prejudice to any specific conditions as to length of residence in a given constituency or locality. Article 6 1. Any citizen of the Union who resides in a Member State of which he is not a national and who, through an individual criminal law or civil law decision, has been deprived of his right to stand as a candidate under either the law of the Member State of residence or the law of his home Member State, shall be precluded from exercising that right in the Member State of residence in elections to the European Parliament. 2. An application from any citizen of the Union to stand as a candidate in elections to the European Parliament in the Member State of residence shall be declared inadmissible where that citizen is unable to provide the attestation referred to in Article 10 (2). Article 7 1. The Member State of residence may check whether the citizens of the Union who have expressed a desire to exercise their right to vote there have not been deprived of that right in the home Member State through an individual civil law or criminal law decision. 2. For the purposes of paragraph 1 of this Article, the Member State of residence may notify the home Member State of the declaration referred to in Article 9 (2). To that end, the relevant and normally available information from the home Member State shall be provided in good time and in an appropriate manner; such information may only include details which are strictly necessary for the implementation of this Article and may only be used for that purpose. If the information provided invalidates the content of the declaration, the Member State of residence shall take the appropriate steps to prevent the person concerned from voting. 3. The home Member State may, in good time and in an appropriate manner, submit to the Member State of residence any information necessary for the implementation of this Article. Article 8 1. A Community voter exercises his right to vote in the Member State of residence if he has expressed the wish to do so. 2. If voting is compulsory in the Member State of residence, Community voters who have expressed the wish to do so shall be obliged to vote. CHAPTER II EXERCISE OF THE RIGHT TO VOTE AND THE RIGHT TO STAND AS A CANDIDATE Article 9 1. Member States shall take the necessary measures to enable a Community voter who has expressed the wish for such to be entered on the electoral roll sufficiently in advance of polling day. 2. In order to have his name entered on the electoral roll, a Community voter shall produce the same documents as a voter who is a national. He shall also produce a formal declaration stating: (a) his nationality and his address in the electoral territory of the Member State of residence; (b) where applicable, the locality or constituency in his home Member State on the electoral roll of which his name was last entered, and (c) that he will exercise his right to vote in the Member State of residence only. 3. The Member State of residence may also require a Community voter to: (a) state in his declaration under paragraph 2 that he has not been deprived of the right to vote in his home Member State; (b) produce a valid identity document, and (c) indicate the date from which he has been resident in that State or in another Member State. 4. Community voters who have been entered on the electoral roll shall remain thereon, under the same conditions as voters who are nationals, until such time as they request to be removed or until such time as they are removed automatically because they no longer satisfy the requirements for exercising the right to vote. Article 10 1. When he submits his application to stand as a candidate, a Community national shall produce the same supporting documents as a candidate who is a national. He shall also produce a formal declaration stating: (a) his nationality and his address in the electroal territory of the Member State of residence; (b) that he is not standing as a candidate for election to the European Parliament in any other Member State, and (c) where applicable, the locality or constituency in his home Member State on the electoral roll of which his name was last entered. 2. When he submits his application to stand as a candidate a Community national must also produce an attestation from the competent administrative authorities of his home Member State certifying that he has not been deprived of the right to stand as a candidate in that Member State or that no such disqualification is known to those authorities. 3. The Member State of residence may also require a Community national entitled to stand as a candidate to produce a valid identity document. It may also require him to indicate the date from which he has been a national of a Member State. Article 11 1. The Member State of residence shall inform the person concerned of the action taken on his application for entry on the electoral roll or of the decision concerning the admissibility of his application to stand as a candidate. 2. Should a person be refused entry on the electoral roll or his application to stand as a candidate be rejected, the person concerned shall be entitled to legal remedies on the same terms as the legislation of the Member State of residence prescribes for voters and persons entitled to stand as candidates who are its nationals. Article 12 The Member State of residence shall inform Community voters and Community nationals entitled to stand as candidates in good time and in an appropriate manner of the conditions and detailed arrangements for the exercise of the right to vote and to stand as a candidate in elections in that State. Article 13 Member States shall exchange the information required for the implementation of Article 4. To that end, the Member State of residence shall, on the basis of the formal declaration referred to in Articles 9 and 10, supply the home Member State, sufficiently in advance of polling day, with information on the latter State's nationals entered on electroal rolls or standing as candidates. The home Member State shall, in accordance with its national legislation, take appropriate measures to ensure that its nationals do not vote more than once or stand as candidates in more than one Member State. CHAPTER III DEROGATIONS AND TRANSITIONAL PROVISIONS Article 14 1. If on 1 January 1993, in a given Member State, the proportion of citizens of the Union of voting age who reside in it but are not nationals of it exceeds 20 % of the total number of citizens of the Union residing there who are of voting age, that Member State may, by way of derogation from Articles 3, 9 and 10: (a) restrict the right to vote to Community voters who have resided in that Member State for a minimum period, which may not exceed five years; (b) restrict the right to stand as a candidate to Community nationals entitled to stand as candidates who have resided in that Member State for a minimum period, which may not exceed 10 years. These provisions are without prejudice to appropriate measures which this Member State may take with regard to the composition of lists of candidates and which are intended in particular to encourage the integration of non-national citizens of the Union. However, Community voters and Community nationals entitled to stand as candidates who, owing to the fact that they have taken up residence outside their home Member State or by reason of the duration of such residence, do not have the right to vote or to stand as candidates in that home State shall not be subject to the conditions as to length of residence set out above. 2. Where, on 1 February 1994, the laws of a Member State prescribe that the nationals of another Member State who reside there have the right to vote for the national parliament of that State and, for that purpose, may be entered on the electoral roll of that State under exactly the same conditions as national voters, the first Member State may, by way of derogation from this Directive, refrain from applying Articles 6 to 13 in respect of such nationals. 3. By 31 December 1997 and thereafter 18 months prior to each election to the European Parliament, the Commission shall submit to the European Parliament and to the Council a report in which it shall check whether the grant to the Member States concerned of a derogation pursuant to Article 8b (2) of the EC Treaty is still warranted and shall propose that any necessary adjustments be made. Member States which invoke derogations under paragraph 1 shall furnish the Commission with all the necessary background information. Article 15 For the fourth direct elections to the European Parliament, the following special provisions shall apply: (a) citizens of the Union who, on 15 February 1994, already have the right to vote in the Member State of residence and whose names appear on the electoral roll in the Member State of residence shall not be subject to the formalities laid down in Article 9; (b) Member States in which the electoral rolls have been finalized before 15 February 1994 shall take the steps necessary to enable Community voters who wish to exercise their right to vote there to enter names on the electoral roll sufficiently in advance of polling day; (c) Member States which do not draw up specific electoral rolls but indicate eligibility to vote in the population register and where voting is not compulsory may also apply this system to Community voters who appear on that register and who, having been informed individually of their rights, have not expressed a wish to exercise their right to vote in their home Member State. They shall forward to the home Member State the document showing the intention expressed by those voters to vote in the Member State of residence; (d) Member States in which the internal procedure for the nomination of candidates for political parties and groups is governed by law may provide that any such procedures which, in accordance with that law, were opened before 1 February 1994 and the decisions taken within that framework shall remain valid. CHAPTER IV FINAL PROVISIONS Article 16 The Commission shall submit a report to the European Parliament and the Council by 31 December 1995 on the application of this Directive to the June 1994 elections to the European Parliament. On the basis of the said report the Council, acting unanimously on a proposal from the Commission and after consulting the European Parliament, may adopt provisions amending this Directive. Article 17 Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 February 1994. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 18 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 19 This Directive is addressed to the Member States.

31993L0110

1993

Commission Directive 93/110/EC of 9 December 1993 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Directive 93/19/EEC (2), and in particular Article 13, second paragraph, fourth indent thereof, Whereas developments in scientific and technical knowledge have shown that the risks presented by Ditylenchus destructor Thorne, an organism listed in the Annexes to Directive 77/93/EEC, are lower than initially assessed; whereas in this respect protection should be restricted only to certain species of the genus Gladiolus; Whereas certain provisions on protective measures against plants of Citrus L., Fortunella Swingle, Poncirus Raf. and their hybrids, in particular those applicable to Citrus clementina Hort. ex Tanaka, should be modified because it is no longer appropriate to maintain the current provisions set out in Directive 77/93/EEC for movements of these plants into the northern part of the Community; Whereas the provisions on protective measures against Ditylenchus dipsaci (Kuehn) Filipjev, an organism listed in the Annexes to the said Directive, should be improved, and in particular the list of hostplants should be extended; Whereas improved measures should be taken to protect the Community against Scirtothrips aurantii Faur, Scirtothrips citri (Moultex) and Elsinoe spp. Bitanc. et Jenk., where these organisms do not occur; Whereas certain provisions on protective measures against Dendroctonus micans Kugelan, in particular those applicable in the United Kingdom, should be modified, because it has been determined that the said organism is not present in a much larger area than originally recognized; Whereas certain provisions on protective measures in Italy against certain bark beetles, i.e. Dendroctonus micans Kugelan, Ips amitinus Eichhof and Ips duplicatus Sahlberg, should be modified because it is no longer appropriate to maintain the current provisions set out in the said Directive; Whereas it has been determined that Fusarium oxysporum f.sp. albedinis (Kilian et Maire) Gordon, an organism listed in the Annexes to Directive 77/93/EEC, has been found in Egypt; whereas it is considered that this disease represents a serious danger to palms grown in, and may be carried on palms imported into, the Community; whereas the measures to combat this disease should be improved; Whereas some provisions on protective measures against plants of Solanaceae should be modified because it is no longer appropriate to maintain the current provisions set out in Directive 77/93/EEC for plants originating in the Mediterranean countries; Whereas it has been determined that there is no longer a need to issue a plant passport for wood of conifers which has been stripped of its bark; Whereas therefore the relevant Annexes to the said 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 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 15 December 1993. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. The Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0112

1993

Commission Directive 93/112/EC of 10 December 1993 amending Commission Directive 91/155/EEC defining and laying down detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC Having regard to the Treaty establishing the European 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 last amended by Commission Directive 93/18/EEC (2) and in particular Article 10 (2) thereof, Whereas Article 10 (2) of Directive 88/379/EEC provides that the Commission shall make detailed arrangements for the implementation of a system of information in the form of safety data sheets relating to dangerous preparations; whereas, therefore, Commission Directive 91/155/EEC (3) laid down such detailed arrangements; Whereas Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions of dangerous substances (4), as last amended by Commission Directive 92/21/EEC (5) and in particular Article 27 thereof, provides that the Commission shall make general rules for the elaboration distribution, contents and format of safety data sheets in relation to dangerous substances; Whereas it is appropriate that the arrangements in relation to safety data sheets be the same for substances and for preparations; whereas this approach was foreseen by Directive 91/155/EEC; whereas, therefore, it is necessary to amend Directive 91/155/EEC in this sense; Whereas it is necessary to make certain changes to the Annex in order to ensure protection of the environment; Whereas given the amendments made to Directive 91/155/EEC Article 4 thereof should accordingly be repealed; 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 Directive 91/155/EEC is hereby amended as follows: 1. Article 4 is repealed. 2. The Annex is replaced by the Annex to this Directive. Article 2 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 1 January 1995 at the latest and shall forthwith inform the Commission thereof. 2. These provisions shall take effect from 1 January 1995. However, information systems of the safety data sheet type in use in some Member States may continue to be used until 1 July 1995. 3. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0111

1993

Commission Directive 93/111/EC of 10 December 1993 amending Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, Whereas Article 2 of Commission Directive 92/15/EEC (2) prohibits, as from 1 July 1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not comply with Council Directive 83/229/EEC (3); Whereas Article 5 of Commission Directive 93/10/EEC (4) prohibits, as from 1 January 1994, the trade in and use of the same products which comply neither with this Directive nor with Directive 83/229/EEC; Whereas Article 5 of Directive 93/10/EEC should therefore be amended to eliminate the inconsistency between the dates specified in Directives 92/15/EEC and 93/10/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 The second indent of Article 5 (1) of Directive 93/10/EEC is replaced by the following: '- prohibit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which complies with neither this Directive nor Directive 83/229/EEC, other than film which Directive 92/15/EEC prohibits as from 1 July 1994.' Article 2 This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0114

1993

Council Directive 93/114/EC of 14 December 1993 amending Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission(1) , Having regard to the opinion of the European Parliament(2) , Having regard to the opinion of the Economic and Social Committee(3) , Whereas Council Directive 70/524/EEC concerning additives in feedingstuffs(4) lays down the principles relating to the authorization and the use of additives; Whereas the inclusion of enzyme and micro-organisms in Directive 70/524/EEC means that products belonging to both of these new categories and their manufacturers are subject to the same requirements which apply to the authorization of additives and to manufacturers in general; whereas it is particularly necessary to ensure that the products marketed are innocuous to the environment, workers, animal owners and consumers of animal products and furthermore that they satisfy the requirements set as regards effectiveness, quality and ability to be checked; Whereas in order to make possible the evaluation and authorization of enzymes produced by or derived from genetically modified organisms, the Commission must provide an assessment of such products with the aim of preventing damage to human or animal health or the environment; Whereas it appears necessary for the Scientific Committee for Feedingstuffs to be assisted by experts in the field of genetic engineering and in assessing risks linked to the use of genetically modified organisms, so as to ensure that the testing procedure is such as to rule out any damaging effects on human or animal health or the environment caused by the products concerned; Whereas in the Community authorization procedure for additives the requirements of Directive 90/220/EEC(5) concerning a specific environmental risk evaluation must be applied in respect of all additives containing or consisting of genetically modified organisms; whereas these requirements should therefore be inserted in Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition(6) , and that they apply concomitantly with this Directive; Whereas advances in scientific and technological knowledge permit the use of certain enzymes, micro-organisms and their preparations in animal nutrition in order to improve the digestibility of nutrients or to stabilize the flora of the digestive system of animals and to reduce the quantity of certain environmentally undesirable substances; Whereas Directive 93/113/EEC(7) permits the Member States to allow temporarily and subject to certain conditions the use and marketing of enzymes, micro-organisms and their preparations at national level until those products receive Community authorization pursuant to Directive 70/524/EEC; Whereas the granting of such authorization implies that special labelling provisions be inserted in the abovementioned Directive for this new generation of additives and for the premixtures and feedingstuffs into which they are incorporated, Article 1 Directive 70/524/EEC is hereby amended as follows: 1. the following Article shall be inserted after Article 7: 'Article 7a If an additive contains or consists of genetically modified organisms within the meaning of Article 2 (1) and (2) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*), a specific environmental risk assessment similar to that laid down in the abovementioned Directive shall be carried out; for this purpose, the following documents to be included in the dossier submitted pursuant to Article 9 of this Directive in order to ensure compliance with the principles set out in Article 7 (2) of this Directive: - a copy of any written consent or consents of the competent authorities to the deliberate release of genetically modified organisms for research and development purposes pursuant to Article 6 (4) of Directive 90/220/EEC and the result of the release(s) with respect to the risk in each case to human health and the environment; - the complete technical dossier supplying the information requested in Annexes I and II to Directive 90/220/EEC and the environmental risk assessment resulting from this information; the results of any investigations performed for the purposes of research or development. (*) OJ No L 117, 8. 5. 1990, p. 15' 2. Article 14 (1) is amended as follows: (a) the title of point A shall be replaced by the following: 'A. for all additives with the exception of enzymes and micro-organisms:' (b) in point B, subparagraph (d) shall read as follows: '(d) trace elements, colorants including pigments, preservatives and other additives with the exception of those belonging to the groups of enzymes and micro-organisms: active substance level.'; (c) the following point shall be added: 'C. for additives belonging to the groups: (a) of enzymes: the specific name of the active components(s) according to its (their) enzymatic activity(ies) in accordance with Annex I or II, the indentification number according to the International Union of Biochemistry, the activity units (1) (activity units per g or activity units per ml), 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, and the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the words 'to be used exclusively in the manufacture of feedingstuffs', the directions for use and, where appropriate, the safety recommendation where the column entitled 'Other provisions', in Annex I or II contains special provisions concerning the additives, the net weight and for liquid additives either the net volume or the net weight and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the column entitled 'Other provisions' in Annex I or II; (b) of micro-organisms: the identification of the strain(s) in accordance with Annex I or II, the file number of the strain(s), the number of colony-forming units (CFU/g), the name or business name and address or registered place of business of the person responsible for the particulars referred to in this paragraph, the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the words 'to be used exclusively in the manufacture of feedingstuffs', the directions for use and, where appropriate, a safety recommendation where the column entitled 'Other provisions' in Annex I or II contains special provisions concerning the additives, the net weight and for liquid additives either the net volume or the net weight and where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the column entitled 'Other provisions' in Annex I or II;' (1) Activity units expressed as mmole of product released per minute per gram of enzymatic preparation. 3. in Article 15 (1) B (a) subparagraph (h) shall become subparagraph (j) and shall be replaced by the following: '(j) other additives belonging to the groups referred to in (b) to (i) for which no maximum level is laid down and additives belonging to other groups provided for in Annex I or II: specific name of the additive in accordance with Annex I or II and active substance level, provided that these additives fulfil a function in the feedingstuff as such and the amounts present can be determined by official methods of analysis or, failing this, by valid scientific methods'; (b) the following subparagraphs shall be added: '(h) enzymes: the specific name of the active component(s) according to its (their) enzymatic activity(ies) in accordance with Annex I or II, the identification number according to the International Union of Biochemistry, the activity units (activity units per g or activity units per ml), the expiry date of the guarantee or the storage life from the date of manufacture, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the column entitled 'Other provisions' in Annex I or II; (i) micro-organisms: the identification of the strain(s) in accordance with Annex I or II, the file number of the strain(s), the number of colony-forming units (CFU/g), the expiry date of the guarantee of the storage life from the date of manufacture, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the column entitled 'Other provisions' in Annex I or II;' 4. the following subparagraphs shall be added to Article 16 (1): '(h) for enzymes: the specific name of the active constituent(s) according to its (their) enzymatic activity(ies) in accordance with Annex I or II, the identification number according to the International Union of Biochemistry, the activity units (activity units per kg or activity unit per l), the expiry date of the guarantee or the storage life from the date of manufacture and, where applicable, indication of any particular characteristic due to the manufacturing process, in accordance with the provisions concerning labelling in the column entitled 'Other provisions' in Annex I or II; (i) for micro-organisms: the identification of the strain(s) in accordance with Annex I or II, the file number of the strain(s), the number of colony-forming units (CFU/kg), the expiry date of the guarantee or the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristic due to the manufacturing process, in accordance with the provisions concerning labelling in the column entitled 'Other provisions' in Annex I or II;' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 October 1994. They shall forthwith notify the Commission thereof. When Member States adopt these provisions they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31993L0113

1993

Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro- organisms and their preparations in animal nutrition Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission(1) , Having regard to the opinion of the European Parliament(2) , Having regard of the opinion of the Economic and Social Committee(3) , Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(4) , lays down the principles relating to the admission and the use of additives; Whereas Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in feedingstuffs(5) constitutes a guide for defining the scientific information necessary to identify and characterize these products as well as the studies necessary to evaluate, in particular, their efficacy and innocuousness for humans, animals and the environment; Whereas advances in scientific and technological knowledge permit the use of certain enzymes, micro-organisms and their preparations in animal nutrition in order in particular to improve the digestibility of such nutrients, or to stabilize the flora of the digestive system of animals and to reduce the ejection of certain undesirable substances into the environment; whereas at the moment no criteria exist for the examination of requests for authorization for use as additives of this new generation of products; Whereas it is essential, pending amendment of the guidelines and in order to allow the preparation of dossiers for these products, to allow provisionally the use and marketing of enzymes, micro-organisms and their preparations at national level, provided they do not present any danger to human or animal health; Whereas allowing these products necessitates an inventory of them in each Member State, and the transmission to the Commission of certain information justifying their inclusion in national lists; Whereas Member States may not restrict the marketing of livestock products obtained from feeds containing enzymes, micro-organisms or their preparations when these are included on a national list established according to this Decision; Whereas this Directive does not apply to enzymes, micro-organisms, or to their preparations when used as silage agents; Whereas this Directive applies without prejudice to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(6) ; Whereas this Directive is to apply without prejudice to Directive 70/524/EEC; Whereas Directive 87/153/EEC should quickly be amended accordingly, with a view to making available the necessary rules for the specific examination of additives belonging to the new group of enzymes and micro-organisms; whereas, in the meantime, the dossiers to be submitted with a view to assessing products included in the national lists must be prepared according to the guidelines established for additives in general; Whereas it is advisable that industry be given sufficient time to apply the new labelling provisions laid down for enzymes, micro-organisms and their preparations as well as premixtures and feedingstuffs containing them, Article 1 1. This Directive shall apply to the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition. 2. This Directive shall apply without prejudice to Directive 70/524/EEC and particularly to the provisions concerning the authorization of enzymes, micro-organisms and their preparations for use as additives. Article 2 1. By way of derogation from Article 3 of Directive 70/524/EEC, Member States shall temporarily allow the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition within their territory, provided that, on the basis of the information available, the products do not present a danger to human or animal health, and that they are included in the list established by virtue of Article 3. 2. All forms of use for animal nutrition other than the incorporation of such products into feedingstuffs shall be prohibited. Article 3 On the basis of the information provided by the persons responsible for putting the products into circulation Member States shall forward: (a) to the Commission before 1 November 1994: - a list of enzymes and micro-organisms and their preparations according to the model given in Annex I, - an identification note drawn up for each product according the the model given in Annex II by the person responsible for putting the product into circulation; (b) to the Commission and to the other Member States before 1 January 1996, the dossiers to justify these authorizations by the person(s) responsible requesting the inclusion of their product(s) in the list referred to in the first indent of point (a). Article 4 1. As and when the requested information reaches it, the Commission shall communicate to Member States the lists of enzymes, micro-organisms or their preparations sent to it in accordance with Article 3. 2. Where enzymes, micro-organisms or preparations manufactured from them are included in several national lists, it may be agreed between the Member States concerned that a single dossier should be submitted by one of them. In this case the Member State appointed to submit the dossier shall inform the Commission accordingly. 3. Before 31 March 1996 and on the basis of the dossiers which have been forwarded to it in accordance with Article 3, the Commission shall publish in the 'C' series of the Official Journal of the European Communities a list of enzymes, micro-organisms and their preparations permitted in the various Member States. Article 5 Before 1 January 1997, a ruling will be given in accordance with the procedure laid down in Article 24 of Directive 70/524/EEC on the dossiers referred to in Article 3 (b) concerning the authorization of additives in animal nutrition. Article 6 Where Member States find it impossible to satisfy one of the conditions referred to in Article 3, for an enzyme, micro-organisms or preparation used in their territory, they shall take all the necessary measures to ensure that the enzyme, micro-organism or preparation obtained from them is no longer used or marketed in their territories. Article 7 1. Enzymes, micro-organisms and their preparations, as well as premixtures and compound feedingstuffs in which they have been incorporated, may be marketed only if the particulars listed below, which must be clearly visible, legible and indelible and for which the producer, packer, importer, vendor or distributor established within the Community shall be held responsible, are shown on the packaging, the container or on a label attached thereto: A. for enzymes and their preparations: (a) the specific name of the active constituent(s) according to their enzymatic activity(ies) and the identification number(s) according to the International Union of Biochemistry; (b) the activity units (activity units(7) per g or activity units per ml); (c) the name or business name and the address or registered place of business of the person responsible for the particulars in this paragraph; (d) the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label; (e) the expiry date of the guarantee or the storage life from the date of manufacture; (f) the batch reference number and the date of manufacture; (g) directions for use and where appropriate, a safety recommendation; (h) the net weight and for liquid additives either the net volume or the net weight; (i) the indication 'to be used exclusively for the manufacture of feedingstuffs'; mB. for micro-organisms and their preparations: (a) the identifications of the strain(s) according to a recognized international code of nomenclature and the deposit number of the strain(s); (b) the number of colony-forming units (CFU/g); (c) the name or business name and address or registered place of business of the person responsible for the particulars referred to in this paragraph; (d) the name or business name and address or registered place of busniess of the manufacturer if he is not responsible for the particulars on the label; (e) the expiry date of the guarantee or the storage life from the date of manufacture; (f) the batch reference number and the date of manufacture; (g) the directions for use and, where appropriate, a safety recommendation; (h) the net weight and for liquid additives either the net volume or the net weight; (i) the indication 'to be used exclusively in the manufacture of feedingstuffs'; (j) where appropriate, indication of any particular significant characteristics due to the manufacturing process; C. for premixtures containing enzymes: (a) the description 'premixture'; (b) the indication 'to be used exclusively in the manufacture of feedingstuffs'; (c) the directions for use and any safety recommendations regarding the use of premixtures; (d) the animal species or category of animals for which the premixture is intended; (e) 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; (f) the net weight and for liquids either the net volume or the net weight; (g) the specific name of the active constituent(s) according to their enzymatic activity(ies) and the identification number(s) according to the International Union of Biochemistry; (h) the activity units (activity units per g or activity units per ml); (i) the expiry date of the guarantee or the storage life from the date of manufacture; (j) the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label; D. for premixtures containing micro-organisms: (a) the description 'premixture'; (b) the indication 'to be used exclusively in the manufacture of feedingstuffs'; (c) the directions for use and any safety recommendations regarding the use of premixtures; (d) the animal species or category of animals for which the premixture is intended; (e) 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; (f) the net weight and for liquids either the volume or net weight; (g) the identification of the strain(s) according to a recognized international code of nomenclature and the deposit number(s) of the strain(s); (h) the number of colony-forming units (CFU/g); (i) the expiry date of the guarantee or the storage life from the date of manufacture; (j) the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label; (k) where appropriate, indication of any particular significant characteristics due to the manufacturing process; E. for compound feeds into which enzymes have been incorporated: (a) the specific name of the active constituent(s) according to their enzymatic activity(ies) and the identification number according to the International Union of Biochemistry; (b) the activity units (activity units per kg or activity units per l) provided that such units are measurable by an official or scientifically valid method); (c) the expiry date of the guarantee or the storage life from the date of manufacture. F. For compound feeds into which micro-organisms have been incorporated: (a) the identification of the strain(s) according to a recognized international code of nomenclature and the deposit number(s) of the strain(s); (b) the number of colony-forming units (CFU/kg) provided that the number is measurable by an official or scientifically valid method; (c) the expiry date of the guarantee or the storage life from the date of manufacture; (d) where appropriate, indication of any particular significant characteristics due to the manufacturing process. 2. Particulars other than those prescribed in paragraph 1, under A, B, C and D such as the trade name, may be included on the packaging, containers or on a label attached thereto, provided that they are clearly separated from the said particulars. Article 8 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than: - 1 January 1995 as regards Article 7, and - 1 October 1994 as regards the other provisions. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 9 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 10 This Directive is addressed to the Member States.

31993L0116

1993

Commission Directive 93/116/EC of 17 December 1993 adapting to technical progress Council Directive 80/1268/EEC relating to the fuel consumption of motor vehicles Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 93/81/EEC (2), and in particular Article 13 (2) 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 (3), as amended by Directive 89/491/EEC (4), and in particular Article 3 thereof, Whereas Directive 80/1268/EEC is one of the separate directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas reference should be made to Council Directive 70/220/EEC (5), as last amended by Directive 93/59/EEC (6), relating to measures to be taken against air pollution by emissions from motor vehicles, because that Directive establishes technical and administrative provisions which apply also to this Directive; Whereas, in view of the increasing concern about the environmental effects of carbon dioxide emissions, the fifth programme of action of the European Communities on the protection of the environment approved by the Council on 16 December 1992 provides for a stabilization target of these emissions; whereas it is necessary to determine the carbon dioxide emissions of light motor vehicles in the framework of the EC type-approval; whereas it is appropriate to base the measurement of carbon dioxide on the test procedure established by Directive 70/220/EEC for the measurement of the air-polluting substances of motor vehicles, and consequently to calculate fuel consumption on the basis of the results of these measurements; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 80/1268/EEC shall be amended as follows: 1. the title shall be replaced by the following: 'Council Directive 80/1268/EEC relating to the carbon dioxide emissions and the fuel consumption of motor vehicles.'; 2. Article 2 shall be replaced by the following: 'Article 2 No Member State may refuse to grant EC type-approval or national type-approval in respect of a vehicle, or refuse or prohibit the sale, registration, entry into service or use of a vehicle, on grounds relating to its carbon dioxide emissions or its fuel consumption if the emission and consumption figures have been determined in accordance with Annexes I and II and are set out in a document given to the vehicle owner at the time of purchase in the manner and form decided by each Member State.'; 3. the Annexes shall be replaced by the Annexes to this Directive. Article 2 1. With effect from 1 April 1994, Member States may not on grounds relating to the emission of carbon dioxide or to fuel consumption: - refuse, in respect of any given type of motor vehicle, to grant EC type-approval or national type-approval; or - prohibit the registration, sale or entry into service of vehicles, if the emission and consumption figures have been determined to be in accordance with the requirements of Directive 80/1268/EEC as amended by this Directive. 2. With effect from 1 January 1996, Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval, for a type of vehicle on grounds relating to the emission of carbon dioxide and to the fuel consumption if the emission and consumption figures have not been determined in accordance with the requirements of Directive 80/1268/EEC, as amended by this Directive. 3. With effect from 1 January 1997, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, and - may refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, on grounds relating to the emission of carbon dioxide and to fuel consumption if the emission and consumption figures have not been determined in accordance with the requirements of Directive 80/1268/EEC, as amended by this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31993L0117

1993

Twelfth Commission Directive 93/117/EC of 17 December 1993 establishing Community analysis methods for official control of feedingstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 2 thereof, Whereas Directive 70/373/EEC requires that official controls on feedingstuffs for the purpose of checking compliance with requirements arising under quality and composition provisions laid down by law, regulation or administrative action shall be carried out using Community sampling and analysis methods; Whereas Community analysis methods for the additives robenidine and methyl benzoquate should be established for use in checking compliance with the conditions for its use in animal feedingstuffs; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Member States shall require that analyses conducted in the course of official checks on feedingstuffs to identify their robenidine and methyl benzoquate content be made using the methods described in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions required for compliance with this Directive by 30 November 1994 at the latest and shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.

31993L0119

1993

Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter or killing Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 74/577/EEC (4) established rules on the stunning of animals before slaughter; Whereas the European Convention for the Protection of Animals for Slaughter was approved on behalf of the Community by Council Decision 88/306/EEC (5); whereas the scope of the Convention is wider than existing Community rules on the matter; Whereas national laws concerning the protection of animals at the time of slaughter or killing have an impact on the conditions of competition and accordingly on the operation of the common market in agricultural products; Whereas there is therefore a need to establish common minimum standards for the protection of animals at the time of slaughter or killing in order to ensure rational development of production and to facilitate the completion of the internal market in animals and animal products; Whereas at the time of slaughter or killing animals should be spared any avoidable pain or suffering; Whereas, however, it is necessary to allow for technical and scientific experiments to be carried out and to take account of the particular requirements of certain religious rites; Whereas the rules should also ensure satisfactory protection, at the time of slaughter or killing, for animals not covered by the Convention; Whereas in the declaration on the protection of animals annexed to the Final Act of the Treaty on European Union, the Conference calls upon the European Parliament, the Council and the Commission, as well as the Member States, when drafting and implementing Community legislation on the common agricultural policy, to pay full regard to the welfare requirements of animals; Whereas in so doing Community action must comply with the requirements arising out of the principle of subsidiarity laid down in Article 3b of the Treaty; Whereas Directive 74/577/EEC should be repealed, CHAPTER I General provisions Article 1 1. This Directive shall apply to the movement, lairaging, restraint, stunning, slaughter and killing of animals bred and kept for the production of meat, skin, fur or other products and to methods of killing animals for the purpose of disease control. 2. It shall not apply to: - technical or scientific experiments relating to the procedures mentioned in paragraph 1, carried out under the supervision of the competent authority, - animals which are killed in cultural or sports events, - wild game killed in accordance with Article 3 of Directive 92/45/EEC. Article 2 For the purposes of this Directive the following definitions shall apply: 1. slaughterhouse: any premises, including facilities for moving or lairaging animals, used for the commercial slaughter of animals referred to in Article 5 (1); 2. movement: unloading of animals or driving of them from unloading platforms, stalls or pens at slaughterhouses to the premises or place where they are to be slaughtered; 3. lairaging: keeping animals in stalls, pens, covered areas or fields used by slaughterhouses in order to give them any necessary attention (water, fodder, rest) before they are slaughtered; 4. restraint: the application to an animal of any procedure designed to restrict its movements in order to facilitate effective stunning or killing; 5. stunning: any process which, when applied to an animal, causes immediate loss of consciousness which lasts until death; 6. killing: any process which causes the death of an animal; 7. slaughter: causing the death of an animal by bleeding; 8. competent authority: the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence. However, in the Member States, the religious authority on whose behalf slaughter is carried out shall be competent for the application and monitoring of the special provisions which apply to slaughter according to certain religious rites. As regards the said provisions, that authority shall operate under the responsibility of the official veterinarian, as defined in Article 2 of Directive 64/433/EEC. Article 3 Animals shall be spared any avoidable excitement, pain or suffering during movement, lairaging, restraint, stunning, slaughter or killing. CHAPTER II Requirements applicable to slaughterhouses Article 4 The construction, facilities and equipment of slaughterhouses, and their operation, shall be such as to spare animals any avoidable excitement, pain or suffering. Article 5 1. Solipeds, ruminants, pigs, rabbits and poultry brought into slaughterhouses for slaughter shall be: (a) moved and if necessary lairaged in accordance with the provisions of Annex A; (b) restrained in accordance with the provisions of Annex B; (c) stunned before slaughter or killed instantaneously in accordance with the provisions of Annex C; (d) bled in accordance with the provisions of Annex D. 2. In the case of animals subject to particular methods of slaughter required by certain religious rites, the requirements of paragraph 1(c) shall not apply. 3. With due regard for the general rules of the Treaty, the competent authorities of the Member States may, for establishments qualifying for derogations pursuant to Articles 4 and 13 of Directive 64/433/EEC, Article 4 of Directive 91/498/EEC and Articles 7 and 18 of Directive 71/118/EEC, grant derogations from paragraph 1(a) in respect of cattle, and from paragraph 1(a) and from the methods for stunning and killing referred to in Annex C in respect of poultry, rabbits, pigs, sheep and goats, provided that the requirements laid down in Article 3 are met. Article 6 1. Instruments, restraint and other equipment and installations used for stunning or killing must be designed, constructed, maintained and used in such a way as to achieve rapid and effective stunning or killing in accordance with the provisions of this Directive. The competent authority shall check that the instruments, restraint and other equipment used for stunning or killing comply with the above principles and shall check regularly to ensure that they are in a good state of repair and will allow the aforementioned objective to be attained. 2. Suitable spare equipment and instruments must be kept at the place of slaughter for emergency use. They shall be properly maintained and inspected regularly. Article 7 No person shall engage in the movement, lairaging, restraint, stunning, slaughter or killing of animals unless he has the knowledge and skill necessary to perform the tasks humanely and efficiently, in accordance with the requirements of this Directive. The competent authority shall ensure that persons employed for slaughtering possess the necessary skill, ability and professional knowledge. Article 8 Inspections and controls in slaughterhouses shall be carried out under the responsibility of the competent authority, which shall at all times have free access to all parts of slaughterhouses in order to ascertain compliance with this Directive. However, such inspections and controls may be carried out at the same time as controls carried out for other purposes. CHAPTER III Slaughter and killing outwith slaughterhouses Article 9 1. Where animals referred to in Article 5 (1) are slaughtered outwith slaughterhouses, Article 5 (1)(b), (c) and (d) shall apply. 2. Member States may, however, grant derogations from paragraph 1 in respect of poultry, rabbits, pigs, sheep and goats slaughtered or killed outwith slaughterhouses by their owner for his personal consumption, provided that Article 3 is complied with and that pigs, sheep and goats have been stunned in advance. Article 10 1. Where animals referred to in Article 5 (1) are to be slaughtered or killed for purposes of disease control, this shall be carried out in accordance with Annex E. 2. Animals farmed for their fur shall be killed in accordance with Annex F. 3. Surplus day-old chicks, as defined in Article 2 (3) of Directive 90/539/EEC, and embryos in hatchery waste shall be killed as rapidly as possible in accordance with Annex G. Article 11 Articles 9 and 10 shall not apply in the case of an animal which has to be killed immediately for emergency reasons. Article 12 Injured or diseased animals must be slaughtered or killed on the spot. However, the competent authority may authorize the transport of injured or diseased animals for the purpose of slaughter or killing provided that such transport does not entail further suffering for the animals. CHAPTER IV Final provisions Article 13 1. If necessary, rules on the protection of animals at the time of slaughter or killing other than those in this Directive shall be adopted by the Council acting by a qualified majority on a proposal from the Commission. 2. (a) The Annexes to this Directive shall be amended by the Council acting on a proposal from the Commission, in accordance with the procedure laid down in paragraph 1, in particular in order to adapt them to technological and scientific progress; (b) in addition, and no later than 31 December 1995, the Commission shall submit to the Council a report drawn up on the basis of an opinion from the Scientific Veterinary Committee together with appropriate proposals concerning the use, in particular, of: - free bullet pistols, applied to the brain, or of gases other than those referred to in Annex C or combinations thereof for stunning and more particularly carbon dioxide for stunning poultry, - gases other than those referred to in Annex C or combinations thereof for killing, - any other scientifically recognized procedure for stunning or killing. The Council shall act by a qualified majority on these proposals; (c) by way of derogation from (a), and no later than 31 December 1995, the Commission, in accordance with the procedure laid down in Article 16, shall submit to the Standing Veterinary Committee a report drawn up on the basis of an opinion from the Scientific Veterinary Committee, together with appropriate proposals, with a view to laying down: (i) the strength and duration of use of the current necessary to stun the various species concerned; (ii) the gas concentration and length of exposure necessary to stun the various species concerned; (d) pending implementation of paragraphs (b) and (c), national rules in the matter shall apply, in compliance with the general provisions of the Treaty. Article 14 1. Commission experts may make on-the-spot checks in so far as is necessary to ensure uniform application of this Directive. In order to do this, they may check a representative sample of establishments to ensure that the competent authority is checking that the said establishments are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out. 2. The checks referred to in paragraph 1 shall be carried out in collaboration with the competent authority. 3. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. 4. The detailed rules for implementing this Article shall be determined in accordance with the procedure laid down in Article 16. Article 15 In the course of the inspection of slaughterhouses or establishments which have been or are to be approved in third countries for the purpose of being able to export to the Community in accordance with Community rules, the Commission experts shall ensure that the animals referred to in Article 5 have been slaughtered under conditions which offer guarantees of humane treatment at least equivalent to those provided for in this Directive. To enable meat to be imported from a third country the health certificate accompanying such meat must be supplemented by an attestation certifying that the above requirement has been met. Article 16 1. Where the procedure laid down in this Article is to be followed, the matter shall without delay be referred to the Standing Veterinary Committee by its chairman, either on his own initiative or at the request of 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 intended measures when they are in accordance with the opinion of the committee. (b) Where the intended measures 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 on which the matter was referred to it, 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 17 Directive 74/577/EEC shall be repealed with effect from 1 January 1995. Article 18 1. Member States shall bring into force the laws, regulations and administrative provisions, including any penalties, necessary to comply with this Directive on 1 January 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. However, as from the date laid down in paragraph 1, Member States may, with due regard for the general rules of the Treaty, maintain or apply in their territory more stringent provisions than those contained in this Directive. They shall inform the Commission of any such measures. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 19 This Directive is addressed to the Member States.

