Datasets:

eu_regulatory_ir

like 2

31984L0569

1984

Council Directive 84/569/EEC of 27 November 1984 revising the amounts expressed in ECU in Directive 78/660/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 78/660/EEC of 25 July 1978 based on Article 54 (3) (g) of the Treaty on the annual accounts of certain types of companies (1), and in particular Article 53 (2) thereof, Having regard to the proposal from the Commission, Whereas Regulation (EEC) No 3180/78 (2), as amended by Regulation (EEC) No 2626/84 (3), defined a new unit of account, known as the ECU; Whereas Regulation (EEC, Euratom) No 3308/80 (4) replaced 'European unit of account' by 'ECU' in all Community legal instruments applying at the time of its entry into force; Whereas Articles 11 and 27 of Directive 78/660/EEC and, by reference thereto, Article 6 of Directive 83/349/EEC (5) and Articles 20 and 21 of Directive 84/253/EEC (6) lay down limits in ECU for the balance sheet total and net turnover within which the Member States may grant certain derogations from the provisions of those Directives; Whereas Article 53 (2) of Directive 78/660/EEC stipulates that every five years the Council, acting on a proposal from the Commission, shall examine and, if need be, revise the amounts expressed in ECU in that Directive, in the light of economic and monetary trends in the Community; Whereas, when measured in real terms, the ECU has not retained the value it had at the time of the adoption of Directive 78/660/EEC; Whereas, to take account of monetary trends with relation to the ECU since that time, equivalents in national currency should be recalculated on the date fixed in Article 53 (2) of Directive 78/660/EEC, Article 1 Directive 78/660/EEC is hereby amended as follows: 1. In Article 11: - the first indent: 'balance sheet total: 1 000 000 ECU' is replaced by: 'balance sheet total: 1 550 000 ECU'; - the second indent: 'net turnover: 2 000 000 ECU' is replaced by 'net turnover: 3 200 000 ECU'; 2. In Article 27: - the first indent: 'balance sheet total: 4 000 000 ECU' is replaced by 'balance sheet total: 6 200 000 ECU'; - the second indent: 'net turnover: 8 000 000 ECU' is replaced by 'net turnover: 12 800 000 ECU'. 3. (a) Article 53 (1) is replaced by the following: '1. For the purpose of this Directive, the ECU shall be that defined by Regulation (EEC) No 3180/78 (1), as amended by Regulation (EEC) No 2626/84 (2). The equivalent in national currency shall be calculated at the rate obtaining on 25 July 1983.'; (b) Footnote (1) shall be replaced by the following footnotes: '(1) OJ No L 379, 30. 12. 1978, p. 1. (2) OJ No L 247, 16. 9. 1984, p. 1.' Article 2 Member States shall forthwith inform the Commission of any laws, regulations or administrative provisions which they bring into force pursuant to this Directive. Article 3 This Directive is addressed to the Member States.

31984L0587

1984

Council Directive 84/587/EEC of 29 November 1984 amending Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the application of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (4), as last amended by the 46th Commission Directive 84/547/EEC (5), has revealed a need to redefine certain fundamental concepts so as to take account of scientific and technical developments and satisfy the imperative need to ensure the best possible protection of animal health, human health and the environment; Whereas experience has demonstrated, in particular, that the current rules on the use of additives in feedingstuffs have not afforded the required degree of safety; whereas it is therefore indispensable that additional measures be taken in connection with the production, marketing and distribution of additives and premixtures of additives; Whereas, to facilitate the application of the Directive, the list of definitions should be extended and certain definitions amended; whereas the concept of an additive should be more clearly defined in such a way that authorizations granted for the use of additives of certain categories refer to the specific preparations, which in future will be named in the Annexes; Whereas the interests of clarity call for a codification of the Annexes so that successive amendments made may be incorporated therein; Whereas the prohibitions on the use of mixtures of additives of certain categories should be extended so as to prevent the unfavourable effects which may arise from certain associations; Whereas, to ensure observance of the fundamental principles which must be obeyed if any new use of an additive is to be authorized, it is necessary - in the case of certain categories of additive - to require that a dossier be submitted officially by a Member State; whereas, to facilitate examination of the additives in question, dossiers must be drawn up in accordance with common guidelines to be determined by the Council; Whereas, for the purpose of identifying additives used in feedingstuffs, it is important that, in the case of antibiotics, coccidiostats and other medicinal substances, as also in that of growth promoters, a monograph be introduced indicating the criteria for the identification and characterization of each authorized additive; Whereas it is, moreover, necessary to introduce precise rules on the labelling of additives and premixtures marketed within the Community; Whereas it is appropriate that the production and use of antibiotics, coccidiostats and other medicinal substances, growth promoters and premixtures prepared from such additives for the purpose of incorporation in compound feedingstuffs be limited to those who have the competence and the appropriate installations and equipment for the manufacture of additives, premixtures or compound feedingstuffs and who are included on the list of manufacturers of a Member State; whereas these manufacturers and any intermediaries should, in addition, be required to maintain a register by means of which the competent authorities can effectively verify the identity and destination of the additives and premixtures produced; Whereas antibiotics, coccidiostats and other medicinal substances could, however, be the subject of provisions to be adopted concerning the application of Directives 81/851/EEC and 81/852/EEC (1) and of rules to be adopted relating to the free movement of medicated feedingstuffs; whereas such new provisions could give rise to the amendment of the rules on these products; Whereas additives authorized for use in human foodstuffs, other than those listed in the Annexes, are tolerated in animal feedingstuffs only where they are present purely due to the fact that they were contained in the edible part of the foodstuff used; whereas such additives must not fulfil any technological function in animal feedingstuffs or have any harmful effect on animal health, Article 1 1. Articles 1 to 16b of Directive 70/524/EEC are hereby replaced by the following: 'Article 1 This Directive shall apply to additives in feedingstuffs. Article 2 For the purposes of this Directive the following definitions shall apply: (a) Additives: substances, or preparations containing substances, other than premixtures referred to in (h) which, when incorporated in feedingstuffs, are likely to affect their characteristics or livestock production; (b) Feedingstuffs: 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; (c) Daily ration: the average total quantity of feedingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs; (d) Complete feedingstuffs: mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration; (e) Supplementary feedingstuffs: mixtures of feedingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if they are used in combination with other feedingstuffs; (f) Straight feedingstuffs: the various vegetable or animal products in their natural state, fresh or preserved, and products derived from the industrial processing thereof, as well as the various organic or inorganic substances, whether or not containing additives, intended as such for oral animal feeding; (g) Compound feedingstuffs: mixtures of products of vegetable or animal origin in their natural state, fresh or preserved, or products derived from the industrial processing thereof, or organic or inorganic substances, whether or not containing additives, for oral animal feeding in the form of complete feedingstuffs or supplementary feedingstuffs; (h) Premixtures: mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs; (i) Animals: animals belonging to species normally nourished and kept or consumed by man; (j) Pet animals: animals belonging to species normally nourished and kept, but not consumed, by man, except animals bred for fur. Article 3 1. Member States shall provide that, as regards feedingstuffs, only those additives listed in Annex I which comply with this Directive may be marketed and that they may be incorporated in feedingstuffs only subject to the requirements set out in that Annex. These additives may not be used in any other way for the purposes of animal feeding. 2. Member States shall, in particular, ensure that additives may be incorporated in straight feedingstuffs only as long as their use is expressly provided for in Annex I or Annex II. Article 4 1. By way of derogation from Article 3 (1), Member States may authorize the marketing and use, within their own territory, of: (a) additives listed in Annex II, provided that they comply with the provisions laid down for them by this Directive; (b) additives belonging to groups other than those listed in Annex I or Annex II, provided that tests have shown that the conditions set out in Article 7 (2) (A) are satisfied. This derogation shall not apply to substances having a hormonal or anti-hormonal effect. 2. Member States shall forward: - before 3 January 1985 the list of groups and additives authorized under paragraph 1 (b) to the other Member States and to the Commission, - before 3 December 1985 the documents justifying these authorizations with reference to the conditions set out in Article 7 (2) (A). Article 5 Before 3 December 1988 the national authorizations granted pursuant to Article 4 (1) (b) shall be decided on in accordance with the procedure laid down in Article 23. Article 6 1. The maximum and minimum contents listed in Annex I and Annex II shall refer to complete feedingstuffs with a moisture content of 12 % in so far as no special provisions are set forth in the said Annexes. If the substance permitted as an additive also exists in the natural state in certain ingredients of the feedingstuff, the amount of additive to be incorporated is calculated so that the total of the elements added and the elements present naturally does not exceed the maximum content provided for in Annexes I and II. 2. The mixing of additives named in this Directive shall be permitted in premixtures and feedingstuffs only where, in relation to the effects desired, there is physical and chemical compatibility between the components of the mixture. 3. Unless the mixture concerned is set out in Annex I or Annex II, Member States shall require that: (a) antibiotics and growth promoters may not be mixed together, either with substances from their own group or with substances from the other group; (b) coccidiostats may not be mixed with antibiotics and growth promoters where coccidiostats also act, for the same category of animal, as an antibiotic or as a growth promoter; (c) coccidiostats and other medicial substances may not be mixed together if their effects are similar. 4. Member States may, for experimental or scientific purposes, provide for derogations from the provisions of Article 3 or of paragraphs 2 or 3 of this Article on condition that there is adequate official supervision. Article 7 1. Amendments to be made to Annexes on account of the growth of scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 23. A codified version of the Annexes shall be adopted at regular intervals in accordance with the same procedure, the aim being to incorporate the successive amendments made pursuant to this paragraph. 2. When amendments are made to Annex I or Annex II, the following principles shall be applied: A. An additive shall be included in Annex I only if: (a) it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs; (b) at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock products; (c) its presence in feedingstuffs can be controlled; (d) at the level permitted in feedingstuffs, treatment or prevention of animal disease is excluded; this condition does not apply to substances of the kind listed in Annex I (D); (e) for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes. B. An additive shall be deleted from Annex I if any of the conditions listed under A is no longer satisfied. However, such an additive may be inserted in Annex II for a specified period, if as a minimum the conditions of subparagraph A (b) and (e) are always satisfied. C. A new additive or a new usage attributed to an additive may be inserted in Annex II only if the conditions stipulated under subparagraph A (b), (c) and (e) are satisfied and it can be assumed, taking into account available results, that the other conditions stipulated under subparagraph A are also satisfied. The length of time for which a new additive or new use is authorized must not exceed five years, from its being entered in that Annex. Article 8 1. When an additive belonging to the groups of "antibiotics", "coccidiostats" and "other medicinal substances" or "growth promoters" is added to Annex I or Annex II, a monograph indicating the identification process or the criteria for the identification and characterization of the additive, particularly its composition and degree of purity and its physico-chemical and biological properties, shall be drawn up by means of a Directive, taking account of scientific and technical knowledge, in accordance with the procedure laid down in Article 23. 2. By 31 December 1988 at the latest, monographs shall also be drawn up for such additives belonging to the groups referred to in paragraph 1 as are added to Annex I or Annex II before the date on which this Directive is adopted. 3. In accordance with paragraph 1, monographs may also be drawn up for additives belonging to groups other than those referred to in that paragraph. 4. The amendments to be made thereafter to the monographs as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 23. Article 9 1. For the purposes of checking whether the additives comply with the principles defined in Article 7 (2), Member States shall ensure that a dossier complying with paragraph 2 below is officially forwarded to the Member States and to the Commission. 2. The Council, acting on a proposal from the Commission, shall adopt, by means of a Directive, the guidelines for preparing the dossiers referred to in paragraph 1, so that these guidelines can be applied by 3 December 1986. The amendments to be made thereafter to the guidelines as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 23. 3. At the reasoned request of the applicant, Member States and the Commission shall ensure that any information which, if disseminated, could affect industrial or commercial property rights is kept confidential. Industrial and commercial secrecy shall not apply to: - the denomination and composition of the additive, - the physico-chemical and biological characteristics of the additive, - the interpretation of the pharmacological, toxicological and ecotoxicological data, - the analytical methods for monitoring the additive in the feedingstuffs. Article 10 Member States shall require that additives and premixtures may be marketed only in closed packages or closed containers. Member States shall require that packages or containers must be closed in such a way that the fastener is damaged on opening and cannot be re-used. Article 11 1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives listed in Annex I or its use in conditions which may be specified constitutes a danger to animal or human health or the environment although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision. 2. The Commission shall, as soon as possible, examine the grounds cited by the Member State concerned and consult the Member States within the Standing Committee for Feedingstuffs; it shall then deliver its opinion without delay and take the appropriate measures. 3. Should the Commission consider that amendments to the Directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of human or animal health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting these amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force. Article 12 1. Member States shall require that supplementary feedingstuffs, diluted as specified, may not contain levels of the additives named in this Directive which exceed those fixed for complete feedingstuffs. 2. Member States may require that the levels of antibiotics, coccidiostats and other medicinal substances, growth promoters, D vitamins and antioxidants in supplementary feedingstuffs may exceed the maximum levels fixed for complete feedingstuffs in the case of: (a) supplementary feedingstuffs which a Member State has authorized to be made available to all users, provided that their level of antibiotics, D vitamins or growth promoters does not exceed five times the fixed maximum level; (b) supplementary feedingstuffs which are intended for certain species of animal and which a Member State is permitted to authorize to be made available within its territory to all users because of special feeding systems, provided that their level does not exceed: - for antibiotics and growth promoters, 1 000 mg/kg and, provided that the use of these substances is permitted, 2 000 mg/kg in the case of cattle for fattening; - for antioxidants, coccidiostats and other medicinal substances, five times the fixed maximum level; - for D vitamins, 200 000 IU/kg. Member States shall prescribe that if, in the manufacture of supplementary feedingstuffs, recourse is had to the possibility referred to in (a), the possibility referred to in (b) may not be made use of at the same time. 3. Where paragraph 2 is invoked, Member States shall require that the feedingstuff has one or more compositional characteristics (as regards, for example, proteins or minerals) which in practice ensure that the level of additives fixed for complete feedingstuffs is not exceeded and that the feedingstuff is not used for other species of animal. Article 13 1. Member States shall require that antibiotics, coccidiostats and other medicinal substances and the growth promoters listed in Annex I or Annex II, premixtures prepared from these additives with a view to being incorporated in compound feedingstuffs and compound feedingstuffs containing these premixtures may only be put on the market under the conditions referred to in Annex III and, in particular, only if they have been produced by manufacturers found by at least one Member State to have fulfilled the minimum conditions laid down in Annex III. Moreover, in the case of additives, premixtures or compound feedingstuffs referred to in the first subparagraph produced in third countries with a view to being marketed in the Community, Member States shall stipulate that manufacturers have a representative established within the Community who fulfils the conditions laid down for him in Annex III. They shall require that the name of the representative established within the Community appears opposite the name of the manufacturer on the list referred to in paragraph 3. 2. Member States shall require that the additives referred to in paragraph 1 may be delivered at the final stage of marketing: - only to manufacturers of premixtures, and - in the form of premixtures, only to manufacturers of compound feedingstuffs who fulfil the minimum conditions set out in Annex III. 3. Each Member State shall publish annually and, at the latest by 30 November each year, the list of manufacturers of additives, premixtures and compound feedingstuffs who have, to the satisfaction of the Member State concerned, complied with the requirements listed in Annex III. It shall forward such list to the other Member States and to the Commission before 31 December each year. Any amendments made to these lists after 30 November shall be forwarded separately to the other Member States and to the Commission. 4. Member States shall require that the additives referred to in paragraph 1 may be incorporated in compound feedingstuffs only if they have been prepared in advance in the form of premixtures including a carrier. These premixtures may be incorporated in the compound feedingstuffs only in a proportion of at least 0,2 % by weight. However, Member States may permit premixtures to be incorporated in compound feedingstuffs in a lower proportion down to 0,05 %. 5. Member States may make paragraphs 1 and 2 applicable to carotenoids and xanthophylls and to trace elements and vitamins. Article 14 1. Member States shall require that additives listed in Annex I or Annex II may be marketed for use in feedingstuffs only if the following particulars, which must be clearly visible, readily legible and indelible and must place responsibility on the producer, packer, importer, seller or distributor established within the Community, are given on the package, the container or a label affixed thereto: A. for all additives: (a) the specific name of the additive, in accordance with Annexes I or II; (b) 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; (c) the net weight and, in the case of liquid additives, either the net volume or the net weight; B. in addition, for: (a) antibiotics, growth promoters, coccidiostats and other medicinal substances: 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 active substance level, expiry date of the guarantee or storage life from the date of manufacture, batch reference number and date of manufacture, the indication: "to be used exclusively by manufacturers of premixtures for compound feedingstuffs", together with the directions for use and, where appropriate, a safety recommendation regarding use in the case of additives which are the subject of special provisions in the "other provisions" column of the Annexes; (b) vitamin E: alpha-tocopherol level and expiry date of the guarantee of that level or storage life from the date of manufacture; (c) vitamins, other than vitamin E, provitamins and substances having a similar effect: active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture; (d) trace elements, colorants including pigments, preserving agents and other additives: active substance level; (e) with respect to the additives referred to in (b), (c) and (d), the indication: "to be used exclusively in the manufacture of feedingstuffs". 2. Member States shall require that the specific name of the additive may be accompanied: (a) by the trade name and the EEC number; (b) by 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 directions for use and, where appropriate, a safety recommendation regarding use in those cases where the last three indications are not required under paragraph 1 B (a). 3. Where Article 13 (5) is applied, Member States may require that the indication "to be used exclusively by manufacturers of premixtures" be mentioned. 4. Member States shall require that information other than that required or authorized pursuant to paragraphs 1, 2 and 3 may appear on packages, containers or labels, provided that they are clearly separated from the abovementioned marking particulars. Article 15 1. Member States shall require that premixtures may be marketed only if the following particulars, which must be clearly visible, readily legible and indelible and must place responsibility on the producer, packer, importer, seller or distributor established within the Community, are given on the package, the container or a label affixed thereto: A. for all premixtures: (a) the description "premixture"; (b) the indication "to be used exclusively in the manufacture of feedingstuffs", except for the premixtures referred to in B (a), directions for use, and any safety recommendations regarding the use of the premixtures; (c) the animal species or category of animals for which the premixture is intended; (d) 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; (e) the net weight and, in the case of liquids, either the volume or net weight; B. in addition, for the premixtures incorporating the additives listed below: (a) antibiotics, growth promoters, coccidiostats and other medicinal substances; the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the details on the label, specific name of the additive in accordance with Annexes I or II, active substance level and expiry date of the guarantee of that level, or storage life from the date of manufacture and the indication "to be used exclusively by manufacturers of compound feedingstuffs"; (b) substances having antioxidant effects: specific name of the additive in accordance with Annexes I or II, and active substance level, provided that a maximum level is fixed for complete feedingstuffs in Annexes I or II; (c) colorants, including pigments: specific name of the additive in accordance with Annexes I or II, and active substance level, provided that a maximum level is fixed for complete feedingstuffs in Annexes I or II; (d) vitamin E: specific name of the additive in accordance with Annexes I or II, alpha-tocopherol level and expiry date of the guarantee of that level or storage life from the date of manufacture; (e) vitamins other than vitamin E, provitamins and substances having a similar effect: specific name of the additive in accordance with Annexes I or II, active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture; (f) trace elements: specific name of the additive in accordance with Annexes I or II, and level of the various elements in so far as a maximum level is fixed for complete feedingstuffs in Annexes I or II; (g) preserving agents: specific name of the additive in accordance with Annexes I or II, and active substance level, provided that a maximum level is fixed for complete feedingstuffs in Annexes I or II; (h) other additives belonging to the groups referred to in (b) to (g) for which no maximum level is laid down and additives belonging to other groups provided for in Annexes I or II: specific name of the additive in accordance with Annexes 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. 2. Member States shall require that: (a) the specific name of additives authorized pursuant to Article 4 (1) (b) must be indicated on the package, the container or the label of premixtures. They may require that the active substance level of such additives must also be indicated; (b) the specific name of additives may be accompanied by the trade name; (c) the name of the producer of the additives referred to in paragraph 1 B (a) may be indicated in the labelling of premixtures. However, they may stipulate that this indication shall be compulsory; (d) the specific name of the additives listed in Annex I may be accompanied by the EEC number. 3. Where, pursuant to paragraph 1, the expiry date of the guarantee or storage life from the date of manufacture of several additives belonging to the same group or different groups has to be stated, Member States shall require that a single date of guarantee or a single reference to the storage life may be indicated for all the additives, namely the deadline which will be reached first. 4. Member States shall require that information other than that required or authorized pursuant to paragraphs 1 to 3 may appear on packages, containers or labels, provided that they are clearly separated from the abovementioned marking particulars. Article 16 1. Member States shall require that feedingstuffs incorporating the additives belonging to the groups listed below may be marketed only if the following particulars, which must be clearly visible, readily legible and indelible and must place responsibility on the producer, packer, importer, seller or distributor established within the Community, are given on the package, the container or a label affixed thereto: (a) for antibiotics, coccidiostats and other medicinal substances and growth promoters: specific name of the additive in accordance with Annexes I or II, active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture; (b) for substances having antioxidant effects: - in the case of pet foods: use of the words "with antioxidant" followed by the specific name of the additive in accordance with Annexes I or II, - in the case of compound feedingstuffs other than pet foods: specific name of the additive in accordance with Annexes I or II; (c) for colorants, including pigments provided that these are used for the coloration of feedingstuffs or animal products: - in the case of pet foods: use of the words "colorant" or "coloured with" followed by the specific name of the additive in accordance with Annexes I or II, - in the case of compound feedingstuffs other than pet foods: specific name of the additive in accordance with Annexes I or II; (d) for vitamin E: specific name of the additive in accordance with Annexes I or II, alpha-tocopherol level and the expiry date of the guarantee of that level or storage life from the date of manufacture; (e) for vitamins A and D: specific name of the additive, in accordance with Annexes I or II, active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture; (f) for copper: specific name of the additive in accordance with Annexes I or II, and the level expressed in Cu; (g) for preserving agents: - in the case of pet foods: use of the words "preservative" or "preserved with" followed by the specific name of the additive in accordance with Annexes I or II, - in the case of compound feedingstuffs other than pet foods: specific name of the additive in accordance with Annexes I or II. 2. In addition to the particulars provided for by paragraph 1, particulars concerning the proper use of the feedingstuffs may be laid down in Annexes I and II in accordance with the procedure provided for in Article 23. Member States shall require that these indications must appear on the package or the container or on a label affixed thereto. 3. The presence of trace elements other than copper and of vitamins other than vitamins A, D and E, provitamins and additives having a similar effect may be indicated if the amounts of these substances can be determined by official methods of analysis or, failing this, by valid scientific methods of analysis. In such cases the following details shall be given: (a) for trace elements other than copper: the specific name of the additive in accordance with Annexes I or II, and level of the various elements; (b) for vitamins other than vitamins A, D and E, provitamins and substances having a similar chemical effect: the specific name of the additive in accordance with Annexes I or II, active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture. 4. Member States shall require that the specific names of additives permitted under Article 4 (1) (b) must be specified on the package, container or label of the feedingstuffs. They may require that the active substance level must also be specified. 5. Member States shall require that: (a) the details provided for in paragraphs 1 to 4 shall be printed close to the particulars which have to appear on the package, container or the label affixed thereto in accordance with Community rules on feedingstuffs; (b) where a level or a quantity is stated pursuant to paragraphs 1 to 4, such statement shall refer to the amount of additive incorporated in the feedingstuff; (c) the details of additives referred to in paragraphs 1 to 4 may be accompanied by the EEC number or the trade name. 6. Where, pursuant to paragraph 1, the expiry date of the guarantee or storage life from the date of manufacture of several additives belonging to the same group or different groups has to be stated, Member States shall require that a single date of guarantee or a single reference to the storage life from the date of manufacture may be indicated for all the additives, namely the deadline which will be reached first. 7. In the case of feedingstuffs distributed by road tankers or similar vehicles or in bulk, the details provided for in paragraphs 1 to 4 shall be given in the accompanying document. Where small quantities intended for the end-user are involved, it shall be sufficient for such details to be conveyed to the purchaser by a suitable notice. 8. By way of derogation from paragraph 1 (b), (c) and (g) and until . . . (two years after the notification of this Directive) Member States may give permission for the indication of the specific name of substances having antioxidant effects, colorants and preservatives to be replaced by an indication of the name of the group of additives concerned accompanied by the word "authorized". 9. Member States shall require that, in the case of pet foods containing colorants, preservatives or substances having antioxidant effects and put up in packages having a net weight of not more than 10 kilograms, it shall be sufficient for the package to bear the words "coloured with", or "preserved with", or the words "with antioxidant" as appropriate, followed by the words "EEC additives", provided that: (a) the package, container or label bears a reference number by means of which the feedingstuff may be identified, and (b) the manufacturer gives, on request, the specific name, or names, of the additive or additives used. 10. Any reference to additives other than in the form provided for in this Directive shall be prohibited. Article 17 1. Without prejudice to the provisions of Directive 79/373/EEC (1), Member States shall require that supplementary feedingstuffs which contain additives in excess of the maximum levels fixed for complete feedingstuffs may be placed on the market only if the directions for use state, according to the species and age of the animal, the maximum quantity in grams or kilograms of supplementary feedingstuff to be given per animal per day. This information must be in accordance with the provisions of Annexes I or II. This provision shall not apply to products delivered to manufacturers of compound feedingstuffs or to their suppliers. 2. The declaration referred to in paragraph 1 shall be so formulated that, when it is correctly followed, the proportion of additives does not exceed the maximum level fixed for complete feedingstuffs. (1) OJ No L 86, 6. 4. 1979, p. 30. Article 18 Where feedingstuffs are marketed in other Member States the details referred to in Articles 14 to 17 shall be given in at least one of the official languages of the country of destination. Article 19 Member States shall ensure that additives, premixtures and feedingstuffs which conform to this Directive are subject only to the marketing restrictions provided for in this Directive. Article 20 Member States shall ensure that livestock products are not subject to any marketing restriction as a result of the application of this Directive. Article 21 1. Member States shall in particular take all necessary measures to ensure that additives, premixtures and feedingstuffs put on the market are officially checked, at least by random sampling, in respect of the identity of the additives used and to verify that the other conditions laid down in this Directive are satisfied. To this end, they shall require in particular that undertakings which intend to manufacture additives or to put them on the market must first inform the competent authorities thereof. 2. Under the procedure provided for in Article 23, margins of tolerance may be fixed, to be allowed where there is a discrepancy between the result of the official check and the stated content of the additive in the compound feedingstuff. Article 22 This Directive shall not apply to additives, premixtures and feedingstuffs which are shown, at least by an appropriate indication, to be for export to third countries. Article 23 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay be the chairman, either on his own initiative or at the request of a Member State, to the Standing Committee for Feedingstuffs, hereinafter called "the Committee". 2. The votes of the Member States within the Committee shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within a time limit set by the chairman according to the urgency of the matters. Opinions shall be delivered by a majority of 45 votes. 4. The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority. If the Council has not adopted any measures within three months of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures. Article 24 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee without delay by the chairman, either on his own initiative or at the request of a Member State. 2. The votes of the Member States within the Committee shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within two days. Opinions shall be delivered by a majority of 45 votes. 4. The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority. If the Council has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures. Article 25 A decision on the transfer of antibiotics, coccidiostats and other medicinal substances, together with preparations based on these products, to Directive 81/851/EEC and to future rules on medicinal feedingstuffs shall be adopted by the Council acting unanimously on a proposal from the Commission once the degree of harmonization with regard to the free movement of products in the sector of veterinary medicinal products and medicated feedingstuffs has reached a level comparable to that obtaining with regard to additives.' 2. Articles 17 and 18 of Directive 70/524/EEC shall become Articles 26 and 27 respectively. 3. The following Annex shall be added to Directive 70/524/EEC: "ANNEX III Minimum conditions which must be fulfilled by manufacturers of the additives, premixtures and compound feedingstuffs referred to in Article 13 and intermediaries 1. The manufacturer must possess the appropriate facilities and technical equipment for the manufacture and storage of additives, premixtures or compound feedingstuffs containing those premixtures. 2. The manufacturer or his staff must possess the skills necessary for the manufacture of additives, premixtures or compound feedingstuffs. 3. The manufacturer must have access to appropriate means enabling him to ensure: (a) in the case of additives: that they conform to the provisions of this Directive; (b) in the case of premixtures: the nature and level of the different additives, and the homogeneity and stability of additives in the premixtures; (c) in the case of compound feedingstuffs: the nature and level of the additives and the homogeneous mixing of those additives in the compound feedingstuff. 4. Additives intended for the manufacture of premixtures and premixtures intended for incorporation in compound feedingstuffs shall be stored in such a way as to enable them to be easily identified and to avoid any confusion with other additives, premixtures or medicinal substances, medicated feedingstuffs or feedingstuffs. They shall be stored in suitable places, which can be locked and which are intended for the storage of these products. 5. The manufacturer or, if the manufacturer is established in a third country, his agent established in the Community must record the following information: (a) for additives: the nature, quantity of additives produced and the respective dates of manufacture, and the names and addresses of the manufacturers of premixtures or intermediaries to whom the additives have been delivered with an indication of the nature and quantity of additive delivered; (b) for premixtures: the name of the manufacturers and the suppliers, the nature and quantity of the additives used, the date of manufacture, the name and address of the compound feedingstuff manufacturers or intermediaries for whom the premixture is intended and the nature and quantity of the premixture delivered; (c) for compound feedingstuffs: the name and address of the supplier of the premixture and of the manufacturer if the latter is not the supplier, the nature and quantity of the premixture and the use to which it has been put. 6. Where the manufacturer delivers additives or premixtures to a person other than a manufacturer of premixtures or compound feedingstuffs, that person and any subsequent intermediary shall be bound by the same recording obligations laid down in paragraph 5 (a) and (b).' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply: - with the new Article 13 (3) of Directive 70/524/EEC, four years after notification (1) of this Directive; - with the other provisions of this Directive, two years after notification. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31984L0631

1984

Council Directive 84/631/EEC of 6 December 1984 on the supervision and control within the European Community of the transfrontier shipment of hazardous waste Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission (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 1973 (4), 1977 (5) and 1983 (6) programmes of action of the European Communities on the environment provide for Community action in order to control the disposal of hazardous waste; Whereas, pursuant to Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (7), Member States are required to take the necessary measures to ensure that toxic and dangerous waste is disposed of without endangering human health and without harming the environment; Whereas shipment of waste between Member States, or between Member States and other States, may be necessary in order to dispose of it under the best possible conditions; Whereas any difference between the provisions on disposal of hazardous waste already applicable or in preparation in the various Member States may distort the conditions of competition and thus directly affect the functioning of the common market; whereas there are, in particular, differences between the procedures applying to the supervision and control of the transfrontier shipment of hazardous waste within the Community; whereas it is therefore necessary to approximate laws in this field, as provided for in Article 100 of the Treaty; Whereas Council Directive 75/442/EEC of 15 July 1975 on waste (8), Council Directive 76/403/EEC of 16 April 1976 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (9) and Council Directive 78/319/EEC have already laid down certain provisions concerning the disposal of dangerous waste, but have not yet regulated the supervision and control of the transfrontier shipment of hazardous waste; Whereas an efficient and coherent system of supervision and control of the transfrontier shipment of hazardous waste should neither create barriers to intra-Community trade nor affect competition; Whereas the growing volume of long-distance transfrontier shipments of hazardous waste in the Community results in increased risk necessitating supervision and control of hazardous waste from the moment of its formation until its treatment or ultimate safe disposal; Whereas this requires compulsory notification of transfrontier shipments of hazardous waste and a uniform consignment note; Whereas the competent authorities of the Member States of destination of waste should be able to raise objections to shipments of waste; whereas any objection should fulfil certain criteria and be duly substantiated; Whereas it is also desirable for the Member State of dispatch and the Member State of transit to be able, subject to certain criteria, to lay down conditions in respect of the shipment of waste on their territory; Whereas, moreover, in certain situations and subject to certain conditions, the Member State of dispatch should be able to object to a shipment; Whereas in the case of waste shipped outside the Community, the third State of destination and, where appropriate, the third State of transit should also be notified; Whereas in this case, in order effectively to control transfrontier shipments of hazardous waste, the customs authorities of the last Member State through which the shipment is due to pass should send a copy of the consignment note to the competent authority of that Member State; whereas the holder should certify to the competent authorities of the Member State of dispatch that the waste has left the Community; Whereas in certain circumstances a general notification procedure may be used; Whereas information relating to the waste concerned, the producers, the existence of a contractual agreement with the consignee, the provisions made for routes and insurance and the conditions for the exercise of the transport operations should be sent to the competent authorities of the Member States concerned as part of the notification procedure; Whereas in order to ensure that hazardous waste does not constitute an unnecessary risk it should be properly packaged and labelled; whereas the instructions to be followed in the event of danger or accident should accompany the waste in order to protect man and the environment from any danger that might arise during the operation; Whereas the Member States may fix border crossing-points after consulting the Commission; Whereas in accordance with the 'polluter pays' principle, the costs of implementing the notification procedure, including the costs of control and analysis, should be borne by the holder and/or the producer of the waste; Whereas it is important that the liability of the producer and that of any other person who may be accountable for damage should be defined and the conditions of application determined in order to guarantee effective and fair compensation for damage which may be caused during the shipment of dangerous waste; whereas the Council should act at the latest within three years of the application of this Directive; whereas the Council should also take a decision within the same time limit on a system of insurance; Whereas, subject to certain conditions, non-ferrous metal waste intended for re-use, regeneration or recycling should be exempted from the provisions of this Directive; Whereas Member States should communicate to the Commission any information relevant to the implementation of this Directive and must in particular prepare reports every two years on the basis of which the Commission will draw up a summary report; Whereas the Technical Committee set up under Directive 78/319/EEC should also be empowered to draw up and adapt as necessary the uniform consignment note on the uniform declaration provided for in this Directive and also to adapt the list of Conventions annexed to this Directive, Article 1 Member States shall, in accordance with the provisions of this Directive, take the necessary measures for the supervision and control, with a view to the protection of human health and the environment, of the transfrontier shipment of hazardous waste both within the Community and on its entering and/or leaving the Community. Article 2 1. For the purposes of this Directive: (a) 'hazardous waste', hereinafter referred to as 'waste', means: - toxic and dangerous waste as defined in Article 1 (b) of Directive 78/319/EEC, except for the chlorinated and organic solvents referred to in points 13 and 14 of the Annex to that Directive, - PCB as defined in Article 1 (a) of Directive 76/403/EEC; (b) 'competent authorities' of the Member States concerned means the competent authority or authorities, designated in accordance with Article 16, of the Member State of destination of the waste, of the Member State of dispatch of the waste and, where applicable, of the Member State or States of transit of the waste; (c) 'the producer of the waste' means anyone whose activities produce waste ('original producer') and/or anyone who carries out pre-processing, mixing or other operations resulting in a change in the nature or composition of this waste; (d) 'the holder of the waste' means the producer of the waste or any other person or undertaking who or which proposes to carry out or to have carried out a transfrontier shipment of waste; (e) 'the consignee of the waste' means the person or undertaking to whom or to which the waste is shipped for disposal; (f) 'disposal' means disposal within the meaning of Article 1 (c) of Directive 78/319/EEC. 2. The off-loading to shore of waste produced by the normal operation of ships, including waste water and residues, shall not be considered a transfrontier shipment of waste within the meaning of this Directive. Article 3 1. Where the holder of the waste intends to ship it or to have it shipped from one Member State to another, to have it routed through one or more Member States or to ship it to a Member State from a third State, he shall notify the competent authorities of the Member States concerned. 2. Notification shall be made by means of a uniform consignment note, hereinafter referred to as the 'consignment note', to be drawn up in accordance with Article 15 and the contents of which are set out in Annex I. 3. When so notifying the competent authorities of the Member States concerned the holder of the waste must provide them with satisfactory information, in particular on: - the source and composition of the waste, including the producer's identity, and in the case of waste from various sources, a detailed inventory of the waste and, where such information exists, the identity of the original producers, - the provisions made for routes and insurance against damage to third parties, - the measures to be taken to ensure safe transport and, in particular, compliance by the carrier with the conditions laid down by the Member States concerned for the exercise of such transport operations, - the existence of a contractual agreement with the consignee of the waste, who should possess adequate technical capacity for the disposal of the waste in question under conditions presenting no danger to human health or the environment. Where the waste is stored, treated or deposited within a Member State, the consignee must also possess a permit in accordance with Article 9 of Directive 78/319/EEC or Article 6 of Directive 76/403/EEC. 4. Where the waste is shipped outside the Community for disposal, the holder of the waste shall notify the third State of destination and where applicable, the third State or States of transit and the competent authorities of the Member States concerned. Article 4 1. A transfrontier shipment may not be executed before the competent authority of the Member State referred to in paragraph 2 (a) or (b) has acknowledged receipt of the notification. The acknowledgement shall be entered on the consignment note. 2. The acknowledgement of receipt or any objection raised in accordance with paragraph 3 shall, not later than one month after receipt of the notification, be forwarded to the holder of the waste: (a) either by the competent authority of the Member State of destination; (b) or, in the case of shipments of waste for disposal outside the Community or of waste from a third country in transit through the Community for disposal outside the Community, by the competent authority of the last Member State through which the shipment is due to pass, with a copy to the consignee of the waste and to the competent authorities of the other Member States concerned. 3. Objections must be substantiated on the basis of laws and regulations relating to environmental protection, safety and public policy or health protection which are in accordance with the provisions of this Directive, with other Community instruments or with international conventions on this subject concluded by the Member State concerned prior to notification of this Directive. 4. Once the competent authority of the Member State referred to in paragraph 2 (a) or (b) is satisfied that the problems giving rise to its objections have been resolved, it shall immediately send an acknowledgement to the holder of the waste with a copy to the consignee of the waste and to the competent authorities of the other Member States concerned. 5. The acknowledgement forwarded by the competent authorities of the Member State referred to in paragraphs 2 (a) or (b) to the holder of the waste pursuant to the provisions of this Article shall not release the producer of such waste or any other person from his obligations under existing national and Community provisions. 6. Without prejudice to the provisions of paragraphs 1 and 2, the competent authorities of the Member State of dispatch and those of the Member State or States of transit, if any, shall have 15 days following the notification in which to lay down, if appropriate, conditions in respect of the shipment of waste on their national territory. These conditions, which shall be forwarded to the holder of the waste, with a copy to the competent authorities of the Member States concerned, may not be more stringent than those laid down in respect of similar shipments occurring wholly within the Member State in question and shall take due account of existing agreements. The holder of the waste must comply with these conditions in order to make the shipment. Not later than 20 days after receipt of the notification, the competent authorities of the Member State of dispatch may raise objections on the grounds that the shipment of waste adversely affects the implementation of plans drawn up pursuant to Article 12 of Directive 78/319/EEC or Article 6 of Directive 76/403/EEC or that it conflicts with obligations resulting from international agreements on this subject concluded by it prior to notification of this Directive. Such objections shall be forwarded to the holder of the waste with copies to the competent authorities of the Member States concerned. Article 5 1. The holder of the waste may use a general notification procedure where waste having the same physical and chemical characteristics is shipped regularly to the same consignee via the same customs office of exit of the Member State of dispatch, via the same customs office of entry of the Member State of destination and, in the case of transit, via the same customs offices of entry and exit of the Member State or States of transit. 2. The competent authorities of the Member State referred to in Article 4 (2) (a) or (b) and, where applicable, those of the Member State or States of transit, may make their agreement to the use of this general notification procedure subject to the supply of certain information, such as the exact quantities or periodical lists of the waste to be shipped. 3. Under a general notification procedure, a single acknowledgement within the meaning of Article 4 (1) may cover several shipments of waste over a maximum period of one year. 4. The general notification shall be made by means of the consignment note. Article 6 1. Upon receipt of the acknowledgement referred to in Articles 4 and 5, the holder of the waste shall complete the consignment note and send copies to the competent authorities of the Member States concerned and to the third States concerned before shipment is carried out. 2. A copy of the consignment note, including the acknowledgement, shall accompany each shipment. 3. All undertakings subsequently involved in the operation shall complete the consignment note where indicated, sign it and retain a copy of it. 4. Within 15 days following receipt of the waste, the consignee of the waste shall forward to the holder of the waste, to the competent authorities of the Member States concerned and to the third States concerned copies of the duly completed consignment note. These copies shall be kept for at least two years. Article 7 By way of derogation from Article 6 (4), when waste leaves the Community for disposal outside the Community, the customs service in the last Member State through which the shipment passes shall forward a copy of the consignment note to the competent authorities in that Member State, which shall keep it for at least two years. The holder of the waste shall declare or certify to the competent authorities of the Member State of dispatch, not later than six weeks after the waste has left the Community, that the waste has reached its proper destination and shall indicate the last customs post in the Community through which the shipment passed. Article 8 1. Transfrontier shipments must comply with the following conditions: (a) The waste must be properly packed. (b) The containers must have appropriate labels indicating, in addition to the nature, composition and quantity of the waste, the telephone number(s) of the person(s) from whom instructions or advice may be obtained at all times during shipment. (c) The instructions to be followed in the event of danger or accident must accompany the waste. (d) The labels and instructions referred to in (b) and (c) must be in the languages of the Member States concerned. 2. The conditions referred to in paragraph 1 shall be deemed to be met where a Member State applies the provisions applicable in the matter under the international transport conventions listed in Annex II to which it is a party in so far as those conventions cover the waste to which this Directive refers. Article 9 Member States may designate border crossing-points for the shipment of waste where necessary and after consulting the Commission. Article 10 In accordance with the 'polluter pays' principle, the cost of implementing the notification and supervision procedure, including the necessary analyses and controls, shall be chargeable to the holder and/or the producer of the waste by the Member State concerned, provided that this cost is comparable to that entailed by the same operations concerning the same types of waste and relating to shipments taking place entirely within that Member State. Article 11 1. Without prejudice to national provisions concerning civil liability, irrespective of the place in which the waste is disposed of, the producer of the waste shall take all necessary steps to dispose of or arrange for the disposal of the waste so as to protect the quality of the environment in accordance with Directives 75/442/EEC and 78/319/EEC and with this Directive. 2. Member States shall take all necessary steps to ensure that the obligations laid down in paragraph 1 are carried out. 3. The Council shall, acting in accordance with the procedure referred to in Article 100 of the Treaty, determine not later than 30 September 1988 the conditions for implementing the civil liability of the producer in the case of damage or that of any other person who may be accountable for the said damage and shall also determine a system of insurance. Article 12 1. Member States shall forward to the Commission not later than 31 December 1985 the name(s), address(es) and telephone and telex numbers of the competent authorities and of the installations, establishments or undertakings with a permit within the meaning of the last indent of Article 3 (3) to dispose of waste. Member States shall forward regularly to the Commission any modifications to the data. 2. The Commission shall forward information referred to under paragraph 1 without delay to the other Member States. Article 13 1. Every two years, and for the first time on 1 October 1987, Member States shall forward to the Commission reports on the implementation of this Directive and on the situation with regard to transfrontier shipments concerning their respective territories. 2. These reports shall in particular comprise the following information: - transfrontier shipments of waste arising from major accidents, in particular within the meaning of Article 1 of Council Directive 82/501/EEC of 24 June 1982 on the major-accident hazards of certain industrial activities (1), - any significant irregularities in transfrontier shipment of waste covered by this Directive which has involved or may yet involve serious hazards for man or the environment, - the quantity and type of waste which has entered their territory for disposal and the quality and type of waste produced in their territory and subsequently definitively exported. Article 14 On the basis of the reports referred to in Article 13, the Commission shall prepare a summary report every two years, which it shall submit to the European Parliament, the Council and the Economic and Social Committee. Article 15 The Technical Committee set up under Article 18 of Directive 78/319/EEC, and acting under the procedure laid down in Article 19 of that Directive, shall be empowered to draw up, in accordance with the information given in Annexes I and III respectively, the consignment note including the general instructions and the uniform declaration document referred to in Article 17. The Committee shall also be empowered, under the same procedure, to adapt to technical progress the consignment note, the declaration document and the list of international transport conventions contained in Annex II. Article 16 Member States shall designate the competent authorities for the purpose of Article 4. Article 17 Waste (including in particular waste, scrap, sludge, ash and dust) from non-ferrous metals which is intended for re-use, regeneration, or recycling on the basis of a contractual agreement regarding such operations shall be exempt from the provisions of this Directive provided that the following conditions are fulfilled: (a) the holder must make a declaration on a uniform document, the contents of which is set out in Annex III, and which must accompany the shipment, to the effect that these materials are intended for the operations in question, and must forward a copy of this document to the competent authorities of the Member State referred to in Article 4 (2) (a) or (b); (b) the consignee must declare in the same document, which he shall forward to the competent authorities of the Member State referred to in (a) not later than 15 days from receipt of the materials that these operations will actually be carried out. Article 18 1. Member States shall take the measures necessary to comply with this Directive as from 1 October 1985. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 19 This Directive is addressed to the Member States.