31993L0121

1993

Council Directive 93/121/EC of 22 December 1993 amending Directive 91/494/EEC on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat Having regard to the Treaty establishing the European 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 Article 3 (A) (1) of Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (4) lays down the rules for Newcastle disease vaccination for flocks of origin of poultrymeat intended for Member States or regions of Member States the status of which has been recognized in accordance with Article 12 (2) of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (5); Whereas it is necessary to lay down the Newcastle disease vaccination rules to be applied from 1 January 1993 to trade in fresh poultrymeat intended for Member States or regions of Member States the status of which has been recognized in accordance with Article 12 (2) of Directive 90/539/EEC; Whereas the Council has adopted Directive 92/66/EEC (6) on the control of Newcastle disease and Directive 92/40/EEC (7) on the control of avian influenza, thus allowing a simplification of Directive 91/494/EEC; Whereas it is desirable to allow an alternative to the use of the special mark defined in Article 5 of Directive 91/494/EEC; Whereas it is necessary to amend the trading rules applied to third countries to ensure they are equivalent to those applied to Member States, particularly as regards Newcastle disease and avian influenza, Article 1 Directive 91/494/EEC is hereby amended as follows: 1. Article 3(A)(1) shall be replaced by the following: '1. has been held in Community territory since hatching or has been imported from third countries in accordance with the requirements of Chapter III of Directive 90/539/EEC. Poultrymeat intended for Member States or regions of Member States the status of which has been recognized in accordance with Article 12 (2) of that Directive must come from poultry which has not been vaccinated against Newcastle disease using a live vaccine during the 30 days preceding slaughter. This rule shall be reviewed by the Council acting by a qualified majority on a proposal from the Commission before Community legislation harmonizing the use of Newcastle disease vaccine enters into force and not later than 31 December 1994.'. 2. In Article 3(A)(2) the second indent shall be replaced by the following: '- which is not located in an area which for animal health reasons is subject to restrictive measures involving controls on poultrymeat in accordance with Community legislation as a result of an outbreak of disease to which poultry is susceptible;'. 3. The following paragraphs shall be added to Article 5: '3. By way of derogation from paragraphs 1 and 2 and in the event of an epizootic of Newcastle disease, fresh poultrymeat may be marked in accordance with Article 3 (1)(A)(e) of Directive 71/118/EEC with the health mark described in Annex I, Chapter X, point 44(a) and (b) to Directive 71/118/EEC, provided that such meat comes from poultry which: (a) comes from a holding situated within the surveillance zone as defined in Article 9 (1) of Directive 92/66/EEC, but not the protection zone defined in Article 9 (1) of Directive 92/66/EEC, and with respect to which, following an epidemiological examination, no contact with an infected holding has been recorded; (b) comes from a flock where a virological examination giving a negative result is carried out on a representative sample of the flock five days before shipment of the poultry; the sampling must be carried out by a veterinarian designated by the competent authority; (c) comes from a holding where no signs or clinical symptoms have been found which could indicate the presence of Newcastle disease following a clinical examination by a veterinarian designated by the competent authorities; such examination must have been carried out within the 24 hours before consignment of the poultry; (d) without prejudice to the provisions of Article 3(A)(3), is directly transported from the holding of origin to the slaughterhouse; the means of transport used must be sealed by the official veterinarian and cleaned and disinfected before and after each transport; (e) is examined in the slaughterhouse at the time of the ante or post-mortem inspection, with a view to detecting symptoms of Newcastle disease. Member States invoking these provisions shall inform the other Member States and the Commission within the Standing Veterinary Committee of the measures they adopt in this matter. The general criteria for sampling, frequency of sampling and any conditions to be observed in implementing (a), (b) and (c) shall be laid down in accordance with the procedure provided for in Article 17, after consultation of the Scientific Veterinary Committee and before 1 January 1995. 4. Before 1 January 1998, the Commission shall submit to the Council a report on experience gained since implementation of these provisions, together with any proposals on which the Council shall decide by a qualified majority.'. 4. Article 10 shall be replaced by the following: 'Article 10 1. Fresh poultrymeat must come from countries: (a) in which avian influenza and Newcastle disease are legally notifiable diseases throughout the country in accordance with international standards; (b) free from avian influenza and Newcastle disease, or which, although they are not free from these diseases, apply measures to control them which are at least equivalent to those laid down in Directives 92/40/EEC and 92/66/EEC respectively. 2. Additional criteria for classifying third countries in respect of paragraph 1 shall be adopted in accordance with the procedure laid down in Article 17 before 1 January 1995. When implementing paragraph 1, the Commission shall adopt, by means of certification, all measures necessary to safeguard the particular animal health situations in certain regions of the Community. 3. The Commission may, in accordance with the procedure laid down in Article 17, decide under which conditions paragraph 1 is to apply only to a part of the territory of third countries.'. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0120

1993

Council Directive 93/120/EC of 22 December 1993 amending Directive 90/539/EEC on animal health conditions governing intra-Community trade in and imports from third countries of poultry and hatching eggs Having regard to the Treaty establishing the European 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 the light of developments in the poultry industry with larger and more intensive units there is a need to adjust certain aspects of Directive 90/539/EEC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (4) to clarify requirements and to simplify their application by Member States; Whereas the Council has adopted Directive 92/66/EEC introducing Community measures for the control of Newcastle disease (5) and Directive 92/40/EEC introducing Community measures for the control of avian influenza (6), thus allowing a simplification of Directive 90/539/EEC; Whereas, taking account of the report from the Commission to the Council on the risks of transmission of Newcastle disease and the requirements to be met by Newcastle disease vaccines, provision should be made for certain Member States or regions to be approved as Newcastle disease non-vaccinating, if appropriate; whereas, however, provision should also be made for this Newcastle disease non-vaccinating status to be withdrawn if necessary; Whereas it is necessary to amend the trading rules as applied to third countries to ensure they are equivalent to those applied in Member States, particularly as Newcastle disease and avian influenza, Article 1 Directive 90/539/EEC is hereby amended as follows: 1. Article 2 (3) shall be replaced by the following: '3. "day-old chicks" shall mean all poultry less than 72 hours old, not yet fed; however, muscovy ducks (Cairina moschata) or their crosses may be fed;'. 2. Article 2 (7) shall be replaced by the following: '7. "flock" shall mean all poultry of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit. In housed poultry this will include all birds sharing the same airspace;'. 3. Article 2 (9)(c) shall be replaced by the following: '(c) rearing establishment: (i) either a breeding poultry rearing establishment which is an establishment which rears breeding poultry prior to the reproductive stage; or (ii) a productive poultry rearing establishment which is an establishment which rears egg-laying productive poultry prior to the laying stage;'. 4. Article 2 (15) shall be deleted. 5. Article 5 shall be replaced by the following: 'Article 5 In order to be traded in the Community: (a) hatching eggs, day-old chicks, breeding poultry and productive poultry must satisfy the conditions laid down in Articles 6, 12, 15 and 17. They must also satisfy any conditions laid down pursuant to Articles 13 and 14. In addition: - hatching eggs must satisfy the conditions laid down in Article 7, - day-old chicks must satisfy the conditions laid down in Article 8, - breeding poultry and productive poultry must satisfy the conditions laid down in Article 9; (b) Slaughter poultry must fulfil the conditions set out in Articles 10, 12, 15 and 17 and those laid down pursuant to Articles 13 and 14; (c) Poultry (including day-old chicks) intended for restocking supplies of game must fulfil the conditions set out in Articles 10a, 12, 15 and 17 and those laid down pursuant to Articles 13 and 14.'. 6. Article 6 (1)(c) shall be replaced by the following: '(c) they must not be located in an area which for animal health reasons is subject to restrictive measures in accordance with Community legislation as a result of the outbreak of a disease to which poultry is susceptible;'. 7. Article 6 (2) shall be replaced by the following: '2. A flock which at the time of consignment presents no clinical sign or suspicion of contagious poultry disease;'. 8. Article 7 shall be replaced by the following: 'Article 7 At the time of consignment, hatching eggs must: 1. come from flocks which: - have been held for more than six weeks in one or more Community establishments as defined in Article 6 (1)(a), - if vaccinated, have been vaccinated in accordance with the vaccination conditions in Annex III; - have either undergone an animal health examination carried out by an official veterinarian or an authorized veterinarian during the 72 hours preceding consignment and, at the time of the examination, have shown no clinical sign or suspicion of contagious disease, - or have had a monthly health inspection visit by an official veterinarian or an authorized veterinarian, the most recent visit having been within 31 days of consignment. If this option is chosen there must also be an examination by the official veterinarian or authorized veterinarian of the records of the health status of the flock and an evaluation of its current health status as assessed by up-to-date information supplied by the person in charge of the flock during the 72 hours preceding consignment. In a case where records or other information give rise to suspicion of disease, the flocks must have had an animal health examination by the official veterinarian or authorized veterinarian that has ruled out the possibility of contagious poultry disease; 2. be marked in accordance with Commission Regulation (EEC) No 1868/77; 3. have been disinfected in accordance with the instructions of the official veterinarian. In addition, if contagious poultry diseases which may be transmitted through eggs develop in the flock which supplied the hatching eggs during the period of their incubation, the hatchery involved and the authority or authorities responsible for the hatchery and the flock of origin must be notified.'. 9. Article 8(b) shall be replaced by the following: '(b) satisfy the vaccination conditions in Annex III, if they have been vaccinated;'. 10. Article 9(b) shall be replaced by the following: '(b) satisfy the vaccination conditions in Annex II, if they have been vaccinated;'. 11. Article 9(c) shall be replaced by the following: '(c) have been submitted to a health examination by an official veterinarian or authorized veterinarian during the 48 hours preceding consignment and, at the time of the examination, have presented no clinical sign or suspicion of contagious poultry disease;'. 12. Article 10(c) shall be replaced by the following: '(c) where the health examination carried out by the official veterinarian or authorized veterinarian during the 5 days preceding dispatch on the flock from which the consignment to be slaughtered is to be drawn has not revealed within that flock any clinical sign or suspicion of contagious poultry disease;'. 13. Article 10(d) shall be replaced by the following: '(d) which is not located in an area which for animal health reasons is subject to restrictive measures in accordance with Community legislation as a result of the outbreak of a disease to which poultry is susceptible.'. 14. The following Article shall be inserted: 'Article 10a 1. At the time of consignment, poultry over 72 hours old intended for restocking supplies of wild game must have come from a holding: (a) where it has been held since hatching or for more than 21 days and where it has not been placed in contact with newly-arrived poultry during the two weeks preceding consignment; (b) which is not the subject of any animal health restrictions applicable to poultry; (c) where the health examination carried out by the official veterinarian or authorized veterinarian during the 48 hours preceding dispatch on the flock from which the consignment is to be drawn has not revealed within that flock any clinical sign or suspicion of contagious poultry disease; (d) which is not located in an area which for animal health reasons is subject to prohibition in accordance with Community legislation as a result of an outbreak of disease to which poultry is susceptible. 2. Articles 6 and 9a shall not apply to the poultry referred to in paragraph 1.'. 15. In Article 11 (2) the third indent shall be replaced by the following: '- satisfy the vaccination conditions in Annex III, if they have been vaccinated;'. 16. In Article 11 (2) the fifth indent shall be replaced by the following: '- are not located in an area which for animal health reasons is subject to restrictive measures in accordance with Community legislation as a result of an outbreak of disease to which poultry is susceptible;'. 17. in Article 11 (2) the last indent shall be replaced by the following: 'All birds in the consignment must have been found negative in serological tests for Salmonella pullorum and Salmonella gallinarum antibodies, in accordance with Annex II, Chapter III, in the month preceding the consignment. In the case of hatching eggs or day-old chicks, the flock of origin must be tested serologically for Salmonella pullorum and Salmonella gallinarum in the three months preceding the consignment at a level which gives 95 % confidence of detecting infection at 5 % prevalence.'. 18. Article 12 (2) and (3) shall be replaced by the following: '2. If a Member State or a region or regions of a Member State wish to be established as Newcastle disease non-vaccinating they can present a programme as laid down in Article 13 (1). The Commission shall examine the programmes presented by the Member States. The programmes may be approved, in compliance with the criteria referred to in Article 13 (1), in accordance with the procedure laid down in Article 32. Any additional guarantees, general or specific, which may be required in intra-Community trade may be defined in accordance with the same procedure. Where a Member State or a region of a Member State considers it has achieved Newcastle disease non-vaccinating status, an application may be made to the Commission for Newcastle disease non-vaccinating status to be established in accordance with the procedure laid down in Article 32. The elements to be taken into account for determination of a Member State's or region's status as Newcastle disease non-vaccinating shall be the data referred to in Article 14 (1) and, in particular, the following criteria: - vaccination against Newcastle disease in the poultry referred to in Article 1 shall not have been authorized for the preceding 12 months, except for the compulsory vaccination of racing pigeons referred to in Article 17 (3) of Directive 92/66/EEC, - breeding flocks shall have been serologically monitored at least once a year for the presence of Newcastle disease according to the detailed rules adopted under the procedure laid down in Article 32, - the holdings shall contain no poultry which has been vaccinated against Newcastle disease in the previous 12 months, with the exception of racing pigeons vaccinated pursuant to Article 17 (3) of Directive 92/66/EEC. 3. The Commission may suspend Newcastle disease non-vaccinating status in accordance with the procedure laid down in Article 32 in the event of: (i) either a serious epizootic of Newcastle disease which is not being brought under control; (ii) or the removal of the legislative restrictions prohibiting systematic recourse to routine vaccination against Newcastle disease. 4. The conditions referred to in paragraph 1 will be reviewed by the Council acting by a qualified majority on a proposal from the Commission before legislation harmonizing the use of Newcastle disease vaccines enters into force and not later than 31 December 1994.'. 19. Article 15 (1) shall be replaced by the following: '1. "Day-old chicks" and hatching eggs must be transported in: - either unused purpose-designed disposable containers to be used only once and then destroyed, - or containers which may be re-used provided they are cleaned and disinfected beforehand. In any event such containers must: (a) contain only day-old chicks or hatching eggs of the same species, category and type of poultry, coming from the same establishment; (b) be labelled with: - the name of the Member State and region of origin, - the establishment of origin's approval number as provided for in Annex II, Chapter I (2), - the number of chicks or eggs in each box, - the poultry species to which the eggs or chicks belong.'. 20. In Article 15 (3) the third indent shall be deleted. 21. In Article 15 (4) the following point shall be added: '(c) poultry intended for restocking supplies of game must be conveyed without delay to the point of destination without coming into contact with other poultry except poultry intended for restocking supplies of game satisfying the conditions laid down in this Directive.'. 22. In Article 17 the last indent shall be replaced by the following: '- bears a stamp and a signature of a different colour from that of the certificate.'. 23. Article 19 shall be deleted. 24. Article 22 shall be replaced by the following: 'Article 22 1. Poultry and hatching eggs must come from third countries: (a) in which avian influenza and Newcastle disease, as defined in Council Directives 92/40/EEC and 92/66/EEC respectively, are legally notifiable diseases; (b) free from avian influenza and Newcastle disease, or which, although they are not free from these diseases, apply measures to control them which are at least equivalent to those laid down in Directives 92/40/EEC and 92/66/EEC respectively. 2. Additional criteria for classifying third countries in respect of paragraph 1(b), particularly as regards the type of vaccine used, shall be adopted in accordance with the procedure laid down in Article 32 before 1 January 1995. 3. The Commission may, in accordance with the procedure laid down in Article 32, decide under which conditions paragraph 1 is to apply only to a part of the territory of third countries.' 25. Article 24(h) shall be replaced by the following: '(h) bear a stamp and a signature of a different colour from that of the certificate.'. 26. Article 35 shall be deleted. 27. In Annex I the national reference laboratory for Denmark is changed to the following: 'National Veterinary Laboratory, Poultry Disease Division, Hangoevej 2, DK-8200 Aarhus N'. 28. In Annex IV, Model 5, point 14(a) shall be replaced by: '(a) the birds described above comply with the provisions of Articles 10 and 15 of Directive 90/539/EEC;'. 29. In Annex IV, Model 6, point 14(a) is replaced by: '(a) the birds described above comply with the provisions of Articles 10a and 15 of Directive 90/539/EEC;'. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0118

1993

Council Directive 93/118/EEC of 22 December 1993 amending Directive 85/73/EEC on the financing of health inspections and controls of fresh meat and poultrymeat Having regard to the Treaty establishing the European 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 animal products are included in the list of products contained in Annex II to the Treaty; whereas the marketing of those products constitutes a significant source of income for a large part of the agricultural population; Whereas Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (4), laid down in particular the requirements for veterinary checks to be carried out in the Member State of dispatch for a large number of animal products; Whereas Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (5) laid down in particular the requirements for checks to be carried out on animal products from third countries; Whereas Directive 85/73/EEC (6) laid down harmonized rules on the financing of health inspections and controls in relation to fresh meat of certain animal species; whereas that Directive lays down in particular that a fee is to be collected for inspections and controls; Whereas Directive 85/73/EEC should be amended to take account of the new provisions concerning controls; Whereas the principles laid down by Directive 85/73/EEC, and in particular the principle of charging fees, should be extended; whereas such an extension is justified by the concern to ensure that the control arrangements operate effectively and distortions of competition are avoided; Whereas the necessary rules should now be laid down to ensure the financing of the checks on meat covered by Directives 64/433/EEC (7), 71/118/EEC (8) and 72/462/EEC (9); Whereas for the other products of animal origin detailed rules will be established at a later date taking account of the specific nature of the products to be checked, the nature of the checks to be made and the advisability, having regard to the rules of competition, of setting a Community fee; Whereas the Community provisions on the matter must be presented homogeneously, Article 1 Directive 85/73/EEC is hereby amended as follows: 1. The title shall be replaced by the following: 'Council Directive 85/73/EEC on the financing of veterinary inspections and controls of animal products covered by Annex A to Directive 89/662/EEC and by Directive 90/675/EEC'. 2. Article 1 shall read as follows: 'Article 1 1. The Member States shall ensure - the collection of a Community fee for the costs occasioned by health inspections and controls on the meat referred to in Directives 64/433/EEC, 72/462/EEC and 71/118/EEC, including the expenses entailed by the checks referred to in Directive 86/469/EEC, as well as those resulting from monitoring the rules laid down in Directive 93/118/EC (*), - the financing of: - other veterinary inspections and controls laid down for the products referred to in the Directives listed in Annex A to Directive 89/662/EEC, - the controls provided for by Directive 90/675/EEC for products of animal origin other than the meat referred to in the first indent, including controls to detect the presence of residues. 2. The fees referred to in paragraph 1 shall be fixed so as to cover the costs incurred by the competent authority for - salary costs, including social-security costs, - administrative costs, which may include the expenditure required for in-service training of inspectors for carrying out the controls and inspections referred to in paragraph 1. 3. Any direct or indirect refund of the fees provided for by this Directive shall be prohibited. 3. Articles 2, 2a, and 3 shall be replaced by the following Articles: 'Article 2 1. The Member States shall ensure, for the purpose of financing the controls carried out pursuant to the Directives referred to in Article 1 by the competent authorities and for that purpose only, the collection - for the types of meat referred to in Directives 64/433/EEC, 71/118/EEC and 72/462/EEC, with effect from 1 January 1994, of the Community fees following the procedures laid down in the Annex, - from a date to be set at the time of adoption of the decisions provided for by Article 6, of a Community fee for the controls carried out on products of animal origin referred to in Article 1 (1), second indent. 2. Pending the decisions referred to in the second indent of paragraph 1, the Member States may collect national fees with due regard to the relevant principles governing the setting of Community fees. 3. Member States shall be authorized to collect an amount exceeding the level or levels of the Community fees, provided that the total fee collected by each Member State is not greater than the actual figure for inspection costs. 4. The Community fees shall replace all other health inspection charges or fees levied by the national, regional or local authorities of the Member States for the inspections and controls referred to in Article 1 and the certification thereof. However, until 31 December 1995, the Member States shall be authorized to collect registration costs for establishments approved in accordance with the rules referred to in Annex A to Directive 89/662/EEC. This Directive shall not preclude Member States from collecting a fee for combating epizootic diseases. 5. The Member States shall forward information - initially two years after the introduction of the new system and subsequently at the Commission's request - to the Commission concerning the distribution and use of the fees and must be able to justify their method of calculation. Article 3 1. As part of the checks provided for in Article 12 of Directive 64/433/EEC, Article 10 of Directive 71/118/EEC and Article 20 of Directive 90/675/EEC, the Commission may, by random spot checks, verify whether the provisions of this Directive are being applied. 2. Where a Member State considers that the controls in another Member State are carried out in such a way that the fees provided for in this Directive do not correspond to the actual costs of the controls, it shall have recourse to the relevant provisions of Directive 89/608/EEC and, in particular, Articles 10 and 11 thereof. Article 4 The fees shall be payable by the operator or owner of the establishment carrying out the operations referred to in the Directives listed in Annex A to Directive 89/662/EEC, who shall have the option of passing on the cost of the fee for the operation concerned to the natural or legal person on whose behalf the said operations are carried out. For imports the fees shall be payable by the importer or the customs agent acting for the importer. Article 5 The rate of conversion into national currency of the amounts in ecus specified in this Directive shall be that published annually on the first working day of the month of September in the C series of the Official Journal of the European Communities. This rate shall apply from 1 January of the following year. However, the Member States shall apply for 1994 the rate of conversion applicable on 1 September 1992 and, for 1995, the average of the conversion rates published in accordance with the first paragraph for the last three years. Article 6 1. The Council, acting by a qualified majority on a proposal from the Commission, may supplement this Directive with specific Annexes, so as to set the standard levels of the Community fees and determine the rules and principles for the application of this Directive, including exceptions to be made, as required for the implementation of the checks laid down in the Directives referred to in Annex A to Directive 89/662/EEC and in Directive 90/675/EEC. 2. The Annex to this Directive may be amended or supplemented by the procedure provided for in paragraph 1. 3. Before 1 January 1996, the Council shall review this Directive on the basis of a report from the Commission, accompanied by proposals where appropriate. Article 7 The Member States shall inform the Commission - of the conversion rates adopted each year in accordance with Article 5, - of the place or places where fees are charged, in accordance with Chapter I.6 of the Annex, giving any necessary explanations. Article 8 1. Greece shall be authorized to derogate from the principles laid down in this Directive where, because of geographical characteristics, the costs of collecting a fee in geographically remote regions are greater than the yield from the fee. The Greek authorities shall inform the Commission of the territorial extent of the derogations granted. The information shall be accompanied by any necessary explanations. 2. In the case of other outermost regions, other Member States may be authorized, in accordance with the procedure provided for in Article 18 of Directive 89/662/EEC, to benefit from the same derogations.' 4. The existing Articles 4 and 5 shall become Articles 9 and 10 respectively. 5. The Annex attached to this Directive is hereby added. Article 2 Decision 88/408/EEC is hereby repealed with effect from 1 January 1994. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1993 as regards the requirements in the Annex and in Article 5, and not later than 31 December 1994 as regards the other provisions. Portugal shall be allowed an additional period of one year to comply with the new provisions in Chapter I of the Annex. Member States shall forthwith inform the Commission of the provisions adopted. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States.

31994L0003

1994

COMMISSION DIRECTIVE 94/3/EC of 21 January 1994 establishing a procedure for the notification of interception of a consignment or a harmful organism from third countries and presenting an imminent phytosanitary danger Having regard to the Treaty establishing the European 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 and against their spread within the Community (1), as last amended by Commission Directive 93/110/EEC (2), and in particular Article 15 (4) thereof, Whereas in the case of consignments of plants, plant products or other objects, or of isolated harmful organisms, from third countries, whether or not listed in Part B of Annex V to Directive 77/93/EEC, which are considered to involve an imminent danger of the introduction or spread of the harmful organisms, whether or not listed in Annexes I and II thereto, the Member State concerned shall inform the Commission and the other Member States of the measures taken to protect the territory of the Community from that danger; Whereas that information should, on the one hand, assist the Commission in evaluating the scope of the interception and the resulting dangers and, where appropriate, in preparing as fast as possible any measures of protection or eradication in cooperation with the Member State concerned and, on the other hand, help the other Member States to face this danger; Whereas for that purpose the Commission should establish a network for the notification of new occurrences of harmful organisms in accordance with the first indent of Article 19a (6) of the said Directive; Whereas it is important that all relevant points of entry into the Community, potentially affected by an interception, as well as the Commission itself, shall immediately be informed of every interception at a point of entry into the Community, of a consignment of plants, plant products or other objects capable of presenting an imminent danger of introducing or spreading harmful organisms; Whereas the role of the single central authority of each Member State is to coordinate matters relating to plant health under Directive 77/93/EEC; Whereas such coordination includes the task of dispatching the notifications of interception between Member States as well as to all relevant points of entry within the territory of the Member State concerned which might be affected by an interception; Whereas it is appropriate to establish a standard Community printed form for notification of interception, to be used by the relevant departments of the Member Sates; Whereas the effective operation of the system requires the establishment of an information network for the use and processing of the information contained in those forms; Whereas management of the system does not preclude use of part of the information contained in notification of interception forms for the purposes of the Convention for the Establishment of the European and Mediterranean Plant Protection Organization, signed in Paris on 18 April 1951, as last amended on 21 September 1988; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 For the purpose of this Directive, ‘interception’ shall mean any action taken or to be taken by a Member State pursuant to Article 12 (8) of Directive 77/93/EEC in respect of all or part of a consignment from a third country of plants, plant products or other objects, or of an organism harmful to plants or plant products, which does not meet the provisions of that Directive. Article 2 1. Member States shall ensure that in the event of an interception, notification of interception is sent no later than two working days after the date of interception, except where a breach of Article 12 (1) (b) of Directive 77/93/EEC is committed, and preferably more rapidly in the case of an interception having involved a refusal, except where this is only a breach of Article 12 (1) (b) of that Directive, to the following: — their own single central authority having responsibility, — their own relevant responsible official bodies, — their own points of entry in question, — the single central authorities of the other Member States, without prejudice to the specific provisions of Article 4 of this Directive, — the Commission. 2. The single central authority of the Member State having received notification of interception from another Member State ensure, immediately on receipt, that the information is sent to its own points of entry in question. Article 3 Notification of interception shall be made on a form which conforms to the model shown in the Annex, duly completed in accordance with the recommendations in the guidelines for experts and national inspectors carrying out their activities under the second indent of Article 19 (a) (6) of Directive 77/93/EEC. Article 4 Without prejudice to the fourth indent of Article 2 (1), and at the request of the Member State concerned, the Commission will take charge of dispatching the notifications of interception as the establishment of the network defined under the first indent of Article 19 (a) (6) of Directive 77/93/EEC progresses, by sending to the other Member States a form which conforms to that set out in the Annex of this Directive, duly completed. Article 5 In order to fulfil the obligations related to this Directive, Member States shall preferably make use of the network set up by the Commission. Article 6 At the request of the Member State concerned and within the limits of the network set up by the Commission, the Commission shall forward the notification of interception forms to the European and Mediterranean Plant Protection Organization, to which Member States are required to forward any information on interception, pursuant to the Convention for the establishment of that Organization. Consequently, the Commission shall send to that Organization a form which conforms to that set out in the Annex, duly completed, but omitting points 1, 2, 3, 15 (c) to (g) and 17 of the form. Article 7 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive three months after its publication in the Official Journal of the European Communities. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission all provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 8 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.

31994L0004

1994

Council Directive 94/4/EC of 14 February 1994 amending Directives 69/169/EEC and 77/388/EEC and increasing the level of allowances for travellers from third countries and the limits on tax-free purchases in intra-Community travel Having regard to the Treaty establishing the European 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 1 (1) of Council Directive 69/169/EEC of 28 May 1969 on the harmonization of provisions laid down by law, regulation or administrative action relating to exemption from turnover tax and excise duty on imports in international travel (4) provides for allowances in respect of goods contained in the personal luggage of travellers coming from third countries on condition that such imports have no commercial character; Whereas the total value of the goods eligible for this exemption may not exceed ECU 45 per person; whereas, in accordance with Article 1 (2) of Directive 69/169/EEC, Member States may reduce the allowance to ECU 23 for travellers under 15 years of age; Whereas account must be taken of measures in favour of travellers recommended by specialized international organizations, in particular the measures contained in Annex F.3 to the International Convention on the Simplification and Harmonization of Customs Procedures; Whereas these objectives could be attained by increasing the allowances; Whereas it is necessary to provide, for a limited period, a derogation for Germany, taking into account the economic difficulties likely to be caused by the amount of the allowances, particularly as regards travellers entering the territory of that Member State by land frontiers linking Germany to countries other than Member States and the EFTA members or by means of coastal navigation coming from the said countries; Whereas there are special links between continental Spain and the Canary Islands, Ceuta and Melilla; Whereas it is necessary to ensure, during the period when these sales are authorized pursuant to the provisions of Article 28k of 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 (5), that the real value of goods likely to be sold in tax-free shops to travellers on intra-Community flights or sea crossings is maintained, Article 1 Directive 69/169/EEC is hereby amended as follows: 1. in Article 1 (1), 'ECU 45' shall be replaced by 'ECU 175'; 2. in Article 1 (2), 'ECU 23' shall be replaced by 'ECU 90'; 3. Article 7b shall be replaced by the following: 'Article 7b 1. By way of derogation from Article 1 (1), Spain is hereby authorized to apply, until 31 December 2000, an allowance of ECU 600 for imports of the goods in question by travellers coming from the Canary Islands, Ceuta and Melilla who enter the territory of Spain as definied in Article 3 (2) and (3) of Directive 77/388/EEC. 2. By way of derogation from Article 1 (2), Spain shall have the option of reducing that allowance to ECU 150 for travellers under 15 years of age.' Article 2 In Article 28k of Directive 77/388/EEC, the first subparagraph of point 2 (a) shall be replaced by the following: '(a) the total value of which per person per journey does not exceed ECU 90. By way of derogation from Article 28m, Member States shall determine the equivalent in national currency of the above amount in accordance with Article 7 (2) of Directive 69/169/EEC.' Article 3 1. Member States shall bring into force the provisions necessary to comply with this Directive by 1 April 1994 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. By way of derogation from paragraph 1, the Federal Republic of Germany shall be authorized to bring into force the measures necessary to comply with this Directive by 1 January 1998 at the latest for goods imported by travellers entering German territory by a land frontier linking Germany to countries other than Member States and the EFTA members or by means of coastal navigation coming from the said countries. 3. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31994L0005