31984L0641

1984

Council Directive 84/641/EEC of 10 December 1984 amending, particularly as regards tourist assistance, the First Directive (73/239/EEC) on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the First Council Directive (73/239/EEC) of 4 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (4), hereinafter referred to as the "First Directive", as amended by Directive 76/580/EEC (5), eliminated certain differences between the laws of Member States in order to facilitate the taking-up and pursuit of the above business; Whereas considerable progress has been achieved in that area of business involving the provision of benefits in kind ; whereas such benefits are governed by provisions which differ from one Member State to another ; whereas those differences constitute a barrier to the exercise of the right of establishment; Whereas, in order to eliminate that barrier to the right of establishment, it should be specified that an activity is not excluded from the application of the First Directive for the simple reason that it constitutes a benefit solely in kind or one for which the person providing it uses his own staff or equipment only ; whereas, therefore such provision of assistance consisting in the promise of aid on the occurrence of a chance event should be covered by the above Directive, taking into account the special characteristics of such assistance; Whereas the purpose of the inclusion, for reasons of supervision, of assistance operations in the scope of the first Directive, which does not involve the definition of these operations, is not to affect the fiscal rules applicable to them; Whereas the sole fact of providing certain forms of assistance on the occasion of an accident or breakdown involving a road vehicle normally occurring in the territory of the Member State of the undertaking providing cover is not a reason for any person or undertaking that is not an insurance undertaking to be subject to the arrangements of the First Directive; Whereas provision should be made for certain relaxations to the condition that the accident or breakdown must occur in the territory of the Member State of the undertaking providing cover in order to take into account either the existence of reciprocal agreements or of certain specific circumstances relating to the geographical situation or to the structure of the organizations concerned, or to the very limited economic importance of the operations referred to; Whereas an organization of a Member State whose main activity is to provide services on behalf of the public authorities should be excluded from the scope of the First Directive; Whereas an undertaking offering assistance contracts must possess the means necessary for it to provide the benefits in kind which it offers within an appropriate period of time ; whereas special provisions should be laid down for calculating the solvency margin and the minimum amount of the guarantee fund which such undertaking must possess; Whereas certain transitional provisions are necessary in order to permit undertakings providing only assistance to adapt themselves to the application of the First Directive; Whereas, having regard to special structural and geographical difficulties, it is necessary to allow a transitional period to the automobile club of a Member State for bringing itself into line with the said Directive concerning repatriation of the vehicle, possibly accompanied by the driver and passengers; (1) OJ No C 51, 10.3.1981, p. 5 ; OJ No C 30, 4.2.1983, p. 6. (2) OJ No C 149, 14.6.1982, p. 129. (3) OJ No C 343, 31.12.1981, p. 9. (4) OJ No L 228, 16.8.1973, p. 3. (5) OJ No L 189, 13.7.1976, p. 13. Whereas it is necessary to keep up-to-date the provisions of the First Directive concerning the legal forms which insurance undertakings may assume ; whereas certain provisions of the said Directive concerning the rules applicable to agencies or branches established within the Community and belonging to undertakings whose head offices are situated outside the Community should be amended in order to make them consistent with the provisions of Directive 79/267/EEC (1), Article 1 Article 1 of the First Directive is hereby replaced by the following: "Article 1 1. This Directive concerns the taking-up and pursuit of the self-employed activity of direct insurance, including the provision of assistance referred to in paragraph 2, carried on by undertakings which are established in the territory of a Member State or which wish to become established there. 2. The assistance activity shall be the assistance provided for persons who get into difficulties while travelling, while away from home or while away from their permanent residence. It shall consist in undertaking, against the prior payment of a premium, to make aid immediately available to the beneficiary under an assistance contract where that person is in difficulties following the occurrence of a chance event, in the cases and under the conditions set out in the contract. The aid may consist in the provision of benefits in cash or in kind. The provision of benefits in kind may also be effected by means of the staff and equipment of the person providing them. The assistance activity does not cover servicing, maintenance, after-sales service or the mere indication or provision of aid as an intermediary. 3. The classification by classes of the activity referred to in this Article appears in the Annex." Article 2 Article 2 of the First Directive is hereby supplemented by the following point: 3. The assistance activity in which liability is limited to the following operations provided in the event of an accident or breakdown involving a road vehicle which normally occurs in the territory of the Member State of the undertaking providing cover: - an on-the-spot breakdown service for which the undertaking providing cover uses, in most circumstances, its own staff and equipment, - the conveyance of the vehicle to the nearest or the most appropriate location at which repairs may be carried out and the possible accompaniment, normally by the same means of assistance, of the driver and passengers to the nearest location from where they may continue their journey by other means, - if provided for by the Member State of the undertaking providing cover, the conveyance of the vehicle, possibly accompanied by the driver and passengers, to their home, point of departure or original destination within the same State, unless such operations are carried out by an undertaking subject to this Directive. In the cases referred to in the first two indents, the condition that the accident or breakdown must have happened in the territory of the Member State of the undertaking providing cover (a) shall not apply where the latter is a body of which the beneficiary is a member and the breakdown service or conveyance of the vehicle is provided simply on presentation of a membership card, without any additional premium being paid, by a similar body in the country concerned on the basis of a reciprocal agreement; (b) shall not preclude the provision of such assistance in Ireland and the United Kingdom by a single body operating in both States. In the circumstances referred to in the third indent, where the accident or the breakdown has occurred in the territory of Ireland or, in the case of the United Kingdom, in the territory of Northern Ireland, the vehicle, possibly accompanied by the driver and passengers, may be conveyed to their home, point of departure or original destination within either territory. Moreover, the Directive does not concern assistance operations carried out on the occasion of an accident to or the breakdown of a road vehicle and consisting in conveying the vehicle which has been involved in an accident or has (1) OJ No L 63, 13.3.1979, p. 1. broken down outside the territory of the Grand Duchy of Luxembourg, possibly accompanied by the driver and passengers, to their home, where such operations are carried out by the Automobile Club of the Grand Duchy of Luxembourg. Undertakings subject to this Directive may engage in the activity referred to under this point only if they have received authorization for class 18 in point A of the Annex without prejudice to point C of the said Annex. In that event this Directive shall apply to the operations in question." Article 3 Article 3 (1) of the First Directive is hereby supplemented by the following subparagraph: "This Directive shall not apply to undertakings which fulfil the following conditions: - the undertaking does not pursue any activity falling within the scope of this Directive other than the one described in class 18 in point A of the Annex, - this activity is carried out exclusively on a local basis and consists only of benefits in kind, and - the total annual income collected in respect of the activity of assistance to persons who get into difficulties does not exceed 200 000 ECU." Article 4 Article 4 of the First Directive is hereby supplemented by the following point: "(f) in Denmark Falcks Redningskorps A/S, København." Article 5 In the penultimate indent of Article 8 (1) (a) of the First Directive "cooperatieve vereniging" is deleted. Article 6 Articles 8 (3) and 10 (3) of the First Directive are hereby supplemented by the following subparagraph: "Nor do they prevent Member States from subjecting undertakings requesting or having obtained authorization for class 18 in point A of the Annex to checks on their direct or indirect resources in staff and equipment, including the qualification of their medical teams and the quality of the equipment, available to the undertakings to meet their commitments arising from this class of insurance." Article 7 In Articles 9, first paragraph, and 11 (1) first subparagraph of the First Directive, point (e) is hereby replaced by the following: "(e) estimates relating to the expenses of installing the administrative services and the organization for securing business ; the financial resources intended to cover them, and, where the risks to be covered are listed under No 18 in point A of the Annex, the resources available to the undertaking for providing the promised assistance;" Article 8 Article 13 of the First Directive is hereby replaced by the following: "Article 13 Member States shall collaborate closely with one another in supervising the financial position of authorized undertakings. Should the undertakings in question be authorized to cover the risks listed under No 18 in point A of the Annex, Member States shall also collaborate in supervising the resources available to those undertakings for carrying out the assistance operations they have undertaken to perform, where their laws provide for supervision of such resources." Article 9 Article 16 (3) of the First Directive is hereby supplemented by the following subparagraph: "In the case of the risks listed under No 18 in point A of the Annex, the amount of claims paid used to calculate the second result (claims basis) shall be the costs borne by the undertaking in respect of assistance given. Such costs shall be calculated in accordance with the national provisions of the Member State in whose territory the head office of the undertaking is situated." Article 10 In Article 17 of the First Directive, the second indent of paragraph 2 (a) is hereby replaced by the following: "- 300 000 ECU in the case where call or some of the risks included in one of the classes listed in point A of the Annex under Nos 1, 2, 3, 4, 5, 6, 7, 8, 16 and 18 are covered." Article 11 Article 19 of the First Directive is hereby replaced by the following: "Article 19 1. Each Member State shall require every undertaking whose head office is situated in its territory to produce an annual account, covering all types of operation, of its financial situation, solvency and, as regards cover for risks listed under No 18 in point A of the Annex, other resources available to them for meeting their liabilities, where its laws provide for supervision of such resources. 2. Member States shall require undertakings operating in their territory to render periodically the returns, together with statistical documents, which are necessary for the purposes of supervision and, as regards cover for risks listed under No 18 in point A of the Annex, to indicate the resources available to them for meeting their liabilities, where their laws provide for supervision of such resources. The competent supervisory authorities shall furnish each other with the documents and information necessary for exercising supervision." Article 12 Article 26 of the First Directive is hereby replaced by the following: "Article 26 1. Any undertaking which has requested or obtained authorization from more than one Member State may apply for the following advantages which may be granted only jointly: (a) the solvency margin referred to in Article 25 shall be calculated in relation to the entire business which it carries on within the Community ; in such case, account shall be taken only of the operations effected by all the agencies or branches established within the Community for the purposes of this calculation; (b) the deposit required under Article 23 (2) (e) shall be lodged in only one of those Member States; (c) the assets representing the guarantee fund shall be localized in any one of the Member States in which it carries on its activities. 2. Application to benefit from the advantages provided for in paragraph 1 shall be made to the competent authorities of the Member States concerned. The application must state the authority of the Member State which in future is to supervise the solvency of the entire business of the agencies or branches established within the Community. Reasons must be given for the choice of authority made by the undertaking. The deposit shall be lodged with that Member State. 3. The advantages provided for in paragraph 1 may only be granted if the competent authorities of all Member States in which an application has been made agree to them. They shall take effect from the time when the selected supervisory authority informs the other supervisory authorities that it will supervise the state of solvency of the entire business of the agencies or branches within the Community. The supervisory authority selected shall obtain from the other Member States the information necessary for the supervision of the overall solvency of the agencies and branches established in their territory. 4. At the request of one or more of the Member States concerned, the advantages granted under this Article shall be withdrawn simultaneously by all Member States concerned." Article 13 The second paragraph of Article 27 of the First Directive is hereby replaced by the following: "As regards the application of Article 20, where an undertaking qualifies for the advantages provided for in Article 26 (1), the authority responsible for verifying the solvency of agencies or branches established within the Community with respect to their entire business shall be treated in the same way as the authority of the State in the territory of which the head office of a Community undertaking is situated." Article 14 In point A of the Annex to the First Directive the following class is hereby added before the last sentence: "18. Assistance Assistance for persons who get into difficulties while travelling, while away from home or while away from their permanent residence." Article 15 Any Member State may, in its territory, make the provision of assistance to persons who get into difficulties in circumstances other than those referred to in Article 1 subject to the arrangements introduced by the First Directive. If a Member State makes use of this possibility it shall, for the purposes of applying these arrangements, treat such activity as if it were listed in class 18 in point A of the Annex to the First Directive without prejudice to point C thereof. The preceding paragraph shall in no way affect the possibilities for classification laid down in the Annex to the First Directive for activities which obviously come under other classes. It shall not be possible to refuse authorization to an agency or branch solely on the grounds that the activity covered by this Article is classified differently in the Member State in the territory of which the head office of the undertaking is situated. Transitional provisions Article 16 1. Member States may allow undertakings which, on the date of notification of this Directive, provide only assistance in their territories, a period of five years from that date in order to comply with the requirements set out in Articles 16 and 17 of the First Directive. 2. Member States may allow any undertakings referred to in paragraph 1 which, upon expiry of the five-year period, have not fully established the solvency margin, a further period not exceeding two years in which to do so provided that such undertakings have, in accordance with Article 20 of the First Directive, submitted for the approval of the supervisory authority the measures which they propose to take for that purpose. 3. Any undertaking referred to in paragraph 1 which wishes to extend its business within the meaning of Article 8 (2) or Article 10 of the First Directive may do so only on condition that it complies forthwith with that Directive. 4. Any undertaking referred to in paragraph 1 which has a form different to those referred to in Article 8 of the First Directive may continue for a period of three years from the date of notification of this Directive to carry on its existing business in the form in which it exists on that date. 5. This Article shall apply mutatis mutandis to undertakings formed after the date of notification of this Directive which take over business already conducted on that date by a legally distinct body. Article 17 Member States may allow agencies and branches referred to in Title III of the First Directive which provide only assistance in the territories of those Member States a maximum period of five years commencing on the date of notification of this Directive in order to comply with Article 25 of the First Directive, provided such agencies or branches do not extend their business within the meaning of Article 10 (2) of the First Directive. Article 18 During a period of eight years from the date of notification of this Directive, the condition that the accident or breakdown must have happened in the territory of the Member State of the undertaking providing cover shall not apply to the operations referred to in the third indent of the first subparagraph of Article 2 (3) of the First Directive where these operations are carried out by the ELPA (Automobile and Touring Club of Greece). Final provisions Article 19 1. Member States shall amend their national provisions in order to comply with this Directive not later than 30 June 1987. They shall forthwith inform the Commission thereof. The provisions thus amended shall, subject to Articles 16, 17 and 18 of this Directive apply at the latest beginning on 1 January 1988. 2. Member States shall communicate to the Commission the texts of the main provisions laid down by law, regulation or administrative action which they adopt in the field governed by this Directive. Article 20 The Commission shall report to the Council, within six years of notification of this Directive, on the difficulties arising from the application thereof, and in particular Article 15 thereof. It shall, if appropriate, submit proposals to put an end to them. Article 21 This Directive is addressed to the Member States.

31984L0643

1984

Council Directive 84/643/EEC of 11 December 1984 amending Directives 64/432/EEC and 72/461/EEC as regards certain measures relating to foot-and-mouth disease and swine vesicular disease Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission [1], Having regard to the opinion of the European Parliament [2], Having regard to the opinion of the Economic and Social Committee [3], Whereas Directive 64/432/EEC [4], as last amended by Directive 83/646/EEC [5], lays down the conditions to be met, as regards health, by live cattle and pigs intended for intra-Community trade; Whereas the Member States currently apply different policies in the matter of the control and prevention of foot-and-mouth disease; whereas it is important to provide all the Member States, regardless of the health policy pursued, with appropriate guarantees, which are strictly necessary until such time as harmonized measures to combat foot-and-mouth disease are implemented; Whereas certain guarantees which may be required in respect of swine vesicular disease must be maintained within the framework of the rules applicable to intra-Community trade in live pigs, Article 1 Directive 64/432/EEC is hereby amended as follows: 1. In Article 3 (3): - point (a) is deleted, - points (b), (c), (d) and (e) become points (a), (b), (c) and (d) respectively. 2. In Article 3 (6): - point (a) is deleted, - points (b) and (c) become points (a) and (b) respectively. 3. In the third sentence of Article 3 (7) (c) the phrase "paragraph 3 (b) and (c)" is replaced by "paragraph 3 (a) and (b)". 4. Article 4 (a) and (b) is replaced by the following: "Article 4a As regards the additional guarantees which may be required in respect of foot-and-mouth disease and swine vesicular disease, the following rules shall apply: 1. Member States which have been free of foot-and-mouth disease for at least two years, which do not practise vaccination and which do not allow on to their territory animals which have been vaccinated less than one year previously may make the introduction on to their territory of live cattle and pigs subject to the following conditions: A. where the animals come from a Member State satisfying the same criteria, a guarantee that they have not been vaccinated against foot-and-mouth disease; B. where the animals come from a Member State which has been free of foot-and-mouth disease for at least two years, which practises vaccination and which allows vaccinated animals on to its territory: (a) a guarantee that the animals have not been vaccinated against foot-and-mouth disease; (b) a guarantee that the cattle have reacted negatively to a foot-and-mouth virus test carried out by the laryngo-pharyngeal scrape method (probang test); (c) a guarantee that the cattle and pigs have reacted negatively to a serological test carried out to detect the presence of foot-and-mouth antibodies; (d) a guarantee that the cattle and pigs have been isolated in the exporting country, either on a holding or at a quarantine station, for 14 days under the surveillance of an official veterinarian. In this connection, no animal located on the holding of origin or, as the case may be, at the quarantine station shall have been vaccinated against foot-and-mouth disease during the 21 days preceding exportation and no animal other than those forming part of the consignment shall have been introduced to the holding or quarantine station during that same period; (e) placing in quarantine for a period of 21 days. C. Where the animals come from a Member State which has not been free of foot-and-mouth disease for at least two years: (a) the guarantees referred to in point B, with the exception of quarantine in the holding of origin; (b) possible further guarantees to be decided on in accordance with the procedure laid down in Article 12. 2. Member States practising vaccination and allowing vaccinated animals on to their territory shall make the introduction on to their territory of live cattle subject to the following conditions: (a) where the animals come from a Member State satisfying the same criteria: (i) a guarantee that cattle for breeding or production which are more than four months old have been vaccinated not less than 15 days and not more than four months before loading against types A, O and C of the foot-and-mouth disease virus, using an inactivated virus vaccine approved and controlled by the competent authority of the exporting country; (ii) a guarantee that cattle for slaughter which are more than four months old have been vaccinated not less than 15 days and not more than four months before loading against types A, O and C of the foot-and-month disease virus, using an inactivated virus vaccine approved and controlled by the competent authority of the exporting country; however, the period of validity of the vaccination shall be extended to 12 months in the case of cattle re-vaccinated in Member States where such animals are vaccinated annually and where they are systematically slaughtered when they contract foot-and-mouth disease; (b) where the animals come from a Member State which has been free of foot-and-mouth disease for at least two years, which does not practise vaccination and which does not allow animals which have been vaccinated on to its territory, a guarantee that they have not been vaccinated against foot-and-mouth disease, without prejudice, however, to the animals possibly being vaccinated against foot-and-mouth disease before they are introduced into the herd to which they are being sent. 3. The Member States referred to in paragraph 1 may also, while complying with the general provisions of the Treaty make the introduction into their territory of animals of the pig species for breeding or production subject to a negative reaction to a test to detect the presence of swine vesicular disease antibodies carried out not more than 30 days before dispatch. 4. Where the tests referred to in this Article are carried out on the holding, the animals to be dispatched must be isolated from other animals until they are dispatched. For the purposes of this Article, a Member State shall continue to be considered as having been free of foot-and-mouth disease for at least two years, even if a limited number of outbreaks of the disease have been recorded on a limited part of its territory, on condition that such outbreaks were eliminated within a period of less than three months. Every three years and for the first time three years after the date appearing in the first paragraph of Article 2, the Council shall, acting by a qualified majority on a Commission proposal, review the provisions of this Article. This review shall be made on the basis of a report from the Commission accompanied, if necessary, by proposals." 5. Article 4c shall become Article 4b. 6. In the first sentence of Article 5, "referred to in Article 3 (3) (a) and (6) (a)" is replaced by "referred to in Article 4a (2)". 7. In Article 7 (1): - point A (a), "by way of derogation from Article 3 (3) (a) or (6) (a)" is replaced by "by way of derogation from Article 4a (2)". - point B (a), "by way of derogation from Article 3 (3) (a)" is replaced by "by way of derogation from Article 4a (2)." Article 2 The following subparagraph is hereby added to Article 12 of Directive 72/461/EEC: "However, so as to allow Ireland and the United Kingdom in respect of Northern Ireland to substitute for the special arrangements which apply to them under Article 13, the general rules concerning foot-and-mouth disease as set out in this Directive, the two Member States concerned shall bring into force the necessary measures to comply therewith not later than 30 September 1985." Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1984 and shall forthwith inform the Commission thereof. However, Ireland and the United Kingdom in respect of Northern Ireland shall have until 30 September 1985 in order to conform thereto. Until that date they shall be authorized to retain their national rules with regard to imports on to their territory from other Member States of bovine animals for breeding, store and slaughter relating to protection against foot-and-mouth disease while complying with the general provisions of the Treaty. Article 4 This Directive is addressed to the Member States.

31985L0001

1984

Council Directive 85/1/EEC of 18 December 1984 amending Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas at international level the definition of the SI unit of measurement of length has been amended by the 17th General Conference on Weights and Measures (CGPM); whereas this new definition shall be used at Community level; Whereas in a recommendation of 22 May 1981 the World Health Organization requested that the millimetre of mercury be retained in addition to the kilopascal as a unit for the measurement of the pressure of blood and other body fluids; whereas it is advisable for the Community to adopt this solution; Whereas the barn is the unit universally used to measure the effective cross-sectional area on the occasion of nuclear reactions; whereas experience has shown that this specific unit could not easily be replaced by an SI unit; whereas it is therefore necessary to authorize its use in the nuclear field; Whereas therefore Directive 80/181/EEC (4) should be amended accordingly, Article 1 The Annex to Directive 80/181/EEC is hereby amended as follows: 1. in point 1.1 of Chapter I the definition of the unit of length is replaced by the following: 'Unit of length A metre is the length of the path travelled in a vacuum by light during 1/299 792 458 seconds. (Seventeenth CGPM (1983), Resolution 1).'; 2. in section 4 of Chapter I: (a) the following is added to the table 1.2,4 // // // 'Quantity // Unit // // 1.2.3.4 // // Name // Symbol // Value // // // // // Blood pressure and pressure of other body fluids // Millimetre of mercury // mm Hg(*) // 1 mm Hg = 133,322 Pa // Effective cross-sectional area // Barn // b // 1 b = 10 -28 m2' // // // // (b) the note is hereby replaced by the following: 'The prefixes and their symbols listed in 1.3 may be used in conjunction with the above units and symbols, with the exception of the millimetre of mercury and its symbol. The multiple of 102a is, however, called a "hectare".' 3. in Chapter II: (a) the unit of measurement for blood pressure in the table is deleted; (b) the note is replaced by the following: 'The prefixes and their symbols listed in 1.3 of Chapter I may be used in conjunction with the above units and symbols, with the exception of the symbol "g".' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 July 1985. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0010

1984

Council Directive 85/10/EEC of 18 December 1984 amending Directive 75/106/EEC on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas total harmonization of the ranges of nominal volumes for products in the wine sector now appears necessary for all the products concerned since the adoption of Council Directive 75/106/EEC (4), as amended by Directive 79/1005/EEC (5); Whereas the deadline laid down in Directive 75/106/EEC for the use of certain volumes does not leave some Member States sufficient time to dispose of returnable bottles still in circulation on their markets; whereas the premature replacement of non-standard bottles would have serious economic consequences; whereas the States concerned should therefore be permitted to authorize the use of the volumes in question on their markets for a limited period; Whereas since the adoption of Directive 75/106/EEC, the trend in consumption habits has shown that it is necessary to add large volumes to the range of capacities for still wines; Whereas Directive 75/106/EEC should be amended accordingly, Article 1 Article 5 of Directive 75/106/EEC is hereby replaced by the following: 'Article 5 1. Member States may not refuse, prohibit or restrict the placing on the market of prepackages which satisfy the requirements of this Directive on grounds related to the determination of their volumes, the methods by which they have been checked or the nominal volumes where these are set out in Annex III, column I. 2. Member States which on 31 December 1973 allowed the nominal volumes listed in Annex III, column II, shall continue to allow them up to 31 December 1988, or in the case of the volume 0,73 litre up to 31 December 1985. 3. (a) Prepackages containing the products listed in Annex III, section 1 (a) and (b) may only be marketed after 31 December 1983 if they have the nominal volumes set out in Annex III, columns I and II. The volume 0,73 litre shall be deleted from column II with effect from 1 January 1986. (b) Prepackages containing the products listed in Annex III, section 1 (a) and (b) may only be marketed after 31 December 1988 if they have the nominal volumes set out in Annex III, column I. (c) Without prejudice to subparagraph (a) above, the products listed in Annex III (1) (a), when contained in returnable packages, may be marketed in the following volumes: - 0,24 litre - 0,73 litre - 0,99 litre in France up to 31 December 1988, - 0,46 litre - 0,64 litre - 0,68 litre in Greece up to 31 December 1988, - 0,19 litre - 0,36 litre - 0,475 litre - 0,72 litre - 0,95 litre - 1,75 litres - 1,88 litres in Italy up to 31 December 1985. 4. This Directive shall be no impediment to national laws governing on environmental grounds the use of packaging with regard to its recycling.' Article 2 1. The following figures are added to Annex III, column I (1) (a) of Directive 75/106/EEC: '6, 9 and 10'. 2. The following line is added at the end of the range of volumes in Annex III, column I (1) (a) of Directive 75/106/EEC: '0,187 (for consumption on board aircraft and ships only)'. Article 3 Member States shall bring the laws, regulations and administrative provisions needed to comply with this Directive into force within 12 months of its notification (1). They shall forthwith inform the Commission thereof. Article 4 This Directive is addressed to the Member States.

31985L0003

1984

Council Directive 85/3/EEC of 19 December 1984 on the weights, dimensions and certain other technical characteristics of certain road vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Articles 75 and 76 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 bearing in mind the conclusions of the European Councils on 19 and 20 March 1984, 25 and 26 June 1984 and 3 and 4 December 1984 the Council should implement without delay the parallel processes of liberalization and harmonization of which this Directive forms part and to that end will adopt instruments, by the end of February 1987 at the latest, which will set out in a coherent fashion the periods over which liberalization and harmonization will become effective; Whereas the differences between standards currently in force in the Member States with regard to the weights and dimensions of commercial road vehicles are such as to have an adverse effect on the conditions of competition and constitute an obstacle to traffic between Member States; Whereas it is therefore necessary, in the framework of the common transport policy, to establish common standards for the weights, dimensions and certain other characteristics of certain vehicles which will permit the improved use of these vehicles in traffic between Member States; Whereas these standards must create a balance between the rational and economical use of the said commercial road vehicles, the requirements of infrastructure maintenance and those of road safety; Whereas it is desirable that the motor vehicles in question should conform to Community standards on noise, safety and emissions; Whereas additional technical requirements related to the weights and dimensions of commercial vehicles may apply to vehicles registered in a Member State; whereas these requirements must not constitute an obstacle to the circulation of commercial vehicles between Member States; Whereas it seems appropriate to permit Member States, which authorize higher weights and greater dimensions on their territory than those provided for in this Directive, to apply these only to vehicles registered on their territory where they are used in domestic traffic; whereas such provisions may be less favourable, in their effect on carriers from the other Member States as compared with the national carriers of the State where they would be applied, than those in force at the time when this Directive is adopted; whereas recourse should therefore be had to Article 76 of the Treaty; Whereas steps should be taken to facilitate the monitoring of the compliance of vehicles with this Directive; Whereas the state of certain portions of the road network in Ireland and the United Kingdom does not make it possible at the present stage to apply all the provisions of this Directive; whereas the application of some of these provisions in those Member States should therefore be temporarily deferred under arrangements to be laid down by the Council in a Decision to be taken by the end of February 1987 at the latest; whereas it is not possible to lay down those arrangements in this Directive; whereas in view of the requirements for substantial improvements to the relevant portions of the road networks which will take a certain number of years to complete, the conditions referred to in Article 75 (3) of the Treaty are at present fulfilled in those Member States and are expected to remain so when the Council takes its Decision; whereas in consequence that Decision will then be adopted unanimously; Whereas the weight per driving axle of five or six-axle combined vehicles should be fixed as soon as possible; Whereas the facilitation of combined transport using 40-foot ISO containers should be taken into account, Article 1 1. This Directive applies to: (a) the dimensions of vehicles intended to be used on the road for carriage of goods and having at least four wheels, a maximum laden weight exceeding 3,5 tonnes and a maximum speed exceeding 25 km/h; (b) the weights and certain other characteristics of the vehicles defined in (a) and specified in Annex I (2). 2. All the values of weights indicated in Annex I are valid as circulation standards and thus refer to loading conditions, not production standards, which will be defined in a later Directive. Article 2 For the purposes of this Directive: - 'motor vehicle' means any power-driven vehicle which travels on the road by its own means, - 'trailer' means any vehicle intended to be coupled to a motor vehicle, excluding semi-trailers; - 'semi-trailer' means any vehicle intended to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle and a substantial part of its weight and of the weight of its load is borne by the motor vehicle; - 'combined vehicle' means either: - a road train, consisting of a motor vehicle coupled to a trailer, or - an articulated vehicle consisting of a motor vehicle coupled to a semi-trailer; - 'maximum authorized dimensions' means the maximum dimensions at which a vehicle is authorized for use in international traffic under this Directive by the competent authority of the State in which the vehicle is registered or put into circulation; - 'maximum authorized weight' means the maximum weight at which a laden vehicle is authorized for use in international traffic under this Directive by the competent authority of the State in which the vehicle is registered or put into circulation, - 'maximum authorized axle weight' means the maximum weight at which a laden axle or group of axles is authorized for use in international traffic under this Directive by the competent authority of the State in which the vehicle is registered or put into circulation. Article 3 1. Member States may not reject or prohibit the use on their territories in international traffic of vehicles registered or put into circulation in any Member State for reasons relating to their weights and dimensions provided that such vehicles comply with the limit values specified in Annex I. This provision shall apply notwithstanding the fact that: (a) the said vehicles are not in conformity with the requirements of the Member State concerned with regard to certain weight and dimension characteristics not covered by Annex I; (b) the competent authority of the Member State in which the vehicles are registered or put into circulation has authorized limits exceeding those laid down in Annex I. 2. However, the provision in paragraph 1 (a) shall not affect the right of Member States, with due regard to Community law, to require vehicles registered or put into circulation in their own territory to be in conformity with their national requirements on weight and dimension characteristics not covered by Annex I. 3. Any Member State which authorizes higher weights and greater dimensions than those laid down in this Directive may limit their application to vehicles registered or put into circulation in that Member State when used in domestic traffic in that Member State. Article 4 Vehicles forming part of a five or six-axle combination which are first put into circulation as from 1 January 1990 must in addition, in order to be covered by Article 3 (1), conform to the technical specifications of the Directives referred to in Annex II. The list of Directives in that Annex shall be adapted to technical progress in accordance with Articles 12 and 13 of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 80/1267/EEC (2). Article 5 To facilitate monitoring of the compliance of vehicles with this Directive, Member States shall take the measures necessary to ensure that these vehicles carry proof of such compliance. Acting on a proposal from the Commission, the Council shall, within six months of the adoption of this Directive, adopt detailed provisions concerning: - the form and content of such proof, and the conditions for its issue, - the mutual recognition by Member States of proof issued by other Member States. Council Directive 76/114/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to statutory plates and inscriptions for motor vehicles and their trailers, and their location and method of attachment (1), as amended by Directive 78/507/EEC (2), shall, if necessary, be amended accordingly. Article 6 This Directive shall not preclude the application of road traffic provisions in force in each Member State which permit the weight and/or dimensions of vehicles on certain roads or civil engineering structures to be limited, irrespective of the State of registration of such vehicles. Article 7 1. After consulting the Commission, Member States shall take the measures necessary to comply with this Directive: - as from 1 July 1986 as regards application of all provisions other than Article 4 and Annex II, - as from 1 January 1990 as regards the application of Article 4 and Annex II. Member States shall inform the Commission of the measures they take to implement this Directive. 2. The Council shall specify the weight on the driving axle of a five or six-axle combined vehicle, including the weight on a driving axle which is part of a tandem axle or a tri-axle, before 31 December 1985. Until the Council specifies this weight, as well as the weight on tandem axles and tri-axles of motor vehicles, the legislation of the Member State where the vehicle circulates, shall continue to apply. Article 8 1. The provisions of Article 3 as regards the standards referred to in points 2.2 and 3.3.2 of Annex I shall temporarily not apply to Ireland and the United Kingdom. However, these two Member States shall apply Article 3 to the articulated vehicles referred to in point 2.2.2 of Annex I where: - the total laden weight does not exceed 38 tonnes, - the weight on any tri-axle at the spacing specified in point 3.3.2 of Annex I does not exceed 22,5 tonnes. 2. Before 30 June 1986, the Commission shall submit to the Council a report on the development of the circumstances which have justified the derogation referred to in the first paragraph. This report will be accompanied by a proposal concerning: (i) the duration of the derogation, and (ii) the procedure for periodic reviews of the circumstances justifying continuation of the derogation. The Council shall decide on this proposal by 28 February 1987, at the latest, according to the procedures laid down in the Treaty. Article 9 This Directive is addressed to the Member States.

31985L0073

1985

Council Directive 85/73/EEC of 29 January 1985 on the financing of health inspections and controls of fresh meat and poultrymeat Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas, in order to make the health safeguards offered to the consumer uniform, Directive 64/433/EEC (4), as last amended by Directive 83/90/EEC (5), provided for the implementation of health inspections and controls in respect of fresh meat likely to be involved in intra-Community trade; Whereas, in order to safeguard human and animal health within the Community, Directive 72/462/EEC (6), as last amended by Directive 83/91/EEC (7), provides for health controls to be carried out by the competent authorities of the Member States upon importation of fresh meat and for inspections to be carried out by veterinary experts of the Member States and the Commission within the exporting third countries; Whereas Directive 64/433/EEC relates only to fresh meat likely to be involved in intra-Community trade; whereas, however, the authorities of the Member States have introduced national controls for fresh meat intended solely for the national market; Whereas Council Directive 71/118/EEC (8), as last amended by Directive 84/642/EEC (9), makes provision for health inspections and controls for fresh poultrymeat; Whereas these health inspections and controls give rise to the collection of fees which are at present financed in different ways in the individual Member States; whereas these differences are liable to affect the conditions of competition between lines of production which are for the most part covered by common organizations of the markets; Whereas, in order to remedy this situation, harmonized rules on the financing of the said health inspections and controls should be laid down; Whereas, owing to the provisions and administrative procedures of national management and financing, a further two-year period should be granted so as to allow the Hellenic Republic to apply the necessary machinery for collecting the fees relating to inspections and controls, Article 1 1. As from 1 January 1986 the Member States shall ensure that: - fees are collected when the animals referred to in paragraph 2 are slaughtered for the costs occasioned by health inspections and controls, - in order both to ensure equivalence of treatment as provided for in Article 15 of Directive 71/118/EEC and to cover the costs provided for in Directive 72/462/EEC, provision is made for the collection of a fee on meat referred to in those Directives imported from third countries, - any direct or indirect refund of fees is prohibited. 2. For the puposes of this Directive, 'animals' means domestic animals of the following species: bovine (including buffalo), swine, sheep and goats, domestic solipeds and hens, turkeys, guinea-fowl, ducks and geese. Article 2 1. The Council, acting by a qualified majority on a proposal from the Commission shall, before 1 January 1986, take a decision on the standard level or levels of the fees referred to in the first two indents of Article 1 (1) and on the detailed rules and principles for the implementation of this Directive, and on possible exceptions. However, the levels of fees to be collected for meat coming from slaughterhouses that are not approved under Directive 64/433/EEC shall not be fixed except in connection with the adoption by the Council before that date of rules of inspection for that meat. 2. Member States shall be authorized to collect an amount exceeding the level or levels referred to in paragraph 1 provided that the total fee collected for each Member State remains lower than or equal to the real figure for inspection costs. Article 3 Before 1 January 1990 the Commission will submit a report on the experience gained, together with proposals for possible amendments to the abovementioned Articles. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1986. They shall forthwith inform the Commission thereof. However, the Hellenic Republic shall have an additional period of two years in which to comply with it. Article 5 This Directive is addressed to the Member States.

31985L0203

1985

Council Directive 85/203/EEC of 7 March 1985 on air quality standards for nitrogen dioxide Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission (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 programmes of action of the European Communities on the environment of 1973 (4), 1977 (5) and 1982 (6) provide that priority is to be given to measures against nitrogen dioxide because of its noxiousness and having regard to the current state of knowledge of its effects on human health and the environment; Whereas insufficient technical and scientific information is available to enable the Council to lay down specific standards for the environment generally and whereas the adoption of limit values for the protection of human health will contribute to the protection of the environment as well; Whereas any discrepancy between the provisions already applicable or being drawn up in the various Member States with regard to nitrogen dioxide in the air could give rise to unequal conditions of competition and could in consequence directly affect the functioning of the common market ; whereas, therefore, the approximation of laws prescribed in Article 100 of the Treaty should be carried out in this area; Whereas one of the basic tasks of the Community is to promote throughout the Community a harmonious development of economic activities and a continued and balanced expansion, which is inconceivable without an attack on pollution and nuisance or an improvement in the quality of life and the protection of the environment ; whereas, since the Treaty has not provided the necessary powers, recourse must be had to Article 235 of the Treaty; Whereas, in order to protect in particular human health and the environment, it is necessary to set for nitrogen dioxide a limit value which must not be exceeded in the territory of the Member States during specified periods and whereas this value should be based on the results of work carried out for the World Health Organization, particularly with regard to the dose/effect relationships established for this pollutant; Whereas, despite the measures taken, it may not be possible to comply with the limit value in certain zones ; whereas the Member States may be allowed temporary derogations on condition that they forward to the Commission plans for the gradual improvement of the quality of the air in these zones; Whereas it is expected that the Council will shortly establish a further legal act enabling Member States to (1) OJ No C 258, 27.9.1983, p. 3. (2) OJ No C 337, 17.12.1984, p. 434. (3) OJ No C 206, 6.8.1984, p. 1. (4) OJ No C 112, 20.12.1973, p. 1. (5) OJ No C 139, 13.6.1977, p. 1. (6) OJ No C 46, 17.2.1983, p. 1. impose significantly lower limit values for exhaust gases from motor vehicles; Whereas the measures taken pursuant to this Directive must be economically feasible and compatible with balanced development; Whereas nitrogen dioxide is also a precursor in the formation of photochemical oxidants which can be harmful to man and the environment and whereas preventive action can help reduce their formation; Whereas it is necessary to establish measuring stations to monitor compliance with the limit value for nitrogen dioxide and whereas it is desirable that these stations also measure nitric oxide which is an intermediary step in the formation of nitrogen dioxide; Whereas, in view of the existence of different methods of analysis in the Member States, it is necessary to permit, under certain conditions, the use of methods of analysis other than the reference method laid down in the Directive; Whereas, in addition to the limit value, there is a need to provide for guide values to improve the protection of human health and contribute to the long-term protection of the environment; Whereas subsequent changes in the reference method of analysis referred to in this Directive may be desirable in the light of technical and scientific progress in this area ; whereas, in order to facilitate the implementation of the work necessary to this end, a procedure should be set up to establish close cooperation between Member States and the Commission within a Committee on Adaptation to Scientific and Technical Progress, Article 1 1. The purpose of this Directive is to: - fix a limit value (Annex I) for nitrogen dioxide in the atmosphere specifically to help protect human beings against the effects of nitrogen dioxide in the environment, - lay down guide values (Annex II) for nitrogen dioxide in the atmosphere in order to improve the protection of human health and contribute to the long-term protection of the environment. 2. This Directive shall not apply to exposure at work or inside buildings. Article 2 For the purposes of this Directive: - "limit value" means the concentration of nitrogen dioxide as defined in the table in Annex I which must not be exceeded throughout the territory of the Member States during specified periods and under the conditions laid down in the following Articles, - "guide values" means the concentrations of nitrogen dioxide as given in Annex II considered over specified periods and intended, in particular, to serve as reference points for the establishment of specific schemes within zones determined by the Member States. Article 3 1. Member States shall take the necessary measures to ensure that as from 1 July 1987 the concentrations of nitrogen dioxide in the atmosphere measured in accordance with Annex III are not greater than the limit value given in Annex I. 2. However, when in particular circumstances the nitrogen dioxide concentrations in the atmosphere in certain zones are likely, despite the measures taken, to exceed the limit value in Annex I after 1 July 1987, the Member State concerned shall inform the Commission thereof before 1 July 1987. It shall forward plans for the gradual improvement of the quality of the air in these zones to the Commission as soon as possible. These plans, drawn up on the basis of relevant information on the nature, origin and development of this pollution, shall describe, in particular, the measures taken or to be taken and the procedures implemented or to be implemented by the Member State concerned. These measures and procedures must aim at reducing the nitrogen dioxide concentrations in the atmosphere within these zones to values not exceeding the limit value given in Annex I as rapidly as possible and by 1 January 1994 at the latest. Article 4 1. In the zones in which the Member State concerned considers it necessary to limit or prevent a foreseeable increase in pollution by nitrogen dioxide in the wake of urban or industrial development in particular, it may fix values lower than the limit value in Annex I. 2. In zones which the Member State concerned considers should be afforded special environmental protection, it may fix values which are generally lower than the guide values in Annex II. Article 5 Member States may, at any time, fix values more stringent than those laid down in this Directive. Article 6 Member States shall establish measuring stations to supply the data necessary for the application of this Directive in accordance with the specifications in Annex III, in particular in zones where the limit value is exceeded or likely to be exceeded and in the zones referred to in Article 4. Such stations may also measure concentrations of nitric oxide. Article 7 1. From 1 July 1987 Member States shall inform the Commission, not later than six months after the end (31 December) of the annual reference period, of instances in which the limit value laid down in Annex I has been exceeded and of the concentrations recorded. 2. Member States shall also notify the Commission, not later than one year after the end of the annual reference period, of the reasons for such instances and of the measures they have taken to deal with them. 3. In addition, Member States shall inform the Commission, at its request, of: - the concentrations they have measured, - the limit values, deadlines and timetables they have laid down, - any appropriate measures they have taken, concerning the zones referred to in Article 4 (1) and (2). This information must also be made available to the public. Article 8 The Commission shall publish periodically a summary report on the application of this Directive. Article 9 The application of the measures taken pursuant to this Directive must not lead to a significant deterioration in the quality of the air in zones, outside urban areas, where the level of pollution by nitrogen dioxide at the time of implementation of this Directive is low in relation to the limit value laid down in Annex I. Article 10 In applying this Directive, Member States shall use: - either the reference method of analysis referred to in Annex IV, - or any other method of analysis which the Commission has been shown is equivalent to the reference method. Article 11 1. Where a Member State intends to fix, in a region near the border with one or more other Member States, values for concentrations of nitrogen dioxide in the atmosphere in accordance with Article 4 (1) and (2), it shall hold prior consultations with the Member States concerned. The Commission shall be informed and may attend such consultations. 2. Where the limit value given in Annex I or the values referred to in Article 4 (1) and (2) - provided that the latter values have been the subject of consultations in accordance with paragraph 1 - are or are likely to be exceeded following significant pollution which originates or may originate in another Member State, the Member States concerned shall hold consultations with a view to remedying the situation. The Commission shall be informed and may attend such consultations. Article 12 The amendments necessary to adapt the specifications in Annex IV to technical progress shall be adopted in accordance with the procedure described in Article 14. These amendments shall not be such as to alter, directly or indirectly, the limit value laid down in Annex I. Article 13 1. For the purposes of Article 12, a Committee on the Adaptation of this Directive to Scientific and Technical Progress, hereinafter called "the Committee", shall be set up, composed of representatives of the Member States with a Commission representative as Chairman. 2. The Committee shall adopt its own rules of procedure. Article 14 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by its Chairman, either on his own initiative or at the request of the representative of a Member State. 2. The Commission representative shall submit a draft of the measures to be taken to the Committee. The Committee shall give its opinion on the draft within a time limit set by the Chairman having regard to the urgency of the matter. Decisions shall be taken by a majority of 45 votes, the votes of the Member States being weighted as provided in Article 148 (2) of the Treaty. The Chairman shall not vote. 3. The Commission shall adopt the proposed measures if they are consistent with the opinion of the Committee. Where the proposed measures are not consistent with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall decide by a qualified majority. If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 15 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1987 at the latest and shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 16 This Directive is addressed to the Member States.

31985L0210

1985

Council Directive 85/210/EEC of 20 March 1985 on the approximation of the laws of the Member States concerning the lead content of petrol Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the protection and improvement of public health and of the environment are at present, and will in the future be, one of the items of major concern for all industrialized countries; whereas the effects on public health and the environment of pollution caused by substances emitted in the exhaust gas of vehicles must be regarded as serious owing to the continuous increase in the volume of motor vehicle traffic; Whereas Council Directive 78/611/EEC of 29 June 1978 on the approximation of the laws of the Member States concerning the lead content of petrol (4) fixed a maximum value for the permitted lead-compound content of petrol of between 0,40 and 0,15 g/l; Whereas the third action programme on the environment, the general approach of which was approved in the resolution of 7 February 1983 (5) by the Council and the representatives of the governments of the Member States meeting within the Council, provides for further efforts to reduce considerably the present levels of exhaust pollution; Whereas existing or future disparities in the national laws of the Member States concerning the composition of petrol and in particular the rules governing the limitations on the lead content and on the benzene content of motor vehicle petrol may directly affect the functioning of the common market; Whereas refining technology allows for a lowering of the lead content of leaded petrol to 0,15 g Pb/l without adverse effects on the quality of petrol; Whereas the reduction and, ultimately, the elimination of lead in petrol will improve the health protection of the population, particularly in areas with dense traffic; whereas the early introduction of unleaded petrol is also desirable to permit, where appropriate, the application of certain anti-pollution technologies for drastically reducing polluting emissions from motor vehicles, in particular nitrogen oxides and unburned hydrocarbons; Whereas for a certain time leaded petrol must continue to be available on Member States' markets alongside unleaded petrol, in order to satisfy, given the prevailing economic and technical conditions, the requirements of a large proportion of the existing vehicle fleet; Whereas, owing to the importance of preventive measures against adverse effects on public health and the environment, Member States should be enabled to introduce unleaded petrol on to their markets before the compulsory date laid down for the Community as a whole; Whereas the protection of public health also requires a limitation on the benzene content of petrol; Whereas the quality of unleaded 'premium' petrol in terms of minimum research and motor octane numbers should be guaranteed in order to ensure satisfactory operation throughout the Community of motor vehicles designed to be fuelled by such petrol; Whereas it should be possible to market another unleaded 'regular' petrol with lower octane ratings; Whereas lead is only an additive to petrol; whereas the reduction or elimination of lead must not have the effect of significantly increasing other pollutants contained in the exhaust gases of motor vehicles as a consequence of modifications in the composition of petrol; Whereas the reduction of lead content and the introduction of unleaded petrol at a given date must in no way affect the free circulation, or the putting on the market, of petrol within the Community; Whereas a regular check at the final distribution stage, on the lead and benzene content of petrol is required to ensure that consumers receive the appropriate type of petrol; Whereas a certain proportion of the existing motor vehicle fleet could run on unleaded petrol; whereas the Member States should therefore be requested to take all appropriate measures compatible with the Treaty to promote the widest possible use of unleaded petrol; Whereas further examination of some aspects of the measures taken to reduce the concentrations of lead or other polluting substitutes in the atmosphere should be continued at Community level; whereas Member States should, where appropriate, provide the Commission with all relevant information; Whereas the subsequent development of reference methods for measuring the lead and benzene content of petrol and for calculating octane ratings referred to in this Directive may be desirable in the light of scientific and technical progress in this area; whereas, in order to facilitate implementation of the work necessary to this end, a procedure should be set up to establish close cooperation between the Member States and the Commission within a Committee on Adaptation to Scientific and Technical Progress; Whereas, by reason of their geographical position and the possible consequences for their oil markets of applying this Directive, the French overseas departments should be excluded from its scope, Article 1 For the purposes of this Directive: (a) 'petrol' shall mean any volatile mineral oil intended for the operation of internal combustion spark-ignited engines used for the propulsion of vehicles; (b) 'unleaded petrol' shall mean any petrol the contamination of which by lead compounds calculated in terms of lead, does not exceed 0,013 g Pb/l; (c) 'leaded petrol' shall mean all petrol other than unleaded petrol. This shall have a maximum permitted lead-compound content, calculated in terms of lead, of not more than 0,40 g Pb/l and not less than 0,15 g Pb/l. Article 2 1. As from the entry into force of this Directive, and subject to paragraph 2, Member States shall continue to ensure the availability and balanced distribution of leaded petrol within their territories. 2. If, as the result of a sudden change in the supply of crude oil or petroleum products, it becomes difficult for a Member State to apply the limit on the maximum lead content of leaded petrol, that Member State may, after having informed the Commission, authorize a higher limit within its territory for a period of four months. The Council, acting by a qualified majority on a proposal from the Commission, may extend this period. 3. Member States shall, as soon as they consider it appropriate, reduce to 0,15 g Pb/l the permitted lead-compound content, calculated in terms of lead, of leaded petrol put on their markets. Article 3 1. Subject to paragraphs 2 and 3, Member States shall take the necessary measures to ensure the availability and balanced distribution within their territories of unleaded petrol from 1 October 1989. The first subparagraph shall not preclude measures being taken to introduce unleaded petrol on the market of a Member State from a date earlier than 1 October 1989. 2. Member States may, with the Commission's agreement, derogate from the first subparagraph of paragraph 1 for a period of four months if, as a result of a sudden change in the supply of crude oil or petroleum products, it becomes impossible to meet the demand for unleaded petrol of the quality specified in Article 5 (1). However, every effort must be made to maintain a minimum distribution network for unleaded petrol. The period of four months may be extended by the Council acting by a qualified majority on a proposal from the Commission. 3. Until 1 April 1990, Member States may, by way of derogation, allow the contamination of unleaded petrol by lead compounds to exceed 0,013 g Pb/l provided it does not exceed 0,020 g Pb/l. Until that date, all pumps carrying unleaded petrol should be clearly labelled to show that the lead content does not exceed either 0,020 or 0,013 g Pb/l, together with any appropriate supplementary advice. Article 4 From 1 October 1989 the benzene content of leaded petrol and of unleaded petrol shall not exceed 5,0 % by volume. Where recourse is had to the second subparagraph of Article 3 (1), this benzene limit shall apply to unleaded petrol from the date chosen at national level for the earlier introduction of such petrol. Article 5 1. Subject to paragraph 2, unleaded petrol made available pursuant to Article 3 of this Directive shall have a minimum motor octane number (MON) of 85,0 and a minimum research octane number (RON) of 95,0 at the pump ('premium'). 2. Paragraph 1 shall not preclude the introduction on to the market of a Member State of another unleaded petrol with lower octane numbers than those provided for in paragraph 1 ('regular'). Article 6 Member States shall take all appropriate steps to ensure that neither the reduction of the lead content of petrol nor the introduction of unleaded petrol causes a significant increase in the quality and/or quantity of pollutants in the gases emitted from motor vehicles. Article 7 1. Subject to paragraph 2, Member States shall not prevent or restrict, on grounds of lead or benzene content, the free circulation and marketing of petrol which complies with this Directive. 2. When a Member State applies Article 2 (3), the maximum permitted lead content of leaded petrol placed on its market shall be fixed at 0,15 g Pb/l. Article 8 1. Member States shall take appropriate measures to ensure compliance, at the final distribution stage, with the provisions relating to the maximum lead and benzene content of petrol, and to the quality of petrol as regards octane rating. 2. Where a Member State establishes that petrol fails to comply with Articles 1, 2, 4 and 5 it shall without undue delay take the necessary measures to ensure compliance with those provisions. Article 9 1. The lead content of petrol shall be established in accordance with the procedures set out in section I of the Annex. 2. The benzene content of leaded and unleaded petrol shall be established in accordance with the procedure set out in Section II of the Annex. 3. The octane ratings (MON and RON) of unleaded petrol shall be determined in accordance with the procedure set out in Section III of the Annex. Article 10 The procedures laid down in Articles 11 and 12 for the adaptation of this Directive to technical progress shall cover the subsequent development of the reference methods of analysis referred to in the Annex, taking into account in particular other equivalent methods. Such adaptation must not result in any direct or indirect modification of the limit values laid down in this Directive. Article 11 1. For the purposes of applying Article 10, a Committee on the adaptation of this Directive to scientific and technical progress, hereinafter called 'the Committee', shall be set up; it shall consist of representatives of the Member States, with a Commission representative as chairman. 2. The Committee shall adopt its own rules of procedure. Article 12 1. Where the procedure laid down in this Article is invoked, the Committee shall be convened by the chairman, either on his own initiative or at the request of the representative of a Member State. 2. The Commission representative shall submit a draft of the measures to be taken to the Committee. The Committee shall give its opinion on the draft within a time limit set by the chairman having regard to the urgency of the matter. Decisions shall be taken by a majority of 45 votes, the votes of the Member States being weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The Commission shall adopt the proposed measures if they are consistent with the opinion of the Committee, Where the proposed measures are not consistent with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall decide by a qualified majority. If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 13 Member States shall take appropriate measures to ensure as far as possible that leaded petrol is not used in motor vehicles designed to run on unleaded petrol. Article 14 Member States are invited, for the purpose of applying Article 3, to promote the widest possible use of unleaded petrol in all existing vehicles capable of running on such fuel. To that end, they are invited to take such measures as they consider appropriate which are compatible with the Treaty. Article 15 1. Member States shall supply the Commission, as early as possible, with information on: - the date of introduction of unleaded petrol on the market in accordance with Article 3, - the measures envisaged pursuant to Article 14. 2. At the request of the Commission, Member States shall supply: (a) information which they have available on the annual quantities of leaded and unleaded petrol supplied to the internal Community market; (b) a summary of the results of the measures taken in accordance with Article 8 (1); (c) information which they have available on the effects on the application of this Directive, and in particular Article 6, on: - the development of the concentrations of lead and polluting substitutes in the atmosphere, - energy policy, in particular in the refinery and distribution sector. Article 16 1. Member States shall take the measures necessary to comply with this Directive at the latest on 1 January 1986. They shall forthwith inform the Commission thereof. 2. Member States shall ensure that they communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 17 Directive 78/611/EEC shall cease to be applicable on 31 December 1985. Article 18 This Directive shall not apply to the French overseas departments. Article 19 This Directive is addressed to the Member States.