1994

Council Directive 94/5/EC of 14 February 1994 supplementing the common system of value added tax and amending Directive 77/388/EEC - Special arrangements applicable to second-hand goods, works of art, collectors' items and antiques Having regard to the Treaty establishing the European Community, and in particular Article 99 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas, in accordance with Article 32 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 (3), the Council is to adopt a Community taxation system to be applied to used goods, works of art, antiques and collectors' items; Whereas the present situation, in the absence of Community legislation, continues to be marked by the application of very different systems which cause distortion of competition and deflection of trade both internally and between Member States; whereas these differences also include a lack of harmonization in the levying of the own resources of the Community; whereas consequently it is necessary to bring this situation to an end as soon as possible; Whereas the Court of Justice has, in a number of judgments, noted the need to attain a degree of harmonization which allows double taxation in intra-Community trade to be avoided; Whereas it is essential to provide, in specific areas, for transitional measures enabling legislation to be gradually adapted; Whereas, within the internal market, the satisfactory operation of the value added tax mechanisms means that Community rules with the purpose of avoiding double taxation and distortion of competition between taxable persons must be adopted; Whereas it is accordingly necessary to amend Directive 77/388/EEC, Article 1 Directive 77/388/EEC is hereby amended as follows: 1. in Article 11 (a) the following paragraph shall be added to Title A: '4. By way of derogation from paragraphs 1, 2 and 3, Member States which, on 1 January 1993, did not avail themselves of the option provided for in the third subparagraph of Article 12 (3) (a) may, where they avail themselves of the option provided for in Title B (6), provide that, for the transactions referred to in the second subparagraph of Article 12 (3) (c), the taxable amount shall be equal to a fraction of the amount determined in accordance with paragraphs 1, 2 and 3. That fraction shall be determined in such a way that the value added tax thus due is, in any event, equal to at least 5 % of the amount determined in accordance with paragraphs 1, 2 and 3.'; (b) the following paragraph shall be added to Title B: '6. By way of derogation from paragraphs 1 to 4, Member States which, on 1 January 1993, did not avail themselves of the option provided for in the third subparagraph of Article 12 (3) (a) may provide that for imports of the works of art, collectors' items and antiques defined in Article 26a (A) (a), (b) and (c), the taxable amount shall be equal to a fraction of the amount determined in accordance with paragraphs 1 to 4. That fraction shall be determined in such a way that the value added tax thus due on the import is, in any event, equal to at least 5 % of the amount determined in accordance with paragraphs 1 to 4.'; 2. in Article 12: (a) paragraph 3 (c) shall be replaced by the following: '(c) Member States may provide that the reduced rate, or one of the reduced rates, which they apply in accordance with the third paragraph of (a) shall also apply to imports of works of art, collectors' items and antiques as referred to in Article 26a (A) (a), (b) and (c). Where they avail themselves of this option, Member States may also apply the reduced rate to supplies of works of art, within the meaning of Article 26a (A) (a): - effected by their creator or his successors in title, - effected on an occasional basis by a taxable person other than a taxable dealer, where these works of art have been imported by the taxable person himself or where they have been supplied to him by their creator or his successors in title or where they have entitled him to full deduction of value-added tax.'; (b) paragraph 5 shall be replaced by the following: '5. Subject to paragraph 3 (c), the rate applicable on the importation of goods shall be that applied to the supply of like goods within the territory of the country.'; 3. the following Article shall be inserted: 'Article 26a Special arrangements applicable to second-hand goods, works of art, collectors' items and antiques A. Definitions For the purposes of this Article, and without prejudice to other Community provisions: (a) works of art shall mean the objects referred to in (a) of Annex I. However, Member States shall have the option of not considering as "works of art" the items mentioned in the final three indents in (a) in Annex I; (b) collectors items shall mean the objects referred to in (b) of Annex I; (c) antiques shall mean the objects referred to in (c) of Annex I; (d) second-hand goods shall mean tangible movable property that is suitable for further use as it is or after repair, other than works of art, collectors' items or antiques and other than precious metals or precious stones as defined by the Member States; (e) taxable dealer shall mean a taxable person who, in the course of his economic activity, purchases or acquires for the purposes of his undertaking, or imports with a view to resale, second-hand goods and/or works of art, collectors' items or antiques, whether that taxable person is acting for himself or on behalf of another person pursuant to a contract under which commission is payable on purchase or sale; (f) organizer of a sale by public auction shall mean any taxable person who, in the course of his economic activity, offers goods for sale by public auction with a view to handing them over to the highest bidder; (g) principal of an organizer of a sale by public auction shall mean any person who transmits goods to an organizer of a sale by public auction under a contract under which commission is payable on a sale subject to the following provisions: - the organizer of the sale by public auction offers the goods for sale in his own name but on behalf of his principal, - the organizer of the sale by public auction hands over the goods, in his own name but on behalf of his principal, to the highest bidder at the public auction. B. Special arrangements for taxable dealers 1. In respect of supplies of second-hand goods, works of art, collectors' items and antiques effected by taxable dealers, Member States shall apply special arrangements for taxing the profit margin made by the taxable dealer, in accordance with the following provisions. 2. The supplies of goods referred to in paragraph 1 shall be supplies, by a taxable dealer, of second-hand goods, works of art, collectors' items or antiques supplied to him within the Community: - by a non-taxable person, or - by another taxable person, in so far as the supply of goods by that other taxable person is exempt in accordance with Article 13 (B) (c), or - by another taxable person in so far as the supply of goods by that other taxable person qualifies for the exemption provided for in Article 24 and involves capital assets, or - by another taxable dealer, in so far as the supply of goods by that other taxable dealer was subject to value added tax in accordance with these special arrangements. 3. The taxable amount of the supplies of goods referred to in paragraph 2 shall be the profit margin made by the taxable dealer, less the amount of value added tax relating to the profit margin. That profit margin shall be equal to the difference between the selling price charged by the taxable dealer for the goods and the purchase price. For the purposes of this paragraph, the following definitions shall apply: - selling price shall mean everything which constitutes the consideration, which has been, or is to be, obtained by the taxable dealer from the purchaser or a third party, including subsidies directly linked to that transaction, taxes, duties, levies and charges and incidental expenses such as commission, packaging, transport and insurance costs charged by the taxable dealer to the purchaser but excluding the amounts referred to in Article 11 (A) (3), - purchase price shall mean everything which constitutes the consideration defined in the first indent, obtained, or to be obtained, from the taxable dealer by his supplier. 4. Member States shall entitle taxable dealers to opt for application of the special arrangements to supplies of: (a) works of art, collectors' items or antiques which they have imported themselves; (b) works of art supplied to them by their creators or their successors in title; (c) works of art supplied to them by a taxable person other than a taxable dealer where the supply by that other taxable person was subject to the reduced rate pursuant to Article 12 (3) (c). Member States shall determine the detailed rules for exercising this option which shall in any event cover a period at least equal to two calendar years. If the option is taken up, the taxable amount shall be determined in accordance with paragraph 3. For supplies of works of art, collectors' items or antiques which the taxable dealer has imported himself, the purchase price to be taken into account in calculating the margin shall be equal to the taxable amount on importation, determined in accordance with Article 11 (B), plus the value added tax due or paid on importation. 5. Where they are effected in the conditions laid down in Article 15, the supplies of second-hand goods, works of art, collectors' item or antiques subject to the special arrangements for taxing the margin shall be exempt. 6. Taxable persons shall not be entitled to deduct from the tax for which they are liable the value added tax due or paid in respect of goods which have been, or are to be, supplied to them by a taxable dealer, in so far as the supply of those goods by the taxable dealer is subject to the special arrangements for taxing the margin. 7. In so far as goods are used for the purpose of supplies by him subject to the special arrangements for taxing the margin, the taxable dealer shall not be entitled to deduct from the tax for which he is liable: (a) the value added tax due or paid in respect of works af art, collectors' items or antiques which he has imported himself; (b) the value added tax due or paid in respect of works of art which have been, or are to be, supplied to him by their creators or their successors in title; (c) the value added tax due or paid in respect of works of art which have been, or are to be, supplied to him by a taxable person other than a taxable dealer. 8. Where he is led to apply both the normal arrangements for value added tax and the special arrangements for taxing the margin, the taxable dealer must follow separately in his accounts the transactions falling under each of these arrangements, according to rules laid down by the Member States, 9. The taxable dealer may not indicate separately on the invoices which he issues, or on any other document serving as an invoice, tax relating to supplies of goods which he makes subject to the special arrangements for taxing the margin. 10. In order to simplify the procedure for charging the tax and subject to the consultation provided for in Article 29, Member States may provide that, for certain transactions or for certain categories of taxable dealers, the taxable amount of supplies of goods subject to the special arrangements for taxing the margin shall be determined for each tax period during which the taxable dealer must submit the return referred to in Article 22 (4). In that event, the taxable amount for supplies of goods to which the same rate of value added tax is applied shall be the total margin made by the taxable dealer less the amount of value added tax relating to that margin. The total margin shall be equal to the difference between: - the total amount of supplies of goods subject to the special arrangements for taxing the margin effected by the taxable dealer during the period; that amount shall be equal to the total selling prices determined in accordance with paragraph 3, and - the total amount of purchases of goods as referred to in paragraph 2 effected, during that period, by the taxable dealer; that amount shall be equal to the total purchase prices determined in accordance with paragraph 3. Member States shall take the necessary measures to ensure that the taxable persons concerned do not enjoy unjustfied advantages or sustain unjustified loss. 11. The taxable dealer may apply the normal value added tax arrangements to any supply covered by the special arrangements pursuant to paragraph 2 or 4. Where the taxable dealer applies the normal value added tax arrangements to: (a) the supply of a work of art, collectors' item or antique which he has imported himself, he shall be entitled to deduct from his tax liability the value added tax due or paid on the import of those goods; (b) the supply of a work of art supplied to him by its creator or his successors in title, he shall be entitled to deduct from his tax liability the value added tax due or paid for the work of art supplied to him; (c) the supply of a work of art supplied to him by a taxable person other than a taxable dealer, he shall be entitled to deduct from his tax liability the value added tax due or paid for the work of art supplied to him. This right to deduct shall arise at the time when the tax due for the supply in respect of which the taxable dealer opts for application of the normal value added tax arrangements become chargeable. C. Special arrangements for sales by public auction 1. By way of derogation from B, Member States may determine, in accordance with the following provisions, the taxable amount of supplies of second-hand goods, works of art, collectors' items or antiques effected by an organizer of sales by public auction, acting in his own name, pursuant to a contract under which commission is payable on the sale of those goods by public auction, on behalf of: - a non-taxable person, or - another taxable person, in so far as the supply of goods, within the meaning of Article 5 (4) (c), by that other taxable person is exempt in accordance with Article 13 (B) (c), or - another taxable person, in so far as the supply of goods, within the meaning of Article 5 (4) (c), by that other taxable person qualifies for the exemption provided for in Article 24 and involves capital assets, or - a taxable dealer, in so far as the supply of goods, within the meaning of Article 5 (4) (c), by that other taxable dealer, is subject to tax in accordance with the special arrangements for taxing the margin provided for in B. 2. The taxable amount of each supply of goods referred to in paragraph 1 shall be the total amount invoiced in accordance with paragraph 4 to the purchaser by the organizer of the sale by public auction, less: - the net amount paid or to be paid by the organizer of the sale by public auction to his principal, determined in accordance with paragraph 3, and - the amount of the tax due by the organizer of the sale by public auction in respect of his supply. 3. The net amount paid or to be paid by the organizer of the sale by public auction to his principal shall be equal to the difference between: - the price of the goods at public auction, and - the amount of the commission obtained or to be obtained by the organizer of the sale by public auction from his principal, under the contract whereby commission is payable on the sale. 4. The organizer of the sale by public auction must issue to the purchaser an invoice or a document in lieu itemizing: - the auction price of the goods, - taxes, dues, levies and charges, - incidental expenses such as commission, packing, transport and insurance costs charged by the organizer to the purchaser of the goods. That invoice must not indicate any value added tax separately. 5. The organizer of the sale by public auction to whom the goods were transmitted under a contract whereby commission is payable on a public auction sale must issue a statement to his principal. That statement must itemize the amount of the transaction, i.e. the auction price of the goods less the amount of the commission obtained or to be obtained from the principal. A statement so drawn up shall serve as the invoice which the principal, where he is a taxable person, must issue to the organizer of the sale by public auction in accordance with Article 22 (3). 6. Organizers of sales by public auction who supply goods under the conditions laid down in paragraph 1 must indicate in their accounts, in suspense accounts: - the amounts obtained or to be obtained from the purchaser of the goods, - the amount reimbursed or to be reimbursed to the vendor of the goods. These amounts must be duly substantiated. 7. The supply of goods to a taxable person who is an organizer of sales by public auction shall be regarded as being effected when the sale of those goods by public auction is itself effected. D. Transitional arrangements for the taxation of trade between Member States During the period referred to in Article 28l, Member States shall apply the following provisions: (a) supplies of new means of transport, within the meaning of Article 28a (2), effected within the conditions laid down in Article 28c (A) shall be excluded from the special arrangements provided for in B and C; (b) by way of derogation from Article 28a (1) (a), intra-Community acquisitions of second-hand goods, works of art, collectors' items or antiques shall not be subject to value added tax where the vendor is a taxable dealer acting as such and the goods acquired have been subject to tax in the Member State of departure of the dispatch or transport, in accordance with the special arrangements for taxing the margin provided for in B, or where the vendor is an organizer of sales by public auction acting as such and the goods acquired have been subject to tax in the Member State of departure of the dispatch or transport, in accordance with the special arrangements provided for in C; (c) Articles 28b (B) and 28c (A) (a), (c) and (d) shall not apply to supplies of goods subject to value added tax in accordance with either of the special arrangements laid down in B and C.'; 4. the following paragraph shall be inserted in Article 28: '1a. Until a date which may not be later than 30 June 1999, the United Kingdom of Great Britain and Northern Ireland may, for imports of works of art, collectors' items or antiques which qualified for an exemption on 1 January 1993, apply Article 11 (B) (6) in such a way that the value added tax due on importation is, in any event, equal to 2,5 % of the amount determined in accordance with Article 11 (B) (1) to (4).'; 5. the following subparagraph shall be added to Article 28 (2) (e): 'This provision may not apply to supplies of second-hand goods, works of art, collectors' items or antiques subject to value added tax in accordance with one of the special arrangements provided for an Article 26a (B) and (C).'; 6. Article 28a (2) (b) shall be amended as follows: '(b) the means of transport referred to in (a) shall not be considered to be "new" where both of the following conditions are simultaneously fulfilled: - they were supplied more than three months after the date of first entry into service. However, this period shall be increased to six months for the motorized land vehicles defined in (a), - they have travelled more than 6 000 kilometres in the case of land vehicles, sailed for more than 100 hours in the case of vessels, or flown for more than 40 hours in the case of aircraft. Member States shall lay down the conditions under which the above facts can be regarded as established.'; 7. the following Title and Article shall be inserted: ' TITLE XVIb TRANSITIONAL PROVISIONS APPLICABLE IN THE FIELD OF SECOND-HAND GOODS, WORKS OF ART, COLLECTORS' ITEMS AND ANTIQUES Article 28o 1. Member States which at 31 December 1992 were applying special tax arrangements other than those provided for in Article 26a (B) to supplies of second-hand means of transport effected by taxable dealers my continue to apply those arrangements during the period referred to in Article 28l in so far as they comply with, or are adjusted to comply with, the following conditions: (a) the special arrangements shall apply only to supplies of the means of transport referred to in Article 28a (2) (a) and regarded as second-hand goods within the meaning of Article 26a (A) (d), effected by taxable dealers within the meaning of Article 26a (A) (e), and subject to the special tax arrangements for taxing the margin pursuant to Article 26a (B) (1) and (2). Supplies of new means of transport within the meaning of Article 28a (2) (b) that are carried out under the conditions specified in Article 28c (A) shall be excluded from these special arrangements; (b) the tax due in respect of each supply referred to in (a) is equal to the amount of tax that would be due if that supply had been subject to the normal arrangements for value added tax, less the amount of value added tax regarded as being incorporated in the purchase price of the means of transport by the taxable dealer; (c) the tax regarded as being incorporated in the purchase price of the means of transport by the taxable dealer shall be calculated according to the following method: - the purchase price to be taken into account shall be the purchase price within the meaning of Article 26a (B) (3), - that purchase price paid by the taxable dealer shall be deemed to include the tax that would have been due if the taxable dealer's supplier had subjected the supply to the normal value added tax arrangements, - the rate to be taken into account shall be the rate applicable within the meaning of Article 12 (1), in the Member State within which the place of the supply to the taxable dealer, determined in accordance with Article 8, is deemed to be situated; (d) the tax due in respect of each supply as referred to in (a), determined in accordance with the provisions of (b), may not be less than the amount of tax that would be due if that supply had been subject to the special arrangements for taxing the margin in accordance with Article 26a (B) (3). For the application of the above provisions, the Member States have the option of providing that if the supply had been subject to the special arrangements for taxation of the margin, that margin would not have been less than 10 % of the selling price, within the meaning of B (3); (e) the taxable dealer shall not be entitled to indicate separately on the invoices he issues, or on any other document in lieu, tax relating to supplies which he is subjecting to the special arrangements; (f) taxable persons shall not be entitled to deduct from the tax for which they are liable tax due or paid in respect of second-hand means of transport supplied to them by a taxable dealer, in so far as the supply of those goods by the taxable dealer is subject to the tax arrangements in accordance with (a); (g) by way of derogation from Article 28a (1) (a), intra-Community acquisitions of means of transport are not subject to value added tax where the vendor is a taxable dealer acting as such and the second-hand means of transport acquired has been subject to the tax, in the Member State of departure of the dispatch or transport, in accordance with (a); (h) Articles 28b (B) and 28c (A) (a) and (d) shall not apply to supplies of second-hand means of transport subject to tax in accordance with (a). 2. By way of derogation from the first sentence of paragraph 1, the Kingdom of Denmark shall be entitled to apply the special tax arrangements laid down in paragraph 1 (a) to (h) during the period referred to in Article 28l. 3. Where they apply the special arrangements for sales by public auction provided for in Article 26a (C), Member States shall also apply these special arrangements to supplies of second-hand means of transport effected by an organizer of sales by public auction acting in his own name, pursuant to a contract under which commission is payable on the sale of those goods by public auction, on behalf of a taxable dealer, in so far as the supply of the second-hand means of transport, within the meaning of Article 5 (4) (c), by that other taxable dealer, is subject to tax in accordance with paragraphs 1 and 2. 4. For supplies by a taxable dealer of works of art, collectors' items or antiques that have been supplied to him under the conditions provided for in Article 26a (B) (2), the Federal Republic of Germany shall be entitled, until 30 June 1999, to provide for the possibility for taxable dealers to apply either the special arrangements for taxable dealers, or the normal VAT arrangements according to the following rules: (a) for the application of the special arrangements for taxable dealers to these supplies of goods, the taxable amount shall be determined in accordance with Article 11 (A) (1), (2) and (3); (b) in so far as the goods are used for the needs of his operations which are taxed in accordance with (a), the taxable dealer shall be authorized to deduct from the tax for which he is liable: - the value added tax due or paid for works of art, collectors' items or antiques which are or will be supplied to him by another taxable dealer, where the supply by that other taxable dealer has been taxed in accordance with (a), - the value added tax deemed to be included in the purchase price of the works of art, collectors' items or antiques which are or will be supplied to him by another taxable dealer, where the supply by that other taxable dealer has been subject to value added tax in accordance with the special arrangements for the taxation of the margin provided for in Article 26a (B), in the Member State within whose territory the place of that supply, determined in accordance with Article 8, is deemed to be situated. This right to deduct shall arise at the time when the tax due for te supply taxed in accordance with (a) becomes chargeable; (c) for the application of the provisions laid down in the second indent of (b), the purchase price of the works of art, collectors' items or antiques the supply of which by a taxable dealer is taxed in accordance with (a) shall be determined in accordance with Article 26a (B) (3) and the tax deemed to be included in this purchase price shall be calculated according to the following method: - the purchase price shall be deemed to include the value added tax that would have been due if the taxable margin made by the supplier had been equal to 20 % of the purchase price, - the rate to be taken into account shall be the rate applicable, within the meaning of Article 12 (1), in the Member State within whose territory the place of the supply that is subject to the special arrangements for taxation of the profit margin, determined in accordance with Article 8, is deemed to be situated; (d) where he applies the normal arrangements for value added tax to the supply of a work of art, collectors' item or antique which has been supplied to him by another taxable dealer and where the goods have been taxed in accordance with (a), the taxable dealer shall be authorized to deduct from his tax liability the value added tax referred to in (b); (e) the category of rates applicable to these supplies of goods shall be that which was applicable on 1 January 1993; (f) for the application of the fourth indent of Article 26a (B) (2), the fourth indent of Article 26a (C) (1) and Article 26a (D) (b) and (c), the supplies of works of art, collectors' items or antiques, taxed in accordance with (a), shall be deemed by Member States to be supplies subject to value added tax in accordance with the special arrangements for taxation of the profit margin provided for in Article 26a (B); (g) where the supplies of works of art, collectors' items or antiques taxed in accordance with (a) are effected under the conditions provided for in Article 28c (A), the invoice issued in accordance with Article 22 (3) shall contain an endorsement indicating that the special taxation arrangements for taxing the margin provided for in Article 28o (4) have been applied.'; 8. the derogation provided for in Article 28 (3) (e) relating to Article 5 (4) (c) shall be deleted; 9. Article 32 shall be deleted; 10. the Annex to this Directive shall be added as Annex I. Article 2 Member States may take measures concerning the right to deduct value added tax in order to avoid the taxable dealers concerned enjoying unjustified advantages or sustaining unjustified loss. Article 3 Acting unanimously on a proposal from the Commission, the Council may authorize any Member State to introduce particular measures for the purpose of combating fraud, by providing that the tax due in application of the arrangements for taxing the profit margin provided for in Article 26a (B) cannot be less than the amount of tax which would be due if the profit margin were equal to a certain percentage of the selling price. This percentage shall be fixed taking into account the normal profit margins realized by economic operators in the sector concerned. Article 4 1. Member States shall adapt their present value added tax system to this Directive. They shall bring into force such laws, regulations and administrative provisions as are necessary for their system thus adapted to enter into force on 1 January 1995 at the latest. 2. Member States shall inform the Commission of the provisions which they adopt to apply this Directive. 3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. 4. When Member States adopt such provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 5 This Directive is addressed to the Member States.

31994L0012

1994

Directive 94/12/EC of the European Parliament and the Council of 23 March 1994 relating to measures to be taken against air pollution by emissions from motor vehicles and amending Directive 70/220/EEC Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty, Whereas measures should be adopted within the framework of the internal market; whereas the internal market comprises an area wihout internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the first programme of action of the European Community on protection of the environment (3), 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 fifth programme of action, which in its general approach was approved by the Council in its resolution of 1 February 1993 (4), provides for additional efforts to be made for a considerable reduction in the present level of emissions of pollutants from motor vehicles; Whereas the objective of reducing the level of pollutant emissions from motor vehicles and the establishment and operation of the internal market for vehicles cannot be sufficiently achieved by individual Member States and can therefore be better achieved by the approximation of the laws of the Member States relating to measures to be taken against air pollution by motor vehicles; Whereas it is recognized that the development of transport in the Community has entailed significant constraints for the environment; whereas a certain number of official estimates of the increase in traffic density have proved to be lower than the official figures; whereas for that reason stringent emission standards should be laid down for all motor vehicles; Whereas the Commission has adopted a European programme on emissions, fuels and engine technologies (EPEFE); whereas that programme was established to ensure that proposals for future Directives on pollutant emissions seek the best solutions both for the consumer and for the economy; whereas that programme forms part of the contributions which can be made both by vehicles and the fuels which propel them; Whereas Council Directive 70/220/EEC (5) which deals with the measures to be taken against air pollution by emissions from motor vehicles, is one of the separate Directives under the type-approval procedure laid down by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (6); Whereas Directive 70/220/EEC lays down the limit values for carbon monoxide and unburnt hydrocarbon emissions from the engines of such vehicles; whereas these limit values were first reduced by Directive 74/290/EEC (7) and supplemented, in accordance with Commission Directive 77/102/EEC (8), by limit values for permissible emissions of nitrogen oxides; whereas the limit values for these three types of pollution were successively reduced by Commission Directives 78/665/EEC (9), 83/351/EEC (10) and 88/76/EEC (11); whereas limit values for particulate pollutant emissions from diesel engines were introduced by Directive 88/436/EEC (12); whereas more stringent European standards for the emissions of gaseous pollutants of motor vehicles below 1 400 cm³ were introduced by Directive 89/458/EEC (13); whereas these standards have been extended to all passenger cars independently of their engine capacity on the basis of an improved European test procedure comprising an extra-urban driving cycle and, whereas requirements relating to the evaporative emissions and to the durability of emission-related vehicle components as well as more stringent particulate pollutant standards for motor vehicles equipped with diesel engines were introduced by Directive 91/441/EEC (1); whereas passenger cars designed to carry more than six passengers or having a maximum mass of more than 2 500 kg, light commercial vehicles, and off-road vehicles, covered by the scope of Directive 70/220/EEC, which hitherto have been subject to less stringent standards, are now, under Directive 93/59/EEC, subject to standards as stringent as those for passenger cars, taking into account the specific conditions of such vehicles; Whereas the work undertaken by the Commission in this field has shown that the best technology currently available to the Community industry can be further improved in order to allow passenger cars to comply with considerably reduced emission limits; whereas the proposed standards will apply both to the approval of new vehicle types and to checks on conformity of production, since the amended method of sampling and statistical evaluation removes the tolerances allowed for the limit values set under previous stages of Directive 70/220/EEC; Whereas, in the light of the worrying level of pollution caused by vehicle emissions and their role in the formation of the gases responsible for the greenhouse effect, it is necessary to reduce emissions, in particular CO2 emissions, in accordance with the commitment entered into under the Framework Convention on Climate Change signed in Rio in June 1992; whereas CO2 results directly from the combustion of carbon-based fuels; whereas CO2 emissions can principally be reduced by lower fuel consumption; whereas this requires progress in the design of engines and vehicles and in fuel quality; whereas all these elements will be taken into account in a subsequent proposal from the Commission; Whereas Member States should be allowed to encourage, by means of tax incentives, the introduction of vehicles which satisfy the requirements adopted at Community level; whereas such tax incentives must comply with the provisions of the Treaty and satisfy certain conditions intended to avoid distortions of the internal market; whereas the provisions of this Directive do not affect the Member States' right to include emissions of pollutants and other substances in the basis on which road traffic taxes on motor vehicles are calculated; Whereas the prior notification requirement of this Directive is without prejudice to notification requirements under other provisions of Community law, notably Article 93 (3) of the Treaty; Whereas the Council should, by 30 June 1996, adopt the requirements for the stage from the year 2000 on the basis of a proposal to be submitted by the Commission by 31 December 1994 and whereas that proposal is to be aimed at substantially reducing motor vehicle emissions; Whereas the Commission has held widespread consultations with interested parties, culminating with the Symposium 'Auto Emissions 2000' on 21 and 22 September 1992, which showed that the present approach, focused on exhaust emissions, must be one element in the stage beyond the implementation of the requirements of this Directive, as part of a 'multifaceted' approach comprising all the measures for reducing air pollution due to road traffic; whereas all the parameters which have been identified as having a significant impact on such pollution can at present only be presented in the form of a list; whereas the Commission will undertake the necessary analysis of environmental, technological and cost effectiveness aspects in order to provide before end of December 1994 quantified objectives for Community measures for the year 2000; Whereas the objective of reducing the level of pollutant emissions from motor vehicles presupposes that, when the Commission makes its proposals for measures to apply after the year 2000 and in the light, inter alia, of the preparation of complementary technical measures as provided for in Article 4, it will if necessary put forward target values involving a further substantial reduction in emissions, Article 1 Annex I to Directive 70/220/EEC is hereby amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 July 1994 or, should this Directive fail to be published in the Official Journal of the European Communities by 31 December 1993 at the latest, six months after it is published, Member States shall accept compliance with the requirements of Directive 70/220/EEC, as amended by this Directive, for the purposes of Articles 4 (1) and 7 (1) of Directive 70/156/EEC. 2. With effect from 1 January 1996, Member States may no longer grant: - EC type-approval pursuant to Article 4 (1) of Directive 70/156/EEC, or - national type-approval, unless the provisions of Article 8 (2) of Directive 70/156/EEC are invoked, for a type of vehicle on grounds relating to air pollution by emissions if it fails to comply with the provisions of Directive 70/220/EEC, as amended by this Directive. 3. With effect from 1 January 1997, Member States shall: - consider certificates of conformity which accompany new vehicles pursuant to Directive 70/156/EEC as no longer valid for the purposes of Article 7 (1) of that Directive, and - refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, unless the provisions of Article 8 (2) of Directive 70/156/EEC are invoked, on grounds relating to air pollution by emissions, if the vehicles fail to comply with the provisions of Directive 70/220/EEC, as amended by this Directive. Article 3 Member States may make provision for tax incentives only in respect of motor vehicles which comply with Directive 70/220/EEC, as amended by this Directive. Such incentives shall comply with the provisions of the Treaty and satisfy the following conditions: - they shall apply to all new vehicles offered for sale on the market of a Member State which comply in advance with the requirements of Directive 70/220/EEC, as amended by this Directive, - they shall be terminated with effect from the mandatory application of the emission values laid down in Article 2 (3) for new motor vehicles, - for each type of motor vehicle, they shall be for an amount lower than the additional cost of the technical solutions introduced to ensure compliance with the values set and of their installation on the vehicle. The Commission shall be informed in sufficient time of plans to institute or change the tax incentives referred to in the first paragraph, so that it can submit its observations. Article 4 The Council, acting under the conditions laid down in the Treaty, shall decide before 30 June 1996 on proposals for a further stage of the Community's measures against air pollution caused by emissions from motor vehicles, which the Commission will submit by 31 December 1994. The measures shall apply from the year 2000 onwards. In these proposals the Commission shall take the following approach: - the measures shall be designed to produce effects to meet the requirements of the Community's air quality criteria and related objectives, - an assessment of the cost effectiveness of taking each measure shall be undertaken; in this global assessment full account shall be taken, inter alia, of the contributions that: - traffic management, for example by spreading the environmental costs appropriately, - enhanced urban public transport, - new propulsion technologies (e.g. electric transmission), - the use of alternative fuels (e.g. biofuels), could make to improving air quality, - the measures shall be proportional and reasonable in the light of the intended objectives. The proposals, taking account of the methodology outlined above and aimed at a substantial reduction of pollutant emissions as regards the vehicles covered by this Directive, shall comprise in particular the following elements: 1. Further improvements in the requirements of this Directive: based on the assessment of - the potential of the traditional engine and post-combustion technology, - possible improvements in the test procedure, e.g. cold-start, starting in low or wintry temperatures, durability (e.g. in the conformity tests), evaporative emissions, - measures at the level of type-approval supporting strengthened inspection and maintenance requirements, including, for example, on-board diagnostic systems, - the possibility of checking the conformity of vehicles in circulation, - the proportional need for: (i) specific limits for HC and NOx in addition to a cumulative limit value, and (ii) measures to cover pollutants not yet regulated. 2. Complementary technical measures in the framework of specific Directives, including: - improvements in fuel quality as far as vehicle emissions of dangerous substances (in particular benzene) are concerned, - strengthening of the requirements of the inspection and maintenance programme. The reduced limit values which will be the subject of the new Directive shall not apply before 1 January 2000 for new type-approvals. The Council shall decide on the conditions for granting tax incentives on the basis of these limit values. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994 or, should the Directive fail to be published in the Official Journal of the European Communities by 31 December 1993, six months after it is published. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 6 This Directive is addressed to the Member States.

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Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty establishing the European Community, Whereas it is the duty of Member States to protect, on their territory, the safety and health of persons and, where appropriate, domestic animals and property and, in particular, that of workers, especially against the hazards resulting from the use of equipment and systems providing protection against potentially explosive atmospheres; Whereas mandatory provisions within the Member States determine the level of safety to be achieved by protective equipment and systems intended for use in potentially explosive atmospheres; whereas these are generally electrical and non-electrical specifications having an effect on the design and structure of equipment which can be used in potentially explosive atmospheres; Whereas the requirements to be met by such equipment differ from one Member State to another in respect of their extent and differing inspection procedures; whereas these differences are, therefore, likely to raise barriers to trade within the Community; Whereas harmonization of national legislation is the only way in which to remove these barriers to free trade; whereas this objective cannot be satisfactorily achieved by the individual Member States; whereas this Directive merely lays down the requirements vital to freedom of movement for the equipment to which it applies; Whereas the regulations intended to remove technical barriers to trade are required to follow the new approach provided for in the Council resolution of 7 May 1985 (3), which requires a definition of the essential requirements regarding safety and other requirements of society without reducing existing, justified levels of protection within the Member States; whereas that resolution provides that a very large number of products be covered by a single Directive in order to avoid frequent amendments and the proliferation of Directives; Whereas the existing Directives on the approximation of the laws of the Member States to electrical equipment for use in potentially explosive atmospheres have made positive steps towards protection against explosions via measures linked with the structure of the equipment at issue and which have helped to remove barriers to trade in this area; whereas, in parallel, a revision and expansion of the existing Directives is necessary since, more particularly, in an overall context, action must be taken to guard against the potential hazards arising from such equipment. This implies in particular that measures intended to guarantee effective protection of users and third parties must already be contemplated at the design and manufacturing states; Whereas the form taken by the hazard, the protective measures and the test methods are often very similar, if not identical, for both mining and surface equipment; whereas it is, therefore, absolutely necessary to cover by a single Directive protective equipment and systems falling within both groups; Whereas the two groups of equipment referred to above are used in a large number of commercial and industrial sectors and possess considerable economic significance; Whereas compliance with the basic safety and health requirements is essential in order to ensure the safety of protective equipment and systems; whereas those requirements have been subdivided into general and additional requirements which must be met by protective equipment and systems; whereas, in particular, the additional requirements are intended to take account of existing or potential hazards; whereas protective equipment and systems will, therefore, embody at least one of those requirements where this is necessary for their proper functioning or is to apply to their intended use; whereas the notion of intended use is of prime importance for the explosion-proofing of protective equipment and systems; whereas it is essential that manufacturers supply full information; whereas specific, clear marking of said equipment, stating its use in a potentially explosive atmosphere, is also necessary; Whereas the intention is to prepare a Directive on operations in potentially explosive atmospheres which is based on Article 118a; whereas that additional Directive will, in particular, aim at explosion hazards which derive from a given use and/or types and methods of installation; Whereas compliance with essential health and safety requirements is imperative if the safety of equipment is to be ensured; whereas judgment will have to be exercised in the implementation of those requirements in order to take account of both the technology obtaining at the time of manufacture and overriding technical and economic requirements; Whereas, therefore, this Directive sets out essential requirements only; whereas, in order to facilitate the task of proving compliance with the essential requirements, harmonized European standards are necessary, more especially with regard to the non-electrical aspects of protection against explosions - standards relating to the design, manufacture and testing of equipment, compliance with which enables a product to be presumed to meet such essential requirements; whereas harmonized European standards are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the bodies competent to adopt harmonized standards which follow 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 other of those bodies, or by both, at the prompting of the Commission pursuant to Council Directive 83/189/EEC of the 28 March 1983 providing for a procedure governing the provision of information on technical standards and regulations (1) and pursuant to the general guidelines referred to above; Whereas the legislative framework should be improved in order to ensure that employers and workers make an effective and appropriate contribution towards the standardization process; whereas this should be completed by the time this Directive is implemented; Whereas, in view of the nature of the risks involved in the use of equipment in potentially explosive atmospheres it is necessary to establish procedures applying to the assessment of compliance with the basic requirements of the Directives; whereas these procedures must be devised in the light of the level of risk which may be inherent in equipment and/or against which systems must protect the immediate environment; whereas, therefore, each category of equipment conformity must be supplemented by an adequate procedure or a choice between several equivalent procedures; whereas the procedures adopted comply fully with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization Directives (2); Whereas the Council has provided for the affixing of the CE marking by either the manufacturer or his authorized representative within the Community; whereas that marking means that the product complies with all the basic requirements and assessment procedures provided for by the Community law applying to that product; Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty, may take temporary measures to limit or prohibit the placing on the market and the use of equipment and protective systems in cases where they present a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure; Whereas the recipients of any decision taken as part of this Directive must be aware of the reasons behind that decision and the means of appeal open to them; Whereas, on 18 December 1985, the Council adopted a framework Directive on electrical equipment for use in potentially explosive atmospheres (76/117/EEC) (3) and, on 15 February 1982, a Directive concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to fire damp (82/130/EEC) (4); whereas, from the outset of harmonization work, the conversion into total harmonization of the optional and partial harmonization on which these Directives are based had been contemplated; whereas this Directive fully covers the scope of the abovementioned Directives and whereas, therefore, these Directives must be repealed; Whereas the internal market incorporates an area without internal frontiers within which the free movement of goods, persons, services and capital is assured; Whereas it is necessary to provide for a transitional arrangement enabling equipment manufactured in compliance with the national regulations in force at the date of adoption of this Directive to be marketed and placed in service, CHAPTER I Scope, placing on the market and freedom of movement Article 1 1. This Directive applies to equipment and protective systems intended for use in potentially explosive atmospheres. 2. Safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion are also covered by the scope of this Directive. 3. For the purposes of this Directive, the following definitions shall apply: Equipment and protective systems intended for use in potentially explosive atmospheres (a) 'Equipment' means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition. (b) 'Protective systems' means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems. (c) 'Components' means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture. Potentially explosive atmosphere An atmosphere which could become explosive due to local and operational conditions. Equipment groups and categories Equipment group I applies to equipment intended for use in underground parts of mines, and to those parts of surface installations of such mines, liable to be endangered by firedamp and/or combustible dust. Equipment group II applies to equipment intended for use in other places liable to be endangered by explosive atmospheres. The categories of equipment defining the required levels of protection are described in Annex I. Equipment and protective systems may be designed for a particular explosive atmosphere. In this case, they must be marked accordingly. Intended use The use of equipment, protective systems, and devices referred to in Article 1 (2) in accordance with the equipment group and category and with all the information supplied by the manufacturer which is required for the safe functioning of equipment, protective systems and devices. 4. The following are excluded from the scope of this Directive: - medical devices intended for use in a medical environment, - equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances, - equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas, - personal protective equipment covered by Directive 89/686/EEC (1), - seagoing vessels and mobile offshore units together with equipment on board such vessels or units, - means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere shall not be excluded, - the equipment covered by Article 223 (1) (b) of the Treaty. Article 2 1. Member States shall take all appropriate measures to ensure that the equipment, protective systems and devices referred to in Article 1 (2) to which this Directive applies may be placed on the market and put into service only if, when properly installed and maintained and used for their intended purpose, they do not endanger the health and safety of persons and, where appropriate, domestic animals or property. 2. The provisions of this Directive shall not affect Member States' entitlement to lay down, in due observance of the provisions of the Treaty, such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected when using the equipment, protective systems, and devices referred to in Article 1 (2) in question provided that this does not mean that such equipment, protective systems, or devices are modified in a way not specified in the Directive. 3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of equipment, protective systems, or the devices referred to in Article 1 (2) which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such equipment, protective systems, and devices referred to in Article 1 (2) do not conform and that they are not for sale until they have 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 Equipment, protective systems, and the devices referred to in Article 1 (2) to which this Directive applies must meet the essential health and safety requirements set out in Annex II which apply to them, account being taken of their intended use. Article 4 1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of equipment, protective systems, or devices referred to in Article 1 (2) which comply with this Directive. 2. Member States shall not prohibit, restrict or impede the placing on the market of components which, accompanied by a certificate of conformity as referred to in Article 8 (3), are intended to be incorporated into equipment or protective systems within the meaning of this Directive. Article 5 1. Member States shall regard as conforming to all the provisions of this Directive, including the relevant conformity assessment procedures laid down in chapter II: - equipment, protective systems, and devices referred to in Article 1 (2) accompanied by the EC declaration of conformity referred to in Annex X and bearing the CE marking provided for in Article 10, - the components referred to in Article 4 (2), accompanied by the certificate of conformity referred to in Article 8 (3). In the absence of harmonized standards, Member States shall take any steps which they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications regarded as important or relevant to the proper implementation of the essential health and safety requirements in Annex II. 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 health and safety requirements, the equipment, protective system, device referred to in Article 1 (2), or the component referred to in Article 4 (2), constructed in accordance with that standard shall be presumed to comply with the relevant essential health and safety 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 influence the process of preparing and monitoring the harmonized standards at national level. 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 relevant essential health and safety 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, hereinafter referred to as 'the Committee', giving 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. The Commission may adopt any appropriate measure with a view to ensuring the practical application in a uniform manner of this Directive in accordance with the procedure laid down in paragraph 3. 3. The Commission shall be assisted by a Standing Committee, 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. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account. 4. The Standing Committee may furthermore examine any question relating to the application of this Directive and raised by its chairman either on the latter's initiative, or at the request of a Member State. Article 7 1. Whee a Member State ascertains that equipment, protective systems or devices referred to in Article 1 (2) bearing the CE conformity marking and used in accordance with their intended use are liable to endanger the safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate meaures to withdraw such equipment or protective systems 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). 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 equipment or a protective system which does not comply bears the CE conformity marking, the competent Member State shall take appropriate action against the person(s) having affixed the marking 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 Conformity assessment procedures Article 8 1. The procedures for assessing the conformity of equipment, including where necessary the devices referred to in Article 1 (2), shall be as follows: (a) equipment-group I and II, equipment-category M 1 and 1 The manufacturer or his authorized representative established in the Community must, in order to affix the CE marking, follow the CE type-examination procedure (referred to in Annex III), in conjunction with: - the procedure relating to production quality assurance (referred to in Annex IV), or - the procedure relating to product verification (referred to in Annex V); (b) Equipment-group I and II, equipment-category M 2 and 2 (i) In the case of internal combustion engines and electrical equipment in these groups and categories, the manufacturer or his authorized representative established in the Community shall, in order to affix the CE mark, follow the EC-type examination procedure (referred to in Annex III), in conjunction with: - the procedure relating to conformity to type referred to in Annex VI, or - the procedure relating to product quality assurance referred to in Annex VII; (ii) in the case of other equipment in these groups and categories, the manufacturer or his authorized representative established in the Community must, in order to affix the CE mark, follow the procedure relating to internal control of production (referred to in Annex VIII) and communicate the dossier provided for in Annex VIII, paragraph 3, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it. (c) equipment-group II, equipment-category 3 The manufacturer or his authorized representative established in the Community must, in order to affix the CE marking, follow the procedure relating to internal control of production referred to n Annex VIII; (d) equipment-groups I and II In addition to the procedures referred to in paragraph 1(a), (b) and (c), the manufacturer or his authorized representative established in the Community may also, in order to affix the CE marking, follow the procedure relating to CE unit verification (referred to in Annex IX). 2. The provisions of 1(a) or 1(d) above shall be used for conformity assessment of autonomous protective systems. 3. The procedures referred to in paragraph 1 shall be applied in respect of components as referred to in Article 4 (2), with the exception of the affixing of the CE marking. A certificate shall be issued by the manufacturer or his authorized representative established in the Community, declaring the conformity of the components with the provisions of this Directive which apply to them and stating their characteristics and how they must be incorporated into equipment or protective systems to assist compliance with the essential requirements applicable to finished equipment or protective systems. 4. In addition, the manufacturer or his authorized representative established in the Community may, in order to affix the CE marking, follow the procedure relating to internal control of production (referred to in Annex VIII) with regard to the safety aspects referred to in point 1.2.7 of Annex II. 5. Notwithstanding the previous paragraphs, the competent authorities may, on a duly justified request, authorize the placing on the market and putting into service on the territory of the Member State concerned of the equipment, protective systems and individual devices referred to in Article 1 (2) in respect of which the procedures referred to in the previous paragraphs have not been applied and the use of which is in the interests of protection. 6. Documents and correspondence relating to the procedures referred to in the abovementioned paragraphs shall be drawn up in one of the official languages of the Member States in which those procedures are being applied or in a language accepted by the notified body. 7. (a) Where the equipment and protective systems are subject to other Community Directives covering other aspects which also provide for the affixing of the CE marking referred to in Article 10, that marking shall indicate that the equipment and protective systems are also presumed to conform with the provisions of those other Directives. (b) However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only with the Directives applied by the manufacturer. In this case, particulars of the said Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying the equipment and protective systems. Article 9 1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 8, together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission. The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies, with their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date. 2. Member States shall apply the criteria laid down in Annex XI in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relative 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 XI. It shall immediately inform the Commission and the other Member States accordingly. CHAPTER III CE conformity marking Article 10 1. The CE conformity marking shall consist of the initials 'CE'. The form of the marking to be used is shown in Annex X. The CE marking shall be followed by the identification number of the notified body where such body is involved in the production control stage. 2. The CE marking shall be affixed distinctly, visibly, legibly and indelibly to equipment and protective systems, supplementary to the provisions of point 1.0.5. of Annex II. 3. The affixing of markings on the equipment or protective systems which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the equipment or protective systems, provided that the visibility and legibility of the CE marking is not thereby reduced. Article 11 Without prejudice to Article 7: (a) where a Member State establishes that the CE marking has been incorrectly affixed, the manufacturer or his authorized representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State; (b) in the event of continuing non-conformity, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7. CHAPTER IV Final provisions Article 12 Any decision taken pursuant to this Directive which restricts or prohibits the placing on the market and/or the putting into service or requires the withdrawal from the market of equipment, a protective system, or a device referred to in Article 1 (2) shall state the exact grounds on which it is based. Such a decision shall be notified forthwith 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 13 Member States shall ensure that all the parties involved in the application of the Directive are bound to observe confidentiality in respect of all information obtained in the performance of carrying out their tasks. This does not affect the obligations of the Member States and of the notified bodies regarding reciprocal information and the dissemination of warnings. Article 14 1. Directive 76/117/EEC, Directive 79/196/EEC (1) and Directive 82/130/EEC shall be repealed as from 1 July 2003. 2. EC certificates of conformity to the harmonized standards obtained in accordance with the procedures laid down in the Directives referred to in paragraph 1 shall continue to be valid until 30 June 2003 unless they expire before that date. Their validity shall continue to be limited to the harmonized standards indicated in the aforementioned Directives. 3. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 8 (1) to (4) for the assessment of the conformity of electrical equipment placed on the market before 1 July 2003 take account of the results of tests and verifications already carried out under the Directives referred to in paragraph 1. Article 15 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 September 1995. They shall forthwith inform the Commission thereof. The Member States shall apply these measures with effect from 1 March 1996. When Member States adopt the measures referred to in the first subparagraph, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States. 2. However, Member States shall allow the placing on the market and the putting into service of equipment and protective systems conforming with the national regulations in force in their territory at the date of adoption of this Directive for the period until 30 June 2003. Article 16 This Directive is addressed to the Member States.

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Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer Having regard to the Treaty establishing the European Community and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty, Whereas in certain Member States there exist Regulations on footwear labelling which are designed to protect and inform the public as well as to secure the legitimate interests of industry; Whereas the disparity of such Regulations risks creating barriers to trade within the Community, thereby prejudicing the functioning of the internal market; Whereas, in order to avoid problems due to different systems, the items of a common labelling system for footwear should be precisely defined; Whereas the Council resolution of 9 November 1989 on future priorities for relaunching consumer protection policy (3) calls for efforts to improve consumer information on products; Whereas it is in the interests of both consumers and the footwear industry to introduce a system reducing the risk of fraud by indicating the exact nature of the materials used in the main components of footwear; Whereas, in Council resolution of 5 April 1993 on future action on the labelling of products in the interest of the consumer (4), labelling is deemed to be one important means of achieving better information and transparency for the consumer and of ensuring that the internal market functions harmoniously; Whereas the harmonization of national legislation is the appropriate way of removing these barriers to free trade; whereas that objective cannot be satisfactorily achieved by the individual Member States; whereas this Directive establishes only those requirements which are indispensable for the free movement of the products to which it applies, Article 1 1. This Directive shall apply to the labelling of the materials used in the main components of footwear for sale to the consumer. For the purposes of this Directive, 'footwear' shall mean all articles with applied soles designed to protect or cover the foot, including parts marketed separately as referred to in Annex I. A non-exhaustive list of the products covered by the Directive appears in Annex II. The following shall be excluded from the Directive: - second-hand, worn footwear, - protective footwear covered by Directive 89/686/EEC (5), - footwear covered by Directive 76/769/EEC (6), - toy footwear. 2. Information on the composition of footwear shall be conveyed by means of labelling as specified in Article 4. (i) The labelling shall convey information relating to the three parts of the footwear as defined in Annex I, namely: (a) the upper; (b) the lining and sock; and (c) the outersole. (ii) The composition of the footwear shall be indicated as specified in Article 4 on the basis either of pictograms or of written indications for specific materials, as stipulated in Annex I. (iii) In the case of the upper, classification of the materials shall be determined on the basis of the provisions contained in Article 4 (1) and in Annex I, no account being taken of accessories or reinforcements such as ankle patches, edging, ornamentation, buckles, tabs, eyelet stays or similar attachments. (iv) In the case of the outersole, classification shall be based on the volume of the materials contained therein, in accordance with Article 4. Article 2 1. Member States shall take all necessary measures to ensure that all footwear placed on the market meets the labelling requirements of this Directive without prejudice to other relevant Community provisions. 2. Where footwear not in conformity with the provisions regarding labelling requirements is placed on the market, the competent Member State shall take appropriate action as specified in its national legislation. Article 3 Without prejudice to other relevant Community provisions, Member States shall not prohibit or impede the placing on the market of footwear which complies with the labelling requirements of this Directive, by the application of unharmonized national provisions governing the labelling of certain types of footwear or of footwear in general. Article 4 1. The labelling shall provide information on the material, determined in accordance with Annex I, which constitutes at least 80 % of the surface area of the upper, and the lining and sock, of the footwear, and at least 80 % of the volume of the outersole. If no one material accounts for at least 80 %, information should be given on the two main materials used in the composition of the footwear. 2. The information shall be conveyed on the footwear. The manufacturer or his authorized agent established in the Community may choose either pictograms or written indications in at least the language or languages which may be determined by the Member State of consumption in accordance with the Treaty, as defined and illustrated in Annex I. Member States, in their national provisions shall ensure that consumers are adequately informed of the meaning of these pictograms, while ensuring that such provisions do not create trade barriers. 3. For the purpose of this Directive, labelling shall involve affixing the required information to at least one article of footwear in each pair. This may be done by printing, sticking, embossing or using an attached label. 4. The labelling must be visible, securely attached and accessible and the dimensions of the pictograms must be sufficiently large to make it easy to understand the information contained therein. It must not be possible for the labelling to mislead the consumer. 5. The manufacturer or his authorized agent established in the Community shall be responsible for supplying the label and for the accuracy of the information contained therein. If neither the manufacturer nor his authorized agent is established in the Community, this obligation shall fall on the person responsible for first placing the footwear on the Community market. The retailer shall remain responsible for ensuring that the footwear sold by him bears the appropriate labelling prescribed by this Directive. Article 5 Additional textual information, affixed, should the need arise, to the labelling may accompany the information required under this Directive. However, Member States may not prohibit or impede the placing on the market of footwear conforming to the requirements of this Directive, in accordance with Article 3. Article 6 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 23 September 1995 at the latest. They shall forthwith inform the Commission thereof. 2. Member States shall apply the measures referred to in paragraph 1 from 23 March 1995. Stock invoiced or delivered to the retailer before that date shall not be subject to the said measures until 23 September 1997. 3. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 4. The Commission shall submit to the Council, three years after this Directive has been brought into application, an assessment report taking into consideration any difficulties which may have been encountered by operators where implementing the provisions of this Directive and shall present, should the need arise, appropriate proposals for review. Article 7 This Directive is addressed to the Member States.