31985L0384

1985

Council Directive 85/384/EEC of 10 June 1985 on the mutual recognition of diplomas, certificates and other evidence of formal qualifications in architecture, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57 and 66 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, pursuant to the Treaty, all discriminatory treatment based on nationality with regard to establishment and provision of services is prohibited as from the end of the transitional period; whereas the resulting principle of non-discriminatory treatment as regards nationality applies inter alia to the grant of any authorization required to take up activities in the field of architecture and also to the registration with or membership of professional organizations or bodies; Whereas it nevertheless seems desirable that certain provisions be introduced to facilitate the effective exercise of the right of establishment and freedom to provide services in respect of activities in the field of architecture; Whereas, pursuant to the Treaty, Member States are required not to grant any form of aid likely to distort the conditions of establishment; Whereas Article 57 (1) of the Treaty provides that directives be issued for the mutual recognition of diplomas, certificates and other evidence of formal qualifications; Whereas architecture, the quality of buildings, the way they blend in with their surroundings, respect for the natural and urban environment and the collective and individual cultural heritage are matters of public concern; whereas, therefore, the mutual recognition of diplomas, certificates and other evidence of formal qualifications must be founded on qualitative and quantitative criteria ensuring that the holders of recognized diplomas, certificates and other evidence of formal qualifications are able to understand and give practical expression to the needs of individuals, social groups and communities as regards spatial planning, the design, organization and construction of buildings, the conservation and enhancement of the architectural heritage and preservation of the natural balance; Whereas methods of education and training for those practising professionally in the field of architecture are at present very varied; whereas, however, provision should be made for progressive alignment of education and training leading to the pursuit of activities under the professional title of architect; Whereas, in some Member States, the taking up and pursuit of the activities of architect are by law conditional upon the possession of a diploma in architecture; where, in certain other Member States where this condition does not exist, the right to hold the professional title of architect is none the less governed by law; whereas, finally, in some Member States where neither the former nor the latter is the case, laws and regulations are being prepared on the taking up and pursuit of these activities under the professional title of architect; whereas, therefore, the conditions under which such activities may be taken up and pursued in those Member States have not yet been laid down; whereas the mutual recognition of diplomas, certificates and other evidence of formal qualifications presupposes that such diplomas, certificates and other evidence of formal qualifications authorize the taking up and pursuit of certain activities in the Member State of issue; whereas, therefore, the recognition of certain certificates under this Directive should continue to apply only in so far as the holders of such certificates will be authorized, in accordance with legal provisions still to be adopted in the Member State of issue, to take up activities under the professional title of architect; Whereas acquisition of the lawful professional title of architect is subject in some Member States to completion of a period of practical experience in addition to the possession of a diploma, certificate or other evidence of formal qualifications; whereas, since practice in this respect of present varies from one Member State to another, to obviate possible difficulties completion of an equal period of appropriate practical experience in another Member State should be recognized as meeting this condition; Whereas the reference in Article 1 (2) to 'activities in the field of architecture' as being 'those activities usually pursued under the professional title of architect', the justification for which lies in the conditions prevailing in certain Member States, is intended solely to indicate the scope of this Directive, without claiming to give a legal definition of activities in the field of architecture; Whereas, in most Member States, activities in the field of architecture are pursued, in law or in fact, by persons who hold the title of architect, whether alone or together with another title, without those persons having a monopoly in pursuing those activities save where there are laws to the contrary; whereas the aforementioned activities, or some of them, may also be pursued by members of other professions, in particular by engineers who have received special training in construction engineering or building; Whereas the mutual recognition of qualifications will facilitate the taking up and pursuit of the activities in question; Whereas in some Member States there is legislation allowing the lawful professional title of architect, by way of exception and notwithstanding the usual educational and training requirements for access to the title, to be granted to certain distinguished persons in the field, who are very few in number and whose work shows exceptional architectural talent; whereas the case of these architects should be covered in this Directive, particularly since they frequently enjoy an international reputation; Whereas the recognition of a number of the existing diplomas, certificates and other evidence of formal qualifications in architecture listed in Articles 10 to 12 is intended to enable the holders thereof to establish themselves or provide services in other Member States with immediate effect; whereas the sudden introduction of this provision in the Grand Duchy of Luxembourg could, in view of the country's small size, lead to distortion of competition and disturb the organization of the profession; whereas, as a result, there appears to be justification for allowing this Member State an additiional period of adjustment; Whereas, since a Directive on the mutual recognition of diplomas, certificates and other evidence of formal qualifications in architecture does not necessarily imply practical equivalence in the education and training covered by such diplomas, certificates and evidence, the use of titles should be authorized only in the language of the Member State of origin or of the Member State from which a foreign national comes; Whereas, to facilitate the application of this Directive by the national authorities, Member States may prescribe that, in addition to evidence of qualifications, persons who satisfy the educational and training requirements of this Directive must provide a certificate from the competent authorities of their Member State of origin or of the country from which they come stating that these qualifications are those referred to by the Directive; Whereas the national provisions with regard to good repute and good character may be applied as standards for the taking up of activities if establishment takes place; whereas, moreover, in the circumstances a distinction should be drawn between cases in which the persons concerned have never yet exercised any activities in the field of architecture and those in which they have already exercised such activities in another Member State; Whereas, in the case of the provision of services, the requirement of registration with, or membership of, professional organizations or bodies would, since it is related to the fixed and permanent nature of the activity pursued in the host Member State, undoubtedly constitute an obstacle to the provider of services by reason of the temporary nature of his activity; whereas this requirement should therefore be abolished; whereas, however, in this event control over professional discipline, which is the responsibility of these professional organizations or bodies, should be guaranteed; whereas, to this end, it should be provided, subject to the application of Article 62 of the Treaty, that the person concerned may be required to notify the provision of services to the competent authority of the host Member State; Whereas, as far as the activities of employed persons in the field of architecture are concerned, Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1) lays down no specific provisions relating to good character or good repute, professional discipline or use of title for the professions covered; whereas, depending on the individual Member State, such rules are or may be applicable both to employed and to self-employed persons; whereas activities in the field of architecture are subject in several Member States to possession of a diploma, certificate or other evidence of formal qualifications; whereas such activities are pursued by both employed and self-employed persons, or by the same persons in both capacities in the course of their professional career; whereas, in order to encourage fully the free movement of members of the profession within the Community, it therefore appears necessary to extend this Directive to employed persons in the field of architecture; Whereas this Directive introduces mutual recognition of diplomas, certificates and other evidence of formal qualifications giving access to professional activities, without concomitant coordination of national provisions relating to education and training; whereas, moreover, the number of members of the profession who are concerned varies considerably from one Member State to another; whereas the first few years of application of this Directive must therefore be followed particularly attentively by the Commission, CHAPTER I SCOPE Article 1 1. This Directive shall apply to activities in the field of architecture. 2. For the purposes of this Directive, activities in the field of architecture shall be those activities usually pursued under the professional title of architect. CHAPTER II DIPLOMAS, CERTIFICATES AND OTHER EVIDENCE OF FORMAL QUALIFICATIONS ENABLING THE HOLDER TO TAKE UP ACTIVITIES IN THE FIELD OF ARCHITECTURE UNDER THE PROFESSIONAL TITLE OF ARCHITECT Article 2 Each Member State shall recognize the diplomas, certificates and other evidence of formal qualifications acquired as a result of education and training fulfilling the requirements of Articles 3 and 4 and awarded to nationals of Member States by other Member States, by giving such diplomas, certificates and other evidence of formal qualifications, as regards the right to take up activities referred to in Article 1 and pursue them under the professional title of architect pursuant to Article 23 (1), the same effect in its territory as those awarded by the Member State itself. Article 3 Education and training leading to diplomas, certificates and other evidence of formal qualifications referred to in Article 2 shall be provided through courses of studies at university level concerned principally with architecture. Such studies shall be balanced between the theoretical and practical aspects of architectural training and shall ensure the acquisition of: 1. an ability to create architectural designs that satisfy both aesthetic and technical requirements, 2. an adequate knowledge of the history and theories of architecture and the related arts, technologies and human sciences, 3. a knowledge of the fine arts as an influence on the quality of architectural design, 4. an adequate knowledge of urban design, planning and the skills involved in the planning process, 5. an understanding of the relationship between people and buildings, and between buildings and their environment, and of the need to relate buildings and the spaces between them to human needs and scale, 6. an understanding of the profession of architecture and the role of the architect in society, in particular in preparing briefs that take account of social factors, 7. an understanding of the methods of investigation and preparation of the brief for a design project, 8. an understanding of the structural design, constructional and engineering problems associated with building design, 9. an adequate knowledge of physical problems and technologies and of the function of buildings so as to provide them with internal conditions of comfort and protection against the climate, 10. the necessary design skills to meet building users' requirements within the constraints imposed by cost factors and building regulations, 11. an adequate knowledge of the industries, organizations, regulations and procedures involved in translating design concepts into buildings and integrating plans into overall planning. Article 4 1. The education and training referred to in Article 2 must satisfy the requirements defined in Article 3 and also the following conditions: (a) the total length of education and training shall consist of a minimum of either four years of full-time studies at a university or comparable educational establishment, or at least six years of study at a university or comparable educational establishment of which at least three must be full time; (b) such education and training shall be concluded by successful completion of an examination of degree standard. Notwithstanding the first subparagraph, recognition under Article 2 shall also be accorded to the training given over three years in the 'Fachhochschulen' in the Federal Republic of Germany in the form in which it exists at the time of notification of this Directive and in so far as it satisfies the requirements laid down in Article 3, giving access to the activities referred to in Article 1 in that Member State with the professional title of architect, provided that such training is supplemented by a four-year period of professional experience in the Federal Republic of Germany sanctioned by a certificate issued by the professional body on whose list the architect wishing to benefit from the provisions of this Directive is registered. The body shall previously have established that the work carried out by the architect concerned in the field of architecture constitutes conclusive proof of the practical application of all the knowledge referred to in Article 3. The certificate shall be issued according to the same procedure as that which applies to registration on the list of architects. On the basis of the experience gained and bearing in mind developments in architectural training, the Commission shall, eight years after the end of the period specified in the first subparagraph of Article 31 (1), submit a report to the Council on the application of this derogation and the appropriate proposals on which the Council shall decide in accordance with the procedures laid down by the Treaty within a period of six months. 2. Recognition under Article 2 shall also be accorded to education and training which, as part of a social betterment scheme or a part-time university course, conforms to the requirements of Article 3 and leads to an examination in architecture successfully completed by persons who have been employed in architecture for not less than seven years under the supervision of an architect or firm of architects. This examination must be of degree standard and be equivalent to the final examination referred to in paragraph 1 (b). Article 5 1. Nationals of a Member State authorized to hold the professional title of architect pursuant to a law giving the competent authority of a Member State the possibility of conferring this title on nationals of Member States who have particularly distinguished themselves by their achievements in the field of architecture shall be considered as meeting the requirements laid down for the pursuit of architectural activities under the professional title of architect. 2. In the case of those persons referred to in paragraph 1, a certificate issued by the Member State of which the holder is a national, or from which he comes, shall constitute proof of the status of architect. Article 6 Certificates issued by the competent authorities of the Federal Republic of Germany attesting the equivalence of qualifications awarded after 8 May 1945 by the competent authorities of the German Democratic Republic with the formal qualifications referred to in Article 2 shall be recognized under the conditions laid down in that Article. Article 7 1. Each Member State shall communicate as soon as possible, simultaneously to the other Member States and to the Commission, the list of diplomas, certificates and other evidence of formal qualifications which are awarded within its territory and which meet the criteria laid down in Articles 3 and 4, together with the establishments and authorities awarding them. The first list shall be sent within 12 months of notification of this Directive. Each Member State shall likewise communicate any amendments made as regards the diplomas, certificates and other evidence of formal qualifications which are awarded within its territory, in particular those which no longer meet the requirements of Articles 3 and 4. 2. For information purposes, the lists and the updating thereof shall be published by the Commission in the Official Journal of the European Communities after expiry of a three-month period following their communication. However, in the cases referred to in Article 8, the publication of a diploma, certificate or other evidence of formal qualifications shall be deferred. Consolidated lists shall be published periodically by the Commission. Article 8 If a Member State or the Commission has doubts as to whether a diploma, certificate or other evidence of formal qualifications meets the criteria laid down in Articles 3 and 4, the Commission shall bring the matter before the Advisory Committee on Education and Training in the Field of Architecture within three months of communication pursuant to Article 7 (1). The Committee shall deliver its opinion within three months. The diploma, certificate or other evidence of formal qualifications shall be published within the three months following delivery of the opinion or expiry of the deadline for delivery thereof except in the following two cases: - where the awarding Member State amends the communication made pursuant to Article 7 (1) or - where a Member State or the Commission implements Articles 169 or 170 of the Treaty with a view to bringing the matter before the Court of Justice of the European Communities. Article 9 1. The Advisory Committee may be consulted by a Member State or the Commission whenever a Member State or the Commission has doubts as to whether a diploma, certificate or other evidence of formal qualifications included on one of the lists published in the Official Journal of the European Communities still meets the requirements of Articles 3 and 4. The Committee shall deliver its opinion within three months. 2. The Commission shall withdraw a diploma from one of the lists published in the Official Journal of the European Communities either in agreement with the Member State concerned or following a ruling by the Court of Justice. CHAPTER III DIPLOMAS, CERTIFICATES AND OTHER EVIDENCE OF FORMAL QUALIFICATIONS ENABLING THE HOLDER TO TAKE UP ACTIVITIES IN THE FIELD OF ARCHITECTURE BY VIRTUE OF ESTABLISHED RIGHTS OR EXISTING NATIONAL PROVISIONS Article 10 Each Member State shall recognize the diplomas, certificates and other evidence of formal qualifications set out in Article 11, awarded by other Member States to nationals of the Member States, where such nationals already possess these qualifications at the time of notification of this Directive or their studies leading to such diplomas, certificates and other evidence of formal qualifications commences during the third academic year at the latest following such notification, even if those qualifications do not fulfil the minimum requirements laid down in Chapter II, by giving them as regards the taking up and pursuit of the activities referred to in Article 1 and subject to compliance with Article 23, the same effect within its territory as the diplomas, certificates and other evidence of formal qualifications which it awards in architecture. Article 11 The diplomas, certificates and other evidence of formal qualifications referred to in Article 10 shall be as follows: (a) in Germany - the diplomas awarded by higher institutes of fine arts (Dipl.-Ing., Architekt (HfbK)); - the diplomas awarded by the departments of architecture (Architektur/Hochbau) of 'Technische Hochschulen', of technical universities, of universities and, in so far as these institutions have been merged into 'Gesamthochschulen', of 'Gesamthochschulen' (Dipl.-Ing. and any other title which may be laid down later for holders of these diplomas); - the diplomas awarded by the departments of architecture (Architektur/Hochbau) of 'Fachhochschulen' and, in so far as these institutions have been merged into 'Gesamthochschulen', by the departments of architecture (Architektur/Hochbau) of 'Gesamthochschulen', accompanied, where the period of study is less than four years but at least three years, by a certificate attesting to a four-year period of professional experience in the Federal Republic of Germany issued by the professional body in accordance with the second subparagraph of Article 4 (1) (Ingenieur grad. and any other title which may be laid down later for holders of these diplomas); - the diplomas (Pruefungszeugnisse) awarded before 1 January 1973 by the departments of architecture of 'Ingenieurschulen' and of 'Werkkunstschulen', accompanied by a certificate from the competent authorities to the effect that the person concerned has passed a test of his formal qualifications in accordance with Article 13; (b) in Belgium - the diplomas awarded by the higher national schools of architecture or the higher national institutes of architecture (architecte - architect); - the diplomas awarded by the higher provincial school of architecture of Hasselt (architect); - the diplomas awarded by the Royal Academies of Fine Arts (architecte - architect); - the diplomas awarded by the 'écoles Saint-Luc' (architecte - architect); - university diplomas in civil engineering, accompanied by a traineeship certificate awarded by the association of architects entitling the holder to hold the professional title of architect (architecte - architect); - the diplomas in architecture awarded by the central or State examining board for architecture (architecte - architect); - the civil engineering/architecture diplomas and architecture/engineering diplomas awarded by the faculties of applied sciences of the universities and by the Polytechnical Faculty of Mons (ingénieur-architecte, ingenieur-architect); (c) in Denmark - the diplomas awarded by the National Schools of Architecture in Copenhagen and AArhus (arkitekt); - the certificate of registration issued by the Board of Architects pursuant to Law No 202 of 28 May 1975 (registreret arkitekt); - diplomas awarded by the Higher Schools of Civil Engineering (bygningskonstruktoer), accompanied by a certificate from the competent authorities to the effect that the person concerned has passed a test of his formal qualifications in accordance with Article 13; (d) in France - the Government architect's diploma awarded by the Ministry of Education until 1959, and subsequently by the Ministry of Cultural Affairs (architecte DPLG); - the diplomas awarded by the 'Ecole spéciale d'architecture' (architecte DESA); - the diplomas awarded since 1955 by the department of architecture of the 'Ecole nationale supérieure des Arts et Industries de Strasbourg' (formerly the 'Ecole nationale d'ingénieurs de Strasbourg') (architecte ENSAIS); (e) in Greece - the engineering/architecture diplomas awarded by the METSOVION POLYTECHNION of Athens, together with a certificate issued by Greece's Technical Chamber conferring the right to pursue activities in the field of architecture; - the engineering/architecture diplomas awarded by the ARISTOTELION PANEPISTIMION of Thessaloniki, together with a certificate issued by Greece's Technical Chamber conferring the right to pursue activities in the field of architecture; - the engineering/civil engineering diplomas awarded by the METSOVION POLYTECHNION of Athens, together with a certificate issued by Greece's Technical Chamber conferring the right to pursue activities in the field of architecture; - the engineering/civil engineering diplomas awarded by the ARISTOTELION PANEPISTIMION of Thessaloniki, together with a certificate issued by Greece's Technical Chamber conferring the right to pursue activities in the field of architecture; - the engineering/civil engineering diplomas awarded by the PANEPISTIMION THRAKIS, together with a certificate issued by Greece's Technical Chamber conferring the right to pursue activities in the field of architecture; - the engineering/civil engineering diplomas awarded by the PANEPISTIMION PATRON, together with a certificate issued by Greece's Technical Chamber conferring the right to pursue activities in the field of architecture; (f) in Ireland - the degree of Bachelor of Architecture awarded by the National University of Ireland (B Arch. (NUI)) to architecture graduates of University College, Dublin; - the diploma of degree standard in architecture awarded by the College of Technology, Bolton Street, Dublin (Dipl. Arch.); - the Certificate of Associateship of the Royal Institute of Architects of Ireland (ARIAI); - the Certificate of Membership of the Royal Institute of Architects of Ireland (MRIAI); (g) in Italy - 'laurea in architettura' diplomas awarded by universities, polytechnic institutes and the higher institutes of architecture of Venice and Reggio Calabria, accompanied by the diploma entitling the holder to pursue independently the profession of architect, awarded by the Minister for Education after the candidate has passed, before a competent board, the State examination entitling him to pursue independently the profession of architect (dott. Architetto); - 'laurea in ingegneria' diplomas in building construction ('sezione costenzione civile') awarded by universities and polytechnic institutes, accompanied by the diploma entitling the holder to pursue independently a profession in the field of architecture, awarded by the Minister for Education after the candidate has passed, before a competent board, the State examination entitling him to pursue the profession independently (dott. Ing. Architetto or dott. Ing. in ingegneria civile); (h) in the Netherlands - the certificate stating that its holder has passed the degree examination in architecture awarded by the departments of architecture of the technical colleges of Delft or Eindhoven (bouwkundig ingenieur); - the diplomas awarded by State-recognized architectural academies (architect); - the diplomas awarded until 1971 by the former architectural colleges (Hoger Bouwkunstonderricht) (architect HBO); - the diplomas awarded until 1970 by the former architectural colleges (Voortgezet Bouwkunstonderricht) (architect VBO); - the certificate stating that the person concerned has passed an examination organized by the Architects Council of the 'Bond van Nederlandse Architecten' (Order of Dutch Architects, BNA) (architect); - the diploma of the 'Stichting Instituut voor Architectuur' ('Institute of Architecture' Foundation) (IVA) awarded on completion of a course organized by this foundation and extending over a minimum period of four years (architect), accompanied by a certificate from the competent authorities to the effect that the person concerned has passed a test of his formal qualifications in accordance with Article 13; - a certificate issued by the competent authorities to the effect that, before the date of entry into force of this Directive, the person concerned passed the degree examination of 'Kandidaat in de bouwkunde' organized by the technical colleges of Delft or Eindhoven and that, over a period of at least five years immediately prior to that date, he pursued architectural activities the nature and importance of which, in accordance with Netherlands requirements, guarantee that he is competent to pursue those activities (architect); - a certificate issued by the competent authorities only to persons who have reached the age of 40 years before the date of entry into force of this Directive, certifying that, over a period of at least five years immediately prior to that date, the person concerned had pursued architectural activities the nature and importance of which, in accordance with Netherlands requirements, guarantee that he is competent to pursue those activities (architect); the certificates referred to in the seventh and eighth indents need no longer be recognized as from the date of entry into force of laws and regulations in the Netherlands governing the taking up and pursuit of architectural activities under the professional title of architect, in so far as under such provisions those certificates do not authorize the taking up of such activities under that professional title; (i) in the United Kingdom - the qualifications awarded following the passing of examinations of: - the Royal Institute of British Architects; - schools of architecture at: - universities, - polytechnics, - colleges, - academies, - schools of technology and art, which were, or are at the time of the adoption of this Directive, recognized by the Architects Registration Council of the United Kingdom for the purpose of admission to the Register (Architect); - a certificate stating that its holder has an established right to hold the professional title of architect by virtue of section 6 (1) a, 6 (1) b or 6 (1) d of the Architects Registration Act 1931 (Architect); - a certificate stating that its holder has an established right to hold the professional title of architect by virue of section 2 of the Architects Registration Act 1938 (Architect). Article 12 Without prejudice to Article 10, each Member State shall recognize, by giving them as regards the taking up and pursuit under the professional title of architect of the activities referred to in Article 1, the same effect within its territory as the diplomas, certificates and other evidence of formal architectural qualifications which it issues: - certificates issued to nationals of Member States by Member States in which there are regulations at the time of notification of this Directive governing the taking up and pursuit of the activities referred to in Article 1 under the professional title of architect, stating that the holder has received authorization to bear the professional title of architect before the implementation of this Directive and has effectively exercised the activities in question under such regulations for at least three consecutive years during the five years preceding the issue of the certificate; - certificates issued to nationals of Member States by Member States which between the time of notification and implementation of the Directive introduce regulations governing the taking up and pursuit of the activities referred to in Article 1 under the professional title of architect, stating that the holder has received authorization to bear the professional title of architect at the time when this Directive is implemented and has effectively exercised the activities in question under such regulations for at least three consecutive years during the five years preceding the issue of the certificate. Article 13 The test of formal qualifications referred to in Article 11 (a), fourth indent, Article 11 (c), third indent, and Article 11 (h), sixth indent, shall comprise an appraisal of plans drawn up and carried out by the person concerned while actually pursuing the activities referred to in Article 1 for not less than six years. Article 14 Certificates issued by the competent authorities of the Federal Republic of Germany attesting the equivalence of qualifications awarded from 8 May 1945 onwards by the competent authorities of the German Democratic Republic with the formal qualifications listed in Article 11 shall be recognized under the conditions listed in that Article. Article 15 The Grand Duchy of Luxembourg shall be authorized, without prejudice to Article 5, to suspend application of Articles 10, 11 and 12 as regards the recognition of non-university diplomas, certificates and other evidence of formal qualifications, in order to avoid distortions of competition, for a transitional period of four-and-a-half years from the date of notification of this Directive. CHAPTER IV USE OF ACADEMIC TITLE Article 16 1. Without prejudice to Article 23, host Member States shall ensure that the nationals of Member States who fulfil the conditions laid down in Chapter II or Chapter III have the right to use their lawful academic title and, where appropriate, the abbreviation thereof deriving from their Member State of origin or the Member State from which they come, in the language of that State. Host Member States may require this title to be followed by the name and location of the establishment or examining board which awarded it. 2. If the academic title used in the Member State of origin, or in the Member State from which a foreign national comes, can be confused in the host Member State with a title requiring, in that State, additional education or training which the person concerned has not undergone, the host Member State may require such a person to use the title employed in the Member State of origin or the Member State from which he comes in a suitable form to be specified by the host Member State. CHAPTER V PROVISIONS TO FACILITATE THE EFFECTIVE EXERCISE OF THE RIGHT OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES A. Provisions specific to the right of establishment Article 17 1. A host Member State which requires of its nationals proof of good character or good repute when they take up for the first time the activities referred to in Article 1 shall accept as sufficient evidence, in respect of nationals of other Member States, a certificate issued by a competent authoritiy in the Member State of origin or in the Member State from which the foreign national comes, attesting that the requirements of that Member State as to good character or good repute for taking up the activity in question have been met. 2. Where the Member State of origin or the Member State from which the foreign national comes does not require proof of good character or good repute of persons wishing to take up the activity in question for the first time, the host Member State may require of nationals of the Member State of origin or of the Member State from which the foreign national comes an extract from the 'judicial record' or, failing this, an equivalent document issued by a competent authority in the Member State of origin or the Member State from which the foreign national comes. 3. Where the Member State of origin or the Member State from which the foreign national comes does not issue the documentary proof referred to in paragraph 2, such proof may be replaced by a declaration on oath - or, in States where there is no provision for declaration on oath, by a solemn declaration - made by the person concerned before a competent judicial or administrative authority or, where appropriate, a notary or qualified professional body of the Member State of origin or the Member State from which the person comes; such authority or notary shall issue a certificate attesting the authenticity of the declaration on oath or solemn declaration. 4. If the host Member State has detailed knowledge of a serious matter which has occurred outside its territory prior to the establishment of the person concerned in that State, or if it knows that the declaration referred to in paragraph 3 contains incorrect information and if the matter or information is likely to affect the taking up within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes. The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts in so far as they might affect the taking up of the activity in question in that Member State. The authorities in that State shall themselves decide on the nature and extent of the investigation to be made and shall inform the host Member State of any consequential action which they take with regard to the certificates or documents they have issued. 5. Member States shall ensure the confidentiality of the information forwarded. Article 18 1. Where, in a host Member State, laws, regulations or administrative provisions impose requirements as to good character or good repute, including provisions in relation to the pursuit of the activities referred to in Article 1 for disciplinary action in respect of serious professional misconduct or conviction on criminal offences, the Member State of origin or the Member State from which the foreign national comes shall forward to the host Member State all necessary information regarding any measures or disciplinary action of a professional or administrative nature taken against the person concerned or any criminal penalties concerning the practise of his profession in the Member State of origin or in the Member State from which he came. 2. If the host Member State has detailed knowledge of a serious matter which has occurred outside its territory prior to the establishment of the person concerned in that State and which is likely to affect the pursuit of the activity concerned in that State, it may inform the Member State of origin or the Member State from which the foreign national comes. The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts in so far as they might affect the pursuit of the activity concerned in that State. The authorities of that State shall themselves decide on the nature and extent of the investigation to be made and shall inform the host Member State of any consequential action which they take with regard to the information forwarded under paragraph 1. 3. Member States shall ensure the confidentiality of the information forwarded. Article 19 Documents issued in accordance with Articles 17 and 18 may not be presented more than three months after their date of issue. Article 20 1. The procedure for authorizing the person concerned to take up the activities referred to in Article 1, pursuant to Article 17 and 18, must be completed as soon as possible and not later than three months after presentation of all the documents relating to that person, without prejudice to delays resulting from any appeal that may be made upon termination of this procedure. 2. In the cases referred to in Article 17 (4) and Article 18 (2), a request for re-examination shall suspend the period laid down in paragraph 1. The Member State consulted shall give its reply within a period of three months. On receipt of the reply or at the end of the period the host Member State shall continue with the procedure referred to in paragraph 1. Article 21 Where a host Member State requires its own nationals wishing to take up or pursue the activities referred to in Article 1 to take an oath or make a solemn declaration and where the form of such oath or declaration cannot be used by nationals of other Member States, that Member State shall ensure that an appropriate and equivalent form of oath or declaration is offered to the person concerned. B. Provisions specific to the provision of services Article 22 1. Where a Member State requires of its own nationals wishing to take up or pursue the activities referred to in Article 1 either an authorization from or membership of or registration with a professional organization or body, that Member State shall, in the case of provision of services, exempt nationals of other Member States from that requirement. The person concerned shall provide services with the same rights and obligations as nationals of the host Member State; in particular he shall be subject to the rules of conduct of a professional or administrative nature which apply in that Member State. For this purpose and in addition to the declaration referred to in paragraph 2 relating to the provision of services, Member States may, so as to permit the implementation of the provisions relating to professional conduct in force in their territory, require automatic temporary registration or pro forma registration with a professional organization or body or in a register, provided that this registration does not delay or in any way complicate the provision of services or impose any additional costs on the person providing the services. Where a host Member State adopts a measure pursuant to the second subparagraph or becomes aware of facts which run counter to these provisions, it shall forthwith inform the Member State in which the person concerned is established. 2. The host Member State may require the person concerned to make a prior declaration to the competent authorities about the services to be provided where they involve the execution of a project in its territory. 3. Pursuant to paragraphs 1 and 2, the host Member State may require the person concerned to supply one or more documents containing the following particulars: - the declaration referred to in paragraph 2, - a certificate stating that the person concerned is lawfully pursuing the activities in question in the Member State where he is established, - a certificate that the person concerned holds the diploma(s), certificate(s) or other evidence of formal qualifications required for the provision of the services in question and that those qualifications comply with the criteria in Chapter II or are as listed in Chapter III of this Directive; - where appropriate, the certificate referred to in Article 23 (2). 4. The document or documents specified in paragraph 3 may not be produced more than 12 months after their date of issue. 5. Where a Member State temporarily or permanently deprives, in whole or in part, one of its nationals or a national of another Member State established in its territory of the right to pursue the activities referred to in Article 1, it shall, as appropriate, ensure the temporary or permanent withdrawal of the certificate referred to in the second indent of paragraph 3. C. Provisions common to the right of establishment and freedom to provide services Article 23 1. Where in a host Member State the use of the professional title of architect relating to the activities referred to in Article 1 is regulated, nationals of other Member States who fulfil the conditions laid down in Chapter II or whose diplomas, certificates or other evidence of formal qualifications referred to in Article 11 have been recognized under Article 10 shall be vested with the professional title of the host Member State and the abbreviated form thereof once they have fulfilled any conditions as to practical training experience laid down by that State. 2. If in a Member State the taking up of the activities referred to in Article 1 or the pursuit of such activities under the title of architect is subject, in addition to the requirements set out in Chapter II or to the possession of a diploma, certificate or other evidence of formal qualifications as referred to in Article 11, to the completion of a given period of practical experience, the Member State concerned shall accept as sufficient evidence a certificate from the Member State of origin or previous residence stating that appropriate practical experience for a corresponding period has been acquired in that country. The certificate referred to in the second subparagraph of Article 4 (1) shall be recognized as sufficient proof within the meaning of this paragraph. Article 24 1. Where the host Member State requires its nationals wishing to take up or pursue the activities referred to in Article 1 to furnish proof of no previous bankruptcy and where the information provided pursuant to Articles 17 and 18 does not contain proof thereof, that state shall accept a declaration on oath - or, in States where there is no provision for declaration on oath, a solemn declaration - made by the person concerned before a competent judicial or administrative authority, a notary or qualified professional body of the Member State of origin or of the Member State from which the person comes; such authority or notary shall issue a certificate attesting the authenticity of the declaration on oath or solemn declaration. Where, in the host Member State, sound financial standing must be proved, that Member State shall accept attestations issued by banks of other Member States as being equivalent to attestations issued in its own territory. 2. The documents referred to in paragraph 1 may not be produced later than three months after their date of issue. Article 25 1. Where a host Member State requires its nationals wishing to take up or pursue the activities referred to in Article 1 to furnish proof that they are covered by insurance against the financial consequences of their professional liability, that State shall accept certificates issued by the insurance undertakings of other Member States as being equivalent to certificates issued in its own territory. Such certificates must specify that the insurer has complied with the laws and regulations in force in the host Member State as regards the conditions and extent of cover. 2. The certificates referred to in paragraph 1 may not be produced latter than three months after their date of issue. Article 26 1. Member States shall take the measures necessary to enable the persons concerned to obtain information on the laws and, where applicable, on the professional ethics of the host Member State. For this purpose, Member States may set up information centres from which such persons may obtain the necessary information. In the event of establishment, the host Member States may require them to contact these centres. 2. Member States may set up the centres referred to in paragraph 1 under the auspices of the competent authorities and bodies which they designate before expiry of the time limit laid down in the first subparagraph of 31 (1). 3. Member States shall ensure that, where appropriate, the persons concerned acquire, in their own interest and in that of their clients, the linguistic knowledge needed to follow their profession in the host Member State. CHAPTER VI FINAL PROVISIONS Article 27 Where legitimate doubt exists, the host Member State may require the competent authorities of another Member State to confirm the authenticity of the diplomas, certificates and other evidence of formal qualifications awarded in that other Member State and referred to in Chapters II and III. Article 28 Within the time limit laid down in the first subparagraph of Article 31 (1), Member States shall designate the authorities and bodies empowered to issue or receive diplomas, certificates and other evidence of formal qualifications as well as the documents and information referred to in this Directive, and shall forthwith inform the other Member States and the Commission thereof. Article 29 This Directive shall also apply to nationals of Member States who, in accordance with Regulation (EEC) No 1612/68, are pursuing or will pursue as employed persons the activities referred to in Article 1. Article 30 Not more than three years after the end of the period provided for in the first subparagraph of Article 31 (1), the Commission shall review this Directive on the basis of experience and if necessary submit to the Council proposals for amendments after consulting the Advisory Committee. The Council shall examine any such proposals within one year. Article 31 1. Member States shall take the measures necessary to comply with this Directive within 24 months of its notification and shall forthwith inform the Commission thereof. Member States shall, however, have three years from the date of notification within which to comply with Article 22. 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 32 This Directive is addressed to the Member States.

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1985

Council Directive 85/323/EEC of 12 June 1985 amending Directive 64/433/EEC on health problems affecting intra- Community trade in fresh meat Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 64/433/EEC (4), as last amended by Directive 83/90/EEC (5), lays down the hygiene conditions under which fresh meat must be produced in slaughterhouses and cutting plants; whereas that Directive provided for health inspections to be carried out; whereas microbiological analyses covering inter alia equipment, utensils and carcases constitute a means for achieving an objective assessment of the standard of hygiene; Whereas microbiological control provides the health inspection service with useful information and thus constitutes an effective means of checking and improving the standard of hygiene in establishments; Whereas the execution of microbiological control in slaughterhouses and cutting plants must be based on the use of harmonized microbiological methods in order to obtain reliable results and to this end a code of good hygiene practices should be worked out, Article 1 The following section is hereby inserted in Chapter IV of Annex I to Directive 64/433/EEC: '18a (a) The operator or proprietor of the establishment or his representative must conduct a regular check on the general hygiene of conditions of production in his establishment, including by microbiological controls in accordance with the fourth subparagraph. These controls should cover utensils, fittings and machinery at all stages of production and, if necessary, products. He must be in a position, upon request from the official service, to inform the official veterinarian or the Commission's veterinary experts of the nature, frequency and results of the controls conducted to this end, together with the name of the investigating laboratory if need be. The nature of these controls, their frequency, as well as the sampling methods and the methods for bacteriological examination will be stipulated in a code of good hygiene practices to be drawn up under the Article 16 procedure. (b) The official veterinarian will regularly analyze the results of the controls provided for in (a). He may, on the basis of this analysis, conduct further microbiological examinations at all stages of production or on the products. The results of these analyses will be written up in a report, the conclusions and recommendations of which will be notified to the operator, who will rectify the shortcomings noted with a view to improving hygiene. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest within six months of the adoption of the code referred to in Article 1. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0322

1985

Council Directive 85/322/EEC of 12 June 1985 amending Directive 72/461/EEC as regards certain measures relating to classical swine fever and African swine fever Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 72/461/EEC (4), as last amended by Directive 84/643/EEC (5), lays down the health requirements to be fulfilled by animals from which meat is obtained for intra-Community trade; Whereas, in view of the development of classical swine fever in certain parts of the territory of the Community, the measures relating to trade should be strengthened and the circumstances in which the status of the officially swine-fever-free regions should be altered in the event of an outbreak of the disease should be more clearly defined; Whereas, even if it occurs only exceptionally in certain parts of the territory of the Community, African swine fever constitutes a danger of contamination to the pig herds of the Member States; whereas rules should therefore be established laying down protective measures to be applied in intra-Community trade in fresh pigmeat, Article 1 Directive 72/461/EEC is hereby amended as follows: 1. The following subparagraph is added to Article 8 (1): 'However, when the disease in question is African swine fever, Article 8a shall apply.' 2. The following Article is inserted: 'Article 8a 1. A Member State in whose territory African swine fever has been recorded within the previous 12 months shall not export fresh pigmeat to the territory of the other Member States. It may be decided, in accordance with the procedure laid down in Article 9, that the provisions of the first subparagraph shall not apply to one or more parts of the territory of the Member State concerned. This derogation shall not preclude recourse to Article 6 should one or more cases of African swine fever reoccur in the above part or parts of territory. 2. Where there is an outbreak of African swine fever in the territory of a Member State where the disease has not been recorded for at least 12 months, it may be decided, in accordance with the procedure laid down in Article 9, that the provisions of paragraph 1 shall apply exclusively to a part of territory concerned. Pending this decision, and without prejudice to Article 8, the Member State concerned shall ensure the immediate prohibition of export to the other Member States of fresh pigmeat from the part of territory in which the epizootic disease has been recorded. The criteria laid down in Article 8b (2) shall be taken into account in determining that part of the territory. One or more cases of African swine fever on a part of a Member State's territory which is not geographically linked to the main part of that Member State's territory shall not prevent the application of the first subparagraph. The conditions prerequisite to the application of the first subparagraph shall still be deemed to be fulfilled if the following conditions have been fulfilled: (i) the outbreak or outbreaks recorded on the occurrence of African swine fever referred to in the first sub-paragraph was or were eradicated in the shortest possible period of time; (ii) the new outbreak, which forms the subject of a fresh request for a decision, as provided for in the first subparagraph, is not connected epidemiologically with the outbreak or outbreaks referred to in (i). 3. Decisions to lift measures applied under paragraph 2 shall be taken in accordance with the procedure laid down in Article 9.' 3. The following Article is inserted: 'Article 8b 1. For the purposes of defining the parts of territory referred to in Article 8a (1), particular account shall be taken of: - the methods used to control and eradicate African swine fever, - the absence of the disease for at least 12 months, recorded by all the methods of detection, including serological surveys, - the surface area of the parts of territory and their administrative and geographical boundaries, - the protective measures taken to prevent the contamination or re-contamination of pig herds, - the measures taken to control the movement of pigs. 2. For the purposes of defining the parts of territory referred to in Article 8a (2), particular account shall be taken of: - the methods used to combat the disease, in particular the elimination of pigs from holdings which are infected, contaminated or suspected of contamination, - the surface area of the parts of territory and their administrative and geographical boundaries, - the incidence of the disease and its tendency to spread, - the measures taken to prevent the disease from spreading, - the measures taken to restrict and control the movement of pigs both inside and outside the part of territory concerned.' 4. Article 13a (2) is replaced by the following: '2. Acting unanimously on a proposal from the Commission, within three months of the date on which the proposal is referred to it, the Council shall draw up the list of the Member States and parts of territory referred to in paragraph 1 (ii) which are swine-fever-free. Without prejudice to the possibility of recourse to Article 8, the Member States in question shall suspend this status upon the occurrence of an outbreak of swine fever and shall forthwith inform the Commission and the other Member States thereof, The Member State concerned shall lift the suspension either 30 days after the eradication of the last outbreak of the disease if there has been no vaccination or 90 days after the eradication of the last outbreak of the disease if there has been a vaccination. It shall inform the Commission and the other Member States of the end of the period of suspension. When two months have elapsed between the dates on which the first and last outbreaks were detected, the Member State concerned shall forthwith inform the Commission thereof. In this case, the status may be withdrawn in accordance with the procedure laid down in Article 9. In the event of withdrawal, the status may be granted afresh to the part of territory in question in accordance with the same procedure only after a period of not less than: - three months after the eradication of the last outbreak of the disease if there has been no vaccination, - six months after the eradication of the last outbreak of the disease if there has been vaccination. 3. This Article shall be applicable until 31 December 1987. By 1 July 1987 the Commission shall submit to the Council a report on development in the situation with particular regard to trade, together with appropriate proposals as regards swine fever. The Council shall take a decision on these proposals not later than 31 December 1987.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than January 1986. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0320

1985

Council Directive 85/320/EEC of 12 June 1985 amending Directive 64/432/EEC as regards certain measures relating to classical swine fever and African swine fever Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 64/432/EEC (4), as last amended by Directive 84/644/EEC (5), lays down the health requirements to be fulfilled by live cattle and pigs intended for intra-Community trade; Whereas, in view of the development of classical swine fever in certain parts of the territory of the Community, the measures relating to trade should be strengthened and the circumstances in which the status of the officially swine-fever-free regions should be altered in the event of an outbreak of the disease should be more clearly defined; Whereas, even if it occurs only exceptionally in certain parts of the territory of the Community, African swine fever constitutes a danger of contamination to the pig herds of the Member States; whereas rules should therefore be established laying down protective measures to be applied in intra-Community trade in live pigs, Article 1 Directive 64/432/EEC is hereby amended as follows: 1. In Article 3 (2) (b) (ii), 'a protective area with a radius of 2 kilometres shall be established around the holding for a period of 15 days' is replaced by 'a protection zone with a radius of 3 kilometres shall be established around the holding for a period of 30 days where the disease is swine fever and with a radius of 2 kilometres for 15 days where other diseases are involved'. 2. Article 4b (1) (c) is replaced by the following: '(c) or a part of territory made up of a region or several adjacent regions recognized as officially swine-fever-free for the purpose of intra-Community trade by the Council acting unanimously on a proposal from the Commission within three months of the date on which the proposal was referred to it. Without prejudice to the possibility of recourse to Article 9, the Member State in question shall suspend this status upon the occurrence of a case of swine fever and shall forthwith inform the Commission and the other Member States thereof. The Member State concerned shall lift the suspension either 30 days after the eradication of the last outbreak of the disease if there has been no vaccination or 30 days after the eradication of the last outbreak of the disease and the elimination of the vaccinated pigs if there has been a vaccination. It shall inform the Commission and the other Member States of the lifting of the suspension. When two months have elapsed between the dates on which the first and last outbreaks were officially confirmed, the Member State concerned shall forthwith inform the Commission thereof. In this case, the status may be withdrawn in accordance with the procedure laid down in Article 13. In the event of withdrawal, the status may be granted afresh to the part of territory in question in accordance with the same procedure only after a period of not less than: - three months after the eradication of the last outbreak of the disease if there has been no vaccination, - six months after the eradication of the last outbreak of the disease and after the elimination of the vaccinated pigs if there has been vaccination.' 3. The following paragraph is added to Article 4b: '3. This Article shall be applicable until 31 December 1987. By 1 July 1987 the Commission shall submit to the Council a report on developments in the situation with particular regard to trade, together with appropriate proposals as regards swine fever. The Council shall take a decision on these proposals not later than 31 December 1987.' 4. The following subparagraph is added to Article 9 (1): 'However, where the disease in question is African swine fever, Article 9a shall apply.' 5. The following Article is inserted: 'Article 9a 1. A Member State in whose territory African swine fever has been recorded within the previous 12 months shall not export live pigs to the territory of the other Member States. It may be decided, in accordance with the procedure laid down in Article 12, that the provisions of the first subparagraph shall not apply to one or more parts of the territory of the Member State concerned. This derogation shall not preclude recourse to Article 9 should one or more cases of African swine fever re-occur in the above part or parts of territory. 2. Where there is an outbreak of African swine fever in the territory of a Member State where the disease has not been recorded for at least 12 months, it may be decided, in accordance with the procedure laid down in Article 13, that the provisions of paragraph 1 shall apply exclusively to the part of territory concerned. Pending this decision, and without prejudice to Article 9, the Member State concerned shall ensure the immediate prohibition of export to the other Member States of live pigs from the part of territory in which the epizootic disease has been recorded. The criteria laid down in Article 9b (2) shall be taken into account in determining that part of the territory. One or more cases of African swine fever on a part of a Member State's territory which is not geographically linked to the main part of that Member State's territory shall not prevent the application of the first subparagraph. The conditions prerequisite to the application of the first subparagraph shall still be deemed to be fulfilled if the following conditions have been fulfilled: (i) the outbreak or outbreaks recorded on the occurrence of African swine fever referred to in the first subparagraph was or were eradicated in the shortest possible period of time; (ii) the new outbreak, which forms the subject of a fresh decision, as provided for in the first subparagraph, is not connected epidemiologically with the outbreak or outbreaks referred to in (i). 3. Decisions to lift measures applied under paragraph 2 shall be taken in accordance with the procedure laid down in Article 13.' 6. The following Article is inserted: 'Article 9b 1. For the purposes of defining the parts of territory referred to in Article 9a (1), particular account shall be taken of: - the methods used to control and eradicate African swine fever, - the absence of the disease for at least 12 months, recorded by all methods of detection, including serological surveys, - the surface area of the parts of territory and their administrative and geographical boundaries, - the protective measures taken to prevent the contamination or recontamination of pig herds, - the measures taken to control the movement of pigs. 2. For the purposes of defining the parts of territory referred to in Article 9a (2), particular account shall be taken of: - the methods used to combat the disease, in particular the elimination of pigs from holdings which are infected, contaminated or suspected of contamination, - the surface area of the parts of territory and their administrative and geographical boundaries, - the incidence of the disease and its tendency to spread, - the measures taken to prevent the disease from spreading, - the measures taken to restrict and control the movement of pigs both inside and outside the part of territory concerned.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1986. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0321

1985

Council Directive 85/321/EEC of 12 June 1985 amending Directive 80/215/EEC as regards certain measures relating to African swine fever Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 80/215/EEC (4), as last amended by Directive 81/476/EEC (5), lays down the health requirements to be fulfilled by meat products intended for intra-Community trade; Whereas, even if it occurs only exceptionally in certain parts of the territory of the Community, African swine fever constitutes a risk of contamination to the pig herds of the Member States; whereas rules should therefore be established laying down protective measures to be applied in intra-Community trade in pigmeat products which have not undergone treatment to destroy the virus of the disease, Article 1 Directive 80/215/EEC is hereby amended as follows: 1. The following subparagraph is added to Article 7 (1): 'However, where the disease in question is African swine fever, Article 7a shall apply.' 2. The following Article is inserted: 'Article 7a 1. A Member State in whose territory African swine fever has been recorded within the previous 12 months shall not export to the territory of other Member States pigmeat products other than those having undergone the treatment referred to in Article 4 (1) (a). It may be decided, in accordance with the procedure laid down in Article 8, that the provisions of the first subparagraph shall not apply to one or more parts of the territory of the Member State concerned. This derogation shall not preclude recourse to Article 7 should one or more cases of African swine fever re-occur in the above part or parts of territory. 2. Where there is an outbreak of African swine fever in the territory of a Member State where the disease has not been recorded for at least 12 months, it may be decided, in accordance with the procedure laid down in Article 8, that the provisions of paragraph 1 shall apply exclusively to a part of territory concerned. Pending this decision, and without prejudice to Article 7, the Member State concerned shall ensure the immediate prohibition of export to the other Member States of pigmeat products from the part of territory in which the epizootic disease has been recorded. The criteria laid down in Article 7b (2) shall be taken into account in determining that part of the territory. One or more cases of African swine fever on a part of a Member State's territory which is not geographically linked to the main part of that Member State's territory shall not prevent the application of the first subparagraph. The conditions prerequisite to the application of the first subparagraph shall still be deemed to be fulfilled if the following conditions have been fulfilled: (i) the outbreak or outbreaks recorded on the occurrence of African swine fever referred to in the first subparagraph was or were eradicated in the shortest possible period of time; (ii) the new outbreak, which forms the subject of a fresh request for a decision, as provided for in the first subparagraph, is not connected epidemiologically with the outbreak or outbreaks referred to in (i). 3. Decisions to lift measures applied under paragraph 2 shall be taken in accordance with the procedure laid down in Article 8.' 3. The following Article is inserted: 'Article 7b 1. For the purposes of defining the parts of territory referred to in Article 7a (1), particular account shall be taken of: - the methods used to control and eradicate African swine fever, - the absence of the disease for at least 12 months, recorded by all the methods of detection, including serological surveys, - the surface area of the parts of territory and their administrative and geographical boundaries, - the protective measures taken to prevent the contamination or recontamination of pig herds, - the measures taken to control the movement of pigs. 2. For the purposes of defining the parts of territory referred to in Article 7a (2), particular account shall be taken of: - the methods used to combat the disease, in particular the elimination of pigs from holdings which are infected, contaminated or suspected of contamination, - the surface area of the parts of territory and their administrative and geographical boundaries, - the incidence of the disease and its tendency to spread, - the measures taken to prevent the disease from spreading, - the measures taken to restrict and control the movement of pigs both inside and outside the part of territory concerned; and, in the case of non-application of prohibition measures to certain products: - the treatment to which the products have been subjected, - the manufacturing dates, and - the measures taken to determine and guarantee the date of manufacture.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1986. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0337