31994L0014

1994

Commission Directive 94/14/EC of 29 March 1994 amending Seventh Directive 76/372/EEC establishing Community methods of analysis for the official control of feedingstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 2 thereof, Whereas the Seventh Commission Directive 76/372/EEC (3), as last amended by Directive 92/95/EEC (4), prescribes the methods to be used for the determination of aflatoxin B1; Whereas it is necessary to revise once more the dosage method used at present, in order to state precisely the operating procedure for preparing the sample and to define the rules for the expression of the results; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 The Annex to Directive 76/372/EEC is amended as shown in the Annex. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive, not later than one year after its entry into force. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31994L0015

1994

Commission Directive 94/15/EC of 15 April 1994 adapting to technical progress for the first time Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), and in particular Article 20 thereof, Whereas Annex II to Directive 90/220/EEC contains the information required to be provided in a notification for a deliberate release of genetically modified organisms (GMOs); Whereas the information requirements for notifications for a deliberate release of GMOs, as set out in Annex II, are very broad in order to apply to all types of GMOs; whereas some of the information is only applicable or appropriate for specific types of organisms; Whereas, on the basis of the experience gained with the releases of genetically modified higher plants, it is appropriate to adapt Annex II to technical progress by making provision for a sub-Annex specific to higher plants; Whereas it is therefore appropriate that Annex II should be divided in two sub-Annexes: Annex II A outlining the information required in the notifications concerning releases of GMOs other than higher plants, and Annex II B outlining the information required in the notifications concerning releases of genetically modified higher plants; Whereas the measures provided for in this Directive are in accordance with the opinion of the committee provided for in Article 21 of Directive 90/220/EEC, Article 1 Annex II to Directive 90/220/EEC is replaced by the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1994. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0016

1994

Commission Directive 94/16/EEC of 22 April 1994 amending Council Directive 74/63/EEC on undesirable substances and products in animal nutrition (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by Directive 93/74/EEC (2), and in particular Article 6 thereof, Whereas Directive 74/63/EEC provides for regular updating of its Annexes to take account of advances in scientific and technical knowledge; Whereas the arsenic content of complete feedstuffs for fish must be altered since fish feed mainly comprises fish meal which has a natural arsenic content, this level does not represent a threat to animal or human health or the environment; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 Annex I to Directive 74/63/EEC is hereby amended in accordance with the Annex hereto. Article 2 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 1995 at the latest. They shall immediately inform the Commission thereof. When the Member States adopt such provisions, the latter shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31994L0017

1994

Commission Directive 94/17/EC of 22 April 1994 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Directive 93/114/EC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regulart 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 91/248/EEC (3); Whereas the use of certain additives belonging to the groups of emulsifiers, stabilizers, thickeners and gelling agents, colouring matters including pigments and acidity regulators has been widely tested in various Member States; whereas, on the basis of experience gained, it appears that these new uses can be authorized throughout the Community; Whereas new uses for additives belonging to the groups of colouring matters including pigments, binders, anti-caking agents and coagulants, enzymes and micro-organisms have been successfully tested in certain Member States; whereas the new uses should be authorized provisionally at national level in anticipation of their approval at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 30 November 1994 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31994L0019

1994

DIRECTIVE 94/19/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 1994 on deposit-guarantee schemes Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 57 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas, in accordance with the objectives of the Treaty, the harmonious development of the activities of credit institutions throughout the Community should be promoted through the elimination of all restrictions on the right of establishment and the freedom to provide services, while increasing the stability of the banking system and protection for savers; Whereas, when restrictions on the activities of credit institutions are eliminated, consideration should be given to the situation which might arise if deposits in a credit institution that has branches in other Member States become unavailable; whereas it is indispensable to ensure a harmonized minimum level of deposit protection wherever deposits are located in the Community; whereas such deposit protection is as essential as the prudential rules for the completion of the single banking market; Whereas in the event of the closure of an insolvent credit institution the depositors at any branches situated in a Member State other than that in which the credit institution has its head office must be protected by the same guarantee scheme as the institution's other depositors; Whereas the cost to credit institutions of participating in a guarantee scheme bears no relation to the cost that would result from a massive withdrawal of bank deposits not only from a credit institution in difficulties but also from healthy institutions following a loss of depositor confidence in the soundness of the banking system; Whereas the action the Member States have taken in response to Commission recommendation 87/63/EEC of 22 December 1986 concerning the introduction of deposit-guarantee schemes in the Community (4) has not fully achieved the desired result; whereas that situation may prove prejudicial to the proper functioning of the internal market; Whereas the Second Council Directive 89/646/EEC of 15 December 1989 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions and amending Directive 77/780/EEC (5), provides for a system for the single authorization of each credit institution and its supervision by the authorities of its home Member State, which entered into force on 1 January 1993; Whereas a branch no longer requires authorization in any host Member State, because the single authorization is valid throughout the Community, and its solvency will be monitored by the competent authorities of its home Member State; whereas that situation justifies covering all the branches of the same credit institution set up in the Community by means of a single guarantee scheme; whereas that scheme can only be that which exists for that category of institution in the State in which that institution's head office is situated, in particular because of the link which exists between the supervision of a branch's solvency and its membership of a deposit-guarantee scheme; Whereas harmonization must be confined to the main elements of deposit-guarantee schemes and, within a very short period, ensure payments under a guarantee calculated on the basis of a harmonized minimum level; Whereas deposit-guarantee schemes must intervene as soon as deposits become unavailable; Whereas it is appropriate to exclude from cover, in particular, the deposits made by credit institutions on their own behalf and for own account; whereas that should not prejudice the right of a guarantee scheme to take any measures necessary for the rescue of a credit institution that finds itself in difficulties, Whereas the harmonization of deposit-guarantee schemes within the Community does not of itself call into question the existence of systems in operation designed to protect credit institutions, in particular by ensuring their solvency and liquidity, so that deposits with such credit institutions, including their branches established in other Member States, will not become unavailable; whereas such alternative systems serving a different protective purpose may, subject to certain conditions, be deemed by the competent authorities to satisfy the objectives of this Directive; whereas it will be for those competent authorities to verify compliance with those conditions; Whereas several Member States have deposit-protection schemes under the responsibility of professional organizations, other Member States have schemes set up and regulated on a statutory basis and some schemes, although set up on a contractual basis, are partly regulated by statute; whereas that variety of status poses a problem only with regard to compulsory membership of and exclusion from schemes; whereas it is therefore necessary to take steps to limit the powers of schemes in this area; Whereas the retention in the Community of schemes providing cover for deposits which is higher than the harmonized minimum may, within the same territory, lead to disparities in compensation and unequal conditions of competition between national institutions and branches of institutions from other Member States; whereas, in order to counteract those disadvantages, branches should be authorized to join their host countries' schemes so that they can offer their depositors the same guarantees as are offered by the schemes of the countries in which they are located; whereas it is appropriate that after a number of years the Commission should report on the extent to which branches have made use of this option and on the difficulties which they or the guarantee schemes may have encountered in implementing these provisions; whereas it is not ruled out that home Member State schemes should themselves offer such complementary cover, subject to the conditions such schemes may lay down; Whereas market disturbances could be caused by branches of credit institutions which offer levels of cover higher than those offered by credit institutions authorized in their host Member States; whereas it is not appropriate that the level of scope of cover offered by guarantee schemes should become an instrument of competition; whereas it is therefore necessary, at least during an initial period, to stipulate that the level and scope of cover offered by a home Member State scheme to depositors at branches located in another Member State should not exceed the maximum level and scope offered by the corresponding scheme in the host Member State; whereas possible market disturbances should be reviewed after a number of years, on the basis of the experience acquired and in the light of developments in the banking sector; Whereas in principle this Directive requires every credit institution to join a deposit-guarantee scheme; whereas the Directives governing the admission of any credit institution which has its head office in a non-member country, and in particular the First Council Directive (77/780/EEC) of 12 December 1977 on the coordination of the laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions (6) allow Member States to decide whether and subject to what conditions to permit the branches of such credit institutions to operate within their territories; whereas such branches will not enjoy the freedom to provide services under the second paragraph of Article 59 of the Treaty, nor the right of establishment in Member States other than those in which they are established; whereas, accordingly, a Member State admitting such branches should decide how to apply the principles of this Directive to such branches in accordance with Article 9 (1) of Directive 77/780/EEC and with the need to protect depositors and maintain the integrity of the financial system; whereas it is essential that depositors at such branches should be fully aware of the guarantee arrangements which affect them; Whereas, on the one hand, the minimum guarantee level prescribed in this Directive should not leave too great a proportion of deposits without protection in the interest both of consumer protection and of the stability of the financial system; whereas, on the other hand, it would not be appropriate to impose throughout the Community a level of protection which might in certain cases have the effect of encouraging the unsound management of credit institutions; whereas the cost of funding schemes should be taken into account; whereas it would appear reasonable to set the harmonized minimum guarantee level at ECU 20 000; whereas limited transitional arrangements might be necessary to enable schemes to comply with that figure; Whereas some Member States offer depositors cover for their deposits which is higher than the harmonized minimum guarantee level provided for in this Directive; whereas it does not seem appropriate to require that such schemes, certain of which have been introduced only recently pursuant to recommendation 87/63/EEC, be amended on this point; Whereas a Member State must be able to exclude certain categories of specifically listed deposits or depositors, if it does not consider that they need special protection, from the guarantee afforded by deposit-guarantee schemes; Whereas in certain Member States, in order to encourage depositors to look carefully at the quality of credit institutions, unavailable deposits are not fully reimbursed; whereas such practices should be limited in respect of deposits falling below the minimum harmonized level; Whereas the principle of a harmonized minimum limit per depositor rather than per deposit has been retained; whereas it is therefore appropriate to take into consideration the deposits made by depositors who either are not mentioned as holders of an account or are not the sole holders; whereas the limit must therefore be applied to each identifiable depositor; whereas that should not apply to collective investment undertakings subject to special protection rules which do not apply to the aforementioned deposits; Whereas information is an essential element in depositor protection and must therefore also be the subject of a minimum number of binding provisions; whereas, however, the unregulated use in advertising of references to the amount and scope of a deposit-guarantee scheme could affect the stability of the banking system or depositor confidence; whereas Member States should therefore lay down rules to limit such references; Whereas, in specific cases, in certain Member States in which there are no deposit-guarantee schemes for certain classes of credit institutions which take only an extremely small proportion of deposits, the introduction of such a system may in some cases take longer than the time laid down for the transposition of this Directive; whereas in such cases a transitional derogation from the requirement to belong to a deposit-guarantee scheme may be justified; whereas, however, should such credit institutions operate abroad, a Member State would be entitled to require their participation in a deposit-guarantee scheme which it had set up; Whereas it is not indispensable, in this Directive, to harmonize the methods of financing schemes guaranteeing deposits or credit institutions themselves, given, on the one hand, that the cost of financing such schemes must be borne, in principle, by credit institutions themsejves and, on the other hand, that the financing capacity of such schemes must be in proportion to their liabilities; whereas this must not, however, jeopardize the stability of the banking system of the Member State concerned; Whereas this Directive may not result in the Member States' or their competent authorities' being made liable in respect of depositors if they have ensured that one or more schemes guaranteeing deposits or credit institutions themselves and ensuring the compensation or protection of depositors under the conditions prescribed in this Directive have been introduced and officially recognized; Whereas deposit protection is an essential element in the completion of the internal market and an indispensable supplement to the system of supervision of credit institutions on account of the solidarity it creates amongst all the institutions in a given financial market in the event of the failure of any of them, Article 1 For the purposes of this Directive: 1. ‘deposit’ shall mean any credit balance which results from funds left in an account or from temporary situations deriving from normal banking transactions and which a credit institution must repay under the legal and contractual conditions applicable, and any debt evidenced by a certificate issued by a credit institution. Shares in United Kingdom and Irish building societies apart from those of a capital nature covered in Article 2 shall be treated as deposits. Bonds which satisfy the conditions prescribed in Article 22 (4) of Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (Ucits) (7) shall not be considered deposits. For the purpose of calculating a credit balance, Member States shall apply the rules and regulations relating to set-off and counterclaims according to the legal and contractual conditions applicable to a deposit; 2. ‘joint account’ shall mean an account opened in the names of two or more persons or over which two or more persons have rights that may operate against the signature of one or more of those persons; 3. ‘unavailable deposit’ shall mean a deposit that is due and payable but has not been paid by a credit institution under the legal and contractual conditions applicable thereto, where either: (i) the relevant competent authorities have determined that in their view the credit institution concerned appears to be unable for the time being, for reasons which are directly related to its financial circumstances, to repay the deposit and to have no current prospect of being able to do so. The competent authorities shall make that determination as soon as possible and at the latest 21 days after first becoming satisfied that a credit institution has failed to repay deposits which are due and payable; or (ii) a judicial authority has made a ruling for reasons which are directly related to the credit institution's financial circumstances which has the effect of suspending depositors' ability to make claims against it, should that occur before the aforementioned determination has been made; 4. ‘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; 5. ‘branch’ shall mean a place of business which forms a legally dependent part of a credit institution and which conducts directly all or some of the operations inherent in the business of credit institutions; any number of branches set up in the same Member State by a credit institution which has its head office in another Member State shall be regarded as a single branch. Article 2 The following shall be excluded from any repayment by guarantee schemes: — subject to Article 8 (3), deposits made by other credit institutions on their own behalf and for their own account, — all instruments which would fall within the definition of ‘own funds’ in Article 2 of Council Directive 89/299/EEC of 17 April 1989 on the own funds of credit institutions (8), — deposits arising out of transactions in connection with which there has been a criminal conviction for money laundering as defined in Article 1 of Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (9). Article 3 1. Each Member State shall ensure that within its territory one or more deposit-guarantee schemes are introduced and officially recognized. Except in the circumstances envisaged in the second subparagraph and in paragraph 4, no credit institution authorized in that Member State pursuant to Article 3 of Directive 77/780/EEC may take deposits unless it is a member of such a scheme. A Member State may, however, exempt a credit institution from the obligation to belong to a deposit-guarantee scheme where that credit institution belongs to a system which protects the credit institution itself and in particular ensures its liquidity and solvency, thus guaranteeing protection for depositors at least equivalent to that provided by a deposit-guarantee scheme, and which, in the opinion of the competent authorities, fulfils the following conditions: — the system must be in existence and have been officially recognized when this Directive is adopted, — the system must be designed to prevent deposits with credit institutions belonging to the system from becoming unavailable and have the resources necessary for that purpose at its disposal, — the system must not consist of a guarantee granted to a credit institution by a Member State itself or by any of its local or regional authorities, — the system must ensure that depositors are informed in accordance with the terms and conditions laid down in Article 9. Those Member States which make use of this option shall inform the Commission accordingly; in particular, they shall notify the Commission of the characteristics of any such protective systems and the credit institutions covered by them and of any subsequent changes in the information supplied. The Commission shall inform the Banking Advisory Committee thereof. 2. If a credit institution does not comply with the obligations incumbent on it as a member of a deposit-guarantee scheme, the competent authorities which issued its authorization shall be notified and, in collaboration with the guarantee scheme, shall take all appropriate measures including the imposition of sanctions to ensure that the credit institution complies with its obligations. 3. If those measures fail to secure compliance on the part of the credit institution, the scheme may, where national law permits the exclusion of a member, with the express consent of the competent authorities, give not less than 12 months' notice of its intention of excluding the credit institution from membership of the scheme. Deposits made before the expiry of the notice period shall continue to be fully covered by the scheme. If, on the expiry of the notice period, the credit institution has not complied with its obligations, the guarantee scheme may, again having obtained the express consent of the competent authorities, proceed to exclusion. 4. Where national law permits, and with the express consent of the competent authorities which issued its authorization, a credit institution excluded from a deposit-guarantee scheme may continue to take deposits if, before its exclusion, it has made alternative guarantee arrangements which ensure that depositors will enjoy a level and scope of protection at least equivalent to that offered by the officially recognized scheme. 5. If a credit institution the exclusion of which is proposed under paragraph 3 is unable to make alternative arrangements which comply with the conditions prescribed in paragraph 4, then the competent authorities which issued its authorization shall revoke it forthwith. Article 4 1. Deposit-guarantee schemes introduced and officially recognized in a Member State in accordance with Article 3 (1) shall cover the depositors at branches set up by credit institutions in other Member States. Until 31 December 1999 neither the level nor the scope, including the percentage, of cover provided shall exceed the maximum level or scope of cover offered by the corresponding guarantee scheme within the territory of the host Member State. Before that date, the Commission shall draw up a report on the basis of the experience acquired in applying the second subparagraph and shall consider the need to continue those arrangements. If appropriate, the Commission shall submit a proposal for a Directive to the European Parliament and the Council, with a view to the extension of their validity. 2. Where the level and/or scope, including the percentage, of cover offered by the host Member State guarantee scheme exceeds the level and/or scope of cover provided in the Member State in which a credit institution is authorized, the host Member State shall ensure that there is an officially recognized deposit-guarantee scheme within its territory which a branch may join voluntarily in order to supplement the guarantee which its depositors already enjoy by virtue of its membership of its home Member State scheme. The scheme to be joined by the branch shall cover the category of institution to which it belongs or most closely corresponds in the host Member State. 3. Member States shall ensure that objective and generally applied conditions are established for branches' membership of a host Member State's scheme in accordance with paragraph 2. Admission shall be conditional on fulfilment of the relevant obligations of membership, including in particular payment of any contributions and other charges. Member States shall follow the guiding principles set out in Annex II in implementing this paragraph. 4. If a branch granted voluntary membership under paragraph 2 does not comply with the obligations incumbent on it as a member of a deposit-guarantee scheme, the competent authorities which issued the authorization shall be notified and, in collaboration with the guarantee scheme, shall take all appropriate measures to ensure that the aforementioned obligations are complied with. If those measures fail to secure the branch's compliance with the aforementioned obligations, after an appropriate period of notice of not less than 12 months the guarantee scheme may, with the consent of the competent authorities which issued the authorization, exclude the branch. Deposits made before the date of exclusion shall continue to be covered by the voluntary scheme until the dates on which they fall due. Depositors shall be informed of the withdrawal of the supplementary cover. 5. The Commission shall report on the operation of paragraphs 2, 3 and 4 no later than 31 December 1999 and shall, if appropriate, propose amendments thereto. Article 5 Deposits held when the authorization of a credit institution authorized pursuant to Article 3 of Directive 77/780/EEC is withdrawn shall continue to be covered by the guarantee scheme. Article 6 1. Member States shall check that branches established by a credit institution which has its head office outwith the Community have cover equivalent to that prescribed in this Directive. Failing that, Member States may, subject to Article 9 (1) of Directive 77/780/EEC, stipulate that branches established by a credit institution which has its head office outwith the Community must join deposit-guarantee schemes in operation within their territories. 2. Actual and intending depositors at branches established by a credit institution which has its head office outwith the Community shall be provided by the credit institution with all relevant information concerning the guarantee arrangements which cover their deposits. 3. The information referred to in paragraph 2 shall be made available in the official language or languages of the Member State in which a branch is established in the manner prescribed by national law and shall be drafted in a clear and comprehensible form. Article 7 1. Deposit-guarantee schemes shall stipulate that the aggregate deposits of each depositor must be covered up to ECU 20 000 in the event of deposits' being unavailable. Until 31 December 1999 Member States in which, when this Directive is adopted, deposits are not covered up to ECU 20 000 may retain the maximum amount laid down in their guarantee schemes, provided that this amount is not less than ECU 15 000. 2. Member States may provide that certain depositors or deposits shall be excluded from guarantee or shall be granted a lower level of guarantee. Those exclusions are listed in Annex I. 3. This Article shall not preclude the retention or adoption of provisions which offer a higher or more comprehensive cover for deposits. In particular, deposit-guarantee schemes may, on social considerations, cover certain kinds of deposits in full. 4. Member States may limit the guarantee provided for in paragraph 1 or that referred to in paragraph 3 to a specified percentage of deposits. The percentage guaranteed must, however, be equal to or exceed 90 % of aggregate deposits until the amount to be paid under the guarantee reaches the amount referred to in paragraph 1. 5. The amount referred to in paragraph 1 shall be reviewed periodically by the Commission at least once every five years. If appropriate, the Commission shall submit to the European Parliament and to the Council a proposal for a Directive to adjust the amount referred to in paragraph 1, taking account in particular of developments in the banking sector and the economic and monetary situation in the Community. The first review shall not take place until five years after the end of the period referred to in Article 7 (1), second subparagraph. 6. Member States shall ensure that the depositor's rights to compensation may be the subject of an action by the depositor against the deposit-guarantee scheme. Article 8 1. The limits referred to in Article 7 (1), (3) and (4) shall apply to the aggregate deposits placed with the same credit institution irrespective of the number of deposits, the currency and the location within the Community. 2. The share of each depositor in a joint account shall be taken into account in calculating the limits provided for in Article 7 (1), (3) and (4). In the absence of special provisions, such an account shall be divided equally amongst the depositors. Member States may provide that deposits in an account to which two or more persons are entitled as members of a business partnership, association or grouping of a similar nature, without legal personality, may be aggregated and treated as if made by a single depositor for the purpose of calculating the limits provided for in Article 7 (1), (3) and (4). 3. Where the depositor is not absolutely entitled to the sums held in an account, the person who is absolutely entitled shall be covered by the guarantee, provided that that person has been identified or is identifiable before the date on which the competent authorities make the determination described in Article 1 (3) (i) or the judicial authority makes the ruling described in Article 1 (3) (ii). If there are several persons who are absolutely entitled, the share of each under the arrangements subject to which the sums are managed shall be taken into account when the limits provided for in Article 7 (1), (3) and (4) are calculated. This provision shall not apply to collective investment undertakings. Article 9 1. Member States shall ensure that credit institutions make available to actual and intending depositors the information necessary for the identification of the deposit-guarantee scheme of which the institution and its branches are members within the Community or any alternative arrangement provided for in Article 3 (1), second subparagraph, or Article 3 (4). The depositors shall be informed of the provisions of the deposit-guarantee scheme or any alternative arrangement applicable, including the amount and scope of the cover offered by the guarantee scheme. That information shall be made available in a readily comprehensible manner. Information shall also be given on request on the conditions for compensation and the formalities which must be completed to obtain compensation. 2. The information provided for in paragraph 1 shall be made available in the manner prescribed by national law in the official language or languages of the Member State in which the branch is established. 3. Member States shall establish rules limiting the use in advertising of the information referred to in paragraph 1 in order to prevent such use from affecting the stability of the banking system or depositor confidence. In particular, Member States may restrict such advertising to a factual reference to the scheme to which a credit institution belongs. Article 10 1. Deposit-guarantee schemes shall be in a position to pay duly verified claims by depositors in respect of unavailable deposits within three months of the date on which the competent authorities make the determination described in Article 1 (3) (i) or the judicial authority makes the ruling described in Article 1 (3) (ii). 2. In wholly exceptional circumstances and in special cases a guarantee scheme may apply to the competent authorities for an extension of the time limit. No such extension shall exceed three months. The competent authorities may, at the request of the guarantee scheme, grant no more than two further extensions, neither of which shall exceed three months. 3. The time limit laid down in paragraphs 1 and 2 may not be invoked by a guarantee scheme in order to deny the benefit of guarantee to any depositor who has been unable to assert his claim to payment under a guarantee in time. 4. The documents relating to the conditions to be fulfilled and the formalities to be completed to be eligible for a payment under the guarantee referred to in paragraph 1 shall be drawn up in detail in the manner prescribed by national law in the official language or languages of the Member State in which the guaranteed deposit is located. 5. Notwithstanding the time limit laid down in paragraphs 1 and 2, where a depositor or any person entitled to or interested in sums held in an account has been charged with an offence arising out of or in relation to money laundering as defined in Article 1 of Directive 91/308/EEC, the guarantee scheme may suspend any payment pending the judgment of the court. Article 11 Without prejudice to any other rights which they may have under national law, schemes which make payments under guarantee shall have the right of subrogation to the rights of depositors in liquidation proceedings for an amount equal to their payments. Article 12 Notwithstanding Article 3, those institutions authorized in Spain or in Greece and listed in Annex III shall be exempt from the requirement to belong to a deposit-guarantee scheme until 31 December 1999. Such credit institutions shall expressly alert their actual and intending depositors to the fact that they are not members of any deposit-guarantee scheme. During that time, should any such credit institution establish or have established a branch in another Member State, that Member State may require that branch to belong to a deposit-guarantee scheme set up within its territory under conditions consonant with those prescribed in Article 4 (2), (3) and (4). Article 13 In the list of authorized credit institutions which it is required to draw up pursuant to Article 3 (7) of Directive 77/780/EEC the Commission shall indicate the status of each credit institution with regard to this Directive. Article 14 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive by 1 July 1995. They shall forthwith inform the Commission thereof. When the Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 15 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States.

31994L0022

1994

DIRECTIVE 94/22/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 1994 on the conditions for granting and using authorizations for the prospection, exploration and production of hydrocarbons Having regard to the Treaty establishing the European Community and in particular Article 57 (2), first and third sentences, Articles 66 and 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, services, persons and capital is ensured; whereas the necessary measures must be adopted for its operation; Whereas in its resolution of 16 September 1986 (4), the Council identified as an objective of the energy policy of the Community and the Member States the greater integration, free from barriers to trade, of the internal energy market with a view to improving security of supply, reducing costs and improving economic competitiveness; Whereas the Community largely depends on imports for its hydrocarbon supply; whereas it is consequently advisable to encourage the best possible prospection, exploration and production of the resources located in the Community; Whereas Member States have sovereignty and sovereign rights over hydrocarbon resources on their territories; Whereas the Community is a signatory to the United Nations Convention on the Law of the Sea; Whereas steps must be taken to ensure the non-discriminatory access to and pursuit of activities relating to the prospection, exploration and production of hydrocarbons under conditions which encourage greater competition in this sector and thereby to favour the best prospection, exploration and production of resources in Member States and to reinforce the integration of the internal energy market; Whereas, for this purpose, it is necessary to set up common rules for ensuring that the procedures for granting authorizations for the prospection, exploration and production of hydrocarbons must be open to all entities possessing the necessary capabilities; whereas authorizations must be granted on the basis of objective, published criteria; whereas the conditions under which authorizations are granted must likewise be known in advance by all entities taking part in the procedure; Whereas Member States must retain the options to limit the access to and the exercise of these activities for reasons justified by public interest and to subject to the payment of a financial contribution or a contribution in hydrocarbons, the detailed arrangements of the said contribution having to be fixed in such a way as not to interfere in the management of entities; whereas these options must be used in a non-discriminatory way; whereas, with the exception of the obligations related to the use of this option, steps must be taken to avoid imposing on entities, conditions and obligations which are not justified by the need to perform this activity properly; whereas the activities of entities must be monitored only to the extent necessary to ensure their compliance with these obligations and conditions; Whereas the extent of the areas covered by an authorization and the duration of the authorization must be limited with a view to preventing the reservation to a single entity of an exclusive right over an area which can be prospected, explored and brought into production more efficiently by several entities; Whereas Member States' entities should enjoy in third countries a treatment comparable to that enjoyed by third countries' entities in the Community by virtue of this Directive; whereas it is necessary to lay down a procedure to this end; Whereas this Directive should apply to authorizations issued after the date by which Member States have to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive; Whereas Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors (5) and Council Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors (6) apply to the entities in the energy sector as regards their procurement of supplies, of works and of services; whereas the application of the alternative arrangements provided for under Article 3 of Directive 90/53 I/EEC is subject in particular to the condition that, in the Member State requesting the application of these arrangements, authorizations be granted in a non-discriminatory and transparent manner; whereas a Member State fulfils this condition from the moment when and for as long as it complies with the requirements of this Directive; whereas it is consequently necessary to amend Directive 90/53I/EEC; Whereas Article 36 of Directive 90/531/EEC provides for a review within four years, in the light of developments concerning in particular progress in market opening and the level of competition, of the field of application of that Directive. This review of the field of application includes hydrocarbon exploration and extraction; Whereas Denmark is in a special situation, due to the fact that it is obliged to enter into negotiations on a possible continuation of the activities after the expiry of the concession, issued on 8 July 1962, concerning the areas which are relinquished on 8 July 2012 and that Denmark will thus be accorded a derogation concerning these areas, Article 1 For the purposes of this Directive: 1. ‘competent authorities’ means the public authorities, as defined in Article 1 (1) of Directive 90/531/EEC, which are responsible for granting authorization and/or monitoring use thereof; 2. ‘entity’ means any natural or legal person or any group of such persons which applies for, is likely to apply for or holds an authorization; 3. ‘authorization’ means any law, regulation, administrative or contractual provision or instrument issued thereunder by which the competent authorities of a Member State entitle an entity to exercise, on its own behalf and at its own risk, the exclusive right to prospect or explore for or produce hydrocarbons in a geographical area. An authorization may be granted for each activity separately or for several activities at a time; 4. ‘public entity’ means a public undertaking as defined in Article 1 (2) of Directive 90/531/EEC. Article 2 1. Member States retain the right to determine the areas within their territory to be made available for the exercise of the activities of prospecting, exploring for and producing hydrocarbons. 2. Whenever an area is made available for the exercise of the activities set out in paragraph 1, Member States shall ensure that there is no discrimination between entities as regards access to and exercise of these activities. However, Member States may refuse, on grounds of national security, to allow access to and exercise of these activities to any entity which is effectively controlled by third countries or third country nationals. Article 3 1. Member States shall take the necessary measures to ensure that authorizations are granted following a procedure in which all interested entities may submit applications in accordance either with paragraph 2 or 3. 2. This procedure shall be initiated: (a) either at the initiative of the competent authorities by means of a notice inviting applications, to be published in the Official Journal of the European Communities at least 90 days before the closing date for applications; (b) or by means of a notice inviting applications, to be published in the Official Journal of the European Communities following submission of an application by an entity without prejudice to Article 2 (1). Other interested entities shall have a period of at least 90 days after the date of publication in which to submit an application. Notices shall specify the type of authorization, the geographical area or areas in part or all of which an application has been or may be made and the proposed date or time limit for granting authorization. Where preference is given to applications by entities which are single natural or legal persons, the notice shall so specify. 3. Member States may grant authorizations without initiating a procedure under paragraph 2 where the area for which authorization is requested: (a) is available on a permanent basis; or (b) has been the subject of a previous procedure according to paragraph 2 which has not resulted in the grant of an authorization; or (c) has been relinquished by an entity and does not fall automatically under (a). A Member State wishing to apply this paragraph shall within three months of the adoption of this Directive or, in case of Member States who have not yet introduced such procedures, without delay arrange for the publication in the Official Journal of the European Communities of a notice indicating the areas within its territory which are available under this paragraph and where detailed information in this regard can be obtained. Any significant change in this information shall be the subject of an additional notice. However, no application for an authorization under this paragraph can be considered until after the publication of the relevant notice under this text. 4. A Member State may decide not to apply the provisions of paragraph 1 if and to the extent that geological or production considerations justify the granting of the authorization for an area to the holder of an authorization for a contiguous area. The Member State concerned shall ensure that the holders of authorizations for any other contiguous areas are able to submit applications in such a case and are given sufficient time to do so. 5. The following shall not be considererd as the grant of an authorization within the meaning of paragraph 1: (a) the grant of an authorization solely by reason of a change of name or ownership of an entity holding an existing authorization, a change in the composition of such an entity or a transfer of an authorization; (b) the grant of an authorization to an entity having another form of authorization where the possession of the latter authorization implies a right to the grant of the former authorization; (c) the decision of the competent authorities taken within the framework of an authorization (whether or not such authorization was granted before the date fixed in Article 14) and relating to the commencement, interruption, prolongation or cessation of the activities or to the prolongation of the authorization itself. 6. Notwithstanding the initiation of the procedures mentioned in paragraph 2, Member States retain the option to refuse the granting of authorizations, whilst ensuring that this option does not give rise to discrimination between entities. Article 4 Member States shall take the necessary measures to ensure that: (a) if the geographical areas are not delimited on the basis of a prior geometric division of the territory, the extent of each area is determined in such a way that it does not exceed the area justified by the best possible exercise of the activities from the technical and economic points of view. In the case of authorizations granted following the procedures laid down in Article 3 (2), objective criteria shall be established to this end and shall be made available to the entities prior to the submission of applications; (b) the duration of an authorization does not exceed the period necessary to carry out the activities for which the authorization is granted. However, the competent authorities may prolong the authorization where the stipulated duration is insufficient to complete the activity in question and where the activity has been performed in accordance with the authorization; (c) entities do not retain exclusive rights in the geographical area for which they have received an authorization for longer than is necessary for the proper performance of the authorized activities. Article 5 Member States shall take the necessary measures to ensure that: 1. authorizations are granted on the basis of criteria concerning, in all cases: (a) the technical and financial capability of the entities; and (b) the way in which they propose to prospect, to explore and/or to bring into production the geographical area in question; and, where applicable: (c) if the authorization is put up for sale, the price which the entity is prepared to pay in order to obtain the authorizations; (d) if, following evaluation under the criteria (a), (b) and, where applicable, (c), two or more applications have equal merit, other relevant objective and non-discriminatory criteria, in order to make a final choice among these applications. The competent authorities may also take account, when appraising applications, of any lack of efficiency and responsibility displayed by the applicants in operations under previous authorizations. Where the competent authorities determine the composition of an entity to which they may grant an authorization, they shall make that determination on the basis of objective and non-discriminatory criteria. Where the competent authorities determine the operator of an entity to which they may grant an authorization, they shall make that determination on the basis of objective and non-discriminatory criteria. The criteria shall be drawn up and published in the Official Journal of the European Communities before the start of the period for submission of applications. Member States which have already published the criteria in their official journals may limit the publication in the Official Journal of the European Communities to a reference to the publication in their official journals. However, any change in criteria shall be published in full in the Official Journal of the European Communities; 2. the conditions and requirements concerning the exercise or termination of the activity which apply to each type of authorizations by virtue of the laws, regulations and administrative provisions in force at the time of submission of the applications, whether contained in the authorization or being one of the conditions to be accepted prior to the grant of such authorization, are established and made available to interested entities at all times. In the case provided for in Article 3 (2) (a), they may be made available only from the date starting from which applications for authorization may be submitted; 3. any changes made to the conditions and requirements in the course of the procedure are notified to all interested entities; 4. the criteria, conditions and requirements referred to in this Article are applied in a non-discriminatory manner; 5. any entity whose application for an authorization is unsuccessful is, if the entity so wishes, informed of the reasons for the decision. Article 6 1. Member States shall ensure that the conditions and requirements referred to in Article 5 (2) and the detailed obligations for use of a specific authorization are justified exclusively by the need to ensure the proper performance of the activities in the area for which an authorization is requested, by the application of paragraph 2 or by the payment of a financial contribution or a contribution in hydrocarbons. 2. Member States may, to the extent justified by national security, public safety, public health, security of transport, protection of the environment, protection of biological resources and of national treasures possessing artistic, historic or archaeological value, safety of installations and of workers, planned management of hydrocarbon resources (for example the rate at which hydrocarbons are depleted or the optimization of their recovery) or the need to secure tax revenues, impose conditions and requirements on the exercise of the activities set out in Article 2 (1). 3. The rules for payment of contributions referred to in paragraph 1, including any requirement for State participation, shall be fixed by Member States in such a way as to ensure that the independence of management of entities is maintained. However, where the grant of authorizations is subject to the State's participation in the activities and where a legal person has been entrusted with the management of this participation or where the State itself manages the participation, neither the legal person nor the State shall be prevented from assuming the rights and obligations associated with such participation, equivalent to the importance of the participation provided that the legal person or the State shall not be party to information nor exercise any voting rights on decisions regarding sources of procurement for entities, that the legal person or the State in combination with any public entity or entities shall not exercise a majority voting right on other decisions and that any vote by the State or the legal person shall be based exclusively on transparent, objective and non-discriminatory principles, and shall not prevent the management decisions of the entity from being based on normal commercial principles. However, the provisions of the preceding sub-paragraph shall not prevent the legal person or the State from opposing a decision by the holders of an authorization which would not respect the conditions and requirements, specified in the authorization, regarding depletion policy and protection of the financial interests of the State. The option to oppose a decision shall be exercised in a non-discriminatory manner, particularly regarding investment decisions and sources of supply of entities. Where the State's participation in the activities is managed by a legal person which also holds the authorizations, the Member State shall put in place arrangements requiring that legal person to keep separate accounts for its commercial role and its role as manager of the State's participation and guaranteeing that there is no flow of information from the part of the legal person responsible for the management of the State's participation to the part of the legal person which holds authorizations in its own right. However, where the part of the legal person responsible for the management of the State's participation engages the part of the legal person which holds authorization as a consultant, the former may make available any information which is necessary for the consultancy work to be carried out. The holders of all authorizations to which the information relates shall be informed in advance of what information will be given in this way and shall be given sufficient time to raise objections. 4. Member States shall ensure that the monitoring of entities under an authorization is limited to that necessary to ensure compliance with the conditions, requirements and obligations referred to in paragraph 1. In particular, they shall take the measures necessary to ensure that no entity is required, by any law, regulation or administrative requirement, or by any agreement or undertaking, to provide information on its intended or actual sources of procurement, except at the request of the competent authorities and exclusively with a view to the objectives set out in Article 36 of the Treaty. Article 7 Without prejudice to the provisions concerning or contained in individual authorizations and to the provisions of Article 3 (5) (b) legal, regulatory and administrative provisions which reserve to a single entity the right to obtain authorizations in a specific geographical area within the territory of a Member State shall be abolished by the Member States concerned before 1 January 1997. Article 8 1. Member States shall inform the Commission of any general difficulty encountered, de jure or de facto, by entities in access to or exercise of the activities of prospecting, exploring for and producing hydrocarbons in third countries, which have been brought to their attention. Member States and the Commission shall ensure that commercial confidentiality is respected. 2. The Commission shall report to the European Parliament and the Council before 31 December 1994, and periodically thereafter, on the situation of entities in third countries and on the state of any negotiations undertaken pursuant to paragraph 3 with those countries or in the framework of international organizations. 3. Whenever the Commission establishes, 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 entities, as regards access to or exercise of the activities referred to in paragraph 1, treatment comparable to that which the Community grants entities from that third country, the Commission may submit proposals to the Community for the appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community entities. The Council shall decide by qualified majority. 4. In the circumstances described in paragraph 3, the Commission may at any time propose that the Council authorize one or more Member States to refuse an authorization to an entity which is effectively controlled by the third country concerned and/or by nationals of that third country. The Commission may make such a proposal on its own initiative or at the request of a Member State. The Council shall act by qualified majority as soon as possible. 5. Measures taken pursuant to this Article shall be without prejudice to the Community's obligations under any international agreement governing access to an exercise of the activities of prospecting, exploring for and producing hydrocarbons. Article 9 Each Member State shall publish and communicate to the Commission an annual report which shall include information on the geographical areas which have been opened for prospecting, exploration and production, authorizations granted, entities holding authorizations and the composition thereof and the estimated reserves contained in its territory. This provision does not imply any obligation for Member States to publish information of a commercially confidential nature. Article 10 Member States shall notify the Commission, no later than 1 May 1995, of the competent authorities. Member States shall notify the Commission without delay of any subsequent changes. The Commission shall publish the list of competent authorities and any changes thereto in the Official Journal of the European Communities. Article 11 This Directive applies to authorizations granted from the date laid down in Article 14. Article 12 The following paragraph shall be added to Article 3 of Directive 90/53 I/EEC: ‘5. As regards the exploitation of geographical areas for the purpose of prospecting for or extracting oil or gas, paragraphs 1 to 4 shall apply as follows from the date on which the Member State concerned has complied with the provisions of the European Parliament and Council Directive 94/22/EC of 30 May on the conditions for granting and using authorizations for the prospection, exploration and production of hydrocarbons (*1): (a) the conditions laid down in paragraph 1 shall be considered to be satisfied with effect from that date without prejudice to paragraph 3; (b) with effect from that date, the Member State referred to in paragraph 4 shall be required to communicate only the provisions relating to compliance with the conditions referred to in paragraphs 2 and 3. Article 13 The provisions of Articles 3 and 5 shall not apply to new authorizations granted by Denmark before 31 December 2012, in respect of the areas which are relinquished on 8 July 2012 upon expiry of the authorization issued on 8 July 1962. The new authorizations shall be granted on the basis of objective and non-discriminatory principles. Consequently, this Article shall not create any precedent for Member States. Article 14 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States. Article 15 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States.