1985

Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission (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 1973 (4) and 1977 (5) action programmes of the European Communities on the environment, as well as the 1983 (6) action programme, the main outlines of which have been approved by the Council of the European Communities and the representatives of the Governments of the Member States, stress that the best environmental policy consists in preventing the creation of pollution or nuisances at source, rather than subsequently trying to counteract their effects; whereas they affirm the need to take effects on the environment into account at the earliest possible stage in all the technical planning and decision-making processes; whereas to that end, they provide for the implementation of procedures to evaluate such effects; Whereas the disparities between the laws in force in the various Member States with regard to the assessment of the environmental effects of public and private projects may create unfavourable competitive conditions and thereby directly affect the functioning of the common market; whereas, therefore, it is necessary to approximate national laws in this field pursuant to Article 100 of the Treaty; Whereas, in addition, it is necessary to achieve one of the Community's objectives in the sphere of the protection of the environment and the quality of life; Whereas, since the Treaty has not provided the powers required for this end, recourse should be had to Article 235 of the Treaty; Whereas general principles for the assessment of environmental effects should be introduced with a view to supplementing and coordinating development consent procedures governing public and private projects likely to have a major effect on the environment; Whereas development consent for public and private projects which are likely to have significant effects on the environment should be granted only after prior assessment of the likely significant environmental effects of these projects has been carried out; whereas this assessment must be conducted on the basis of the appropriate information supplied by the developer, which may be supplemented by the authorities and by the people who may be concerned by the project in question; Whereas the principles of the assessment of environmental effects should be harmonized, in particular with reference to the projects which should be subject to assessment, the main obligations of the developers and the content of the assessment; Whereas projects belonging to certain types have significant effects on the environment and these projects must as a rule be subject to systematic assessment; Whereas projects of other types may not have significant effects on the environment in every case and whereas these projects should be assessed where the Member States consider that their characteristics so require; Whereas, for projects which are subject to assessment, a certain minimal amount of information must be supplied, concerning the project and its effects; Whereas the effects of a project on the environment must be assessed in order to take account of concerns to protect human health, to contribute by means of a better environment to the quality of life, to ensure maintenance of the diversity of species and to maintain the reproductive capacity of the ecosystem as a basic resource for life; Whereas, however, this Directive should not be applied to projects the details of which are adopted by a specific act of national legislation, since the objectives of this Directive, including that of supplying information, are achieved through the legislative process; Whereas, furthermore, it may be appropriate in exceptional cases to exempt a specific project from the assessment procedures laid down by this Directive, subject to appropriate information being supplied to the Commission, Article 1 1. This Directive shall apply to the assessment of the environmental effects of those public and private projects which are likely to have significant effects on the environment. 2. For the purposes of this Directive: 'project' means: - the execution of construction works or of other installations or schemes, - other interventions in the natural surroundings and landscape including those involving the extraction of mineral resources; 'developer' means: the applicant for authorization for a private project or the public authority which initiates a project; 'development consent' means: the decision of the competent authority or authorities which entitles the developer to proceed with the project. 3. The competent authority or authorities shall be that or those which the Member States designate as responsible for performing the duties arising from this Directive. 4. Projects serving national defence purposes are not covered by this Directive. 5. This Directive shall not apply to projects the details of which are adopted by a specific act of national legislation, since the objectives of this Directive, including that of supplying information, are achieved through the legislative process. Article 2 1. Member States shall adopt all measures necessary to ensure that, before consent is given, projects likely to have significant effects on the environment by virtue inter alia, of their nature, size or location are made subject to an assessment with regard to their effects. These projects are defined in Article 4. 2. The environmental impact assessment may be integrated into the existing procedures for consent to projects in the Member States, or, failing this, into other procedures or into procedures to be established to comply with the aims of this Directive. 3. Member States may, in exceptional cases, exempt a specific project in whole or in part from the provisions laid down in this Directive. In this event, the Member States shall: (a) consider whether another form of assessment would be appropriate and whether the information thus collected should be made available to the public; (b) make available to the public concerned the information relating to the exemption and the reasons for granting it; (c) inform the Commission, prior to granting consent, of the reasons justifying the exemption granted, and provide it with the information made available, where appropriate, to their own nationals. The Commission shall immediately forward the documents received to the other Member States. The Commission shall report annually to the Council on the application of this paragraph. Article 3 The environmental impact assessment will identify, describe and assess in an appropriate manner, in the light of each individual case and in accordance with the Articles 4 to 11, the direct and indirect effects of a project on the following factors: - human beings, fauna and flora, - soil, water, air, climate and the landscape, - the inter-action between the factors mentioned in the first and second indents, - material assets and the cultural heritage. Article 4 1. Subject to Article 2 (3), projects of the classes listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10. 2. Projects of the classes listed in Annex II shall be made subject to an assessment, in accordance with Articles 5 to 10, where Member States consider that their characteristics so require. To this end Member States may inter alia specify certain types of projects as being subject to an assessment or may establish the criteria and/or thresholds necessary to determine which of the projects of the classes listed in Annex II are to be subject to an assessment in accordance with Articles 5 to 10. Article 5 1. In the case of projects which, pursuant to Article 4, must be subjected to an environmental impact assessment in accordance with Articles 5 to 10, Member States shall adopt the necessary measures to ensure that the developer supplies in an appropriate form the information specified in Annex III inasmuch as: (a) the Member States consider that the information is relevant to a given stage of the consent procedure and to the specific characteristics of a particular project or type of project and of the environmental features likely to be affected; (b) the Member States consider that a developer may reasonably be required to compile this information having regard inter alia to current knowledge and methods of assessment. 2. The information to be provided by the developer in accordance with paragraph 1 shall include at least: - a description of the project comprising information on the site, design and size of the project, - a description of the measures envisaged in order to avoid, reduce and, if possible, remedy significant adverse effects, - the data required to identify and assess the main effects which the project is likely to have on the environment, - a non-technical summary of the information mentioned in indents 1 to 3. 3. Where they consider it necessary, Member States shall ensure that any authorities with relevant information in their possession make this information available to the developer. Article 6 1. Member States shall take the measures necessary to ensure that the authorities likely to be concerned by the project by reason of their specific environmental responsibilities are given an opportunity to express their opinion on the request for development consent. Member States shall designate the authorities to be consulted for this purpose in general terms or in each case when the request for consent is made. The information gathered pursuant to Article 5 shall be forwarded to these authorities. Detailed arrangements for consultation shall be laid down by the Member States. 2. Member States shall ensure that: - any request for development consent and any information gathered pursuant to Article 5 are made available to the public, - the public concerned is given the opportunity to express an opinion before the project is initiated. 3. The detailed arrangements for such information and consultation shall be determined by the Member States, which may in particular, depending on the particular characteristics of the projects or sites concerned: - determine the public concerned, - specify the places where the information can be consulted, - specify the way in which the public may be informed, for example by bill-posting within a certain radius, publication in local newspapers, organization of exhibitions with plans, drawings, tables, graphs, models, - determine the manner in which the public is to be consulted, for example, by written submissions, by public enquiry, - fix appropriate time limits for the various stages of the procedure in order to ensure that a decision is taken within a reasonable period. Article 7 Where a Member State is aware that a project is likely to have significant effects on the environment in another Member State or where a Member State likely to be significantly affected so requests, the Member State in whose territory the project is intended to be carried out shall forward the information gathered pursuant to Article 5 to the other Member State at the same time as it makes it available to its own nationals. Such information shall serve as a basis for any consultations necessary in the framework of the bilateral relations between two Member States on a reciprocal and equivalent basis. Article 8 Information gathered pursuant to Articles 5, 6 and 7 must be taken into consideration in the development consent procedure. Article 9 When a decision has been taken, the competent authority or authorities shall inform the public concerned of: - the content of the decision and any conditions attached thereto, - the reasons and considerations on which the decision is based where the Member States' legislation so provides. The detailed arrangements for such information shall be determined by the Member States. If another Member State has been informed pursuant to Article 7, it will also be informed of the decision in question. Article 10 The provisions of this Directive shall not affect the obligation on the competent authorities to respect the limitations imposed by national regulations and administrative provisions and accepted legal practices with regard to industrial and commercial secrecy and the safeguarding of the public interest. Where Article 7 applies, the transmission of information to another Member State and the reception of information by another Member State shall be subject to the limitations in force in the Member State in which the project is proposed. Article 11 1. The Member States and the Commission shall exchange information on the experience gained in applying this Directive. 2. In particular, Member States shall inform the Commission of any criteria and/or thresholds adopted for the selection of the projects in question, in accordance with Article 4 (2), or of the types of projects concerned which, pursuant to Article 4 (2), are subject to assessment in accordance with Articles 5 to 10. 3. Five years after notification of this Directive, the Commission shall send the European Parliament and the Council a report on its application and effectiveness. The report shall be based on the aforementioned exchange of information. 4. On the basis of this exchange of information, the Commission shall submit to the Council additional proposals, should this be necessary, with a view to this Directive's being applied in a sufficiently coordinated manner. Article 12 1. Member States shall take the measures necessary to comply with this Directive within three years of its notification (1). 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 13 The provisions of this Directive shall not affect the right of Member States to lay down stricter rules regarding scope and procedure when assessing environmental effects. Article 14 This Directive is addressed to the Member States.

31985L0346

1985

Council Directive 85/346/EEC of 8 July 1985 amending Directive 83/181/EEC determining the scope of Article 14 (1) (d) of Directive 77/388/EEC as regards exemption from value added tax on the final importation of certain goods Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 83/181/EEC (4) laid down the minimum quantity of fuel contained in the fuel tanks of commercial motor vehicles which must be exempted from value added tax on admission; Whereas, in order to facilitate passage at the internal frontiers of the Community, the said quantity should be increased, in an initial stage, for vehicles designed for, and capable of, the transport of persons and travelling between Member States; whereas, in a second stage, the Council is to decide, on a proposal from the Commission, on the increase of the said quantity applicable to vehicles travelling between Member States and designed for, and capable of, the transport of goods, Article 1 Directive 83/181/EEC is hereby amended as follows: 1. Article 83 is replaced by the following: 'Article 83 Member States may limit the application of the exemption for fuel contained in the standard fuel tanks of commercial motor vehicles: (a) when the vehicle comes from a third country, to 200 litres per vehicle and per journey; (b) when the vehicle comes from another Member State: - to 200 litres per vehicle and per journey in the case of vehicles designed for, and capable of, the transport, with or without remuneration, of goods, - to 600 litres per vehicle and per journey in the case of vehicles designed for, and capable of, the transport, with or without remuneration, of more than nine persons, including the driver. Acting in accordance with the procedures provided for by the Treaty on this point, the Council shall decide, on a proposal from the Commission, before 1 July 1986, on the increase of the quantity of fuel admitted duty-free and contained in the standard fuel tanks of the vehicles referred to in the first indent of (b) of the first subparagraph.' 2. Article 84 (a) is replaced by the following: '(a) commercial motor vehicles engaged in international transport coming from third countries to their frontier zone, to a maximum depth of 25 kilometres as the crow flies, where such transport consists of journeys made by persons residing in that zone;'. Article 2 Member States shall take the necessary measures to conform with this Directive by 1 October 1985 at the latest. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0391

1985

Sixth Commission Directive 85/391/EEC of 16 July 1985 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 84/415/EEC (2), and in particular Article 8 (2) thereof, Whereas with a view to safeguarding public health the use of certain hydroquinone ethers in cosmetic products should be prohibited; Whereas on the basis of the most recent scientific and technical research and subject to certain restrictions and conditions, the use of selenium disulphide in anti-dandruff shampoos may be permitted; whereas the use of certain aluminium zirconium complexes as antiperspirants may be definitively permitted; Whereas certain preservatives may release formaldehyde and consequently finished products containing them must be made subject to the labelling conditions laid down for formaldehyde; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, Article 1 Directive 76/768/EEC is hereby amended as follows: 1. In Annex II: - under reference No 167, 'Annex IV, Part 1' is replaced by 'Annex VII, Part 2'; - reference No 178 is replaced by: '178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol'; - reference No 297 is replaced by: '297. Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III, Part 1'; 2. In Annex III, Part 1, the following reference numbers are added: 1.2.3.4.5.6 // // // // // // // a // b // c // d // e // f // // // // // // // 49 // Selenium disulphide // Antidandruff shampoos // 1 % // // - Contains selenium disulphide - Avoid contact with eyes or damaged skin // // // // // // // 50 // Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride sydroxide glycine complexes // Antiperspirants // 20 % as anhydrous aluminium zirconium chloride hydroxide 5,4 % as zirconium // 1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between two and 10 2. The ratio of the number of (Al+Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1 3. Prohibited in aerosol dispensers (sprays) // Do not apply to irritated or damaged skin // // // // // // 3. In Annex IV, Part 1, No 7 is deleted. 4. In Annex V, No 6 is replaced b: '6. Zirconium and its compounds, with the exception of the complexes under reference No 50 in Annex III, Part 1, and of zirconium lakes, salts and pigments of colouring agents listed with reference (5) in Annex III, Part 2, and in Annex IV, Part 2'. 5. In Annex VI, - the following paragraph 5 is added to the preamble: '5. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0,05 %.' - the warning 'contains formaldehyde' in column (e) is deleted for substance No 5 in Part 1 and substances 39, 44 and 50 in Part 2; - the maximum authorized concentrations in column (c) is deleted for substance No 5 in Part 1 and substances 39, 44 and 50 in Part 2; - the maximum authorized concentrations in column (c) for substances 39, 44 and 50 in Part 2 are replaced respectively by 1 % 0,15 % and 0,6 %; - footnote (2) in Part 1 and footnote (1) in Part 2 are deleted. Article 2 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1986. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0358

1985

Council Directive 85/358/EEC of 16 July 1985 supplementing Directive 81/602/EEC concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to Council Directive 81/602/EEC of 31 July 1981 concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action (1), and in particular Article 7 thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas Community control measures should be introduced to guarantee the uniform application, in all Member States, of the standards fixed in Directive 81/602/EEC; Whereas such control measures must cover the various phases running from manufacturing to the sale of the substances and the veterinary pharmaceutical preparations referred to in Directive 81/602/EEC; Whereas under Article 7 of Directive 81/602/EEC it is incumbent upon the Council to adopt in particular the detailed rules for carrying out controls covering farm animals in their farms of origin and at the slaughterhouse, and the meat of such animals and the meat products obtained therefrom; Whereas provisions should be made for the official taking of samples at the slaughterhouse; whereas, furthermore, where there is a justified suspicion of infringement, provision should be made for the possibility taking such samples at the farm of origin; Whereas the analysis of samples must be carried out in an officially approved laboratory; Whereas, pending the adoption of a uniform Community method of analysis and reference methods, a common methodology should be adopted to be used in the event of dispute; Whereas, where the presence of prohibited substances or of the residues of such substances is confirmed, an investigation should be made at the farm of origin in order to exclude the meat in question from human and animal consumption and to place the prohibited substances under official control; Whereas in order to facilitate the implementation of the envisaged provisions, provision should be made for a procedure establishing close cooperation between the Member States and the Commission within the Standing Veterinary Committee set up by the Council Decision of 15 October 1968, Article 1 The Member States shall ensure that official on-the-spot random controls are made on the substances referred to in Directive 81/602/EEC at the manufacturing, handling, storage, transport, distribution and sales stages for the presence of prohibited substances and veterinary pharmaceutical preparations containing prohibited substances which may be intended to be administered to animals for fattening purposes. Article 2 Without prejudice to the controls provided for in Directives 64/433/EEC (1) and 72/462/EEC (2), Member States shall ensure that controls on farm animals, the meat of such animals and the meat products obtained therefrom are carried out within their territories, in accordance with the following Articles, in order to secure compliance in particular with the provisions of Directive 81/602/EEC. Article 3 Member States shall ensure that: 1. where there is justified suspicion of an infringement, the competent departments make or arrange to have made: - random controls on animals on their farms of origin, particularly in order to detect traces of implants, - an official control for the presence of the substances the use of which is prohibited on farms where animals are reared, kept or fattened; such controls may include the official taking of samples; 2. random samples are taken from animals from fattening farms. Article 4 Member States shall ensure that, at the slaughterhouse, before slaughter the animals are examined and that samples are taken officially to reveal the illegal use of the substances referred to in Directive 81/602/EEC or the presence of residues of such substances. Depending on the nature of the substances sought, these samples are to be taken from: - live animals, including specimens of urine or controls of any remains of solid implants, or - carcases after slaughter including a histopathological examination, or - animals and meat. Article 5 1. The samples referred to in Articles 3 and 4 shall be analysed in a laboratory approved by the competent authorities for the analysis of hormone residues. 2. Analysis of the samples provided for in paragraph 1 shall be carried out in accordance with methods to be determined in accordance with the procedure laid down in Article 11, within eighteen months of notification of this Directive. Pending decisions to this effect, the Member States shall, in the event of dispute, recognize the findings obtained by radio-immunoassay (RIA) and by thin layer chromatography or by gas chromatography. 3. All positive findings must, if contested, be confirmed by an official laboratory duly approved for the purpose by the competent authorities, using the reference methods established by virtue of Article 4 (1) (b) of Directive 64/433/EEC. Article 6 1. Where the analysis referred to in Article 5 confirms the presence of prohibited substances or of residues either exceeding the maximum natural physiological levels for the authorized substances or proving that authorized substances have been used abusively, the competent authorities shall be informed immediately of: (a) all the particulars needed to identify the animal and its farm of origin. These particulars shall be determined in accordance with the procedure laid down in Article 10; (b) the result of the analysis. 2. The competent authorities shall then ensure that: (a) an investigation is made at the farm of origin to determine the reason for the presence of hormone residues; (b) an investigation of the source or sources of the substance concerned is made, as necessary, at the manufacturing, handling, storage, transport, distribution or sales stage. 3. The competent authorities shall also ensure that: (a) the herd or animals at the farm of origin and the herds which, as a result of the investigations referred to in paragraph 2 may be considered to contain the residue in question, are officially marked and subjected to appropriate analysis; (b) if these analyses reveal the presence of prohibited substances, the animals may not be placed on the market for human or animal consumption; (c) if the analyses reveal the presence of residues of authorized hormone substances exceeding the limits mentioned in paragraph 1, the slaughter of the animals intended for human consumption shall be prohibited until it is possible to be sure that the residue level does not exceed the permitted limits. That period may in no case be shorter than the waiting period laid down for the preparation in question. However, where it is established that the conditions of use of the products have not been complied with, the animals concerned must be definitely excluded from human consumption; (d) the animals are not disposed of to other persons during the analysis period unless this occurs under the supervision of the official veterinarian. 4. By way of derogation from paragraph 3 (c), animals, the slaughter of which is prohibited, may be slaughtered before the end of the prohibition period if the competent authority is informed thereof before the proposed date of slaughter, and has been made aware of the place of slaughter. Animals which have been officially marked must be accompanied at the place of slaughter by an official veterinary certificate containing the information required under paragraph 1 (a). The carcase of each animal the slaughter of which is communicated pursuant to the first subparagraph shall be officially subjected to analysis of the residue in question and shall be kept until the result of the analysis is known. Article 7 Where, without prejudice to the provisions of Article 4 of Directive 81/602/EEC, the controls and investigations laid down in Articles 2 to 6 disclose the presence of prohibited substances, the Member States shall ensure that these substances are placed under official control until the necessary sanctions are imposed. Article 8 Where the results of the controls carried out in one Member State indicate the need for investigation in one or more other Member States on in one or more third countries, the Member State concerned shall inform the other Member States and the Commission thereof. Member States in which an investigation proves to be necessary shall take the necessary measures. If the need arises, at the request of the Member State which has requested the investigation or on its own initiative, the Commission may send an expert on the spot. The detailed rules of application of this Article shall be adopted in accordance with the procedure laid down in Article 10. Article 9 1. Member States shall forward information to the Commission at least once a year on the control measures they have taken, including details of samplings, analyses and investigations carried out for detection of the presence of residues of substances the use of which is promibited. 2. On the basis of that information, the Commission shall report to the representatives of the Member States meeting in the Standing Veterinary Committee, hereinafter referred to as the 'Committee'. If necessary, measures may be taken in accordance with the procedure laid down in Article 10, to ensure uniform application of the controls provided for in this Directive. Article 10 1. Where the procedure laid down in this Article is to be used, the matter shall be referred to the Committee immediately by its Chairman, either on his own initiative or at the request of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. 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 a majority of forty-five votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The Chairman shall not vote. 3. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall act by a qualified majority. If within three months of the date on which a matter was referred to it the Council has not adopted any measures, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the measures by a simple majority. Article 11 1. Where the procedure laid down in this Article is to be followed, the Chairman shall refer the matter to the Committee without delay either on his own initiative or at the request of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. 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 a majority of 45 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The Chairman shall not vote. 3. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall act by a qualified majority. If within fifteen working days of the date on which the matter was referred to it the Council has not adopted any measures, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the measure by a simple majority. Article 12 Member States shall ensure, except where expenses are incurred by the application of Articles 3 and 6, that the expenses entailed by the controls referred to in Article 2 et seq. are charged against the fees laid down by Directive 85/73/EEC (1). Article 13 For the purposes of implementing Article 4 (2) (a) of Directive 72/462/EEC, the guarantees to be requested from third countries as regards compliance with the requirement laid down under (b) of the said provision must not be more favourable than those provided for in this Directive. In accordance with the procedure laid down in Article 11, guarantees at least equivalent to those resulting from application of this Directive may be accepted. Article 14 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by a date to be fixed by the Council, acting unanimously on a proposal from the Commission, before 31 December 1985. Before that latter date, the Council, acting unanimously on a proposal from the Commission, shall adopt the Decision provided for in Article 5 of Directive 81/602/EEC. Article 15 This Directive is addressed to the Member States.

31985L0469

1985

Commission Directive 85/469/EEC of 22 July 1985 adapting to technical progress Council Directive 84/631/EEC on the supervision and control within the European Community of the transfrontier shipment of hazardous waste Having regard to the Treaty establishing the European Economic Community,Having regard to Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (1), and in particular Article 18 thereof,Having regard to Council Directive 84/631/EEC of 6 December 1984 on the supervision and control within the European Community of the transfrontier shipment of hazardous waste (2), and in particular Article 15 thereof,Whereas it is necessary to finalize Annexes I and III to Directive 84/631/EEC;Whereas, in order to ensure effective supervision and control, it is necessary that the holder of waste intending to ship it or to have it shipped from one Member State to another or through one or more Member States or to ship it to a Member State from a third State should notify the competent authorities of the Member States concerned;Whereas such notification must be made by means of a uniform consignment note, the contents of which are set out in Annex I to Directive 84/631/EEC;Whereas, in the case of non-ferrous metal waste intended for re-use, regeneration or recycling on the basis of a contractual agreement regarding such operations, only declarations on a uniform document are required, the content of which is given in Annex III to Directive 84/631/EEC;Whereas this uniform document should conform with the layout-key drawn up under the auspices of the United Nations Economic Commission for Europe;Whereas the measures provided for in this Directive are in conformity with the opinion of the Committee for adaptation to technical progress of Directive 78/319/EEC, Article 1 Annex I to Directive 84/631/EEC is hereby replaced by Annex I to this Directive. Article 2 Annex III to Directive 84/631/EEC is hereby replaced by Annex II to this Directive. Article 3 The forms set out in Annexes I and II must conform to the technical conditions set out in Annex III and must be completed in accordance with the instructions given in Annex IV. Article 4 Member States shall take the measures necessary to ensure that Annex IV is brought to the attention of all parties required to complete the form contained in Annex I. Article 5 Member States shall take the measures necessary to comply with this Directive as from 1 October 1985. They shall forthwith inform the Commission thereof. Article 6 This Directive is addressed to the Member States.

31985L0411

1985

Commission Directive 85/411/EEC of 25 July 1985 amending Council Directive 79/409/EEC on the conservation of wild birds Having regard to the Treaty establishing the European Economic Community,Having regard to Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (1), as last amended by Directive 81/854/EEC (2), in particular Article 15 thereof,Whereas Annex I to Directive 79/409/EEC should be altered to take account of the latest information on the situation as regards avifauna;Whereas the provisions of this Directive are in accordance with the opinion of the Committee to adapt Directive 79/409/EEC to technical and scientific progress, Article 1 Annex I to Directive 79/409/EEC shall be replaced by 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 31 July 1986.2. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0374