31994L0026

1994

Commission Directive 94/26/EC of 15 June 1994 adapting to technical progress Council 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 Community, Having regard to 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 (1), and in particular Article 5 thereof, Having regard to Council Directive 79/196/EEC of 6 February 1979 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection (2), as last amended by Directive 90/487/EEC (3), and in particular Article 5 thereof, Whereas it is necessary to adapt the contents of Annex 1 to Directive 79/196/EEC to technical progress by incorporating five new European standards recently drawn up by Cenelec; Whereas, in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonized standards referred to in Annex I to Directive 79/196/EEC; Whereas, in view of the nature of the equipment concerned, a transitional arrangement must be allowed in order to enable the industry to adapt adequately to the amendments introduced into the standards; 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 Elimination of Technical Barriers in the Sector of Electrical Equipment for Use in Potentially Explosive Atmospheres, Article 1 Annex I to Directive 79/196/EEC, is replaced by the Annex to this Directive. Article 2 1. Member States shall bring into force the necessary provisions in order to comply with this Directive not later than 31 March 1995 and shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Until 30 June 2003 the Member States shall continue to apply the measures provided for in Article 4 of Directive 76/117/EEC as regards the equipment for which conformity to the harmonized standards referred to in Directive 79/196/EEC, in its version of 17 September 1990, is attested by the certificate of conformity referred to in Article 8 of Directive 76/117/EEC, provided that this certificate has been issued before 1 March 1996. Article 3 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0025

1994

Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the laws, regulations and administrative provisions in force in the various Member States relating to the safety characteristics of recreational craft differ in scope and content; whereas such disparities are liable to create barriers to trade and unequal conditions of competition within the internal market; Whereas harmonization of national legislation is the only way in which to remove these barriers to free trade; whereas this objective cannot be satisfactorily achieved by the individual Member States; whereas this Directive merely lays down the requirements vital to freedom of movement for recreational craft; Whereas this Directive should cover only recreational craft of a minimum length of 2,5 m and a maximum length of 24 m, derived from the ISO standards; Whereas the removal of technical barriers in the field of recreational craft and their components, 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; whereas paragraph 3 of Article 100a provides that, in its proposals, concerning health, safety, environmental protection and consumer protection, the Commission will take as a base a high level of protection; whereas the essential requirements constitute the criteria with which recreational craft, partly completed craft and their components when separate and when installed must comply; Whereas, therefore, this Directive sets out essential requirements only; whereas, in order to facilitate the task of proving compliance with the essential requirements, harmonized European standards are necessary for recreational craft and their components as referred to in Annex II; whereas harmonized European standards are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the bodies competent to adopt harmonized standards which follow 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 other of those bodies, or by both, at the prompting of the Commission pursuant to 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) and pursuant to the general guidelines referred to above; Whereas, in view of the nature of the risks involved in the use of recreational craft and their components, it is necessary to establish procedures applying to the assessment of compliance with the essential requirements of the Directive; whereas these procedures must be devised in the light of the level of risk which may be inherent in recreational craft and their components; whereas, therefore, each category of conformity must be supplemented by an appropriate procedure or a choice between several equivalent procedures; whereas the procedures adopted comply with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking which are intended to be used in the technical harmonization Directives (1); Whereas the Council has provided for the affixing of the CE marking by either the manufacturer or his authorized representative within the Community; whereas that mark means that the recreational craft and components comply with all the essential requirements and assessment procedures provided for by the Community law applying to the product; Whereas it is appropriate that the Member States, as provided for by Article 100a (5) of the Treaty, may take provisional measures to limit or prohibit the placing on the market and the use of recreational craft or constituent products thereof in cases where they present a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure; Whereas the recipients of any decision taken as part of this Directive must be aware of the reasons behind that decision and the means of appeal open to them; Whereas it is necessary to provide for a transitional arrangement enabling recreational craft and their components manufactured in compliance with the national regulations in force at the date of adoption of this Directive to be marketed and placed in service; Whereas this Directive does not contain any provisions directed towards limiting the use of the recreational craft after it has been put into service; Whereas the construction of recreational craft may have an impact on the environment to the extent that the craft may discharge polluting substances; whereas it is therefore necessary to include provisions on the protection of the environment in the Directive, in so far as those provisions concern the construction of recreational craft from the point of view of its direct impact on the environment; Whereas the provisions of this Directive should not affect Member States' entitlement to lay down, in accordance with the Treaty, such requirements as they may deem necessary concerning navigation on certain waters for the purpose of protection of the environment, the fabric of waterways and ensuring safety on waterways, provided that this does not mean that the recreational craft is modified in a way not specified in this Directive, CHAPTER I Article 1 1. This Directive shall apply to recreational craft, partly completed boats and components referred to in Annex II when separate and when installed. 2. 'Recreational craft' shall mean any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes. The fact that the same boat could be used for charter or for recreational boating training shall not prevent it being covered by this Directive when it is placed on the market for recreational purposes. 3. The following shall be excluded from the scope of this Directive: (a) craft intended solely for racing, including rowing racing boats and training rowing boats labelled as such by the manufacturer; (b) canoes and kayaks, gondolas and pedalos; (c) sailing surfboards; (d) powered surfboards, personal watercraft and other similar powered craft; (e) original, and individual replicas of, historical craft designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer; (f) experimental craft, provided that they are not subsequently placed on the Community market; (g) craft built for own use, provided that they are not subsequently placed on the Community market during a period of five years; (h) craft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to paragraph 2, in particular those defined in Directive 82/716/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels (2), regardless of the number of passengers; (i) submersibles; (j) air cushion vehicles; (k) hydrofoils. Article 2 Placing on the market and putting into service 1. Member States shall take all necessary measures to ensure that the products referred to in Article 1 (1) may be placed on the market and put into service for use in accordance with their intended purpose only if they do not endanger the safety and health of persons, property or the environment when correctly constructed and maintained. 2. The provisions of this Directive shall not prevent Member States from adopting, in compliance with the Treaty, provisions concerning navigation on certain waters for the purpose of protection of the environment, the fabric of waterways, and ensuring safety of waterways, providing that this does not require modification to craft conforming to this Directive. Article 3 Essential requirements The products referred to in Article 1 (1) shall meet the essential safety, health, environmental protection and consumer protection requirements set out in Annex I. Article 4 Free movement of the products referred to in Article 1 (1) 1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of the products referred to in Article 1 (1) bearing the CE marking referred to in Annex IV, which indicates their conformity with all provisions of this Directive, including the conformity procedures set out in Chapter II. 2. Member States shall not prohibit, restrict or impede the placing on the market of partly-completed boats where the builder or his authorized representative established in the Community or the person responsible for the placing on the market declares, in accordance with Annex IIIA, that they are intended to be completed by others. 3. Member States shall not prohibit, restrict or impede the placing on the market and putting into service of components referred to in Annex II and bearing the CE marking referred to in Annex IV which indicates their conformity with the relevant essential requirements where these components are intended to be incorporated into recreational craft, in accordance with the declaration, referred to in Annex IIIB, of the manufacturer, his authorized representative established in the Community or, in the case of imports from a third country, of any person who places those components on the Community market. 4. At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacles to the showing of the products referred to in Article 1 (1) which do not comply with this Directive, provided that a visible sign clearly indicates that such products may not be marketed or put into service until they have been made to comply. 5. Where the products referred to in Article 1 (1) are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that such products also fulfil the provisions of those other Directives. However, should one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the product fulfils the provisions only of those Directives applied by the manufacturer. In this case, the particulars of those Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by those Directives and accompanying such products. Article 5 Member States shall presume compliance with the essential requirements referred to in Article 3 of products referred to in Article 1 (1) which meet the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Communities; Member States shall publish the references of such national standards. Article 6 1. Where a Member State or the Commission is of the opinion that the harmonized standards referred to in Article 5 do not fully meet the essential requirements referred to in Article 3, the Commission or the Member State shall notify the committee set up under Directive 83/189/CEE, setting out its reasons. The committee shall deliver an urgent opinion. In the light of the opinion of the committee, the Commission shall inform Member States if the standards concerned should be withdrawn from the publications referred to in Article 5. 2. The Commission may adopt any appropriate measure with a view to ensuring that this Directive is applied practically in a uniform manner in pursuance of paragraph 3. 3. The Commission shall be assisted by a Standing Committee composed of representatives appointed by the Member States and chaired by a representative from the Commission. The Standing Committee shall draw up its own rules of 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. 4. The Standing Committee may, in addition, examine any question concerning the application of this Directive and raised by its chairman, either at the chairman's initiative or at the request of a Member State. Article 7 Safeguard clause 1. Where a Member State ascertains that recreational craft or components referred to in Annex II and bearing the CE marking referred to in Annex IV when correctly constructed, installed, maintained and used in accordance with their intended purpose may endanger the safety and health of persons, property or the environment, it shall take all appropriate interim measures to withdraw them from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision, in particular where non-conformity is the result of: (a) failure to comply with the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that those standards have been applied; (c) shortcomings in the standards referred to in Article 5 themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that: - the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6 (1) within two months, if the Member State which has taken the decision intends to maintain it, and shall initiate the procedure referred to in Article 6 (1), - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established in the Community. 3. Where a non-complying component referred to in Annex II or craft bears the CE marking, the appropriate measures shall be taken by the Member State which has authority over whomsoever affixed the marking; that Member State 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 Before producing and placing on the market products referred to in Article 1 (1), the manufacturer or his authorized representative established in the Community shall apply the following procedures for boat design categories A, B, C and D as referred to in Section 1 of Annex I. 1. For categories A and B: - for boats of less than 12 m hull length: the internal production control plus tests (module Aa) referred to in Annex VI, - for boats from 12 m to 24 m hull length: the EC type-examination (module B) referred to in Annex VII supplemented by module C (type conformity) referred to in Annex VIII, or any of the following modules: B + D, or B + F, or G or H. 2. For category C: (a) for boats from 2,5 m to 12 m hull length: - where the harmonized standards relating to sections 3.2 and 3.3 of Annex I are complied with: the internal production control (module A), referred to in Annex V, - where the harmonized standards relating Sections 3.2 and 3.3 of Annex I are not complied with: the internal production control plus tests (module Aa) referred to in Annex VI. (b) for boats from 12 m to 24 m hull length: the EC type-examination (module B) referred to in Annex VII followed by module C (type conformity) referred to in Annex VIII, or any of the following modules: B + D, or B + F, or G or H. 3. For category D: For boats from 2,5 m to 24 m hull length: the internal production control (module A) referred to in Annex V. 4. For components referred to in Annex II: any of the following modules: B + C, or B + D, or B + F, or G or H. Article 9 Notified bodies 1. Member States shall notify the Commission and other Member States of the bodies which they have appointed to carry out the tasks pertaining to the conformity assessment procedures referred to in Article 8, together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission. The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date. 2. Member States shall apply the criteria laid down in Annex XIV 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 is established that the latter no longer satisfies the criteria referred to in Annex XIV. It shall inform the Commission and the other Member States of its action forthwith. CHAPTER III CE Marking Article 10 1. Recreational craft and components as referred to in Annex II which are regarded as meeting the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market. 2. The CE marking of conformity, as shown in Annex IV, must appear in a visible, legible and indelible form on the recreational craft as in point 2.2 of Annex I and on components as referred to in Annex II and/or on their packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes VI, IX, X, XI and XII. 3. The affixing of markings or inscriptions on the craft which are likely to mislead third parties with regard to the meaning or the form of the CE marking shall be prohibited. Any other markings may be affixed to the recreational craft and components as referred to in Annex II and/or on their packaging, provided that the visibility and legibility of the CE marking is not thereby reduced. 4. Without prejudice to Article 7: (a) where a Member State establishes that the CE marking has been affixed wrongly, the manufacturer or his authorized representative established in the Community shall be obliged to end the infringement under conditions laid down by the Member State; (b) where non-compliance continues, the Member State shall take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure laid down in Article 7. CHAPTER IV Final provisions Article 11 Detailed grounds shall be given for any decision taken pursuant to this Directive leading to a restriction on the marketing and putting into service of products referred to in Article 1 (1). The party concerned shall be informed of the decision as soon as possible together with the means of redress available under the laws in force in the Member State concerned and the periods within which appeals must be lodged. Article 12 The Commission shall take the necessary measures to ensure that data affecting all pertinent decisions concerning the management of this Directive are made available. Article 13 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 16 December 1995. They shall immediately inform the Commission thereof. Member States shall apply these provisions from 16 June 1996. The Standing Committee referred to in Article 6 (3) may assume its tasks from the date of the entry into force of this Directive. Member States may take the measures referred to in Article 9 of such date. When Member States adopt the provisions referred to in the first subparagraph, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive. 3. Member States shall accept the placing on the market and putting into service of products referred to in Article 1 (1) which comply with the rules in force in their territory on the date of adoption of this Directive during a period of four years from that date. Article 14 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 15 This Directive is addressed to the Member States.

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COUNCIL DIRECTIVE 94/33/EC of 22 June 1994 on the protection of young people at work Having regard to the Treaty establishing the European Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189c of the Treaty (3), Whereas Article 118a of the Treaty provides that the Council shall adopt, by means of directives, minimum requirements to encourage improvements, especially in the working environment, as regards the health and safety of workers; Whereas, under that Article, such directives must avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas points 20 and 22 of the Community Charter of the Fundamental Social Rights of Workers, adopted by the European Council in Strasbourg on 9 December 1989, state that: ‘20. Without prejudice to such rules as may be more favourable to young people, in particular those ensuring their preparation for work through vocational training, and subject to derogations limited to certain light work, the minimum employment age must not be lower than the minimum school-leaving age and, in any case, not lower than 15 years; 22. Appropriate measures must be taken to adjust labour regulations applicable to young workers so that their specific development and vocational training and access to employment needs are met.The duration of work must, in particular, be limited — without it being possible to circumvent this limitation through recourse to overtime — and night work prohibited in the case of workers of under eighteen years of age, save in the case of certain jobs laid down in national legislation or regulations.’; Whereas account should be taken of the principles of the International Labour Organization regarding the protection of young people at work, including those relating to the minimum age for access to employment or work; Whereas, in this Resolution on child labour (4), the European Parliament summarized the various aspects of work by young people and stressed its effects on their health, safety and physical and intellectual development, and pointed to the need to adopt a Directive harmonizing national legislation in the field; Whereas Article 15 of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5) provides that particularly sensitive risk groups must be protected against the dangers which specifically affect them; Whereas children and adolescents must be considered specific risk groups, and measures must be taken with regard to their safety and health; Whereas the vulnerability of children calls for Member States to prohibit their employment and ensure that the minimum working or employment age is not lower than the minimum age at which compulsory schooling as imposed by national law ends or 15 years in any event; whereas derogations from the prohibition on child labour may be admitted only in special cases and under the conditions stipulated in this Directive; whereas, under no circumstances, may such derogations be detrimental to regular school attendance or prevent children benefiting fully from their education; Whereas, in view of the nature of the transition from childhood to adult life, work by adolescents should be strictly regulated and protected; Whereas every employer should guarantee young people working conditions appropriate to their age; Whereas employers should implement the measures necessary to protect the safety and health of young people on the basis on an assessment of work-related hazards to the young; Whereas Member States should protect young people against any specific risks arising from their lack of experience, absence of awareness of existing or potential risks, or from their immaturity; Whereas Member States should therefore prohibit the employment of young people for the work specified by this Directive; Whereas the adoption of specific minimal requirements in respect of the organization of working time is likely to improve working conditions for young people; Whereas the maximum working time of young people should be strictly limited and night work by young people should be prohibited, with the exception of certain jobs specified by national legislation or rules; Whereas Member States should take the appropriate measures to ensure that the working time of adolescents receiving school education does not adversely affect their ability to benefit from that education; Whereas time spent on training by young persons working under a theoretical and/or practical combined work/training scheme or an in-plant work-experience should be counted as working time; Whereas, in order to ensure the safety and health of young people, the latter should be granted minimum daily, weekly and annual periods of rest and adequate breaks; Whereas, with respect to the weekly rest period, due account should be taken of the diversity of cultural, ethnic, religious and other factors prevailing in the Member States; whereas in particular, it is ultimately for each Member State to decide whether Sunday should be included in the weekly rest period, and if so to what extent; Whereas appropriate work experience may contribute to the aim of preparing young people for adult working and social life, provided it is ensured that any harm to their safety, health and development is avoided; Whereas, although derogations from the bans and limitations imposed by this Directive would appear indispensable for certain activities or particular situations, applications thereof must not prejudice the principles underlying the established protection system; Whereas this Directive constitutes a tangible step towards developing the social dimension of the internal market; Whereas the application in practice of the system of protection laid down by this Directive will require that Member States implement a system of effective and proportionate measures; Whereas the implementation of some provisions of this Directive poses particular problems for one Member State with regard to its system of protection for young people at work; whereas that Member State should therefore be allowed to refrain from implementing the relevant provisions for a suitable period, SECTION I Article 1 Purpose 1. Member States shall take the necessary measures to prohibit work by children. They shall ensure, under the conditions laid down by this Directive, that the minimum working or employment age is not lower than the minimum age at which compulsory full-time schooling as imposed by national law ends or 15 years in any event. 2. Member States ensure that work by adolescents is strictly regulated and protected under the conditions laid down in this Directive. 3. Member States shall ensure in general that employers guarantee that young people have working conditions which suit their age. They shall ensure that young people are protected against economic exploitation and against any work likely to harm their safety, health or physical, mental, moral or social development or to jeopardize their education. Article 2 Scope 1. This Directive shall apply to any person under 18 years of age having an employment contract or an employment relationship defined by the law in force in a Member State and/or governed by the law in force in a Member State. 2. Member States may make legislative or regulatory provision for this Directive not to apply, within the limits and under the conditions which they set by legislative or regulatory provision, to occasional work or short-term work involving: (a) domestic service in a privat household, or (b) work regarded as not being harmful, damaging or dangerous to young people in a family undertaking. Article 3 Definitons For the purposes of this Directive: (a) ‘young person’ shall mean any person under 18 years of age referred to in Article 2 (1); (b) ‘child’ shall mean any young person of less than 15 years of age or who is still subject to compulsory full-time schooling under national law; (c) ‘adolescent’ shall mean any young person of at least 15 years of age but less than 18 years of age who is no longer subject to compulsory full-time schooling under national law; (d) ‘light work’ shall mean all work which, on account of the inherent nature of the tasks which it involves and the particular conditions under which they are performed: (i) is not likely to be harmful to the safety, health or development of children, and (ii) is not such as to be harmful to their attendance at school, their participation in vocational guidance or training programmes approved by the competent authority or their capacity to benefit from the instruction received; (e) ‘working time’ shall mean any period during which the young person is at work, at the employer's disposal and carrying out his activity or duties in accordance with national legislation and/or practice; (f) ‘rest period’ shall mean any period which is not working time. Article 4 Prohibition of work by children 1. Member States shall adopt the measures necessary to prohibit work by children. 2. Taking into account the objectives set out in Article 1, Member States may make legislative or regulatory provision for the prohibition of work by children not to apply to: (a) children pursuing the activities set out in Article 5; (b) children of at least 14 years of age working under a combined work/training scheme or an in-plant work-experience scheme, provided that such work is done in accordance with the conditions laid down by the competent authority; (c) children of at least 14 years of age performing light work other than that covered by Article 5; light work other than that covered by Article 5 may, however, be performed by children of 13 years of age for a limited number of hours per week in the case of categories of work determined by national legislation. 3. Member States that make use of the opinion referred to in paragraph 2 (c) shall determine, subject to the provisions of this Directive, the working conditions relating to the light work in question. Article 5 Cultural or similar activities 1. The employment of children for the purposes of performance in cultural, artistic, sports or advertising activities shall be subject to prior authorization to be given by the competent authority in individual cases. 2. Member States shall by legislative or regulatory provision lay down the working conditions for children in the cases referred to in paragraph 1 and the details of the prior authorization procedure, on condition that the activities: (i) are not likely to be harmful to the safety, health or development of children, and (ii) are not such as to be harmful to their attendance at school, their participation in vocational guidance or training programmes approved by the competent authority or their capacity to benefit from the instruction received. 3. By way of derogation from the procedure laid down in paragraph 1, in the case of children of at least 13 years of age, Member States may authorize, by legislative or regulatory provision, in accordance with conditions which they shall determine, the employment of children for the purposes of performance in cultural, artistic, sports or advertising activities. 4. The Member States which have a specific authorization system for modelling agencies with regard to the activities of children may retain that system. SECTION II Article 6 General obligations on employers 1. Without prejudice to Article 4 (1), the employer shall adopt the measures necessary to protect the safety and health of young people, taking particular account of the specific risks referred to in Article 7 (1). 2. The employer shall implement the measures provided for in paragraph 1 on the basis of an assessment of the hazards to young people in connection with their work. The assessment must be made before young people begin work and when there is any major change in working conditions and must pay particular attention to the following points: (a) the fitting-out and layout of the workplace and the workstation; (b) the nature, degree and duration of exposure to physical, biological and chemical agents; (c) the form, range and use of work equipment, in particular agents, machines, apparatus and devices, and the way in which they are handled; (d) the arrangement of work processes and operations and the way in which these are combined (organization of work); (e) the level of training and instruction given to young people. Where this assessment shows that there is a risk to the safety, the physical or mental health or development of young people, an appropriate free assessment and monitoring of their health shall be provided at regular intervals without prejudice to Directive 89/391/EEC. The free health assessment and monitoring may form part of a national health system. 3. The employer shall inform young people of possible risks and of all measures adopted concerning their safety and health. Furthermore, he shall inform the legal representatives of children of possible risks and of all measures adopted concerning children's safety and health, 4. The employer shall involve the protective and preventive services referred to in Article 7 of Directive 89/391/EEC in the planning, implementation and monitoring of the safety and health conditions applicable to young people. Article 7 Vulnerability of young people — Prohibition of work 1. Member States shall ensure that young people are protected from any specific risks to their safety, health and development which are a consequence of their lack of experience, of absence of awareness of existing or potential risks or of the fact that young people have not yet fully matured. 2. Without prejudice to Article 4 (1), Member States shall to this end prohibit the employment of young people for: (a) work which is objectively beyond their phyiscal or psychological capacity; (b) work involving harmful exposure to agents which are toxic, carcinogenic, cause heritable genetic damage, or harm to the unborn child or which in any other way chronically affect human health; (c) work involving harmful exposure to radiation; (d) work involving the risk of accidents which it may be assumed cannot be recognized or avoided by young persons owing to their insufficient attention to safety or lack of experience or training; or (e) work in which there is a risk to health from extreme cold or heat, or from noise or vibration. Work which is likely to entail specific risks for young people within the meaning of paragraph 1 includes: — work involving harmful exposure to the physical, biological and chemical agents referred to in point I of the Annex, and — processes and work referred to in point II of the Annex. 3. Member States may, by legislative or regulatory provision, authorize derogations from paragraph 2 in the case of adolescents where such derogations are indispensable for their vocational training, provided that protection of their safety and health is ensured by the fact that the work is performed under the supervision of a competent person within the meaning of Article 7 of Directive 89/391/EEC and provided that the protection afforded by that Directive is guaranteed. SECTION III Article 8 Working time 1. Member States which make use of the option in Article 4 (2) (b) or (c) shall adopt the measures necessary to limit the working time of children to: (a) eight hours a day and 40 hours a week for work performed under a combined work/training scheme or an in-plant work-experience scheme; (b) two hours on a school day and 12 hours a week for work performed in term-time outside the hours fixed for school attendance, provided that this is not prohibited by national legislation and/or practice; in no circumstances may the daily working time exceed seven hours; this limit may be raised to eight hours in the case of children who have reached the age of 15; (c) seven hours a day and 35 hours a week for work performed during a period of at least a week when school is not operating; these limits may be raised to eight hours a day and 40 hours a week in the case of chidren who have reached the age of 15; (d) seven hours a day and 35 hours a week for light work performed by children no longer subject to compulsory full-time schooling under national law. 2. Member States shall adopt the measures necessary to limit the working time of adolescents to eight hours a day and 40 hours a week. 3. The time spent on training by a young person working under a theoretical and/or practical combined work/training scheme or an in-plant work-experience scheme shall be counted as working time. 4. Where a young person is employed by more than one employer, working days and working time shall be cumulative. 5. Member States may, by legislative or regulatory provision, authorize derogations from paragraph 1 (a) and paragraph 2 either by way of exception or where there are objective grounds for so doing. Member States shall, by legislative or regulatory provision, determine the conditions, limits and procedure for implementing such derogations. Article 9 Night work 1. (a) Member States which make use of the option in Article 4 (2) (b) or (c) shall adopt the measures necessary to prohibit work by children between 8 p.m. and 6 a.m. (b) Member States shall adopt the measures necessary to prohibit work by adolescents either between 10 p.m. and 6 a.m. or between 11 p.m. and 7 a.m. 2. (a) Member States may, by legislative or regulatory provision, authorize work by adolescents in specific areas of activity during the period in which night work is prohibited as referred to in paragraph 1 (b). In that event, Member States shall take appropriate measures to ensure that the adolescent is supervised by an adult where such supervision is necessary for the adolescent's protection. (b) If point (a) is applied, work shall continue to be prohibited between midnight and 4 a.m. However, Member States may, by legislative or regulatory provision, authorize work by adolescents during the period in which night work is prohibited in the following cases, where there are objective grounds for so doing and provided that adolescents are allowed suitable compensatory rest time and that the objectives set out in Article 1 are not called into question: — work performed in the shipping or fisheries sectors; — work performed in the context of the armed forces or the police; — work performed in hospitals or similar establishments; — cultural, artistic, sports or advertising activities. 3. Prior to any assignment to night work and at regular intervals thereafter, adolescents shall be entitled to a free assessment of their health and capacities, unless the work they do during the period during which work is prohibited is of an exceptional nature. Article 10 Rest period 1. (a) Member States which make use of the option in Article 4 (2) (b) or (c) shall adopt the measures necessary to ensure that, for each 24-hour period, children are entitled to a minimum rest period of 14 consecutive hours. (b) Member States shall adopt the measures necessary to ensure that, for each 24-hour period, adolescents are entitled to a minimum rest period of 12 consecutive hours. 2. Member States shall adopt the measures necessary to ensure that, for each seven-day period: — children in respect of whom they have made use of the option in Article 4 (2) (b) or (c), and — adolescents are entitled to a minimum rest period of two days, which shall be consecutive if possible. Where justified by technical or organization reasons, the minimum rest period may be reduced, but may in no circumstances be less than 36 consecutive hours. The minimum rest period referred to in the first and second subparagraphs shall in principle include Sunday. 3. Member States may, by legislative or regulatory provision, provide for the minimum rest periods referred to in pargraphs 1 and 2 to be interrupted in the case of activities involving periods of work that are split up over the day or are of short duration. 4. Member States may make legislative or regulatory provision for derogations from paragraph 1 (b) and paragraph 2 in respect of adolescents in the following cases, where there are objective grounds for so doing and provided that they are granted appropriate compensatory rest time and that the objetives set out in Article 1 are not called into question: (a) work performed in the shipping or fisheries sectors; (b) work performed in the context of the armed forces or the police; (c) work performed in hospitals or similar establishments; (d) work performed in agriculture; (e) work performed in the tourism industry or in the hotel, restaurant and cafe sector; (f) activities involving periods of work split up over the day. Article 11 Annual rest Member States which make use of the option referred to in Article 4 (2) (b) or (c) shall see to it that a period free of any work is included, as far as possible, in the school holidays of children subject to compulsory full-time schooling under national law. Article 12 Breaks Member States shall adopt the measures necessary to ensure that, where daily working time is more than four and a half hours, young people are entitled to a break of at least 30 minutes, which shall be consecutive if possible. Article 13 Work by adolescents in the event of force majeure Member States may, by legislative or regulatory provision, authorize derogations from Article 8 (2), Article 9 (1) (b), Article 10 (1) (b) and, in the case of adolescents, Article 12, for work in the circumstances referred to in Article 5 (4) of Directive 89/391/EEC, provided that such work is of a temporary nature and must be performed immediately, that adult workers are not available and that the adolescents are allowed equivalent compensatory rest time within the following three weeks. SECTION IV Article 14 Measures Each Member State shall lay down any necessary measures to be applied in the event of failure to comply with the provisions adopted in order to implement this Directive; such measures must be effective and proportionate. Article 15 Adaptation of the Annex Adaptations of a strictly technical nature to the Annex in the light of technical progress, changes in international rules or specifications and advances in knowledge in the field covered by this Directive shall be adopted in accordance with the procedure provided for in Article 17 of Directive 89/391/EEC. Article 16 Non-reducing clause Without prejudice to the right of Member States to develop, in the light of changing circumstances, different provisions on the protection of young people, as long as the minimum requirements provided for by this Directive are complied with, the implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to young people. Article 17 Final provisions 1. (a) Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 22 June 1996 or ensure, by that date at the latest, that the two sides of industry introduce the requisite provisions by means of collective agreements, with Member States being required to make all the necessary provisions to enable them at all times to guarantee the results laid down by this Directive. (b) The United Kingdom may refrain from implementing the first subparagraph of Article 8 (1) (b) with regard to the provision relating to the maximum weekly working time, and also Article 8(2) and Article 9 (1) (b) and (2) for a period of four years from the date specified in subparagraph (a). The Commission shall submit a report on the effects of this provision. The Council, acting in accordance with the conditions laid down by the Treaty, shall decide whether this period should be extended. (c) Member States shall forthwith inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, such measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they have already adopted or adopt in the field governed by this Directive. 4. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the viewpoints of the two sides of industry. The Commission shall inform the European Parliament, the Council and the Economic and Social Committee thereof. 5. The Commission shall periodically submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of this Directive taking into account pargraphs 1, 2, 3 and 4. Article 18 This Directive is addressed to the Member States.

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1994

Council Directive 94/30/EC of 23 June 1994 amending Annex II to Directive 90/642/EEC relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables and providing for the establishment of a list of maximum levels Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (1), and in particular Article 1 thereof, Having regard to the proposal from the Commission, Whereas the Commission has received a mandate in the framework of Directive 90/642/EEC to prepare the list of pesticide residues and their maximum levels for approval by Council; Whereas pesticide residues may arise in products of plant origin, including fruit and vegetables as a result of agricultural practices; whereas, to establish maximum levels for the former, it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials; whereas, however, available data is frequently insufficient by current standards to estabish maximum levels; Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where possible, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable; Whereas, it is now appropriate that maximum levels be fixed for certain pesticides, namely, daminozide, lambda-cyhalothrin, propiconazole, carbofuran, carbosulfan, benfuracarb, furathiocarb, cyfluthrin, metalaxyl, benalaxyl, fenarimol and ethephon in products of plant origin; whereas, however, it is not possible to establish maximum pesticide residue levels for all pesticide residue product combinations due to insufficient data; Whereas, in cases of insufficient data availability a period of time should be allowed for the generation of the necessary data; whereas a period not exceeding four years would seem reasonable for this purpose; whereas, therefore, maximum levels should be established on the basis of such data by 30 June 1999 at the latest; whereas failure to provide satisfactory data normally results in the estabishment of levels at the appropriate limit of determination; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme established in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), Article 1 The following pesticide residues shall be added to Annex II to Directive 90/642/EEC: ID="1"> "" ID="1">1. Fruit, fresh, dried or uncooked preserved by freezing not containing added sugar; nuts"> ID="1">(i) CITRUS FRUIT> ID="2">0,02 (4)()> ID="3">(5)()> ID="4">0,05 (4)()"> ID="1">grapefruit"> ID="1">lemons"> ID="1">limes"> ID="1">mandarins (including clementines and similar hybrids)"> ID="1">oranges"> ID="1">pommelo"> ID="1">others"> ID="1">(ii) TREE NUTS (shelled or unshelled)> ID="2">0,05 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">almonds"> ID="1">brazil nuts"> ID="1">cashew nuts"> ID="1">chestnuts"> ID="1">coconuts"> ID="1">hazelnuts"> ID="1">macadamia"> ID="1">pecans"> ID="1">pine nuts"> ID="1">pistachios"> ID="1">walnuts"> ID="1">others"> ID="1">(iii) POME FRUIT> ID="3">0,1> ID="4">0,05 (4)()"> ID="1">apples> ID="2">0,02 (4)() (×)"> ID="1">pears"> ID="1">quinces"> ID="1">others> ID="2">0,02 (4)()"> ID="1">(iv) STONE FRUIT> ID="2">0,02 (4)()"> ID="1">apricots> ID="3">0,2> ID="4">0,2"> ID="1">cherries> ID="4">(6)()"> ID="1">peaches (including nectarines and similar hybrids)> ID="3">0,2> ID="4">0,2"> ID="1">plums> ID="4">(6)()"> ID="1">others> ID="3">0,1> ID="4">0,05 (4)()"> ID="1">(v) BERRIES AND SMALL FRUITS> ID="2">0,02 (4)()"> ID="1">(a) table and wine grapes> ID="3">0,2> ID="4">0,5"> ID="1">table grapes"> ID="1">wine grapes"> ID="1">(b) strawberries (other than wild)> ID="3">(5)()> ID="4">0,05 (4)()"> ID="1">(c) cane fruit (other than wild):> ID="3">0,02> ID="4">0,05 (4)()"> ID="1">blackberries"> ID="1">dewberries"> ID="1">loganberries"> ID="1">raspberries"> ID="1">others"> ID="1">(d) other small fruit and berries (other than wild)> ID="4">0,05"> ID="1">bilberries (fruits of species vaccinium myrtyllus)"> ID="1">cranberries"> ID="1">currants (red, black and white)> ID="3">0,1"> ID="1">gooseberries> ID="3">0,1"> ID="1">others> ID="3">0,02 (4)()"> ID="1">(e) wild berries and wild fruit> ID="3">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">(vi) MISCELLANEOUS> ID="2">0,02 (4)()> ID="3">0,02 (4)()"> ID="1">avocados"> ID="1">bananas"> ID="1">dates"> ID="1">figs"> ID="1">kiwi"> ID="1">kumquats"> ID="1">litchis"> ID="1">mangoes"> ID="1">olives"> ID="1">passion fruit"> ID="1">pineapples"> ID="1">pomegranate"> ID="1">others> ID="4">0,05 (4)()"> ID="1">2. Vegetables, fresh or uncooked, frozen or dry"> ID="1">(i) ROOT AND TUBER VEGETABLES> ID="2">0,02 (4)()> ID="3">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">Beetroot"> ID="1">carrots"> ID="1">celeriac"> ID="1">horseradish"> ID="1">jerusalem artichokes"> ID="1">parsnip"> ID="1">parsley root"> ID="1">radishes"> ID="1">salsify"> ID="1">sweet potatoes"> ID="1">swedes"> ID="1">turnips"> ID="1">yam"> ID="1">others"> ID="1">(ii) BULB VEGETABLES> ID="2">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">garlic"> ID="1">onions"> ID="1">shallots"> ID="1">spring onions> ID="3">(5)()"> ID="1">others> ID="3">0,02 (4)()"> ID="1">(iii) FRUITING> ID="2">0,02 (4)()"> ID="1">(a) Solanacea> ID="3">(5)()"> ID="1">tomatoes"> ID="1">peppers"> ID="1">aubergines> ID="4">(6)()"> ID="1">others> ID="4">0,05 (4)()"> ID="1">(b) cucurbits - edible peel> ID="3">0,1> ID="4">(6)()"> ID="1">cucumbers"> ID="1">gherkins"> ID="1">courgettes"> ID="1">others"> ID="1">(c) cucurbits - inedible peel> ID="3">(5)()> ID="4">(6)()"> ID="1">melons"> ID="1">squashes"> ID="1">watermelons"> ID="1">others"> ID="1">(d) sweet corn> ID="3">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">(iv) BRASSICA VEGETABLES> ID="2">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">(a) flowering brassicas> ID="3">(5)()"> ID="1">broccoli"> ID="1">cauliflower"> ID="1">others"> ID="1">(b) head brassicas"> ID="1">brussels sprouts> ID="3">0,05 "> ID="1">head cabbage> ID="3">0,2"> ID="1">others> ID="3">0,02 (4)()"> ID="1">(c) leafy brassicas> ID="3">(5)()"> ID="1">chinese cabbage"> ID="1">kale"> ID="1">others"> ID="1">(d) kohlrabi> ID="3">(5)()"> ID="1">(v) LEAF VEGETABLES AND FRESH HERBS> ID="2">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">(a) lettuce and similar> ID="3">1"> ID="1">cress"> ID="1">lamb's lettuce"> ID="1">lettuce"> ID="1">scarole"> ID="1">others"> ID="1">(b) spinach and similar> ID="3">(5)()"> ID="1">beet leaves (chard)"> ID="1">(c) watercress> ID="3">0,02 (4)()"> ID="1">(d) witloof> ID="3">(5)()"> ID="1">(e) herbs> ID="3">1"> ID="1">chervil"> ID="1">chives"> ID="1">parsley"> ID="1">celery leaves"> ID="1">others"> ID="1">(vi) LEGUME VEGETABLES (fresh)> ID="2">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">beans (with pods)> ID="3">0,2"> ID="1">beans (without pods)"> ID="1">peas (with pods)> ID="3">0,2"> ID="1">peas (without pods)> ID="3">0,2"> ID="1">others> ID="3">0,02 (4)()"> ID="1">(vii) STEM VEGETABLES> ID="2">0,02 (4)()"> ID="1">asparagus> ID="3">0,02 (4)()"> ID="1">cardoons> ID="4">(6)()"> ID="1">celery"> ID="1">fennel> ID="4">(6)()"> ID="1">globe artichokes"> ID="1">leek"> ID="1">rhubarb"> ID="1">others> ID="3">(5)()> ID="4">0,05 (4)()"> ID="1">(viii) FUNGI> ID="2">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">cultivated mushrooms> ID="3">(5)()"> ID="1">wild mushrooms> ID="3">0,02 (4)()"> ID="1">3. Pulses> ID="2">0,02 (4)()> ID="3">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">beans"> ID="1">lentils"> ID="1">peas"> ID="1">others"> ID="1">4. Oil seeds> ID="2">0,05 (4)()> ID="3">0,02"> ID="1">linseed> ID="4">(6)()"> ID="1">peanuts"> ID="1">poppy seed"> ID="1">sesame seed"> ID="1">sunflower seed (with shell)"> ID="1">rape seed"> ID="1">soya bean"> ID="1">mustard"> ID="1">cotton seed"> ID="1">others> ID="4">0,05 (4)()"> ID="1">5. Potatoes> ID="2">0,02 (4)()> ID="3">0,02 (4)()> ID="4">0,05 (4)()"> ID="1">early and ware"> ID="1">potatoes"> ID="1">6. Tea (black tea processed from the leaves of camellia sinensis)> ID="2">0,1 (4)()> ID="3">1> ID="4">0,1 (4)()"> ID="1">7. Hops (dried), including hop pellets and unconcentrated powder> ID="2">0,1 (4)()> ID="3">10> ID="4">0,1 (4)()"> "" ID="1">1. Fruit, fresh, dried or uncooked, preserved by freezing not containing added sugar; nuts"> ID="1">(i) CITRUS FRUIT> ID="2">(7)()> ID="3">(6)()> ID="4">(6)()> ID="5">0,05 (4)()"> ID="1">grapefruit"> ID="1">lemons"> ID="1">limes"> ID="1">mandarins (including clementines and similar hybrids)"> ID="1">oranges"> ID="1">pommelo"> ID="1">others"> ID="1">(ii) TREE NUTS (shelled or unshelled)> ID="3">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">almonds"> ID="1">brazil nuts"> ID="1">cashew nuts"> ID="1">chestnuts"> ID="1">coconuts"> ID="1">hazelnuts> ID="2">(7)()> ID="4">(6)()"> ID="1">macadamia"> ID="1">pecans"> ID="1">pine nuts"> ID="1">pistachios"> ID="1">walnuts"> ID="1">others> ID="2">0,1 (4)()> ID="4">0,05 (4)()"> ID="1">(iii) POME FRUIT> ID="2">(7)()> ID="3">(6)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">apples"> ID="1">pears"> ID="1">quinces"> ID="1">others"> ID="1">(iv) STONE FRUIT> ID="2">(7)()> ID="3">(6)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">apricots"> ID="1">cherries"> ID="1">peaches (including nectarines and similar hybrids)"> ID="1">plums"> ID="1">others"> ID="1">(v) BERRIES AND SMALL FRUIT> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">(a) Table and wine grapes> ID="2">0,01 (4)()"> ID="1">table grapes"> ID="1">wine grapes"> ID="1">(b) strawberries (other than wild)> ID="2">(7)()"> ID="1">(c) cane fruit (other than wild)> ID="2">0,1 (4)()"> ID="1">blackberries"> ID="1">dewberries"> ID="1">loganberries"> ID="1">raspberries"> ID="1">others"> ID="1">(d) other small fruit and berries (other than wild)> ID="2">0,1 (4)()"> ID="1">bilberries (fruit of species"> ID="1">vaccinium myrtyllus)"> ID="1">cranberries"> ID="1">currants (red, black and white)"> ID="1">gooseberries (cynorrhodon)"> ID="1">others"> ID="1">(e) wild berries and wild fruit> ID="2">0,1 (4)()"> ID="1">(vi) MISCELLANEOUS> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">avocados"> ID="1">bananas"> ID="1">dates"> ID="1">figs"> ID="1">kiwi"> ID="1">kumquats"> ID="1">litchis"> ID="1">mangoes"> ID="1">olives (table consumption)"> ID="1">olives (oil extraction)"> ID="1">passion fruit"> ID="1">pineapples"> ID="1">pomegranate"> ID="1">others"> ID="1">2. Vegetables, fresh or uncooked, frozen or dry"> ID="1">(i) ROOT AND TUBER VEGETABLES> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">beetroot"> ID="1">carrots> ID="2">0,3> ID="3">0,1"> ID="1">celeriac> ID="2">(7)()"> ID="1">horseradish"> ID="1">jerusalem artichokes"> ID="1">parsnip> ID="2">0,3> ID="3">0,1"> ID="1">parsley root"> ID="1">radishes> ID="2">0,5"> ID="1">salsify"> ID="1">sweet potatoes"> ID="1">swedes> ID="2">(7)()> ID="3">(6)()"> ID="1">turnips> ID="2">(7)()> ID="3">(6)()"> ID="1">yam"> ID="1">others> ID="2">0,1 (4)()> ID="3">0,05 (4)()"> ID="1">(ii) BULB VEGETABLES> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">garlic> ID="2">0,3"> ID="1">onions> ID="2">0,3> ID="3">(6)()"> ID="1">shallots> ID="2">0,3"> ID="1">spring onions"> ID="1">others> ID="2">0,1 (4)()> ID="3">0,05 (4)()"> ID="1">(iii) FRUITING"> ID="1">(a) Solanacea> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">tomatoes"> ID="1">peppers"> ID="1">aubergines"> ID="1">others"> ID="1">(b) cucurbits - edible peel> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">cucumbers"> ID="1">gherkins"> ID="1">courgettes"> ID="1">others"> ID="1">(c) cucurbits - inedible peel> ID="3">(6)()> ID="4">(6)()> ID="5">0,05 (4)()"> ID="1">melons> ID="2">(7)()"> ID="1">squashes"> ID="1">watermelons"> ID="1">others> ID="2">0,1 (4)()"> ID="1">(d) sweet corn> ID="2">(7)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">(iv) BRASSICA"> ID="1">(a) flowering brassicas> ID="2">0,2> ID="3">(6)()> ID="4">(6)()> ID="5">0,1"> ID="1">broccoli"> ID="1">cauliflower"> ID="1">others"> ID="1">(b) head brassicas> ID="2">(7)()> ID="3">(6)()> ID="4">(6)()> ID="5">0,05"> ID="1">brussels sprouts"> ID="1">head cabbage"> ID="1">others"> ID="1">(c) leafy brassicas> ID="2">(7)()> ID="3">(6)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">chinese cabbage"> ID="1">kale"> ID="1">others"> ID="1">(d) kohlrabi> ID="2">0,2> ID="3">(6)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">(v) LEAF VEGETABLES AND FRESH HERBS> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">(a) lettuce and similar"> ID="1">cress"> ID="1">lamb's lettuce"> ID="1">lettuce"> ID="1">scarole"> ID="1">others"> ID="1">(b) spinach and similar"> ID="1">beet leaves (chard)"> ID="1">(c) watercress"> ID="1">(d) witloof"> ID="1">(e) herbs"> ID="1">chervil"> ID="1">chives"> ID="1">parsley"> ID="1">celery leaves"> ID="1">others"> ID="1">(vi) LEGUME VEGETABLES (fresh)> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">beans (with pods)> ID="2">(7)()> ID="5">(6)()"> ID="1">beans (without pods)> ID="2">(7)()> ID="5">(6)()"> ID="1">peas (with pods)"> ID="1">peas (without pods)"> ID="1">others> ID="2">0,1 (4)()> ID="5">0,05 (4)()"> ID="1">(vii) STEM VEGETABLES> ID="4">0,05 (4)()"> ID="1">asparagus"> ID="1">cardoons"> ID="1">celery> ID="2">(7)()> ID="3">(6)()> ID="5">(6)()"> ID="1">fennel"> ID="1">globe artichokes"> ID="1">leek> ID="2">(7)()> ID="3">(6)()"> ID="1">rhubarb"> ID="1">others> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">(viii) FUNGI> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">cultivates mushrooms"> ID="1">wild mushrooms"> ID="1">3. Pulses> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">beans> ID="2">(7)()> ID="5">(6)()"> ID="1">lentils"> ID="1">peas"> ID="1">others> ID="2">0,1 (4)()> ID="5">0,05 (4)()"> ID="1">4. Oil seeds> ID="3">0,05 (4)()"> ID="1">linseed> ID="2">(7)()"> ID="1">peanuts> ID="2">(7)()"> ID="1">poppy seed"> ID="1">sesame seed> ID="2">(7)()"> ID="1">sunflower seed> ID="2">(7)()> ID="3">(6)()"> ID="1">rape seed> ID="2">(7)()> ID="3">(6)()> ID="5">(6)()"> ID="1">soya bean> ID="2">(7)()> ID="5">(6)()"> ID="1">mustard"> ID="1">cotton seed> ID="2">(7)()> ID="3">(6)()> ID="4">(6)()> ID="5">(6)()"> ID="1">others> ID="2">0,1 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">5. Potatoes> ID="2">(7)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,05 (4)()"> ID="1">Early and ware potatoes"> ID="1">6. Tea (black tea processed from the leaves of camellia sinensis)> ID="2">0,2 (4)()> ID="3">0,1 (4)()> ID="4">0,1 (4)()> ID="5">0,1 (4)()"> ID="1">7. Hops (dried), including hop pellets and unconcentrated powder> ID="2">10> ID="3">(6)()> ID="4">5> ID="5">5"> "" ID="1">1. Fruit, fresh, dried or uncooked, preserved by freezing not containing added sugar; nuts"> ID="1">(i) CITRUS FRUIT> ID="2">0,02 (4)()> ID="3">(6)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">(6)()"> ID="1">grapefruit"> ID="1">lemons"> ID="1">limes"> ID="1">mandarins (including clementines and similar hybrids)"> ID="1">oranges"> ID="1">pommelo"> ID="1">others"> ID="1">(ii) TREE NUTS (shelled or unshelled)> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">0,1 (4)()"> ID="1">almonds"> ID="1">brazil nuts"> ID="1">cashew nuts"> ID="1">chestnuts"> ID="1">coconuts"> ID="1">hazelnuts"> ID="1">macadamia"> ID="1">pecans"> ID="1">pine nuts"> ID="1">pistachios"> ID="1">walnuts"> ID="1">others"> ID="1">(iii) POME FRUIT> ID="2">0,2> ID="3">1> ID="4">0,05 (4)()> ID="5">0,3> ID="6">3"> ID="1">apples"> ID="1">pears"> ID="1">quinces"> ID="1">others"> ID="1">(iv) STONE FRUIT> ID="4">0,05 (4)()> ID="5">(5)()"> ID="1">apricots"> ID="1">cherries> ID="2">0,2> ID="3">(6)()> ID="6">3"> ID="1">peaches (including nectarines and similar hybrids)> ID="3">(6)()"> ID="1">plums> ID="2">0,2"> ID="1">others> ID="2">(5)()> ID="3">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">(v) BERRIES AND SMALL FRUIT"> ID="1">(a) table and wine grapes> ID="2">0,3> ID="4">0,2> ID="5">0,3> ID="6">(6)()"> ID="1">table grapes> ID="3">2"> ID="1">wine grapes> ID="3">1"> ID="1">(b) strawberries (other than wild)> ID="2">(5)()> ID="3">0,5> ID="4">0,05 (4)()> ID="5">0,3> ID="6">0,05 (4)()"> ID="1">(c) cane fruit (other than wild)> ID="2">0,02 (4)()> ID="3">(6)()> ID="4">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">blackberries"> ID="1">dewberries"> ID="1">loganberries"> ID="1">raspberries> ID="5">(5)()"> ID="1">others> ID="5">0,02 (4)()"> ID="1">(d) other small fruit and berries (other than wild)> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">bilberries (fruit of species vaccinium myrtyllus)"> ID="1">cranberries"> ID="1">currants (red, black and white)> ID="2">(5)()> ID="5">1> ID="6">5"> ID="1">gooseberries> ID="2">(5)()> ID="5">1"> ID="1">others> ID="2">0,02 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">(e) wild berries and wild fruit> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">(vi) MISCELLANEOUS> ID="2">0,02 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()"> ID="1">avocados> ID="3">(6)()"> ID="1">bananas"> ID="1">dates"> ID="1">figs> ID="6">(6)()"> ID="1">kiwi> ID="3">(6)()"> ID="1">kumquats"> ID="1">litchis"> ID="1">mangoes"> ID="1">olives (table consumption)> ID="6">(6)()"> ID="1">olives (oil extraction)> ID="6">(6)()"> ID="1">passion fruit"> ID="1">pineapples> ID="6">(6)()"> ID="1">pomegranate"> ID="1">others> ID="3">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">2. Vegetables, fresh or uncooked, frozen or dry"> ID="1">(i) ROOT AND TUBER VEGETABLES> ID="2">0,02 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">beetroot"> ID="1">carrots> ID="3">0,1"> ID="1">celeriac"> ID="1">horseradish"> ID="1">jerusalem artichokes"> ID="1">parsnip> ID="3">0,1"> ID="1">parsley root"> ID="1">radishes"> ID="1">salsify> ID="4">(6)()"> ID="1">sweet potatoes"> ID="1">swedes"> ID="1">turnips"> ID="1">yam"> ID="1">others> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">(ii) BULB VEGETABLES> ID="2">0,02 (4)()> ID="3">(6)()> ID="5">0,02 (4)()"> ID="1">garlic"> ID="1">onions> ID="4">0,2> ID="6">(6)()"> ID="1">shallots"> ID="1">spring onions"> ID="1">others> ID="4">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">(iii) FRUITING"> ID="1">(a) solanacea> ID="5">(5)()"> ID="1">tomatoes> ID="2">0,05 (4)()> ID="3">(6)()> ID="4">0,2> ID="6">3"> ID="1">peppers> ID="2">(5)()> ID="3">(6)()> ID="4">0,2> ID="6">3"> ID="1">aubergines"> ID="1">others> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">(b) cucurbits - edible peel> ID="2">(5)()> ID="3">(6)()> ID="4">0,05 (4)()> ID="5">(5)()> ID="6">0,05 (4)()"> ID="1">cucumbers"> ID="1">gherkins"> ID="1">courgettes"> ID="1">others"> ID="1">(c) cucurbits - inedible peel> ID="2">0,02 (4)()> ID="5">(5)()> ID="6">0,05 (4)()"> ID="1">melons> ID="3">(6)()> ID="4">(6)()"> ID="1">squashes"> ID="1">watermelons> ID="3">(6)()> ID="4">(6)()"> ID="1">others> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">(d) sweet corn> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">(6)()"> ID="1">(iv) BRASSICA VEGETABLES> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">(a) flowering brassicas> ID="3">(6)()"> ID="1">broccoli> ID="2">(5)()"> ID="1">cauliflower> ID="2">0,05"> ID="1">others> ID="2">0,02 (4)()"> ID="1">(b) head brassicas> ID="2">0,2"> ID="1">brussels sprouts"> ID="1">head cabbage> ID="3">1"> ID="1">others> ID="3">0,05 (4)()"> ID="1">(c) leafy brassicas> ID="2">(5)()"> ID="1">chinese cabbage> ID="3">(6)()"> ID="1">kale> ID="3">(6)()"> ID="1">others> ID="3">0,05 (4)()"> ID="1">(d) kohlrabi> ID="2">0,02 (4)()> ID="3">0,05 (4)()"> ID="1">(v) LEAF VEGETABLES AND FRESH HERBS> ID="4">0,02 (4)()> ID="5">0,05 (4)()"> ID="1">(a) lettuce and similar> ID="2">0,5> ID="3">(6)()"> ID="1">cress"> ID="1">lamb's lettuce"> ID="1">lettuce> ID="4">(6)()"> ID="1">scarole"> ID="1">others> ID="4">0,05 (4)()"> ID="1">(b) spinach and similar> ID="2">0,02 (4)()> ID="3">(6)()> ID="4">0,05 (4)()"> ID="1">beet leaves (chard)"> ID="1">(c) watercress> ID="2">0,02 (4)()> ID="3">(6)()> ID="4">0,05 (4)()"> ID="1">(d) witloof> ID="2">0,02 (4)()> ID="3">(6)()> ID="4">0,05 (4)()"> ID="1">(e) herbs> ID="2">0,02 (4)()> ID="3">(6)()> ID="4">0,05 (4)()"> ID="1">chervil"> ID="1">chives"> ID="1">parsley"> ID="1">celery leaves"> ID="1">others"> ID="1">(vi) LEGUME VEGETABLES (fresh)> ID="2">0,05> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">beans (with pods)"> ID="1">beans (without pods)"> ID="1">peas (with pods)> ID="5">(5)()"> ID="1">peas (without pods)> ID="5">(5)()"> ID="1">others> ID="5">0,02 (4)()"> ID="1">(vii) STEM VEGETABLES> ID="4">0,05 (4)()> ID="6">0,05 (4)()"> ID="1">Asparagus"> ID="1">cardoons"> ID="1">celery"> ID="1">fennel"> ID="1">globe artichokes> ID="3">(6)()> ID="5">(5)()"> ID="1">leek> ID="2">(5)()> ID="3">(6)()"> ID="1">rhubarb"> ID="1">others> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="5">0,02 (4)()"> ID="1">(viii) FUNGI> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">cultivated mushrooms"> ID="1">wild mushrooms"> ID="1">3. Pulses> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">beans"> ID="1">lentils"> ID="1">peas"> ID="1">others"> ID="1">4. Oil seeds> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">linseed> ID="3">(6)()"> ID="1">peanuts"> ID="1">poppy seed"> ID="1">sesame seed"> ID="1">sunflower seed"> ID="1">rape seed> ID="2">0,05> ID="4">(6)()"> ID="1">soya bean> ID="4">(6)()"> ID="1">mustard"> ID="1">cotton seed"> ID="1">others> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()"> ID="1">5. Potatoes> ID="2">0,02 (4)()> ID="3">0,05 (4)()> ID="4">0,05 (4)()> ID="5">0,02 (4)()> ID="6">0,05 (4)()"> ID="1">early and ware potatoes"> ID="1">6. Tea (black tea processed from the leaves of camellia sinensis)> ID="2">(7)()> ID="3">0,1 (4)()> ID="4">0,1 (4)()> ID="5">0,05 (4)()> ID="6">0,1 (4)()"> ID="1">7. Hops (dried), including hop pellets and unconcentrated powder> ID="2">20> ID="3">10> ID="4">0,1 (4)()> ID="5">5> ID="6">0,1 (4)()"> > " Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1995. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31994L0029

1994

Council Directive 94/29/EC of 23 June 1994 amending the Annexes to Directives 86/362/EEC and 86/363/EEC on the fixing of maximum levels for pesticide residues in and on cereals and foodstuffs of animal origin respectively Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 11 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 11 thereof, Having regard to the proposal from the Commission, Whereas the Commission has received a mandate in the framework of Directives 86/362/EEC and 86/363/EEC to prepare the list of pesticide residues and their maximum levels for approval by the Council; Whereas, in the light of technical and scientific progress and the requirements of public health and agriculture, it is now desirable to amend Annex II to the abovementioned Directives by adding provisions relating to further pesticide residues for cereals and foodstuffs of animal origin, namely, daminozide, lambda-cyhalothrin, ethephon, propiconazole, carbofuran, carbosulfan, benfuracarb, furathiocarb, cyfluthrin, metalaxyl, benalaxyl and fenarimol; Whereas, however, available data are insufficient for certain pesticide-cereal/foodstuffs of animal origin combinations as appropriate; whereas a period of time, not exceeding four years, will be necessary to generate such data; whereas, therefore, maximum levels should be established on the basis of such data by 30 June 1999 at the latest; whereas failure to provide satisfactory data should normally result in the establishment of levels at the appropriate limit of determination; Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where possible, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable; Whereas the maximum residue levels established in the current Directive will have to be reviewed in the framework of the re-evaluations of active substances provided for in the work programme established in Annex 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), Article 1 The following pesticide residues shall be added to Part A of Annex II to Directive 86/362/EEC: "" ID="1">42. CYFLUTHRIN, including other mixed isomeric constituents (sum of isomers)> ID="2">0,05 (4)():> ID="3">maize"> ID="2">0,02 (4)():> ID="3">other cereals"> ID="1">43. METALAXYL> ID="2">0,05 (4)()"> ID="1">44. BENALAXYL> ID="2">0,05 (4)()"> ID="1">45. FENARIMOL> ID="2">(5)():> ID="3">wheat, barley"> ID="2">0,02 (4)():> ID="3">other cereals"> ID="1">46. PROPICONAZOLE> ID="2">0,05 (4)()"> ID="1">47. DAMINOZIDE, (sum of daminozide and 1,1-dimethylhydrazine expressed as daminozide)> ID="2">0,02 (4)()"> ID="1">48. LAMBDA-CYHALOTHRIN> ID="2">0,05:> ID="3">barley"> ID="2">0,02 (4)():> ID="3">other cereals"> ID="1">49. ETHEPHON> ID="2">(6)():> ID="3">maize"> ID="2">0,2:> ID="3">wheat and triticale"> ID="2">0,5:> ID="3">barley and rye"> ID="2">0,05 (4)():> ID="3">other cereals"> ID="1">50. CARBOFURAN (sum of carbofuran and 3-hydroxy-carbofuran expressed as carbofuran)> ID="2">(7)():> ID="3">rice and oats"> ID="2">0,1 (4)():> ID="3">other cereals"> ID="1">51. CARBOSULFAN> ID="2">0,05 (4)()"> ID="1">52. BENFURACARB> ID="2">(6)():> ID="3">maize"> ID="2">0,05 (4)():> ID="3">other cereals"> ID="1">53. FURATHIOCARB> ID="2">0,05 (4)() ""> Article 2 1. The following pesticide residues shall be added to Part A of Annex II to Directive 86/363/EEC: >(9) (12)(10)(12)(11) (12)"> ID="1">15. CYFLUTHRIN, including other mixed isomeric constituents (sum of isomers)> ID="2">0,05> ID="3">0,02 (8)()> ID="4">0,02 (8)()"> ID="1">16. LAMBDA-CYHALOTHRIN, including other mixed isomeric constituents (sum of isomers)> ID="2">0,5 (except 0207 poultrymeat) 0,02 (8)() (0207 poultrymeat)> ID="3">0,05> ID="4">0,02 (8)()"" > 2. The following pesticide residues shall be added in Part B of Annex II to Directive 86/363/EEC: "" ID="1">17. FENARIMOL> ID="2">Ex 0208 (14)() liver + kidney 0,02 (13)() other products> ID="3">0,02 (13)()> ID="4">0,02 (13)()"> ID="1">18. METALAXYL> ID="2">0,5 (13)()> ID="3">0,05 (13)()> ID="4">0,05 (13)()"> ID="1">19. BENALAXYL> ID="2">0,5 (13)()> ID="3">0,05 (13)()> ID="4">0,05 (13)()"> ID="1">20. DAMINOZIDE> ID="2">0,05> ID="3">0,05 (13)()> ID="4">0,05 (13)()"> ID="1">(sum of daminozide and 1,1-dimethylhydrazine expressed as daminozide)"> ID="1">21. ETHEPHON> ID="2">0,05 (13)()> ID="3">0,05 (13)()> ID="4">0,05 (13)()"> ID="1">22. PROPICONAZOLE> ID="2">Ex 0206 0,1 ruminant liver 0,05 (13)() other products> ID="3">0,1 (13)()> ID="4">0,05 (13)()"> ID="1">23. CARBOFURAN> ID="2">0,1 (13)()> ID="3">0,1 (13)()> ID="4">0,1 (13)()"> ID="1">(sum of carbofuran and 3-hydroxy-carbofuran expressed as carbofuran)"> ID="1">24. CARBOSULFAN> ID="2">0,5 (13)()> ID="3">0,05 (13)()> ID="4">0,05 (13)()"> ID="1">25. BENFURACARB> ID="2">0,5 (13)()> ID="3">0,05 (13)()> ID="4">0,05 (13)()"> ID="1">26. FURATHIOCARB> ID="2">0,5 (13)()> ID="3">0,05 (13)()> ID="4">0,05 (13)()"" > Article 3 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1995. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31994L0028

1994

Council Directive 94/28/EC of 23 June 1994 laying down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species Having regard to the Treaty establishing the European 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 rearing of pure-bred animals is generally part of normal farming activities; whereas they constitute a source of income for a proportion of the farming population; Whereas pure-bred animals, as live animals, are included in the list in Annex II to the Treaty; Whereas rules harmonized at Community level rating to the zootechnical and genealogical conditions governing intra-Community trade or the marketing of all animals, particularly the bovine, porcine, ovine and caprine species and equidae, have been drawn up; Whereas, in this context, the Council has adopted Directive 77/504/EEC of 25 July 1977 on pure-bred breeding animals of the bovine species (4), Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (5), Directive 89/361/EEC of 30 May 1989 concerning pure-bred sheep and goats (6), Directive 90/427/EEC of 26 June 1990 on the zootechnical and genealogical conditions governing intra-Community trade in equidae (7) and Directive 91/174/EEC of 25 March 1991 laying down zootechnical and pedigree requirements for the marketing of pure-bred animals (8); Whereas, in order especially to ensure rational development of the rearing of pure-bred livestock and thus increase productivity in this sector, principles should be laid down at Community level relating to the zootechnical and genealogical conditions applicable to the importation of these animals, their semen, ova and embryos from third countries; Whereas provision should be made for Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (9) and Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries (10) to apply to the animals and products referred to in this Directive; Whereas the Commission should be entrusted with the responsibility of adopting implementing measures in certain fields of a technical nature, Article 1 1. This Directive lays down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, semen, ova and embryos which are covered by Directives 77/504/EEC, 88/661/EEC, 89/361/EEC, 90/427/EEC and 91/174/EEC and by the Community decisions implementing these Directives. 2. This Directive shall apply without prejudice to the Community animal health rules applicable to imports from third countries of animals, their semen, ova and embryos as referred to in paragraph 1. 3. This Directive shall not affect: - the application of the rules on certain substances having a hormonal or thyrostatic action or on beta-agonists in stockfarming, - imports of animals, semen, ova and embryos referred to in paragraph 1 and intended for technical or scientific experiments carried out under the control of competent authorities. 4. Imports of animals, including those not covered by paragraph 1, referred to in paragraph 1, of ova and embryos may not be prohibited, restricted or prevented by zootechnical or genealogical reasons other than those resulting from this Directive. However, as concerns the import of semen from animals not referred to in paragraph 1 the national zootechnical and genealogical rules shall apply pending the adoption of Community rules. Article 2 1. For the purposes of this Directive, 'authorities' means any organization, stockrearing organization, breeders' association, private undertaking or official service which is recognized in respect of the species and/or breed concerned, for the purpose of keeping a herd book or register in accordance with the relevant provisions of Directives 77/504/EEC, 88/661/EEC, 89/361/EEC, 90/427/EEC and 91/174/EEC. 2. Furthermore, (a) the definitions in Article 1 of Directives 77/504/EEC, 88/661/EEC and 91/174/EEC and in Article 2 of Directives 89/361/EEC and 90/427/EEC shall be respectively applicable as required; (b) for the purposes of applying the combined nomenclature (11), pure-bred horses for breeding shall mean registered horses, with the exception of geldings. Article 3 1. A list of authorities in respect of the species and/or race concerned which are approved for the purposes of this Directive shall be drawn up, in accordance with the procedure laid down in Article 12, in respect of the animals and products referred to in Article 1 (1) and for each third country. 2. In order to appear on the list provided for in paragraph 1, the third country authority must: (a) appear on a list drawn up by the competent authorities of the third country and communicated to the Commission and to the Member States; (b) comply, in the case of each species and/or each breed, with the relevant requirements laid down by Community legislation for authorities approved in the Community and in particular: - the provisions applicable to entry and registration in herd books or registers, - the provisions applicable to the acceptance of animals for breeding purposes, - the provisions applicable to the use of semen, ova and embryos of animals, - the methods used to check performance and assess the genetic value of animals; (c) be surprised by an official inspection service of the third country, (d) undertake to enter or register in their herd books or registers the animals, semen, ova and embryos and the animals resulting therefrom as referred to in Article 1 (1) which originate in an authority in respect of the species and/or race concerned and recognized under Community legislation. 3. The list referred to in paragraph 1 may be amended by the procedure laid down in Article 12. 4. The implementing rules resulting from this Article, and in particular from paragraph 2 (d), should the occasion arise, shall be adopted by the procedure laid down in Article 12. Article 4 To be imported, animals referred to in Article 1 must: - be entered or registered in a herd book or register kept by an authority named on a list as referred to in Article 3 (1), - be accompanied by a pedigree and zootechnical certificate to be drawn up in accordance with the procedure laid down in Article 12, - be accompanied by evidence that they are going to be entered or registered in a Community herd book or register in accordance with detailed rules to be established under the procedure laid down in Article 12. Article 5 To be imported, semen as referred to in Article 1 must: - come from an animal which is entered or registered in a herd book or register kept by an authority shown on one of the lists referred to in Article 3 (1); - come from an animal which has undergone the performance checks and genetic value assessment to be determined in accordance with the procedure laid down in Article 12 on the basis of the principles provided for in this respect by Community rules; - be accompanied by a pedigree and zootechnical certificate to be drawn up in accordance with the procedure laid down in Article 12. Article 6 To be imported, ova of the animals referred to in Article 1 must: - come from an animal which is entered or registered in a herd book or register kept by an authority shown on one of the lists referred to in Article 3 (1); - be accompanied by a pedigree and zootechnical certificate to be drawn up in accordance with the procedure laid down in Article 12. Article 7 To be imported, the embryos referred to in Article 1 must: - come from an animal which is entered or registered in a herd book or register kept by an authority shown on one of the lists referred to in Article 3 (1); - be accompanied by a pedigree and zootechnical certificate to be drawn up in accordance with the procedure laid down in Article 12. Article 8 At the request of a Member State, accompanied by the necessary justifications or on its own initiative, the Commission may, according to the procedure in Article 12, lay down additional zootechnical and genealogical requirements for the import, from third countries, of certain animals, semen, ova and embryos to take account of the specific situation of such third countries. Article 9 1. Directive 91/496/EEC shall be applicable in respect of animals as referred to in Article 1 (1). 2. Directive 90/675/EEC of 10 December 1990 shall be applicable in respect of semen, ova and embryos as referred to in Article 1 (1). 3. Specific detailed implementing rules for the purposes of the zootechnical checks resulting from this Article shall be adopted, as and when required, in accordance with the procedure laid down in Article 12. Article 10 With a view to allowing the lists referred to in Article 3 (1) and the conditions provided for in Articles 4, 5, 6 and 7 to be drawn up, on-the-spot checks shall be carried out by experts from the Commission and the Member States. The experts from the Member States responsible for these inspections shall be designated by the Commission on a proposal from the Member States. These inspections shall be carried out on behalf of the Community, which shall meet the costs involved. The frequency of, and arrangements for, these inspections shall be determined in accordance with the procedure laid down in Article 12. Article 11 Directive 77/504/EEC is hereby amended as follows: - in Article 2, second indent, Article 3, second paragraph, and in Article 5, the term 'embryos' shall be replaced by 'ova and embryos'. Article 12 Where the procedure laid down in this Article is to be used, the Standing Committee on Zootechnics set up by Decision 77/505/EEC (12) shall act in accordance with the rules set out in Article 11 of Directive 88/661/EEC. Article 13 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 July 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. 3. Pending implementation of the provisions referred to in this Directive, the relevant national rules shall apply in compliance with the general provisions of the Treaty. Article 14 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 15 This Directive is addressed to the Member States.

31994L0035

1994

European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (2) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the Economic and Social Committee (3), After consultation of the Scientific Committee for Food, Acting in accordance with the procedure referred to in Article 189b of the Treaty (4), Whereas differences between national laws relating to sweeteners and their conditions of use hinder the free movement of foodstuffs; whereas this situation may create conditions of unfair competition; Whereas the prime consideration for any rules on sweeteners and their conditions of use should be the need to protect and inform the consumer; Whereas, having regard to the most recent scientific and toxicological information, these substances are to be permitted only for certain foodstuffs and under certain conditions of use; Whereas this Directive does not affect rules relating to functions other than the sweetening properties of the substances covered by this Directive; Whereas the use of sweeteners to replace sugar is justified for the production of energy-reduced food, non-cariogenic foodstuffs or food without added sugars, for the extension of shelf life through the replacement of sugar, and for the production of dietetic products, Article 1 1. This Directive is a specific directive forming a part of the comprehensive directive within the meaning of Article 3 of Directive 89/107/EEC. 2. This Directive shall apply to food additives, hereinafter referred to as 'sweeteners`, which are used: - to impart a sweet taste to foodstuffs, - as table-top sweeteners. 3. For the purposes of this Directive, 'with no added sugar` and 'energy-reduced` in column III of the Annex shall be defined as follows: - 'with no added sugar`: without any added mono- or disaccharides or any other foodstuff used for its sweetening properties, - 'energy-reduced`: with an energy value reduced by at least 30 % compared with the original foodstuff or a similar product. 4. This Directive shall not apply to foodstuffs with sweetening properties. Article 2 1. Only sweeteners listed in the Annex may be placed on the market with a view to: - sale to the ultimate consumer, or - use in the manufacture of foodstuffs. 2. Sweeteners referred to in the second indent of paragraph 1 may only be used in the manufacture of the foodstuffs listed in the Annex under the conditions specified therein. 3. Except where specially provided for, sweeteners may not be used in foods for infants or young children, as specified in Directive 89/398/EEC (5). 4. The maximum usable doses indicated in the Annex refer to ready-to-eat foodstuffs prepared according to the instructions for use. Article 3 1. This Directive shall apply without prejudice to specific directives permitting additives listed in the Annex to be used for purposes other than sweetening. 2. This Directive shall also apply without prejudice to Community provisions governing the composition and the description of foodstuffs. Article 4 Where there are differences of opinion as to whether sweeteners can be used in a given foodstuff under the terms of this Directive, it may be decided by the procedure laid down in Article 7 whether that foodstuff is to be considered as belonging to one of the categories listed in column III of the Annex. Article 5 1. The sales description of a table-top sweetener must include the term '. . . -based table-top sweetener`, using the name(s) of the sweetening substance(s) used in its composition. 2. The labelling of a table-top sweetener containing polyols and/or aspartame must bear the following warnings: - polyols: 'excessive consumption may induce laxative effects`, - aspartame: 'contains a source of phenylalanine`. Article 6 Provisions concerning: - the details which must appear on the labelling of foodstuffs containing sweeteners in order to make their presence clear, - warnings concerning the presence of certain sweeteners in foodstuffs, shall be adopted in accordance with the procedure laid down in Article 7 before expiry of the time limit laid down in the first indent of Article 9 (1). Article 7 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee for Foodstuffs (hereinafter referred to as 'the Committee`) by the chairman on his own initiative or at the request of the representative of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 8 1. Within three years of adoption of this Directive, in accordance with the general criteria of point 4 of Annex II to Directive 89/107/EEC, Member States shall establish a system of consumer surveys to monitor sweetener consumption. The details of this monitoring system shall be coordinated in accordance with the procedure laid down in Article 7. 2. Within five years of adoption of this Directive, the Commission shall submit to the European Parliament and the Council a report, based on information obtained through the monitoring system referred to in paragraph 1, on changes in the sweeteners market, levels of use, and whether there is a further need to restrict conditions of use, including by means of appropriate warnings to consumers, to ensure that use does not exceed the acceptable daily intake. If necessary, the report shall be accompanied by proposals for amendment to this Directive. Article 9 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1995. These measures are intended to: - allow, not later than 31 December 1995, trade in and use of products conforming to this Directive, - prohibit, not later than 30 June 1996, trade in and use of products not conforming to this Directive; products put on the market or labelled before that date which do not comply with this Directive may, however, be marketed until stocks are exhausted. They shall inform the Commission forthwith thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 10 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States.

31994L0036

1994

European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (2) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the Economic and Social Committee (3), Acting in accordance with the procedure referred to in Article 189b of the Treaty (4), Whereas differences between national laws relating to the conditions of use of colours in food hinder the free movement of foodstuffs; whereas this may create conditions of unfair competition; Whereas the prime consideration for any rules on these food additives and their conditions of use should be the need to protect and inform the consumer; Whereas a food additive may only be used when there is evidence that it is technologically necessary and that its use is not harmful to health; Whereas colours are used to restore original appearance of food whose colour has been affected by processing, storage, packaging and distribution, whereby visual acceptability may have been impaired; Whereas colours are used to make food more visually appealing and help identify flavours normally associated with particular foods and to give colour to food otherwise colourless; Whereas it is necessary to include certain colours intended for health marking of meat under the responsibility of the official veterinarian pursuant to the requirements of Directive 91/497/EEC (5), in particular Chapter XI of Annex I thereto; Whereas only those colours authorized by this Directive should be used for the decoration of eggs or for the stamping of eggs as provided in Regulation (EEC) No 1274/91 (6); Whereas colours are used to reinforce colours already present in food; Whereas it is generally recognized that unprocessed foodstuffs and certain other basic foodstuffs should be free from food additives; Whereas, having reagard to the most recent scientific and toxicological information on additives, some of these are to be permitted only for certain foodstuffs and under certain conditions of use; Whereas it is necessary to lay down strict rules for the use of additives in food for infants and young children; Whereas the Scientific Committee for Food has been consulted for those substances not yet being the subject of a Community provision; Whereas it is desirable that when a decision is taken on whether a particular foodstuff belongs to a certain category of foods, the consultation of the Standing Committee for Food procedure be followed; Whereas this Directive replaces partially the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption (7); Whereas the modification of existing purity criteria on colouring matters and new specification for those where no purity criteria exist, will be proposed in accordance with the procedure of Article 11 of Directive 89/107/EEC; Whereas, in order to protect consumers, the Community should promote research into the possible effects (including those of a cumulative and synergic nature) on human health of colours used in foodstuffs, with special reference to those whose harmlessness is in doubt, Article 1 1. This Directive is a specific directive forming a part of the comprehensive directive within the meaning of Article 3 of Directive 89/107/EEC. 2. For the purposes of this Directive, 'colours' are substances which add or restore colour in a food, and include natural constituents of foodstuffs and natural sources which are normally not consumed as foodstuffs as such and not normally used as characteristic ingredients of food. Preparations obtained from foodstuffs and other natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents are colours within the meaning of this Directive. 3. However, the following substances shall not be considered colours for the purposes of this Directive: - foodstuffs, whether dried or in concentrated form and flavourings incorporated during the manufacturing of compound foodstuffs, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect, such as paprika, turmeric and saffron, - colours used for the colouring of the inedible external parts of foodstuffs, such as cheese coatings and sausage casings. Article 2 1. Only the substances listed in Annex I may be used as colours in foodstuffs. 2. Colours may be used only in the foodstuffs listed in Annexes III, IV and V and under the conditions specified therein; colours may be used in those same foodstuffs when they are intended for particular uses in accordance with Directive 89/398/EEC (1). 3. Colours may not be used in the foodstuffs listed in Annex II except where specifically provided for in Annex III, IV or V. 4. Colours permitted for certain uses only are listed in Annex IV. 5. Colours permitted in general in foodstuffs and the conditions of use therefor are listed in Annex V. 6. The maximum levels indicated in the Annexes: - relate to ready-to-eat foodstuffs prepared according to the instructions for use, - refer to the quantities of colouring principle contained in the colouring preparation. 7. In the Annexes to this Directive 'quantum satis' means that no maximum level is specified. However, colouring matters shall be used according to good manufacturing practice at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer. 8. For the purpose of health marking as provided in Directive 91/497/EEC and other marking required on meat products, only E 155 Brown HT, E 133 Brilliant Blue FCF or E 129 Allura Red AC or an appropriate mixture of E 133 Brilliant Blue FCF and E 129 Allura Red AC may be used. 9. Only those colours mentioned in Annex I may be used for the decorative colouring of eggshells or for the stamping of eggshells as provided in Regulation (EEC) No 1274/91. 10. Only those colours listed in Annex I, except E 123, E 127, E 128, E 154, E 160b, E 161g, E 173 and E 180, may be sold directly to consumers. 11. Within the meaning of this Directive 'unprocessed' means not having undergone any treatment resulting in a substantial change in the original state of the foodstuffs. However, they may have been for example divided, parted, servered, boned, minced, skinned, pared, peeled, ground, cut, cleaned, trimmed, deep-frozen, frozen, chilled, milled or husked, packed or unpacked. Article 3 Without prejudice to other Community provisions, the presence of a colour in a foodstuff is permissible: - in a compound foodstuff other than one mentioned in Annex II to the extent that the colour is permitted in one of the ingredients of the compound foodstuff, or - if the foodstuff is destined to be used solely in the preparation of a compound foodstuff and to such an extent that the compound foodstuff conforms to the provisions of this Directive. Article 4 It may be decided by the procedure laid down in Article 5, whether a particular foodstuff belongs to a category of foods mentioned in the Annexes, and whether substances are colours in the meaning of Article 1. Article 5 1. Where the procedure laid down in this Article is to be followed, the Commission shall be assisted by the Standing Committee on Foodstuffs, set up pursuant to Decision 69/414/EEC (1), hereinafter referred to as 'the Committee'. 2. The chairman shall refer the matter to the Committee either on his own initiative or at the request of the representative of a Member State. 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 down in that Article. The chairman shall not vote. 4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the Committee's opinion. (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 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 6 Member States shall, within three years of the adoption of this Directive, establish systems to monitor the consumption and use of colours and report their findings to the Commission. The Commission shall report to the European Parliament within five years of the adoption of the Directive on changes which have taken place in the colours market, the levels of use and consumption. In accordance with the general criteria of point 4 of Annex II to Directive 89/107/EEC, within five years from the adoption of this Directive, the Commission shall review the conditions of use mentioned in this Directive, and propose modifications where necessary. Article 7 Articles 1 to 7, Article 8 (1), second indent and (2), and Articles 9 to 15 of the Directive of 23 October 1962 on colouring matters in foodstuffs are hereby repealed. References to the repealed provisions shall be construed as references to the corresponding provisions of this Directive. Article 8 The Commission shall, to coincide with the date of entry into force of this Directive, launch a campaign, in conjunction with the European Parliament, national ministries, the food and retail industries and consumer bodies, to inform consumers about the evaluation and authorization procedures for permitted colours, and the meaning of the 'E' number system. Article 9 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1995 in order to: - allow, not later than 31 December 1995, trade in and use of products conforming to this Directive, - prohibit, not later than 30 June 1996, trade in and use of products not conforming to this Directive; products put on the market or labelled before that date which do not comply with this Directive may, however, be marketed until stocks are exhausted. They shall at once inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 10 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States.

31994L0041

1994

Commission Directive 94/41/EC of 18 July 1994 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 94/17/EC (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 91/248/EEC (3); Whereas the use of an additive belonging to the group of binders, anti-caking agents and coagulants has been widely tested in various Member States; whereas, on the basis of experience gained, it appears that this new substance can be authorized throughout the Community; Whereas new uses for additives belonging to the groups of antibiotics and micro-organisms have been successfully tested in certain Member States; whereas the new uses should be authorized provisionally at national level in anticipation of their approval at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 30 June 1995 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0037

1994

Commission Directive 94/37/EC of 22 July 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 93/71/EEC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC lay down the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary to indicate in Annexes II and III to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossier; Whereas greater precision can now be given to the data requirements concerning the identity, physical and chemical properties and further on the active substance, provided for in sections 1, 2 and 3 of Part A of Annex II; Whereas greater precision can now be given to the data requirements concerning the identity, physical, chemical and technical properties and other general information on the plant protection product, provided for in sections 1 to 4 of Part of Annex III; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 91/414/EEC is amended as follows: 1. In Part A of Annex II, the sections headed '1. Identity of the active substance', '2. Physical and chemical properties of the active substance' and '3. Further information on the active substance' are replaced by Annex I hereto; 2. In Part A of Annex III, the sections headed '1. Identity of the plant protection product', '2. Physical, chemical and technical properties of the plant protection product', '3. Data on application' and '4. Further information on the plant protection product' are replaced by Annex II hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 July 1995. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on 1 August 1994.

31994L0039

1994

Commission Directive 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (1), and in particular Article 6 (a) thereof, Whereas Council Directive 93/74/EEC provides for the establishment of a positive list of the intended uses of animal feedingstuffs for particular nutritional purposes; whereas that list must indicate the precise use, that is to say, the particular nutritional purpose, the essential nutritional characteristics, the labelling declarations and where apropriate the special labelling requirements; Whereas certain nutritional purposes cannot be included at present in the list of intended uses due to the absence of Community methods of control for the energy value in pet foods and for dietary fibre in feedingstuffs; whereas this list must be completed as soon as these methods have been adopted; Whereas the established list may be modified, where appropriate, following developments in scientific and technical knowledge; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Council Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of the Annex to this Directive and if they fulfil the other provisions laid down in that Part of the Annex. Furthermore, the Member States shall ensure that the provisions under 'General provisions' of Part A of the Annex are complied with. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1995. They shall immediately inform the Commission thereof. When Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force 20 days after its publication in the Official Journal of the European Communities.

31994L0038

1994

Commission Directive 94/38/EC of 26 July 1994 amending Annexes C and D to Council Directive 92/51/EEC on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC (1), and in particular Article 15 thereof, Whereas, when examining a reasoned request for adding an education or training course to the list in Annex C or D or for removing such a course from one of those Annexes, the Commission, pursuant to Article 15 (2) of Directive 92/51/EEC, is required to verify in particular whether the qualification resulting from the course in question confers on the holder a level of professional education or training of a comparably high level to that of the post-secondary course referred to in point (i) of the second indent of the first subparagraph of Article 1 (a), and a similar level of responsibility and activity; Whereas the German Government has made reasoned requests for the amendment of Annexes C and D to the Directive and the Italian Government has made a reasoned request for the amendment of Annex C; Whereas, in particular, the reference to the professional title of physiotherapist ('Krankengymnast(in)') in Germany needs to be amended following a change in national legislation which has introduced ane professional title without, however, altering the structure of the professional education and training; Whereas, in particular, the training courses to be added to the list in Annex C in respect of Germany have the same structure as those already listed, in respect of Germany, Italy and Luxembourg, at point 1 ('Paramedical and childcare training courses') in that Annex; Whereas Italy has altered its education and training courses for accountants ('regioniere') and accountancy experts ('perito commerciale'), with the result that those courses now come under Council Directive 89/48/EEC (2); whereas, in the case of work consultants ('consulenti del lavoro'), the course of education and training covered by Directive 89/48/EEC is now the principal form of education and training for the profession concerned; whereas, accordingly, education and training courses for those two professions should no longer be included in Annex C, since holders of qualifications covered by Directive 92/51/EEC could, by virtue of Article 1 (a) of Directive 89/48/EEC, apply to be treated in the same way; Whereas in accordance with Article 2 of Directive 92/51/EEC the provisions of that Directive are not applicable to activities covered by any of the Directives listed in Annex A thereto, including the Directives made applicable to the pursuit as an employed person of the activities listed in Annex B, even if a national of a Member State has completed one of the 'courses having a special structure' referred to in Annex D; Whereas, in particular, the training courses to be added to the list in Annex D in respect of Germany are similar in structure to certain training courses in Annex C and invariably feature a total duration of 13 years or more, including three years or more of vocational training; Whereas, in accordance with Article 17 (2) of Directive 92/51/EEC and in order to increase the effectiveness of the general system, those Member States whose education and training courses are listed in Annex D should send a list of the diplomas concerned to the Commission; Whereas, in order to make Annexes C and D easier to read, the lists as amended should be published; Whereas the measures provided for in this Directive are in accordance with the opinion given by the Committee established by Article 15 of Directive 92/51/EEC, Article 1 Annexes C and D to Directive 92/51/EEC are hereby amended as shown in Annex I hereto. Article 2 The amended lists of the courses of education and training which appear in Annexes C and D to Directive 92/51/EEC are shown in Annex II to this Directive. Article 3 1. Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive before 1 October 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0042

1994

Council Directive 94/42/EC of 27 July 1994 amending Directive 64/432/EEC on health problems affecting intra- Community trade in bovine animals and swine Having regard to the Treaty establishing the European Community, and in particualr 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 Council has adopted 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 (4) and Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries (5); Whereas it is necessary, in the light of this situation, to amend Council Directive 64/432/EEC of 26 June 1964 on health problems affecting intra-Community trade in bovine animals and swine (6), in particular concerning the period of presence in a Member State prior to movement and the rules for trade in animals under thirty days of age, Article 1 Directive 64/432/EEC is hereby amended as follows: 1. In Article 2, the following point shall be inserted; 'collection centre: shall mean any site, including holdings and markets, at which bovine animals or swine originating from different holdings are grouped together to form consignments of animals intended for trade, which has the equipment and facilities required for holding animals and which is placed under the care of the veterinary authority responsible. The latter shall take all the measures needed to ensure that, for the animals passing through it, this collection centre constitutes an animal health unit of the level required by this Directive which is cleared of animals, eaned and disinfected after each sale and the admission of further animals. These collection centres must be approved for trading purposes'; 2. In Article 3, the following shall be added to point 2 (i): 'However, where several destinations are involved, the animals must be regrouped in as many consignments as there are destiantions. Each consignment must be accompanied to the destination given on the aforementioned certificate. This exemption can be granted only to recipients who have been registered by the competent authority of the place of destination in advance and to approved transport operators subject to specifications concerning the disinfection of the vehicles and animal welfare rules'; 3. The following subparagraph shall be inserted in Article 3 (2) (f) (iii): 'Rules for the approval of sites where disinfection may be carried out and the procedures necessary to ensure and verify compliance with veterinary requirements shall be determined in accordance with the provisions of Article 12'; 4. In Article 3 (7) and (9): (i) 'market' shall be replaced by 'collection centre'; (ii) 'and/or the assembly point' shall be deleted; 5. The following Article shall be inserted: 'Article 3a Without prejudice to the checks provided for by Directive 90/425/EEC, Member States shall ensure that animals which were not born on a given holding and wahich have not remained during the previous thirty days on the territory of the Member States within which the holding is situated may not be brought into the herd until the veterinarian responsible for that holding has ascertained that the animals in question are not likely to jeopardize the health status of the holding'; 6. Article 4 shall be deleted. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. 3. Pending implementation of the provisions referred to in this Directive, the relevant national rules shall apply in compliance with the general provisions of the Treaty. Article 3 This Directive is addressed to the Member States.

31994L0044

1994

Commission Directive 94/44/EC of 19 September 1994 adapting to technical progress Council Directive 82/130/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp Having regard to the Treaty establishing the European Community, Having regard to Council Directive 82/130/EEC of 15 February 1982 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp (1) as last amended by European Parliament and Council Directive 94/9/EC (2), and in particular Article 7 thereof, Whereas in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonized standards referred to in Annex A of Directive 82/130/EEC; Whereas in view of the nature of the equipment mentioned above, it is necessary to provide for a transition period in order to allow the industry to adapt to the amendments of standards; Whereas the measures provided for in this Directive are in accordance with the opinion delivered by the Restricted Committee of the Safety and Health Commission for the Mining and other Extractive Industries, Article 1 Annex A of Directive 82/130/EEC is replaced by Annex A in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 September 1995 and shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference all the time of their official publication. The procedure for such reference shall be adopted by the Member States. 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. 2. However, until 30 June 2003, Member States shall continue to apply the measures provided for in Article 4 of Directive 82/130/EEC as regards the equipment for which conformity to the harmonized standards is attested by the certificate of conformity referred to in Article 8 of Directive 82/130/EEC, provided that this certificate was issued before 1 January 1997. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0046

1994

Commission Directive 94/46/EC of 13 October 1994 amending Directive 88/301/EEC and Directive 90/388/EEC in particular with regard to satellite communications Having regard to the Treaty establishing the European Community, and in particular Article 90 (3) thereof, Whereas: 1. The Green Paper on a common approach in the field of satellite communications in the European Community, adopted by the Commission in November 1990, set out the major changes in the regulatory environment necessary to exploit the potential of this means of communications. This Satellite Green Paper called for, inter alia, full liberalization of the satellite services and equipment sectors, including the abolition of all exclusive or special nights in this area, subject to licensing procedures, as well as for the free (unrestricted access to space segment capacity. 2. The Council Resolution of 19 December 1991 on the development of the common market for satellite communications services and equipment (1), gave general support to the positions set out in the Commission's Satellite Green Paper, and considered as major goals: the harmonization and liberalization of the market for appropriate satellite earth stations, including where applicable the abolition of exclusive or special rights in this field, subject in particular to the conditions necessary for compliance with essential requirements. 3. The European Parliament, in its Resolution on the development of the common market for satellite communications services and equipment (2) calls upon the Commission to enact the necessary legislation in order to create the environment to enable existing constraints to be removed and new activities developed in the field of satellite communications, while stressing the need to harmonize and liberalize the markets in satellite equipment and services. 4. Several Member States have already opened up certain satellite communications services to competition and have introduced licensing schemes. Nevertheless, the granting of licences in some Member States still does not follow objective, proportional and non-discriminatory criteria or, in the case of operators competing with the telecommunications organizations, is subject to technical restrictions such as a ban on connecting their equipment to be switched network operated by the telecommunications organization. Other Member States have maintained the exclusive rights granted to the national public undertakings. 5. Commission Directive 88/301/EEC of 16 May 1988 on competition in the markets in telecommunications terminal equipment (3), as amended by the Agreement on the European Economic Area, provides for the abolition of special or exclusive rights to import, market, connect, bring into service and maintain telecommunications terminal equipment. It does not cover all types of satellite earth station equipment. 6. In its judgment in Case C-202/88, France v. Commission (4), the Court of Justice of the European Communities upheld Commission Directive 88/301/EEC. However, in so far as it relates to special rights, the Directive was declared void on the grounds that neither the provisions of the Directive nor the preamble thereto specify the type of rights which are actually involved and in what respect the existence of such rights is contrary to the various provisions of the Treatry. As far as importation, marketing, connection, bringing into service and maintenance of telecommunications equipment are concerned, special rights are in practice rights that are granted by a Member State to a limited number of undertakings, through any legislative, regulatory or administrative instrument which, within a given geographical area, - limits to two or more the number of such undertaking, otherwise than according to objective, proportional and non-discriminatory criteria, or - designates, otherwise than according to such criteria, several competing undertakings, or - confers on any undertaking or undertakings, otherwise than according to such criteria, legal or regulatory advantages which substantially affect the ability of any other undertaking to engage in any of the abovementioned activities in the same geographical area under substantially equivalent conditions. This definition is without prejudice to the application of Article 92 of the EC Treaty. 7. The existence of exclusive rights has the effect of restricting the free movement of such equipment either as regards the importation and marketing of telecommunications equipment (including satellite equipment), because certain products are not marketed, or as regards the connection, bringing into service or maintenance because, taking into account the characteristics of the market and in particular the diversity and technical nature of the products, a monopoly has no incentive to provide these services in relation to products which it has not marketed or imported, nor to align its prices on costs, since there is no threat of competition from new entrants. Taking into account the fact that in most equipment markets there is typically a large range of telecommunication equipment markets there is typically a large range of telecommunication equipment, and the likely development of the markets in which there are as yet a limited number of manufacturers, any specialy right which directly or indirectly - for example by not providing for an open and non-discrimnatory authorization procedure - limits the number of the undertakings authorized to import, market, connect, bring into service and maintain such equipment, is liable to have the same kind of effect as the grant of exclusive rights. Such exclusive or special rights constitute measures having equivalent effect to quantitative restrictions incompatible with Article 30 of the EC Treaty. None of the specific features of satellite earth stations or of the market for their sale or maintenance is such as to justify their being treated differently in law from other telecommunications terminal equipment. Thus it is necessary to abolish all existing exclusive rights in the importation, marketing, connection, bringing into service and maintenance of satellite earth station equipment, as well as those rights having comparable effects - that is to say, all special rights except those consisting in legal or regulatory advantages conferred on one or more undertakings and affecting only the ability of other undertakings to engage in any of the abovementioned activities in the same geographical area under substantially equivalent conditions. 8. Satellite earth station equipment must satisfy the essential requirements harmonized by Council Directive 93/97/EEC (5) with special reference to the efficient use of frequencies. It will be possible to monitor the application of these essential requirements partly through the licences granted for the provision of the services concerned. Alignment on the essential requirements will be achieved mainly through the adoption of common technical rules and harmonization of the conditions attached to licences. Even where these conditions are not harmonized, Member States will nevertheless have to adapt their rules. In either case, Member States must in the meantime ensure that the application of such rules does not create barriers to trade. 9. The abolition of special or exclusive rights relating to the connection of satellite earth station equipment makes it necessary to recognize the right to connect this equipment to the switched networks operated by the telecommunications organizations so that licensed operators can offer their services to the public. 10. Commission Directive 90/388/EEC of 28 June 1990 on competition in the markets for telecommunications services (6), as amended by the Agreement on the EEA, provides for the abolition of special or exclusive rights granted by Member States in respect of the provision of telecommunications services. However, the Directive excludes satellite services from its field of application. 11. In Joined Cases C-271/90, C-281/90 and C-289/90, Spain v. Commission (7), the Court of Justice of the European Communities upheld this Commission Directive on 17 November 1992. However, in so far as it relates to special rights, the Directive was declared void by the Court of Justice on the grounds that neither the provisions of the Directive nor the preamble thereto specify the type of rights which are actually involved and in what respect the existence of such rights is contrary to the various provisions of the Treaty. Consequently, these rights must be defined in this Directive. As far as telecommunications services are concerned, special rights are in practice rights that are granted by a Member State to a limited number of undertakings, through any legislative, regulatory or administrative instrument which, within a given geographical area, - limits to two or more, otherwise than according to objective, proportional and non-discriminatory criteria, the number of undertakings which are authorized to provide any such service, of - designates, otherwise than according to such criteria, several competing undertakings as those which are authorized to provide any such service, or - confers on any undertaking or undertakings, otherwise than according to such criteria, legal or regulatory advantages which substantially affect the ability of any other undertaking to provide the same telecommunications service in the same geographical area under substantially equivalent conditions. This definition is without prejudice to the application of Article 92 of the EC Treaty. In the field of telecommunications services, such special legal or regulatory advantages may consist, among other things, in a right to make compulsory purchases in the general interest, in derogations from law on town-and-country planning, or in the possibility of obtaining an authorization without having to go through the usual procedure. 12. Where the number of undertakings authorized to provide satellite telecommunications services is limited by a Member State through special rights, and a fortiori exclusive rights, these constitute restrictions that could be incompatible with Article 59 of the Treaty, whenever such limitation is not justified by essential requirements, since these rights prevent other undertakings from supplying (or obtaining) the services concerned to (or from) other Member States. In the case of satellite network services, such essential requirements could be the effective use of the frequency spectrum and the avoidance of harmful interference between satellite telecommunications systems a other space-based or terrestrial technical systems. Consequently, provided that equipment used to offer the services satisfies the essential requirement applicable to satellite communications, separate legal treatment of the latter is not justified. On the other hand, special rights consisting only in special legal or regulatory advantages, do not, in principle, preclude other undertakings from entering the market. The compatibility of these rights with the EC Treaty must therefore be assessed on a case-by-case basis, regard being had to their impact on the effective freedom of other entities to provide the same telecommunications service and their possible justifications regarding the activity concerned. 13. The exclusive rights that currently exist in the satellite communications field were generally granted to organizations that already enjoyed a dominant position in creating the terrestrial networks, or to one of their subsidiaries. Such rights have the effect of extending the dominant position enjoyed by those organizations and therefore strengthening that position. The exclusive rights granted in the satellite communications field are consequently incompatible with Article 90 of the EC Treaty, read in conjunction with Article 86. 14. These exclusive rights limiting access to the market also have the effect of restricting or preventing, to the detriment of users, the use of satellite communications that could be offered, thereby holding back technical progress in this area. Because their investment decisions are likely to be based on exclusive rights, the undertakings concerned are often in a position to decide to give priority to terrestrial technologies, whereas new entrants might exploit satellite technology. The telecommunications organizations have generally given preference to the development of optical-fibre terrestrial links, and satellite communications have been used chiefly as a technical solution of last resort in cases where the cost of the terrestrial alternatives has been prohibitive, or for the purpose of data broadcasting and/or television broadcasting, rather than being used as a fully complementary transmission technology in its own right. Thus the exclusive rights imply a restriction on the development of satellite communication, and this is incompatible with Article 90 of the Treaty, read in conjunction with Article 86. 15. However, where the provision of satellite services is concerned, licensing or declaration procedures are justified in order to ensure compliance with essential requirements, subject to the proportionality principle. Licensing is not justified when a mere declaration procedure would suffice to attain thte relevant objective. For example, in the case of provision of a satellite service which involves only the use of a dependent VSAT earth station in a Member State, the latter should impose no more than a declaration procedure. 16. Article 90 (6) of the Treaty provides for an exception to Article 86 in cases where the application of the latter would obstruct the performance, in law or infact, of the particular tasks assigned to the telecommunications organizations. Pursuant to that provision, Directive 90/388/EEC allows exclusive rights to be maintained for a transitional period in respect of voice telephony. 'Voice telephony' is defined in Article 1 of Directive 90/388/EEC as 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. In the case of direct transport and switching of speech via satellite earth station networks, such commercial provision for the public in general can take place only when the satellite earth station network is connected to the public switched network. As regards all services other than voice telephony, no special treatment under Article 90 (2) is justified especially in view of the insignificant contribution of such services to the turnover of the telecommunications organizations. 17. The provision of satellite network services for the conveyance of radio and television programmes is a telecommunications service for the purpose of this Directive and thus subject to its provisions. Notwithstanding the abolition of certain special and exclusive rights in respect of receive-only satellite earth stations not connected to the public network of a Member State and the abolition of special and exclusive rights in respect of satellite services provided for public or private broadcasters, the content of satellite broadcasting services to the general public or private broadcasters, the content of satellite broadcasting services to the general public provided via frequency bands defined in the Radio Regulations for both Broadcasting Satellite Services (BSS) and Fixed-Satellite Services (FSS) will continue to be subject to specific rules adopted by Member States in accordance with Community law and is not, therefore, subject to the provisions of this Directive. 18. This Directive does not prevent measure being adopted in accordance with Community law and existing international obligations so as to ensure that nationals of Member States are afforded equivalent treatment in third countries. 19. The offering by satellite operators of space segment capacity of national, private or international satellite systems to licensed satellite earth station network operators, is still, in some Member States, subject to regulatory restrictions other than those compatible with frequency and site coordination arrangements required under the international commitments of Member States. These additional restrictions are contrary to Article 59, which implies that such satellite operators should have full freedom to provide their services in the whole Community, once they are licensed in one Member State. 20. Tests to establish whether satellite earth stations of licensed operators other than national operators conform to specifications governing technical and operational access to intergovernmental satellite systems, are, in most of the Member States, carried out by the national Signatory of the nation upon whose territory the station is operating. These conformity assessments are therefore performed by service providers which are competitors. This is not compatible with the Treaty provisions, notably Articles 3 (g) and 90, read in conjunction with Article 86. Member States therefore need to ensure that these conformity assessments can be carred out direct between the satellite earth station network operator concerned and the intergovernmental organization itself, under supervision of the regulatory authorities alone. 21. Most of the available space segment capacity is offered by the international satellite organizations. The charges for using such capacity are still high in many Member States because the capacity can be acquired only from the signatory for the Member State in question. Such exclusivity, permitted by some Member States, leads to a partitioning of the Common Market to the detriment of customers requiring capacity. In its resolution of 19 December 1991, the Council consequently called on the Member States to improve access to the space segment of the intergovernmental organizations. As regards the establishment and use of separate systems, restrictive measure taken under international conventions signed by Member States could also have effects incompatible with Community law, by limiting supply at the expense of the consumer within meaning of Article 86 (b). Within the international satellite organizations, reviews of the provisions of the relevant constituent instruments are under way, inter alia, in respect of improved access and in respect of the establishment and use of separate systems. In order to enable the Commission to carry out the monitoring task assigned to it by the EC Treaty, instruments should be provided to help Member States to comply with the duty of cooperation enshrined in the first paragraph of Article 5, read in conjunction with Article 234 (2), of the Treaty. 22. In assessing the measures of this Directive, 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 130 (a), will also take into account the situation of those Member States in which the terrestrial network is not yet sufficiently developed and which could justify the deferment for these Member States, as regards satellite services and to the extent necessary, of the date of full application of the provisions of this Directive until 1 January 1996, Article 1 Directive 88/301/EEC is hereby amended as follows: (a) The last sentence of the first indent is replaced by the following: 'Terminal equipment also means satellite earth station equipment'. (b) The following indents are added after the second indent: '- "special rights" means rights that are granted by a Member State to a limited number of undertakings, through any legislative, regulatory or administrative instrument, which, within a given geographical area, - limits to two or more the number of such undertakings, otherwise than according t objective, proportional and non-discriminatory criteria, or - designates, otherwise than according to such criteria, several competing undertakings, or - confers on any undertaking or undertakings, otherwise than according to such criteria, any legal or regulatory advantages which substantially affect the ability of any other undertaking to import, market, connect, bring into service and/or maintain telecommunication terminal equipment in the same geographical area under substantially equivalent conditions; - "satellite earth station equipment" means equipment which is capable of being used for the transmission only, or for the transmission and reception ("transmit/receive"), or for the reception only ("receive-only") of radiocommunication signals by means of satellites or other space-based systems' 2. The first paragraph of Article 2 is replaced by the following text. 'Member States which habe granted special or exclusive rights to undertakings shall ensure that all exclusive rights are withdrawn, as well as those special rights which (a) limit two or more the number of undertakings within the meaning of Article 1, otherwise than according to objective, proportional and non-discriminatory criteria, or (b) designate, otherwise than according to such criteria, several competing undertakings within the meaning of Article 1.' 3. The first indent of Article 3 is replaced by the following text: '- in the case of satellite earth station equipment, refuse to allow such equipment to be connected to the public telecommunications network and/or to be brought into service where it does not satisfy the relevant common technical regulations adopted in pursuance of Council Directive 93/97/EEC (8)() or, in the absence thereof, the essential requirements laid down in Article 4 of that Directive. In the absence of common technical rules of harmonized regulatory conditions, national rules shall be proportionate to those essential requirements and shall be notified to the Commission in pursuance of Directive 83/189/EEC where that Directive so requires. - in the case of other terminal equipment, refuse to allow such equipment to be connected to the public telecommunications network where it does not satisfy the relevant common technical regulations adopted in pursuance of Council Directive 91/263/EEC (9)() or, in the absence thereof, the essential requirements laid down in Article 4 of that Directive. ' Article 2 Directive 90/388/EEC is hereby amended as follows: 1. Article 1 is amended as follows: (a) Paragraph 1 is amended as follows: (i) the seconds indent is replaced by the following: '- "exclusive rights" means the rights that are granted by a Member State to one undertaking through any legislative, regulatory or administrative instrument, reserving it the right to provide a telecommunication service or undertake an activity within a given geographical area.'; (ii) The following is inserted as the third indent: '- "special rights" means the rights that are granted by a Member State to a limited number of undertakings through any legislative, regulatory or administrative instrument which, within a given geographical area, - limits to two or more the number of such undertakings authorized to provide a service or undertake an activity, otherwise than according to objective, proportional and non-discriminatory criteria, or - designates, otherwise than according to such criteria, several competing undertakings as being authorized to provide a service or undertake an activity, or - confers on any undertaking or undertakings, otherwise than according to such criteria, legal or regulatory advantages which substantially affect the ability of any other undertaking to provide the same telecommunications service or to undertake the same activity in the same geographical area under substantially equivalent conditions.' (iii) The fourth indent is replaced by the following: '- "telecommunications services" means services whose provision consists wholly or partly in the transmission and routing of signales on a public telecommunications network by means of telecommunications processes, with the exception of radio- and television-broadcasting to the public, and satellite services.' (iv) the following indents are inserted after the fourth indent: '- "satellite earth station network" means a configuration of two or more earth stations which interwork by means by means of a satellite; - "satellite network services" means the establishment and operation of satellite earth station networks; these services consist, as a minimum, in the establishment, by satellite earth stations, of radiocommunications to space segment ("uplinks"), and in the establishment of radiocommunications between space segment and satellite earth stations ("downlinks"); - "satellite communications services" means service whose provision makes use, wholly or partly, of satellite network services; - "satellite services" means the provision of satellite communications services and/or the provision of satellite networks services;' (v) the second sentence of the sixth indent is replaced by the following text: 'Those reasons are security of network operations, maintenance of network integrity, and, in justified cases, interoperability of services, data protection and, in the case of satellite network services, the effective use of the frequency spectrum and the avoidance of harmful interference between satellite telecommunications systems and other space-based or terrestrial tecnical systems.' (b) Paragraph 2 is replaced by the following: '2. This Directive shall not apply to the telex service or to terrestrial mobile radiocommunications.' 2. Article 2 is amended as follows: (a) The first paragraph is replaced by the following: 'Without prejudice to Article 1 (2), Member States shall withdraw all those measures which grant: (a) exclusive rights for the supply of telecommunications services otherwise than voice telephony and (b) special rights which limit to two or more the number of undertakings authorized to supply such telecommunication services, otherwise than according to objective, proportional and non-discriminatory criteria, or (c) special rights which designate, otherwise than according to such criteria, several competing undertakings to provide such telecommunication services. They shall take the measures necessary to ensure that any operator is entitled to supply any such telecommunications services, otherwise than voice telephony'. (b) The following paragraphs are added: 'Member States shall communicate the criteria on which authorizations are granted, together with the conditions attached to such authorizations and to the declaration procedures for the operation of transmitting earth stations. Member States shall continue to inform the Commission of any plans to introduce new licensing procedures or to change existing procedures'. 3. Article 6 is amended as follows: (a) The following paragraphs are added after the second paragraph: 'Member States shall ensure that any fees imposed on providers of services as part of authorization procedures, shall be based on objective, transparent and non-discriminatory criteria. Fees, the criteria upon which they are based, and any changes thereto, shall be published in an appropriate and sufficiently detailed manner, so as to provide easy access to that information. Member States shall notify to the Commission no later than nine months after publication of this Directive, and thereafter whenever changes occur, the manner in which the information is made available. The Commission shall regularly publish references to such notifications.' (b) The following paragraph is added: 'Member States shall ensure that any regulatory prohibition or restrictions on the offer of space-segment capacity to any authorized satellite earth station network operator are abolished, and shall autorize within their territory any space-segment supplier to verify that the satellite earth station network for use in connection with the space segment of the supplier in question is in conformity with the published conditions for access to his space segment capacity.' Article 3 Member States which are party to the international conventions setting up the international organizations Intelsat, Inmarsat, Eutelsat and Intersputnik for the purposes of satellite operatons shall communicate to the Commission, at its request, the information they psses on any measure that could prejudice compliance with the competition rules of the EC Treaty or affect the aims of this Directive or of the Council Directives on telecommunications. Article 4 Member States shall supply to the Commission, not later than nine months after this Directive has entered into force, such information as will allow the Commission to confirm that Articles 1 and 2 have been complied with. Article 5 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31994L0047

1994

Directive 94/47/EC of the European Parliament and the Council of 26 October 1994 on the protection of purchasers in respect of certain aspects of contracts relating to the purchase of the right to use immovable properties on a timeshare basis Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), 1. Whereas the disparities between national legislations on contracts relating to the purchase of the right to use one or more immovable properties on a timeshare basis are likely to create barriers to the proper operation of the internal market and distortions of competition and lead to the compartmentalization of national markets; 2. Whereas the aim of this Directive is to establish a minimum basis of common rules on such matters which will make it possible to ensure that the internal market operates properly and will thereby protect purchasers; whereas it is sufficient for those rules to cover contractual transactions only with regard to those aspects that relate to information on the constituent parts of contracts, the arrangements for communicating such information and the procedures and arrangements for cancellation and withdrawal; whereas the appropriate instrument to achieve that aim is a Directive; whereas this Directive is therefore consistent with the principle of subsidiarity; 3. Whereas the legal nature of the rights which are the subject of the contracts covered by this Directive varies considerably from one Member State to another; whereas reference should therefore be made in summary form to those variations, giving a sufficiently broad definition of such contracts, without thereby implying harmonization within the Community of the legal nature of the rights in question; 4. Whereas this Directive is not designed to regulate the extent to which contracts for the use of one or more immovable properties on a timeshare basis may be concluded in Member States or the legal basis for such contracts; 5. Whereas, in practice, contracts relating to the purchase of the right to use one or more immovable properties on a timeshare basis differ from tenancy agreements; whereas that difference can be seen from, inter alia, the means of payment; 6. Whereas it may be seen from the market that hotels, residential hotels and other similar residential tourist premises are involved in contractual transactions similar to those which have made this Directive necessary; 7. Whereas it is necessary to avoid any misleading or incomplete details in information concerned specifically with the sale of the rights to use one or more immovable properties on a timeshare basis; whereas such information should be supplemented by a document which must be made available to anyone who requests it; whereas the information therein must constitute part of the contract for the purchase of the right to use one or more immovable properties on a timeshare basis; 8. Whereas, in order to give purchasers a high level of protection and in view of the specific characteristics of systems for using immovable properties on a timeshare basis, contracts for the purchase of the right to use one or more immovable properties on a timeshare basis must include certain minimal items; 9. Whereas, with a view to establishing effective protection for purchasers in this field, it is necessary to stipulate minimum obligations with which vendors must comply vis-à-vis purchasers; 10. Whereas the contract for the purchase of the right to use one or more immovable properties on a timeshare basis must be drawn up in the official language or one of the official languages of the Member State in which the purchaser is resident or in the official language or one of the official languages of the Member State of which he is a national which must be one of the official languages of the Community; whereas, however, the Member State in which the purchaser is resident may require that the contract be drawn up in its language or its languages which must be an official language or official languages of the Community; whereas provision should be made for a certified translation of each contract for the purposes of the formalities to be completed in the Member State in which the relevant property is situated; 11. Whereas to give the purchaser the chance to realize more fully what his obligations and rights under the contract are he should be allowed a period during which he may withdraw from the contract without giving reasons since the property in question is often situated in a State and subject to legislation which are different from his own; 12. Whereas the requirement on the vendor's part that advance payments be made before the end of the period during which the purchaser may withdraw without giving reasons may reduce the purchaser's protection; whereas, therefore, advance payments before the end of that period should be prohibited; 13. Whereas in the event of cancellation of or withdrawal from a contract for the purchase of the right to use one or more immovable properties on a timeshare basis the price of which is entirely or partly covered by credit granted to the purchaser by the vendor or by a third party on the basis of an agreement concluded between that third party and the vendor, it should be provided that the credit agreement should be cancelled without penalty; 14. Whereas there is a risk, in certain cases, that the consumer may be deprived of the protection provided for in this Directive if the law of a non-Member State is specified as the law applicable to the contract; whereas this Directive should therefore include provisions intended to obviate that risk; 15. Whereas it is for the Member States to adopt measures to ensure that the vendor fulfils his obligations, Article 1 The purpose of this Directive shall be to approximate the laws, regulations and administrative provisions of the Member States on the protection of purchasers in respect of certain aspects of contracts relating directly or indirectly to the purchase of the right to use one or more immovable properties on a timeshare basis. This Directive shall cover only those aspects of the above provisions concerning contractual transactions that relate to: - information on the constituent parts of a contract and the arrangements for the communication of that information, - the procedures and arrangements for cancellation and withdrawal. With due regard to the general rules of the Treaty, the Member States shall remain competent for other matters, inter alia determination of the legal nature of the rights which are the subject of the contracts covered by this Directive. Article 2 For the purposes of this Directive: - 'contract relating directly or indirectly to the purchase of the right to use one or more immovable properties on a timeshare basis`, hereinafter referred to as 'contract`, shall mean any contract or group of contracts concluded for at least three years under which, directly or indirectly, on payment of a certain global price, a real property right or any other right relating to the use of one or more immovable properties for a specified or specifiable period of the year, which may not be less than one week, is established or is the subject of a transfer or an undertaking to transfer, - 'immovable property` shall mean any building or part of a building for use as accommodation to which the right which is the subject of the contract relates, - 'vendor` shall mean any natural or legal person who, acting in transactions covered by this Directive and in his professional capacity, establishes, transfers or undertakes to transfer the right which is the subject of the contract, - 'purchaser` shall mean any natural person who, acting in transactions covered by this Directive, for purposes which may be regarded as being outwith his professional capacity, has the right which is the subject of the contract transferred to him or for whom the right which is the subject of the contract is established. Article 3 1. The Member States shall make provision in their legislation for measures to ensure that the vendor is required to provide any person requesting information on the immovable property or properties with a document which, in addition to a general description of the property or properties, shall provide at least brief and accurate information on the particulars referred to in points (a) to (g), (i) and (l) of the Annex and on how further information may be obtained. 2. The Member States shall make provision in their legislation to ensure that all the information referred to in paragraph 1 which must be provided in the document referred to in paragraph 1 forms an integral part of the contract. Unless the parties expressly agree otherwise, only changes resulting from circumstances beyond the vendor's control may be made to the information provided in the document referred to in paragraph 1. Any changes to that information shall be communicated to the purchaser before the contract is concluded. The contract shall expressly mention any such changes. 3. Any advertising referring to the immovable property concerned shall indicate the possibility of obtaining the document referred to in paragraph 1 and where it may be obtained. Article 4 The Member States shall make provision in their legislation to ensure that: - the contract, which shall be in writing, includes at least the items referred to in the Annex, - the contract and the document referred to in Article 3 (1) are drawn up in the language or one of the languages of Member State in which the purchaser is resident or in the language or one of the languages of the Member State of which he is national which shall be an official language or official languages of the Community, at the purchaser's option. The Member State in which the purchaser is resident may, however, require that the contract be drawn up in all cases in at least its language or languages which must be an official language or official languages of the Community, and - the vendor provides the purchaser with a certified translation of the contract in the language or one of the languages of the Member State in which the immovable property is situated which shall be an official language or official languages of the Community. Article 5 The Member States shall make provision in their legislation to ensure that: 1. in addition to the possibilities available to the purchaser under national laws on the nullity of contracts, the purchaser shall have the right: - to withdraw without giving any reason within 10 calendar days of both parties' signing the contract or of both parties' signing a binding preliminary contract. If the 10th day is a public holiday, the period shall be extended to the first working day thereafter, - if the contract does not include the information referred to in points (a), (b), (c), (d) (1), (d) (2), (h), (i), (k), (l) and (m) of the Annex, at the time of both parties' signing the contract or of both parties' signing a binding preliminary contract, to cancel the contract within three months thereof. If the information in question is provided within those three months, the purchaser's withdrawal period provided for in the first indent, shall then start, - if by the end of the three-month period provided for in the second indent the purchaser has not exercised the right to cancel and the contract does not include the information referred to in points (a), (b), (c), (d) (1), (d) (2), (h), (i), (k), (l) and (m) of the Annex, to the withdrawal period provided for in the first indent from the day after the end of that three-month period; 2. if the purchaser intends to exercise the rights provided for in paragraph 1 he shall, before the expiry of the relevant deadline, notify the person whose name and address appear in the contract for that purpose by a means which can be proved in accordance with national law in accordance with the procedures specified in the contract pursuant to point (l) of the Annex. The deadline shall be deemed to have been observed if the notification, if it is in writing, is dispatched before the deadline expires; 3. where the purchaser exercises the right provided for in the first indent of paragraph 1, he may be required to defray, where appropriate, only those expenses which, in accordance with national law, are incurred as a result of the conclusion of and withdrawal from the contract and which correspond to legal formalities which must be completed before the end of the period referred to in the first indent of paragraph 1. Such expenses shall be expressly mentioned in the contract; 4. where the purchaser exercises the right of cancellation provided for in the second indent of paragraph 1 he shall not be required to make any defrayal. Article 6 The Member States shall make provision in their legislation to prohibit any advance payments by a purchaser before the end of the period during which he may exercise the right of withdrawal. Article 7 The Member States shall make provision in their legislation to ensure that: - if the price is fully or partly covered by credit granted by the vendor, or - if the price is fully or partly covered by credit granted to the purchaser by a third party on the basis of an agreement between the third party and the vendor, the credit agreement shall be cancelled, without any penalty, if the purchaser exercises his right to cancel or withdraw from the contract as provided for in Article 5. The Member States shall lay down detailed arrangements to govern the cancellation of credit agreements. Article 8 The Member States shall make provision in their legislation to ensure that any clause whereby a purchaser renounces the enjoyment of rights under this Directive or whereby a vendor is freed from the responsibilities arising from this Directive shall not be binding on the purchaser, under conditions laid down by national law. Article 9 The Member States shall take the measures necessary to ensure that, whatever the law applicable may be, the purchaser is not deprived of the protection afforded by this Directive, if the immovable property concerned is situated within the territory of a Member State. Article 10 The Member States shall make provision in their legislation for the consequences of non-compliance with this Directive. Article 11 This Directive shall not prevent Member States from adopting or maintaining provisions which are more favourable as regards the protection of purchasers in the field in question, without prejudice to their obligations under the Treaty. Article 12 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 months after its publication in the Official Journal of the European Communities. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall include references to this Directive or shall accompany them with such references on their official publication. The Member States shall lay down the manner in which such references shall be made. 2. The 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 13 This Directive is addressed to the Member States.

31994L0053

1994

Commission Directive 94/53/EC of 15 November 1994 amending Article 2 of Commission Directive 93/91/EEC adapting to technical progress Council Directive 78/316/EEC on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (Identification of controls, tell-tales and indicators) Having regard to the Treaty establishing the European 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 Commission Directive 93/81/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 78/316/EEC of 21 December 1977 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (identification of controls, tell-tales and indicators) (3), as last amended by Commission Directive 93/91/EEC (4), and in particular Article 4 thereof, Whereas it is not essential that vehicles already type-approved in conformity with the provisions of Directive 78/316/EEC should be amended to conform to the provisions of Directive 93/91/EEC; Whereas, however, such conformity must be ensured for the new vehicle types for which EC type approval concerning identification of controls, tell-tales and indicators is required with effect from 1 October 1995; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 The third indent of Article 2 (2) of Directive 93/91/EEC shall be deleted, as well as the word 'and' at the end of the second indent and the comma at the end of the first indent, which shall be replaced by the word 'and'. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 March 1995. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 3. 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 shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0054

1994

Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), as last amended by Commission Directive 93/102/EC (2), and in particular Article 4 (2) thereof, Whereas, having regard to the scope and effects of the proposed action, the Community measures introduced by this Directive are essential if the objectives set are to be attained; whereas those objectives cannot be attained by the Member States acting individually; whereas, moreover, Directive 79/112/EEC already provides for the attainment of such objectives at Community level; Whereas, in order to ensure that consumers receive adequate information, it is necessary to provide for compulsory indication, for certain foodstuffs, of other particulars in addition to those provided for in Article 3 of Directive 79/112/EEC; Whereas packaging gases used in packaging certain foodstuffs should not be regarded as ingredients for the purposes of Article 6 (1) of Directive 79/112/EEC and therefore should not be included in the list of ingredients on the label; Whereas, however, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf-life than similar products packaged differently; Whereas, in order to prevent new barriers to trade being created by unilateral measures taken by Member States, it is necessary to adopt Community provisions; Whereas, in accordance with the procedure of Article 17 of Council Directive 79/112/EEC, this Directive was submitted to the Standing Committee for Foodstuffs which was unable to express an opinion; whereas, under the same procedure, the Commission submitted to the Council a proposal relating to the measures to be taken; Whereas, since the Council has not adopted any measures by the end of the three months it was given, the Commission should adopt the proposed measures, Article 1 Without prejudice to the provisions of Article 3 of Directive 79/112/EEC, the labelling of the foodstuffs listed in the Annex to this Directive shall include additional particulars, as set out in that Annex. Article 2 Member States shall, where necessary, amend their laws, regulations and administrative provisions by 30 June 1995 in such a way so as to: - permit trade in products complying with this Directive no later than 1 July 1995, - prohibit trade in products not complying with this Directive with effect from 1 January 1997; 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. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31994L0056

1994

COUNCIL DIRECTIVE 94/56/EC of 21 November 1994 establishing the fundamental principles governing the investigation of civil aviation accidents and incidents Having regard to the Treaty establishing the European Community, and in particular Article 84 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189c of the Treaty (3), Whereas a high general level of safety should be maintained in civil aviation in Europe and all efforts should be made to reduce the number of accidents and incidents; Whereas the expeditious holding of technical investigations of civil aviation accidents and incidents improves air safety in helping to prevent the occurrence of such accidents and incidents; Whereas account should be taken of the Convention on International Civil Aviation, signed in Chicago on 7 December 1994, which provides for implementation of the measures necessary to ensure the safe operation of aircraft; whereas particular account should be taken of Annex 13 to this Convention which lays down recommended international standards and practices for aircraft accident investigation; Whereas, according to the international standards in Annex 13, the investigation of accidents is to be carried out under the responsibility of the State where the accident occurs; Whereas if, in the case of serious incidents, investigation is not carried out by the State where the incident occurs, such investigation should be conducted by the State of registry; Whereas investigation of serious incidents should be carried out in a similar way to investigation of accidents; Whereas the scope of investigations must depend on the lessons which can be drawn from them for the improvement of safety; Whereas air safety requires investigations to be carried out in the shortest possible time, Whereas investigators should be able to accomplish their tasks unhindered; Whereas the Member States must, in compliance with the legislation in force as regards the powers of the authorities responsible for the judicial inquiry and, where appropriate, in close collaboration with those authorities, ensure that those responsible for the technical inquiry are allowed to carry out their tasks in the best possible conditions; Whereas investigation of accidents and incidents which have occurred in civil aviation should be carried out by or under the control of an independent body or entity in order to avoid any conflict of interest and any possible involvement in the causes of the occurrences being investigated; Whereas the body or entity should be suitably equipped and its tasks could include prevention activities; Whereas Member States should take measures to ensure mutual assistance, if required, in carrying out investigations; Whereas a Member State must be able to delegate the task of carrying out an investigation to another Member State; Whereas it is important for accident prevention to make public the findings of accident investigations in the shortest time possible; Whereas the particular nature of incidents should be taken into account when circulating the findings of investigations into them; Whereas the safety recommendations resulting from an accident or incident investigation should be duly taken into account by the Member States; Whereas the sole aim of the technical investigation is to draw lessons which could prevent future accidents and incidents and whereas therefore the analysis of the occurrence, the conclusions and the safety recommendations are not designed to apportion blame or liability, Article 1 Objective The purpose of this Directive is to improve air safety by facilitating the expeditious holding of investigations, the sole objective of which is the prevention of future accidents and incidents. Article 2 Scope 1. This Directive shall apply to investigations into civil aviation accidents and incidents which have occurred in the territory of the Community taking into account the international obligations of the Member States. 2. This Directive shall also apply outside the territory of the Community to: (i) investigations into accidents involving aircraft registered in a Member State, when such investigations are not carried out by another State; (ii) investigations into serious incidents involving aircraft registered in a Member State or operated by an undertaking established in a Member State, when such investigations are not carried out by another State. Article 3 Definitions For the purposes of this Directive: (a) ‘accident’ means an occurrence associated with the operation of an aircraft which takes place between the time any person boards the aircraft with the intention of flight until such time as all such persons have disembarked, in which: 1. a person is fatally or seriously injured as a result of: — being in the aircraft, or — direct contact with any part of the aircraft, including parts which have become detached from the aircraft, or — direct exposure to jet blast, except when the injuries are from natural causes, self-inflicted or inflicted by other persons, or when the injuries are to stowaways hiding outside the areas normally available to the passengers and crew; or 2. the aircraft sustains damage or structural failure which: — adversely affects the structural strength, performance or flight characteristics of the aircraft, and — would normally require major repair or replacement of the affected component, except for engine failure or damage, when the damage is limited to the engine, its cowlings or accessories; or for damage limited to propellers, wing tips, antennas, tyres, brakes, fairings, small dents or puncture holes in the aircraft skin; 3. the aircraft is missing or is completely inaccessible; (b) ‘serious injury’ mens an injury which is sustained by a person in an accident and which: 1. requires hospitalization for more than 48 hours, commencing within seven days from the date the injury was received; or 2. results in a fracture of any bone (except simple fractures of fingers, toes, or nose); or 3. involves lacerations which cause severe haemorrhage, nerve, muscle or tendon damage; or 4. involves injury to any internal organ; or 5. involves second or third degree burns, or any burns affecting more than 5% of the body surface; or 6. involves verified exposure to infectious substances or harmful radiation; (c) ‘fatal injury’ means an injury which is sustained by a person in an accident and which results in his/her death within 30 days of the date of the accident; (d) ‘causes’ means actions, omissions, events or conditions, or a combination thereof, which led to the accident or incident; (e) ‘investigation’ means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of cause(s) and, when appropriate, the making of safety recommendations; (f) ‘investigator-in-charge’ means a person charged, on the basis of his qualifications, with responsibility for the organization, conduct and control of an investigation; (g) ‘flight recorder’ means any type of recorder installed in the aircraft for the purpose of facilitating accident/incident investigations; (h) ‘undertaking’ means any natural person, any legal person, whether profit-making or not, or any official body whether having its own legal personality or not; (i) ‘operator’ means any person, body or undertaking operating or proposing to operate one or more aircraft; (j) ‘incident’ means an occurrence, other than an accident, associated with the operation of an aircraft which affects or would affect the safety of operation; (k) ‘serious incident’ means an incident involving circumstances indicating- that an accident nearly occurred (a list of examples of serious incidents can be found in the Annex); (l) ‘safety recommendation’ means any proposal by the investigating body of the State conducting the technical investigation, based on information derived from that investigation, made with the intention of preventing accidents and incidents. Article 4 Obligation to investigate 1. Every accident or serious incident shall be the subject of an investigation. However, Member States may take measures to enable incidents not covered by the first subparagraph to be investigated when the investigating body may expect to draw air safety lessons from it. 2. The extent of investigations and the procedure to be followed in carrying out such investigations shall be determined by the investigating body, taking into account the principles and the objective of this Directive and depending on the lessons it expects to draw from the accident or serious incident for the improvement of safety. 3. The investigations referred to in paragraph 1 shall in no case be concerned with apportioning blame or liability. Article 5 Status of investigation 1. Member States shall define, in the framework of their respective internal legal systems, a legal status of the investigation that will enable the investigators-in-charge to carry out their task in the most efficient way and within the shortest time. 2. In accordance with the legislation in force in the Member States and, where appropriate, in cooperation with the authorities responsible for the judicial inquiry, the investigators shall be authorized inter alia to: (a) have free access to the site of the accident or incident as well as to the aircraft, its contents or its wreckage; (b) ensure an immediate listing of evidence and controlled removal of debris, or components for examination or analysis purposes; (c) have immediate access to and use of the contents of the flight recorders and any other recordings; (d) have access to the results of examination of the bodies of victims or of tests made on samples taken from the bodies of victims; (e) have immediate access to the results of examinations of the people involved in the operation of the aircraft or of tests made on samples taken from such people; (f) examine witnesses; (g) have free access to any relevant information or records held by the owner, the operator or the manufacturer of the aircraft and by the authorities responsible for civil aviation or airport operation. Article 6 Investigating body or entity 1. Each Member State shall ensure that technical investigations are conducted or supervised by a permanent civil aviation body or entity. The body or entity concerned shall be functionally independent in particular of the national aviation authorities responsible for airworthiness, certification, flight operation, maintenance, licensing, air traffic control or airport operation and, in general, of any other party whose interests could conflict with the task entrusted to the investigating body or entity. 2. Notwithstanding paragraph 1, the activities entrusted to this body or entity may be extended to the gathering and analysis of air safety related data, in particular for prevention purposes, in so far as these activities do not affect its independence and entail no responsibility in regulatory, administrative or standards matters. 3. The body or entity referred to in paragraph 1 shall be given the means required to carry out its responsibilities independently of the authorities referred to in paragraph 1 and should be able to obtain sufficient resources to do so. Its investigators shall be afforded status giving them the necessary guarantees of independence. It shall comprise at least one investigator able to perform the function of investigator-in-charge in the event of an aircraft accident or serious incident. 4. If necessary, the body or entity may request the assistance of bodies or entities from other Member States to supply: (a) installations, facilities and equipment for: — the technial investigation of wreckage and aircraft equipment and other objects relevant to the investigation, — the evaluation of information from flight recorders, and — the computer storage and evaluation of air accident data. (b) accident investigation experts to undertake specific tasks but only when an investigation is opened following a major accident. When available, such assistance should, as far as possible, be free of charge. 5. A Member State may delegate the task of carrying out an investigation into an accident or incident to another Member State. Article 7 Accident report 1. Any investigation into an accident shall be the subject of a report in a form appropriate to the type and seriousness of the accident. The report shall state the sole objective of the investigation as referred to in Article 1 and contain, where appropriate, safety recommendations. 2. The investigating body or entity shall make public the final accident report in the shortest possible time, and if possible within 12 months of the date of the accident. Article 8 Incident report 1. Any investigation into an incident shall be the subject of a report in a form appropriate to the type and seriousness of the incident. The report shall, where appropriate, contain relevant safety recommendations. The report shall protect the anonymity of the persons involved in the incident. 2. The incident report shall be circulated to the parties likely to benefit from its findings with regard to safety. Article 9 Safety recommendations The reports and the safety recommendations referred to in Articles 7 and 8 shall be communicated to the undertakings or national aviation authorities concerned and copies forwarded to the Commission. Member States shall take the necessary measures to ensure that the safety recommendations made by the investigating bodies or entities are duly taken into consideration, and, where appropriate, acted upon without prejudice to Community law. Article 10 A safety recommendation shall in no case create a presumption of blame or liability for an accident or incident. Article 11 Council Directive 80/1266/EEC of 16 December 1980 on future cooperation and mutual assistance between the Member States, in the field of air accident investigation (4) is hereby repealed. Article 12 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 21 November 1994. They shall forthwith inform the Commission thereof. 2. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 13 This Directive is addressed to the Member States.

31994L0055

1994

Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), (1) Whereas, over the years, both the national and the international transport of dangerous goods by road have significantly increased, adding to the dangers in the event of an accident; (2) Whereas all Member States except Ireland are Contracting Parties to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), the geographical scope of which extends beyond the Community and which lays down uniform rules for the safe international transport of dangerous goods by road; whereas it is consequently desirable that such rules be extended to cover national traffic in order to harmonize across the Community the conditions under which dangerous goods are transported by road; (3) Whereas no Community legislation embraces the full range of measures required to ensure the safe transport of dangerous goods and the relevant national measures vary from one Member State to another; whereas those divergences are an obstacle to the free provision of transport services and, moreover, to the free movement of vehicles and transport equipment; whereas in order to overcome that obstacle uniform rules applicable to all intra-Community transport should be defined; (4) Whereas an action of this nature must be carried out at Community level to ensure consistency with other Community legislation, to ensure a satisfactory degree of harmonization to facilitate the free movement of goods and services and to ensure a high level of safety for national and international transport operations; (5) Whereas the provisions of this Directive are without prejudice to the commitment entered into by the Community and its Member States, in accordance with the goals set under Agenda 21, Chapter 19, at the Unced conference of June 1992 in Rio de Janeiro, to strive for the future harmonization of systems for the classification of dangerous substances; (6) Whereas no specific Community legislation yet governs the safety conditions under which biological agents and genetically modified micro-organisms, regulated under Council Directives 90/219/EEC (4), 90/220/EEC (5) and 90/679/EEC (6), should be transported; (7) Whereas this Directive takes account of other Community policies in the fields of worker safety, vehicle construction and environmental protection; (8) Whereas the Member States remain free to regulate any operation for the transport of dangerous goods carried out within their territory by a vehicle not covered by the Directive regardless of where the vehicle is registered; (9) Whereas the Member States must be able to apply specific road-traffic regulations to the transport of dangerous goods within their territories; (10) Whereas the Member States must be able to maintain their quality-control requirements as regards certain national transport operations until the Commission reports to the Council on these matters; (11) Whereas the provisions of the ADR authorize the conclusion of agreements derogating therefrom, and whereas the large number of agreements concluded bilaterally between Member States impedes the free provisions of dangerous-goods transport services; whereas including the necessary provisions in the Annexes to this Directive should overcome the need for such derogations; whereas provision should be made for a transitional period during which the Member States may continue to apply existing agreements amongst themselves; (12) Whereas it is necessary to transpose into Community law the provisions of the ADR, including the requirements concerning the construction of vehicles transporting dangerous goods; whereas, in this context, provision should be made for a transitional period so that the Member States may temporarily maintain certain specific national provisions on construction requirements for nationally registered vehicles; (13) Whereas existing information procedures in the field of related national legislative proposals must be used in order to increase transparency for all economical operators; (14) Whereas as regards national transport, the Member States must retain the right to apply rules complying with the United Nations multimodal Recommendations on the Transport of Dangerous Goods, in so far as the ADR is not yet harmonized with those rules, the purpose of which is to facilitate the inter-modal transport of dangerous goods; (15) Whereas the Member States must be able to regulate or prohibit the transport by road of certain dangerous goods within their territories, but only for reasons other than transport safety; whereas in this context the Member States may retain the right in the case of certain transports of very dangerous substances to impose the use of transport by rail or inland waterway or may maintain very specific packaging for certain very dangerous substances; (16) Whereas for the purposes of this Directive the Member States must be able to apply more stringent or more lenient rules to certain transport operations performed within their territories by means of vehicles registered there; (17) Whereas the harmonization of conditions should take account of specific national circumstances and therefore this Directive must be sufficiently flexible in providing the Member States with the possibility of granting certain derogations; whereas the application of new technological and industrial developments must not be impeded and provision must therefore be made for temporary derogations; (18) Whereas vehicles registered in non-member countries must be allowed to perform international transport within the territories of Member States if they comply with the ADR; (19) Whereas it must be possible to adapt this Directive rapidly to technical progress, in order to take account of new provisions incorporated in the ADR and to decide upon the application and implementation of emergency measures in the event of accidents or incidents; whereas a committee should be created for that purpose and a procedure should be established for close cooperation between the Member States and the Commission within that committee; (20) Whereas the Annexes to this Directive contain provisions covering the vocational training of certain drivers of vehicles transporting dangerous goods by road; whereas, therefore, Council Directive 89/684/EEC of 21 December 1994 on vocational training for certain drivers of vehicles carrying dangerous goods by road (7) should be repealed, CHAPTER I Scope, definitions and general provisions Article 1 1. This Directive shall apply to the transport of dangerous goods by road within or between Member States. It shall not apply to the transport of dangerous goods by vehicles belonging to or under the responsibility of the armed forces. 2. This Directive shall not, however, affect the Member States' right, with due regard to Community law, to lay down requirements as regards: (a) the national and international transport of dangerous goods within their territories performed by vehicles not covered by this Directive, (b) road-traffic regulations specific to the national and international transport of dangerous goods; (c) quality controls on undertakings, in accordance with ISO standards 9001 and 9002, where they carry out national transport operations involving: (i) explosive substances and article in Class 1, where the quantity of explosive substance contained per transport unit exceeds: - 1 000 kg for division 1.1, or - 3 000 kg for division 1,2, or - 5 000 kg for divisions 1.3 and 1.5; (ii) the following very dangerous substances in tanks or in tank-containers of a total capacity exceeding 3 000 litres: - substances of Class 2 - gas classified under (at) (bt) (b) (ct) (c) - deeply refrigerated liquified gases of 7° (b) and 8° (b), - substances of Classes 3, 4.1, 4.2, 4.3, 5.1, 5.2, 6.1 and 8 - not listed under (b) or (c) in those classes, or - listed therein but having a hazard code with three or more significant digits (not including any zero); (iii) the following packages of Class 7 (radioactive materials): packages of fissile materials, packages of type B (U), packages of type B (M). The scope of the national provisions concerning these requirements may not be extended. The provisions in question shall cease to apply if similar measures are made obligatory under Community provisions. Before 31 December 1998 the Commission shall submit to the Council a report assessing the safety aspects covered by this provision together with an appropriate proposal for its continuation or repeal. Article 2 For the purposes of this Directive: - 'ADR` shall mean the European Agreement concerning the International Carriage of Dangerous Goods by Road, concluded at Geneva on 30 September 1957, as amended, - 'vehicle` shall mean any motor vehicle intended for use on the road, being complete or incomplete, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails, and of agricultural and forestry tractors and all mobile machinery, - 'dangerous goods` shall mean those substances and articles the transport of which by road is prohibited or authorized only in certain circumstances by Annexes A and B to this Directive, - 'transport` shall mean any road transport operation performed by a vehicle wholly or partly on public roads within the territory of a Member State, including the activity of loading and unloading, covered by Annexes A and B, without prejudice to the arrangements laid down by the laws of the Member States concerning liability in respect of such operations. It shall not include transport wholly performed within the perimeter of an enclosed area. Article 3 1. Without prejudice to Article 6, dangerous goods the transport of which is prohibited by Annexes A and B to this Directive shall not be transported by road. 2. Save as otherwise provided in this Directive, the transport of other dangerous goods listed in Annex A shall be authorized subject to compliance with the conditions imposed in Annexes A and B, in particular as regards: (a) the packaging and labelling of the goods in question; and (b) the construction, equipment and proper operation of the vehicle carrying the goods in question. CHAPTER II Derogations, restrictions and exemptions Article 4 Solely for the purposes of national transport operations performed by vehicles registered within its territory each Member State may retain provisions of its national law on the transport of dangerous goods by road which are consistent with the UN Recommendations on the Transport of Dangerous Goods until Anexes A and B to this Directive are revised to reflect those recommendations. The Member States concerned shall inform the Commission accordingly. Article 5 1. Without prejudice to other Community legislation, in paticular that on market access, each Member State shall retain the right, strictly for reasons other than safety during transport, such as reasons of national security or environmental protection, to regulate or prohibit the transport of certain dangerous goods within its territory. 2. Any rules imposed by a Member State on vehicles performing internaitonal transport through its territory and authorized by Marginal 10 599 of Annex B shall be limited in scope locally, shall apply to both national and international transport and may not result in any discrimination. 3. (a) Each Member State may apply more stringent provisions concerning transport, with the exception of construction requirements, performed by vehicles registered or put into circulation within its territory. (b) The Member States may, however, maintain specific national provisions on the centres of gravity of tank-vehicles registered within their territories until the amendment, if any, of Marginal 211 128 of Annex B to this Directive, but not, in any event, after 31 December 1998. 4. If a Member State considers that the safety provisions applicable have been found to be insufficient, on the occasion of an accident or an incident, to limit the hazards involved in transport and if there is an urgent need to take action, it shall notify the Commission, at the planning stage, of the measures which it proposes to take. Acting in accordance with the procedure laid down in Article 9, the Commission shall decide whether the implementation of those measures should be authorized and determine their duration. 5. The Member States may maintain any national provisions applicable on 31 December 1996 with regard to: - the transport of Class 1.1 substances, - the transport of toxic, unstable and/or flammable gases of Class 2, - the transport of substances containing dioxins or furans, - the transport in tanks or tank-containers of more than 3 000 litres of liquids of Classes 3, 4.2, 4.3, 5.1, 6.1 or 8 which do not appear under (b) or (c) in these classes. Such provisions may concern only: - the prohibition of such transport operations by road where it is possible for them to be carried out by rail or by inland waterway, - a requirement to follow certain preferred routes, - any other provisions concerning the packaging of substances containing dioxins or furans. These provisions may not be extended or made more stringent. The Member States shall communicate these national provisions to the Commission, which shall inform the other Member States accordingly. Article 6 1. Each Member State may authorize the transport by road within its territory of dangerous goods classified, packaged and labelled in accordance with the international requirements for maritime or air transport whenever the transport operation involves a sea or air voyage. 2. Any provisions in Annexes A and B concerning the use of languages in relevant marking or documentation shall not apply to transport operations confined to the territory of a single Member State. Member States may authorize the use of languages other than those provided for in the Annexes for transport operations performed within their territories. 3. Within its territory each Member State may authorize the use of vehicles constructed before 1 January 1997 which do not comply with this Directive but were constructed in accordance with the national requirements in force on 31 December 1996 provided that such vehicles are maintained to the required safety levels. 4. Each Member State may maintain provisions of national legislation in force on 31 December 1996 relating to the construction, use and conditions of carriage of new receptacles within the meaning of Marginal 2 212 of Annex A and new tanks which do not comply with Annexes A and B, until references to standards for the construction and use of tanks and receptacles with the same binding force as the provisions of this Directive are added to Annexes A and B and in any event no later than 31 December 1998. Receptacles and tanks constructed before 1 January 1999 and maintained to the required safety levels may continue to be used under the original conditions. 5. Each Member State may maintain national provisions other than those set out in Annexes A and B with regard to the reference temperature for the transport within its territory of liquified gases or mixtures of liquified gases until provisions relating to appropriate reference temperatures for designated climatic areas are incorporated into European standards and references to those standards are added to Annexes A and B. 6. Each Member State may allow the use, for transport within its territory, of packagings constructed but not certified in accordance with the ADR before 1 January 1997 provided that such packaging shows the date of manufacture and is capable of passing the tests laid down in national legislation in force on 31 December 1996 and provided that all such packagings are maintained to the relevant safety levels (including testing and inspection where required), in accordance with the following scheme: intermediate metal bulk containers and metal drums exceeding 50 litres in capacity, for up to 15 years after their date of manufacture; other metal packagings and all plastics packagings, for up to five years after their date of manufacture; other metal packagings and all plastics packagings, for up to five years after their date of manufacture but not after 31 December 1998. 7. Each Member State may allow the transport within its territory of certain dangerous goods packaged before 1 January 1997 until 31 December 1998, provided that the goods are classified, packaged and labelled in accordance with the requirements of national legislation in force before 1 January 1997. 8. Each Member State may maintain provisions of national legislation in force on 31 December 1996 relating to the display of an emergency action code in place of the hazard identification number provided for in Annex B for transport operations performed within its territory by vehicles registered within that territory. 9. Each Member State may, after consulting the Commission, maintain provisions less stringent than those set out in Annexes A and B to this Directive for the transport within its territory of small quantities of certain dangerous goods, with the exception of substances having a medium or high level of radioactivity. 10. Provided that safety is not compromised, the Member States may grant temporary derogations from Annexes A and B for the purpose of carrying out within their territories the trials necessary before the amendment of those Annexes to adapt them to technological and industrial developments. The Commission shall be informed thereof and shall inform the other Member States accordingly. A temporaty derogation agreed on between Member States' competent authorities on the basis of Marginals 2 010 and 10 602 of Annexes A and B shall take the form of a multilateral agreement proposed to all Member States' competent authorities by the authority taking the initiative in respect of the agreement. The Commission shall be informed accordingly. Any derogation such as referred to in the first and second subparagraphs shall be applied without discrimination on grounds of the nationality or the place of establishment of the consignor, haulier or consignee; they may last for up to five years and shall not be renewable. 11. Each Member State may authorize single transports of dangerous goods which are either prohibited by Annexes A and B or performed under conditions different from those laid down in Annexes A and B. 12. Without prejudice to paragraph 2, each Member State may until 31 December 1998 at the latest apply existing agreements with other Member States that comply with the ADR, without discrimination on grounds of the nationality or the place of establishment of the consignor, haulier or consignee. Any other derogation authorized by Marginals 2 010 and 10 602 of Annexes A and B shall comply with paragraph 10. Article 7 Subject to national or Community provisions on market access, vehicles registered or put into circulation in non-member countries shall be authorized to perform the international transport of dangerous goods within the Community if the transport in question complies with the ADR. CHAPTER III Final privisions Article 8 The amendments necessary to adapt Annexes A and B to scientific and technical progress in the fields covered by this Directive in order to take account of amendments to the Annexes to the ADR shall be adopted in accordance with the procedure laid down in Article 9. Article 9 1. The Commission shall be assisted by a committee on the transport of dangerous goods, hereinafter referred to as 'the Committee`, which shall consist of representatives of the Member States and be chaired by a representative of the Commission. 2. 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 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 Committee's opinion. (b) If the measures envisaged are not in accordance with the Committee's opinion 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 the Council does not act within three months of the date of referral to the Council the Commission shall adopt the proposed measures. Article 10 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive before 1 January 1997. They shall forthwith inform the Commission thereof. When the Member States adopt those measures they shall include references or shall accompany them with such references on their official publication. The Member States shall lay down the manner in which such references shall be made. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 11 1. Directive 89/684/EEC is hereby repealed as from the deadline for the transposition of this Directive into national legislation. 2. Provisional certificates issued by the Member States in accordance with Article 4 (2) of that Directive for national transport only shall remain valid until 31 December 1996. Certificates issued in accordance with Article 4 (4) of that Directive may continue to be used until the end of their period of validity, but not later than 1 July 1997 for dangerous goods transported in tanks or for explosives and not later than 1 January 2000 for other dangerous goods. Article 12 This Directive is addressed to the Member States.

31994L0058

1994

Council Directive 94/58/EC of 22 November 1994 on the minimum level of training of seafarers Having regard to the Treaty establishing the European Community, and in particular Article 84 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189c of the Treaty (3), Whereas in its conclusions of 25 January 1993 on maritime safety and pollution prevention in the Community, the Council noted the importance of the human element in the safe operation of ships; Whereas in its resolution of 8 June 1993 on a common policy on safe seas (4), the Council set the objective of removing substandard crews and gave priority to Community action aiming at enhancing training and education by developing common standards for minimum training levels of key personnel, including the question of a common language on board Community vessels; Whereas the standards of training for the award of vocational competency certificates to seafarers vary from one Member State to another; whereas such a diversity of national laws in the area of training covered by this Directive does not ensure the consistent level of training required in the interests of maritime safety; Whereas Council Directive 89/48/EEC (5) and 92/51/EEC (6) on the general systems for the recognition of professional education and training apply to maritime occupations covered by this Directive; whereas they will help promote compliance with the obligations laid down in the Treaty abolishing obstacles to the free movement of persons and services between Member States; Whereas the mutual recognition of diplomas and certificates provided for under the general systems Directives does not always ensure a standardized level of training for all seafarers serving on board vessels flying the flag of a Member State including ships registered in Euros once that register is approved by the Council; whereas this is, however, vital from the viewpoint of maritime safety; Whereas it is therefore essential to define a minimum level of training for seafarers in the Community; whereas it is appropriate that the action in this field should be based on the standards of training already agreed at international level, namely the IMO Convention on Standards of Training, certification and Watchkeeping for Seafarers, 1978, (STCW Convention); whereas all Member States are parties to that Convention; Whereas the amendment to STCW of 22 May 1991 (Resolution MSC 21 (59)) introduces the function of radio operator in order to conform to the GMDSS-requirements; Whereas in order to enhance maritime safety and prevent loss of human life and maritime pollution, communication among crew members on board ships sailing in Community waters should be improved; Whereas personnel on board passenger ships nominated to assist passengers in emergency situations should be able to communicate with the passengers; whereas in this context, all relevant provisions of IMO Resolution A.770 (18) on minimum training requirements for personnel nominated to assist passengers in emergency situations on passenger ships should be taken into account; Whereas crews serving on board tankers carrying noxious or polluting cargo should be capable of coping efficiently with accident prevention and emergency situations; whereas it is paramount that a proper communication link between the master, officers and ratings is established, covering the requirements provided for in Article 8; Whereas Article 8 (3) is necessitated by the fact that the relevant standards, to be established through an amendment to the 1978 STCW Convention, have not yet been agreed in the IMO; Whereas measures should be taken to ensure that seafarers holding certificates issued by third countries have a level of competence commensurate with that required by the STCW Convention; Whereas in order to attain this objective, common criteria should be defined for the recognition of foreign certificates in the Community; whereas for this purpose, the Council should decide on the common criteria acting in accordance with the conditions of the Treaty; Whereas a committee should be established to assist the Commission in carrying out the tasks related to the exercise of the recognition of certificates issued by training institutes or administrations of third countries; Whereas measures should be taken for allowing seafarers serving on board ships flying the flag of a Member State, including ships registered in Euros once that register is approved by the Council, and holding certificates not issued according to this Directive, to continue their work during a transitional period up to and beyond the adoption of the common criteria; Whereas Member States, as port authorities, are required to enhance safety and prevention of pollution in Community waters through priority inspection of vessels flying the flag of a third country which has not ratified the STCW Convention, or which have crews holding certificates which have not been recognized under the provisions of this Directive, thereby ensuring no more favourable treatment to vessels flying the flag of a third State; Whereas it is necessary to provide for procedures for adapting the Directive to changes in international conventions and codes, Article 1 This Directive shall apply to seafarers as mentioned in this Directive serving on board seagoing ships flying the flag of a Member State with the exception of: - warships, naval auxiliaries or other ships owned or operated by a Member State and engaged only on government non-commercial service, - fishing vessels, - pleasure yachts not engaged in trade, - wooden ships of primitive build. Article 2 Member States shall take the measures necessary to ensure that masters, officers, ratings forming part of the navigational watch or the engine room watch and lifeboatmen, serving on a ship referred to in Article 1, are trained as a minimum in compliance with the requirements of the STCW Convention, as laid down in the Annex to this Directive, and hold a certificate as defined in Article 3. Article 3 A certificate shall be a valid document by whatever name it may be known, issued by or under the authority of the competent authority of a Member State, authorizing the holder to serve as stated in that document or as authorized by national regulations. Article 4 For the purpose of this Directive: (a) 'master` means the person having command of a ship; (b) 'officer` means a member of the crew, other than the master, designated as such by national law or regulations or, in the absence of such designation, by collective agreement or custom; (c) 'deck officer` means a qualified officer in the deck department; (d) 'chief mate` means the deck officer next in rank to the master and upon whom the command of a ship will fall in the event of the incapacity of the master; (e) 'engineer officer` means a qualified officer in the engine department; (f) 'chief engineer officer` means the senior engineer officer responsible for the mechanical propulsion of the ship; (g) 'second engineer officer` means the engineer officer next in rank to the chief engineer officer and upon whom the responsibility for the mechanical propulsion of the ship will fall in the event of the incapacity of the chief engineer officer; (h) 'assistant engineer officer` means a person under training to become an engineer officer and designated as such by national law or regulations; (i) 'radio operator` means a person holding an appropriate certificate related to the global maritime distress and safety system issued or recognized by the competent authority or body designated by a Member State under the provisions of the Radio Regulations; (j) 'rating` means a member of the ship's crew other than the master or an officer; (k) 'lifeboatman` means a Member of the ship's crew holding a certificate of proficiency in survival craft and rescue boats issued as a separate document or as included in his certificate of competency; (l) 'sea-going ship` means a ship other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply; (m) 'ship flying the flag of a Member State` means a ship registered in and flying the flag of a Member State in accordance with its legislation, including ships registered in Euros once that Register is approved by the Council. Ships not corresponding to this definition are assimilated to ships flying the flag of a third country; (n) 'near-coastal voyages` means voyages in the vicinity of a Member State as defined by that Member State; (o) 'propulsion power` means the power in kilowatts which appears on a ship's Certificate of Registry or other official document; (p) 'oil tanker` means a ship constructed and used for the carriage of petroleum and petroleum products in bulk; (q) 'chemical tanker` means a ship constructed and used for the carriage in bulk of any liquid chemical listed in the 'Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk` as it is in force at the time of adoption of this Directive; (r) 'liquefied gas tanker` means a ship constructed and used for the carriage in bulk of any liquefied gas listed in the 'Code for the Construction and Equipment of Ships carrying Liquefied Gases in Bulk` as it is in force at the time of adoption of this Directive; (s) 'Radio Regulations` means the revised radio regulations, adopted by the World Administrative Radio Conference for the Mobile Service; (t) 'passenger ship` means a sea-going ship which carries more than 12 passengers; (u) 'fishing vessel` means a vessel used for catching fish, whales, seals, walrus or other living resources of the sea; (v) 'STCW Convention` means the IMO International Convention on Standards of Training Certification and Watchkeeping for Seafarers, 1978, as it is in force at the time of adoption of this Directive. Article 5 The training required by Article 2 shall be in a form appropriate to the theoretical knowledge and practical skills required by the Annex to this Directive, in particular the use of life saving and firefighting equipment, and approved by the competent authority or body designated by each Member State. Article 6 1. In circumstances of exceptional necessity, competent authorities may, if in their opinion this does not cause danger to persons, property or the environment, issue a dispensation permitting a specified seafarer to serve in a specified ship for a specified period not exceeding six months in a capacity, other than that of the radio operator, except as provided by the relevant Radio Regulations, for which he does not hold the appropriate certificate, provided that the person to whom the dispensation is issued shall be adequately qualified to fill the vacant post in a safe manner to the satisfaction of the competent authorities. However, dispensations shall not be granted to a master or chief engineer officer, except in circumstances of force majeure and then only for the shortest possible period. 2.Any dispensation granted for a post shall be granted only to a person properly certificated to fill the post immediately below. Where certification of the post below is not required, a dispensation may be issued to a person whose qualification and experience are, in the opinion of the competent authorities, of a clear equivalence to the requirements for the post to be filled, provided that, if such a person holds no appropriate certificate, he or she shall be required to pass a test accepted by the competent authorities as demonstrating that such a dispensation may safely be issued. In addition, competent authorities shall ensure that the post in question is filled by the holder of an appropriate certificate as soon as possible. Article 7 Member States shall designate the authorities or bodies which shall: - give the training referred to in Article 5, - organize and/or supervise the examinations where required. The Member State shall ensure that all examiners are properly qualified, - issue the certificate of competence, - grant the dispensations provided for in Article 6. Article 8 Member States shall ensure that: 1. on board all ships flying the flag of a Member State and on all passenger ships starting and/or finishing a voyage in a Member State port, there are at any time means in place for effective oral communication related to the safety between all members of the ship's company particularly with regard to the correct and timely reception and understanding of messages and instructions. Furthermore, there should be adequate means for communication between the ship and the shore-based authorities, either in a common language or in the language of those authorities; 2. on board passenger ships, personnel nominated on muster lists to assist passengers in emergency situations are readily identifiable and have communication skills that are sufficient for that purpose, taking into account an appropriate and adequate combination of any of the following criteria: (a) the language or languages appropriate to the principal nationalities of passengers carried on a particular route; (b) the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language; (c) the possible need to communicate during an emergency by some other means (e. g. by demonstration, or hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes when verbal communication is impractical; (d) the extent to which complete safety instructions have been provided to passengers in their native language or languages; and (e) the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers; 3. on board oil tankers, chemical tankers and liquefied gas tankers flying the flag of a Member State, the master, officers and ratings are able to communicate with each other in (a) common working language(s). Furthermore, there should be adequate means for communication between the ship and the shore-based authorities either in a common language or in the language of those authorities; 4. when carrying out a ship inspection in their capacity of State of the port, Member States shall check that ships flying the flag of a State other than a Member State also comply with this Article. Article 9 1. Mutual recognition among Member States of certificates referred to in Article 3 held by seafarers who are nationals of Member States shall be subject to the provisions of Directives 89/48/EEC and 92/51/EEC. 2. Mutual recognition among Member States of certificates referred to in Article 3 held by seafarers who are not nationals of Member States shall also be subject to the provisions of Directives 89/48/EEC and 92/51/EEC. 3. Seafarers who do not possess the certificate provided for in Article 3, may be allowed to serve on ships flying the flag of a Member State provided a decision on the recognition of their type of certificate has been adopted through the procedure set out below: (a) A set of criteria for the recognition of types of certificates issued by institutes or administrations will be defined by the Council before 1 July 1995, acting in accordance with the conditions of the Treaty. (b) Member States shall notify the Commission and the other Member States of the types of certificates they have recognized or intend to recognize in compliance with the criteria mentioned under (a). (c) If, within a period of three months following that notification, an objection is raised by a Member State or the Commission on the basis of the criteria referred to in (a), the matter shall be submitted by the Commission to the procedure in Article 13. The Member State concerned shall take the appropriate measures to implement the decisions taken in accordance with the procedure in that Article. (d) The Commission shall draw up and update a list of the certificates notified by the Member States. The list shall be published in the Official Journal of the European Communities. 4. Seafarers who do not possess the certificates provided for in Article 3 but who are serving on a ship flying the flag of a Member State may be allowed to continue to serve on ships flying the flag of that Member State until two years after the common criteria provided for in paragraph 3 (a) have been fixed. After that date they shall possess either a type of certificate provided for in Article 3 or a type of certificate recognized in accordance with the procedure mentioned in paragraph 3 above. Article 10 Member States shall take the measures necessary to ensure that ships flying the flag of a third country which has not ratified the STCW Convention, or which have a master, officers and ratings holding certificates which have not been recognized under the provisions of Article 9, are inspected, as a matter of priority, by the competent authority of the port State to check whether the level of vocational training and competence of their crews meet the standards laid down in the STCW Convention and in Article 8. Article 11 Member States shall take appropriate steps, including the possible detention of a ship, if the competent authorities of the port State discover in the course of an inspection that crews are unable to provide proof of professional proficiency for the duties assigned to them for the safety of the ship and the prevention of pollution. Article 12 1. This Directive may be amended in accordance with the procedure laid down in Article 13, in order to apply, for the purposes of this Directive, subsequent amendments to the international codes referred to in Article 4 (q), (r) and (s) which have entered into force. 2. Following the adoption of new instruments or protocols to the STCW Convention referred to in Article 4 (v), the Council, acting on a proposal from the Commission, shall decide, taking into account the Member States' parliamentary procedures, as well as the relevant procedures within IMO on the detailed arrangements for ratifying those new instruments or protocols, while ensuring that they are applied uniformly and simultaneously in the Member States. Article 13 1. The Commission shall be assisted by a committee composed of 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. (c) If, on the expiry of eight weeks from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 14 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1995. 2. When Member States adopt these provisions they shall contain a reference to this Directive or shall be announced by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States 3. The Member States shall immediately communicate to the Commission the texts of all the provisions which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 15 This Directive is addressed to the Member States.

31994L0052

1994

Directive 94/52/EC of the European Parliament and of the Council of 7 December 1994 amending for the second time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas Directive 88/344/EEC (4), deleted from Part III of the Annex, as from 1 January 1994 the solvent cyclohexane, used in the preparation of flavourings; Whereas, on the basis of complementary information meanwhile received, the Scientific Committee for Food has decided to re-instate its previous temporary acceptance for this substance; whereas the use of the solvent can therefore be continued, pending the definitive opinion of that Committee, Article 1 The Annex to Directive 88/344/EEC is hereby amended as follows: in Part III: The solvent cyclohexane shall be reinstated with a maximum residue limit of 1mg/kg. Article 2 1. Member States shall amend their laws, regulations and administrative provisions in such a way as to permit trade in products complying with this Directive at the latest by 7 December 1995. They shall forthwith inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31994L0070

1994

Council Directive 94/70/EEC of 13 December 1994 amending Council Directive 92/120/EEC on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of certain products of animal origin Having regard to the Treaty establishing the European 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, under Directive 92/120/EEC of 17 December 1992 (4), the minimum output for slaughterhouses benefiting from the derogation was increased to 20 livestock units per week and 1 000 livestock units per year respectively, until 31 December 1994; Whereas the Commission has submitted to the Council a proposal the purpose of which is to review the provisions applicable to small establishments benefiting from the derogation and whereas the Council has been unable to act on the proposal by 31 December 1994; whereas that provision should therefore be maintained pending the Council's decision, Article 1 The date '31 December 1994' in Article 2 (2) of Directive 92/120/EEC shall be replaced by '28 February 1995'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 3 This Directive is addressed to the Member States.