1985

Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas approximation of the laws of the Member States concerning the liability of the producer for damage caused by the defectiveness of his products is necessary because the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property; Whereas liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production; Whereas libility without fault should apply only to movables which have been industrially produced; whereas, as a result, it is appropriate to exclude liability for agricultural products and game, except where they have undergone a processing of an industrial nature which could cause a defect in these products; whereas the liability provided for in this Directive should also apply to movables which are used in the construction of immovables or are installed in immovables; Whereas protection of the consumer requires that all producers involved in the production process should be made liable, in so far as their finished product, component part or any raw material supplied by them was defective; whereas, for the same reason, liability should extend to importers of products into the Community and to persons who present themselves as producers by affixing their name, trade mark or other distinguishing feature or who supply a product the producer of which cannot be identified; Whereas, in situations where several persons are liable for the same damage, the protection of the consumer requires that the injured person should be able to claim full compensation for the damage from any one of them; whereas, to protect the physical well-being and property of the consumer, the defectiveness of the product should be determined by reference not to its fitness for use but to the lack of the safety which the public at large is entitled to expect; whereas the safety is assessed by excluding any misuse of the product not reasonable under the circumstances; Whereas a fair apportionment of risk between the injured person and the producer implies that the producer should be able to free himself from liability if he furnishes proof as to the existence of certain exonerating circumstances; Whereas the protection of the consumer requires that the liability of the producer remains unaffacted by acts or omissions of other persons having contributed to cause the damage; whereas, however, the contributory negligence of the injured person may be taken into account to reduce or disallow such liability; Whereas the protection of the consumer requires compensation for death and personal injury as well as compensation for damage to property; whereas the latter should nevertheless be limited to goods for private use or consumption and be subject to a deduction of a lower threshold of a fixed amount in order to avoid litigation in an excessive number of cases; whereas this Directive should not prejudice compensation for pain and suffering and other non-material damages payable, where appropriate, under the law applicable to the case; Whereas a uniform period of limitation for the bringing of action for compensation is in the interests both of the injured person and of the producer; Whereas products age in the course of time, higher safety standards are developed and the state of science and technology progresses; whereas, therefore, it would not be reasonable to make the producer liable for an unlimited period for the defectiveness of his product; whereas, therefore, liability should expire after a reasonable length of time, without prejudice to claims pending at law; Whereas, to achieve effective protection of consumers, no contractual derogation should be permitted as regards the liability of the producer in relation to the injured person; Whereas under the legal systems of the Member States an injured party may have a claim for damages based on grounds of contractual liability or on grounds of non-contractual liability other than that provided for in this Directive; in so far as these provisions also serve to attain the objective of effective protection of consumers, they should remain unaffected by this Directive; whereas, in so far as effective protection of consumers in the sector of pharmaceutical products is already also attained in a Member State under a special liability system, claims based on this system should similarly remain possible; Whereas, to the extent that liability for nuclear injury or damage is already covered in all Member States by adequate special rules, it has been possible to exclude damage of this type from the scope of this Directive; Whereas, since the exclusion of primary agricultural products and game from the scope of this Directive may be felt, in certain Member States, in view of what is expected for the protection of consumers, to restrict unduly such protection, it should be possible for a Member State to extend liability to such products; Whereas, for similar reasons, the possibility offered to a producer to free himself from liability if he proves that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of a defect to be discovered may be felt in certain Member States to restrict unduly the protection of the consumer; whereas it should therefore be possible for a Member State to maintain in its legislation or to provide by new legislation that this exonerating circumstance is not admitted; whereas, in the case of new legislation, making use of this derogation should, however, be subject to a Community stand-still procedure, in order to raise, if possible, the level of protection in a uniform manner throughout the Community; Whereas, taking into account the legal traditions in most of the Member States, it is inappropriate to set any financial ceiling on the producer's liability without fault; whereas, in so far as there are, however, differing traditions, it seems possible to admit that a Member State may derogate from the principle of unlimited liability by providing a limit for the total liability of the producer for damage resulting from a death or personal injury and caused by identical items with the same defect, provided that this limit is established at a level sufficiently high to guarantee adequate protection of the consumer and the correct functioning of the common market; Whereas the harmonization resulting from this cannot be total at the present stage, but opens the way towards greater harmonization; whereas it is therefore necessary that the Council receive at regular intervals, reports from the Commission on the application of this Directive, accompanied, as the case may be, by appropriate proposals; Whereas it is particularly important in this respect that a re-examination be carried out of those parts of the Directive relating to the derogations open to the Member States, at the expiry of a period of sufficient length to gather practical experience on the effects of these derogations on the protection of consumers and on the functioning of the common market, Article 1 The producer shall be liable for damage caused by a defect in his product. Article 2 For the purpose of this Directive 'product' means all movables, with the exception of primary agricultural products and game, even though incorporated into another movable or into an immovable. 'Primary agricultural products' means the products of the soil, of stock-farming and of fisheries, excluding products which have undergone initial processing. 'Product' includes electricity. Article 3 1. 'Producer' means the manufacturer of a finished product, the producer of any raw material or the manufacturer of a component part and any person who, by putting his name, trade mark or other distinguishing feature on the product presents himself as its producer. 2. Without prejudice to the liability of the producer, any person who imports into the Community a product for sale, hire, leasing or any form of distribution in the course of his business shall be deemed to be a producer within the meaning of this Directive and shall be responsible as a producer. 3. Where the producer of the product cannot be identified, each supplier of the product shall be treated as its producer unless he informs the injured person, within a reasonable time, of the identity of the producer or of the person who supplied him with the product. The same shall apply, in the case of an imported product, if this product does not indicate the identity of the importer referred to in paragraph 2, even if the name of the producer is indicated. Article 4 The injured person shall be required to prove the damage, the defect and the causal relationship between defect and damage. Article 5 Where, as a result of the provisions of this Directive, two or more persons are liable for the same damage, they shall be liable jointly and severally, without prejudice to the provisions of national law concerning the rights of contribution or recourse. Article 6 1. A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product; (b) the use to which it could reasonably be expected that the product would be put; (c) the time when the product was put into circulation. 2. A product shall not be considered defective for the sole reason that a better product is subsequently put into circulation. Article 7 The producer shall not be liable as a result of this Directive if he proves: (a) that he did not put the product into circulation; or (b) that, having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that this defect came into being afterwards; or (c) that the product was neither manufactured by him for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business; or (d) that the defect is due to compliance of the product with mandatory regulations issued by the public authorities; or (e) that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered; or (f) in the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product. Article 8 1. Without prejudice to the provisions of national law concerning the right of contribution or recourse, the liability of the producer shall not be reduced when the damage is caused both by a defect in product and by the act or omission of a third party. 2. The liability of the producer may be reduced or disallowed when, having regard to all the circumstances, the damage is caused both by a defect in the product and by the fault of the injured person or any person for whom the injured person is responsible. Article 9 For the purpose of Article 1, 'damage' means: (a) damage caused by death or by personal injuries; (b) damage to, or destruction of, any item of property other than the defective product itself, with a lower threshold of 500 ECU, provided that the item of property: (i) is of a type ordinarily intended for private use or consumption, and (ii) was used by the injured person mainly for his own private use or consumption. This Article shall be without prejudice to national provisions relating to non-material damage. Article 10 1. Member States shall provide in their legislation that a limitation period of three years shall apply to proceedings for the recovery of damages as provided for in this Directive. The limitation period shall begin to run from the day on which the plaintiff became aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer. 2. The laws of Member States regulating suspension or interruption of the limitation period shall not be affected by this Directive. Article 11 Member States shall provide in their legislation that the rights conferred upon the injured person pursuant to this Directive shall be extinguished upon the expiry of a period of 10 years from the date on which the producer put into circulation the actual product which caused the damage, unless the injured person has in the meantime instituted proceedings against the producer. Article 12 The liability of the producer arising from this Directive may not, in relation to the injured person, be limited or excluded by a provision limiting his liability or exempting him from liability. Article 13 This Directive shall not affect any rights which an injured person may have according to the rules of the law of contractual or non-contractual liability or a special liability system existing at the moment when this Directive is notified. Article 14 This Directive shall not apply to injury or damage arising from nuclear accidents and covered by international conventions ratified by the Member States. Article 15 1. Each Member State may: (a) by way of derogation from Article 2, provide in its legislation that within the meaning of Article 1 of this Directive 'product' also means primary agricultural products and game; (b) by way of derogation from Article 7 (e), maintain or, subject to the procedure set out in paragraph 2 of this Article, provide in this legislation that the producer shall be liable even if he proves that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of a defect to be discovered. 2. A Member State wishing to introduce the measure specified in paragraph 1 (b) shall communicate the text of the proposed measure to the Commission. The Commission shall inform the other Member States thereof. The Member State concerned shall hold the proposed measure in abeyance for nine months after the Commission is informed and provided that in the meantime the Commission has not submitted to the Council a proposal amending this Directive on the relevant matter. However, if within three months of receiving the said information, the Commission does not advise the Member State concerned that it intends submitting such a proposal to the Council, the Member State may take the proposed measure immediately. If the Commission does submit to the Council such a proposal amending this Directive within the aforementioned nine months, the Member State concerned shall hold the proposed measure in abeyance for a further period of 18 months from the date on which the proposal is submitted. 3. Ten years after the date of notification of this Directive, the Commission shall submit to the Council a report on the effect that rulings by the courts as to the application of Article 7 (e) and of paragraph 1 (b) of this Article have on consumer protection and the functioning of the common market. In the light of this report the Council, acting on a proposal from the Commission and pursuant to the terms of Article 100 of the Treaty, shall decide whether to repeal Article 7 (e). Article 16 1. Any Member State may provide that a producer's total liability for damage resulting from a death or personal injury and caused by identical items with the same defect shall be limited to an amount which may not be less than 70 million ECU. 2. Ten years after the date of notification of this Directive, the Commission shall submit to the Council a report on the effect on consumer protection and the functioning of the common market of the implementation of the financial limit on liability by those Member States which have used the option provided for in paragraph 1. In the light of this report the Council, acting on a proposal from the Commission and pursuant to the terms of Article 100 of the Treaty, shall decide whether to repeal paragraph 1. Article 17 This Directive shall not apply to products put into circulation before the date on which the provisions referred to in Article 19 enter into force. Article 18 1. For the purposes of this Directive, the ECU shall be that defined by Regulation (EEC) No 3180/78 (1), as amended by Regulation (EEC) No 2626/84 (2). The equivalent in national currency shall initially be calculated at the rate obtaining on the date of adoption of this Directive. 2. Every five years the Council, acting on a proposal from the Commission, shall examine and, if need be, revise the amounts in this Directive, in the light of economic and monetary trends in the Community. Article 19 1. Member States shall bring into force, not later than three years from the date of notification of this Directive, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof (1). 2. The procedure set out in Article 15 (2) shall apply from the date of notification of this Directive. Article 20 Member States shall communicate to the Commission the texts of the main provisions of national law which they subsequently adopt in the field governed by this Directive. Article 21 Every five years the Commission shall present a report to the Council on the application of this Directive and, if necessary, shall submit appropriate proposals to it. Article 22 This Directive is addressed to the Member States.

31985L0397

1985

Council Directive 85/397/EEC of 5 August 1985 on health and animal-health problems affecting intra-Community trade in heat-treated milk Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas, so long as intra-Community trade is hindered by differences between the health requirements of Member States concerning milk, the harmonious functioning of the common market and in particular of the relevant common organization of markets will not have the desired effect; Whereas, to eliminate such differences, the health provisions of the Member States must be approximated; Whereas, in view of the magnitude of the dairy sector and the diversity of the problems to be resolved, initial action should be limited to the fixing of standards to apply to heat-treated milk provisionally excluding other products derived from milk except, by way of derogation and in view of the special use made of that product, concentrated pasteurized milk delivered in tankers; Whereas the milk must come from cattle which are free from diseases which are dangerous to human health; whereas account should nevertheless be taken of the differences which still persist between Member States as regards the state of health of their cattle; Whereas production holdings must themselves be equipped in such a way as to ensure that cattle are kept and milk is obtained under hygienically satisfactory conditions; whereas provision should be made for the preparation of a code of hygiene laying down those conditions; Whereas it is necessary to establish rules of hygiene regarding the collection and transport of milk to collection or standardization centres or treatment establishments, and to lay down the health requirements for staff engaged in those operations; Whereas the untreated milk from each production holding must undergo periodic analysis or testing in order to ensure that it complies with the standards introduced; whereas it must also be possible to carry out inspections, at holdings, of the hygiene of milk production and of the general state of health of dairy cattle; whereas the arrangement for carrying out such inspections must be adopted at Community level; Whereas the principle of sampling inspections for the presence of residues of substances likely to affect adversely the wholesomeness of milk should be adopted; Whereas countries of destination should be enabled to carry out non-discriminatory checks and inspections, subject to compliance with the general provisions of the Treaty, as to whether consignments are complying with the requirements of this Directive; Whereas heat-treated milk must be produced, stored and transported under conditions which give every guarantee of hygiene; whereas the necessity for collection and standardization centres and treatment establishments to be registered or approved is likely to facilitate checking on the observance of these conditions; whereas a procedure should be introduced for the settlement of disputes which might arise between Member States over the justification for the approval of a treatment establishment or a centre; Whereas Community surveillance should be introduced to verify whether the standards laid down are being applied in a uniform manner in all the Member States; whereas it should be laid down that the manner in which that surveillance is carried out must be specified following a Community procedure within the Standing Veterinary Committee; Whereas, in the case of intra-Community trade, the issue of a certificate drawn up by the competent authority of the exporting country is the most appropriate means of giving the competent authorities of the country of destination the assurance that a consignment of heat-treated milk complies with the requirements of this Directive; Whereas a Member State must be able to refuse entry into free circulation within its territory in the case of heat-treated milk from another Member State where it has been found that that milk does not satisfy the provisions of this Directive; whereas, however, the return of such milk should be permitted, provided that there are no health reasons why that should not be done and if the consignor or his representative so requests; whereas, moreover, in order that those concerned may be aware of the reasons for a ban or a restriction, the grounds for importing it must be communicated to the consignor or his representative and, in certain cases, to the competent authorities of the exporting country; Whereas the consignor should have the possibility of seeking expert opinion in the event of a dispute between himself and the authorities of the Member State of destination over the justification for a ban or a restriction; Whereas it should be open to the Member States to prohibit the introduction, into their territory, of milk from a Member State in which an epizootic disease has broken out; whereas, depending on the nature and characteristics of the disease, such a ban either must extend only to milk from a region of the territory of the exporting country, or may cover milk from the whole of that territory; whereas, in the event of an outbreak of an infectious disease in the territory of a Member State, it is necessary that the appropriate measures to combat the disease be taken swiftly; whereas the dangers of such diseases and the defensive measures which they render necessary should be assessed in the same way throughout the Community; whereas to that end an emergency Community procedure should be introduced, within the Standing Veterinary Committee referred to above, for the purpose of taking the necessary measures; Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas to that end provision should be made for a procedure creating close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, Article 1 This Directive lays down health and animal-health requirements for heat-treated milk intended for intra-Community trade. Pending the entry into force of Community provisions on this matter, and subject to compliance with the general provisions of the Treaty, intra-Community trade in products derived from milk other than heat-treated milk shall not be affected by this Directive. By derogation from the definitions laid down in Article 2, however, concentrated, pasteurized milk imported into a Member State in tankers for marketing there with or without further processing shall be subject to the requirements of this Directive. Article 2 For the purposes of this Directive, the definitions which appear in Article 2 of Directive 64/432/EEC (1) as last amended by Directive 85/320/EEC (2) and in Article 3 of Regulation (EEC) No 1411/71 (3) shall apply as necessary. In addition: (a) 'untreated milk' shall mean milk as produced by secretion from the mammary glands of one or more dairy cows; (b) 'production holding' shall mean an establishment situated within the territory of a Member State at which one or more milk-producing cows are kept; (c) 'heat-treated milk' shall mean milk fit for human consumption obtained directly and exclusively from untreated milk as defined in (a) by heat treatment and presented in the form of pasteurized, UHT or sterilized milk as defined in Annex A, Chapter VII, paragraphs 2, 3, 4, 5 and 6; (d) 'exporting country' shall mean the Member State from which heat-treated milk is sent to another Member State; (e) 'country of destination' shall mean the Member State to which heat-treated milk from another Member State is sent; (f) 'official department' shall mean the veterinary department or any other equivalent department designated by the Member State concerned to monitor the implementation of this Directive; (g) 'milk treatment establishment' shall mean an establishment situated within the territory of a Member State at which milk is heat-treated. Article 3 A. The Member States shall ensure that only the following milk is exported to another Member State: 1. heat-treated milk which satisfies the following general conditions: (a) it must have been obtained from untreated milk within the meaning of Article 2 (a) (i) from which nothing has been removed or to which nothing has been added, except as an inherent consequence of fat-content standardization operations; (ii) which comes from cows which fulfil the conditions imposed in Annex A, Chapter VI, Section A; (iii) which comes from production holdings which meet the general hygiene conditions laid down in Annex A, Chapter VI, Section B; (iv) in respect of which the standards of hygiene observed during milking, collection, handling and transport, and those of the staff carrying out those operations, satisfy the requirements of Annex A, Chapter VI, Section C; (v) which comes from cows and production holdings which are checked at regular intervals by the competent national authorities in application of Article 11 (1) in particular; (vi) which has been checked in accordance with Article 11 (2) and which meets the standards set in Annex A, Chapter VI, Section D; (b) it must come from a milk-treatment establishment which fulfils the conditions laid down in Annex A, Chapters I, II and V; in addition if the untreated milk has been channelled through a milk-collection centre, that collection centre must fulfil the conditions laid down in Annex A, Chapters I, III and V and if the untreated milk has been channelled through a milk-standardization centre, that standardization centre must fulfil the conditions laid down in Annex A, Chapters I, IV and V; (c) it must have been treated there in accordance with the requirements laid down in Annex A, Chapter VII; (d) if it is packaged, it must have been packaged in accordance with Annex A, Chapter VIII, at a milk-treatment establishment where the milk has been treated; (e) it must have been stored in accordance with Annex A, Chapter IX; (f) when being transported to a country of destination it must, in accordance with Annex A, Chapter X, be accompanied by a health certificate which conforms to the model in Annex B; (g) it must be transported under satisfactory conditions of hygiene in accordance with Annex A, Chapter XI; 2. pasteurized milk which fulfils the requirements laid down in paragraph 1 and has undergone one pasteurization process only; 3. heat-treated milk intended for direct human consumption which, moreover, has a weight of not less than 1 030 grammes per litre established from milk at 15 °C or the equivalent from totally fat-free milk at 20 °C and contains a minimum of 28 grammes of protein per litre and a fat-free dry matter content of not less than 8,50 %, on the understanding that, without prejudice to the provisions adopted in the context of the common organization of the market in milk and milk products, stricter requirements may not be set for milk intended for industry. B. Those Member States which grant approved establishments situated within their territories one of the derogations provided for in Article 4 (2) and Annex A, Chapter VII, paragraph 6 may not prohibit or limit the introduction into their territories of heat-treated milk from a treatment establishment in another Member State covered by the same derogation. Article 4 Member States shall ensure that: - milk tankers are used exclusively for the transport of milk, milk products and potable water; - premises, installations and working equipment are not used for purposes other than the collection, treatment and storage of milk and milk products. Where an establishment makes products obtained in whole or in part from milk and milk products, the foodstuffs used in the manufacture of these products must, if they have not previously undergone heat treatment or another kind of treatment which does not adversely affect milk or milk products, be stored and treated in separate premises specially provided for this purpose. 2. Member States which, by way of derogation from paragraph 1, authorize the use of tankers and working equipment for the transport and manufacture of other liquid foodstuffs at different times, shall ensure that all appropriate measures are taken to prevent contamination or deterioration of the products covered by this Directive. Member States shall inform the Commission and the other Member States of the derogations granted and provide a list of the establishments covered by these derogations. 3. The list of foodstuffs intended for human consumption which are referred to in paragraph 2 and which may form the subject of the derogation concerning transport shall be drawn up by the Council, acting on a proposal from the Commission. The conditions to be complied with when reassigning tankers to milk transport after their use for transporting the foodstuffs referred to in the first subparagraph shall be adopted in accordance with the same procedure. 4. Member States shall ensure that: (a) the tankers covered by the derogation provided for in paragraph 2 may not be used for the transport of heat-treated milk intended for a Member State which does not grant such a derogation. At its request, the competent authority of the exporting Member State shall supply the Member State of designation with a list of tankers not covered by this derogation; (b) the health certificate contains a clear indication whereby tankers used for the exclusive transport of heat-treated milk can be identified. Article 5 1. Each Member State shall draw up a list of its approved milk-treatment establishments and, in so far as they are concerned with intra-Community trade in heat-treated milk, a list of approved collection centres and standardization centres, each such establishment or centre having an approval number. The Member States shall send those lists to the other Member States and to the Commission. No Member State shall approve an establishment or centre unless compliance with this Directive is assured. A Member State shall withdraw approval if the conditions for granting it cease to be fulfilled. The other Member States and the Commission shall be informed of the withdrawal of approval. 2. Regular inspection of approved establishments and centres shall be carried out by the official department. the supervision and continuous checking of establishments and of collection and standardization centres shall be carried out under the responsibility of the official department. The staff of the official department may be assisted by staff specially trained for the purpose. The staff of the official department must at all times have free access to all parts of establishments or centres involved in the production of heat-treated milk in order to ensure compliance with this Directive. 3. Where a Member State considers, in particular after carrying out a check or inspection provided for in Article 7 (1) and (2), that the provisions governing approval are not being, or have ceased to be, observed in an establishment or centre in another Member State, it shall inform the competent central authority of that State accordingly. That authority shall take all necessary measures, which may include the withdrawal of approval, and notify the competent central authority of the first Member State of the decisions taken and the reasons for such decisions. If the first Member State fears that such measures are not being taken or are inadequate, the two Member States shall together seek ways and means of remedying the situation; if appropriate, that may involve a visit. In the event of a dispute over the application of provisions of this Directive which are not covered by Article 10, a solution shall be sought on the basis of a reference method and/or reference standards approved, after the Scientific Veterinary Committee has delivered its opinion, in accordance with the procedure laid down in Article 14. The Member States concerned shall inform the Commission of disputes and of the solutions reached. 4. If those Member States cannot reach agreement, one of them shall, within a reasonable time, bring the matter before the Commission, which shall instruct one or more experts to give an opinion. Pending that opinion, the exporting Member State must, for serious public-health reasons, at the request of the Member State of destination, intensify checks on heat-treated milk coming from the establishment in question. The Member State of destination may, for its part, intensify checks on heat-treated milk coming from the same establishment and, if a positive result is obtained, take the measures laid down in Article 7 (4). At the request of one of the two Member States concerned, the Commission shall immediately instruct an expert to go to the place where the consignment under dispute is stored and/or the consignor establishment, in order to propose appropriate interim protective measures. In the light of the opinion provided for in the first subparagraph, the Member States may be authorized, under the procedure laid down in Article 13, to prohibit provisionally the introduction into their territories of heat-treated milk from that establishment. Such authorization may be withdrawn under the procedure laid down in Article 13 in the light of a further opinion delivered by one or more experts. An expert must be a national of a Member State other than those involved in the dispute. 5. The general rules for the application of this Article shall be adopted in accordance with the procedure set out in Article 14. Article 6 1. Veterinary experts from the Commission may, in cooperation with the competent authorities of the Member States, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of the Directive; they may verify whether approved establishments and centres are actually complying with the Directive, particularly with Annex A. A Member State within the territory of which a check is being carried out shall give all necessary assistance to the experts in carrying our their duties. The Commission shall inform the Member State concerned of the results of the investigation. The Member State concerned shall take any measures required to take account of the results of the investigation. If the Member State does not take those measures, the Commission may, after the situation has been examined by the Standing Veterinary Committee, have recourse to the provisions of the fifth and sixth subparagraphs of Article 5 (4). 2. Before the checks referred to in paragraph 1 are carried out, in accordance with the procedure laid down in Article 14, the general provisions for applying this Article shall be determined and a vade-mecum shall be established, containing the rules to be followed for the purpose of the checks provided for in paragraph 1. 3. Before 1 July 1990 the Council shall review this Article on the basis of a report from the Commission, which may also submit proposals in this connection. Article 7 1. Without prejudice to Articles 5 and 6, a country of destination may check that all consignments of heat-treated milk as defined in Article 2 are accompanied by the prescribed health certificate. 2. If irregularities are seriously suspected, the country of destination may carry out non-discriminatory checks to verify whether the requirements of this Directive have been met. 3. As a general rule, checks and inspections shall be carried out at the place of destination of the goods or at another suitable place, provided that in the latter case the place chosen interferes as little as possible with the routing of the goods. The checks and inspections referred to in paragraphs 1 and 2 may not unduly delay the passage of the goods and their placing on the market, or cause delays which might adversely affect the quality of the milk. 4. If, during a check carried out on the basis of paragraph 2, it is found that the milk does not comply with this Directive, the competent authority in the country of destination may, provided that health considerations so permit, give the consignor, the consignee or their representatives, at their expense, the choice of whether the consignment is to be turned back, the milk used for other purposes or destroyed or, if health considerations do not so permit, order destruction of the milk. in any event, precautionary measures shall be taken to prevent improper use of such milk, and the certificate must bear a clear indication of the purpose for which that milk is intended. 5. (a) Such decisions, and the grounds for taking them, must be communicated to the consignor or his representative. Should such person so request, they must be communicated forthwith in writing, together with an indication of the channels of appeal provided for under current legislation, their forms and the time-limits within which they are open. (b) If such decisions are based on the diagnosis of a contagious or infectious disease, or a deterioration dangerous to human or animal health, or a serious infringement of this Directive, they shall be communicated forthwith to the competent central authority of the producing Member State and to the Commission. (c) Following that communication, appropriate measures may be taken in accordance with the procedure laid down in Article 13, in particular for the purpose of coordinating the measures taken in other Member States with regard to the milk involved. 6. Before 1 July 1990 the Council shall review this Article on the basis of a report from the Commission, which may also submit proposals in this connection. Article 8 1. This Directive shall not affect any channels of appeal available under current legislation in the Member States against decisions taken by the competent authorities and provided for in this Directive. 2. Each Member State shall grant consignors of milk the marketing of which is prohibited pursuant to Article 7 the right to obtain the opinion of an expert. Each Member State shall ensure that, before the competent authorities take any other measures such as destroying the milk, the experts have an opportunity of determining whether the conditions of Article 7 (4) were in fact fulfilled. An expert must be a national of a Member State other than the exporting country or the country of destination. Acting on proposals from the Member States, the Commission shall draw up a list of the experts who may be instructed to formulate such opinions. The general rules for applying this Article, in particular as regards the procedure for formulating such opinions, shall be adopted in accordance with the procedure laid down in Article 14. Article 9 Amendments to the Annexes to this Directive for the purpose of adapting them to technological developments shall be decided on by the Council acting by a qualified majority on a proposal from the Commission. Article 10 1. The Member States shall ensure that, without prejudice to the additional requirements laid down in Article 3 (A) (3), only heat-treated milk from milk-treatment establishments satisfying the standards laid down in Annex A, Chapters VI and VII for step 1 may be exported to another Member State. However, a Member State which, from the date laid down in Article 16, applies to heat-treated milk intended for home consumption the microbiological standards laid down for step 2 may, after such application has been established in accordance with the procedure in Article 14, make the entry of sterilized and UHT milk into its territory subject to the standards laid down in that step for the finished product, and the entry of pasteurized milk subject to the standards laid down for both untreated milk and pasteurized milk. The Member States ahall ensure that no later than 1 January 1993 the standards laid down in Annex A, Chapters VI and VII for step 2 are applicable to intra-Community trade unless the Council, on the basis of a Commission report together with any proposals, decides by a qualified majority to postpone that deadline by up to two years. Furthermore, as from 1 April 1990, the standards of step 2 shall apply to milk intended for direct human consumption. 2. The methods of analysis and testing to be used to monitor compliance with the standards referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 14 before 1 January 1989. In accordance with the same procedure, a method shall be established, following an opinion from the Scientific Veterinary Committee, which replaces the modified Aschaffenburg turbidity test and enables a distinction to the made between sterilized milk and UHT milk. Pending those decisions, however, the Member States shall, during the application period of step 1, recognize as reference methods any analysis and test methods accepted internationally. Article 11 1. The Member States shall ensure that production holdings undergo periodic inspection in order to ensure that hygiene requirements are fulfilled. In addition, if there are reasonable grounds for suspecting that the animal health requirements laid down in Annex A, Chapter VI, are not being fulfilled, they shall ensure that the official veterinarian checks the general state of health of the dairy animals and, should it prove necessary, has a clinical examination of the udders of those animals carried out. If the inspection or inspections referred to in the first or second subparagraphs show that not all hygiene requirements are being fulfilled, the official department shall take appropriate steps. 2. The Member States shall ensure that untreated milk and heat-treated milk undergo checks carried out by milk-treatment establishments, under the supervision and responsibility of the official department and with periodic inspection by the official department, in order to ensure that the milk complies with the requirements of this Directive. 3. The Member States shall ensure that checks are effected to detect any residues of substances having a pharmalogical or hormonal action, and of antibiotics, pesticides, detergents and other substances which are harmful or which might alter the organoleptic characteristics of milk or make its consumption dangerous or harmful to human health, in so far as those residues exceed the tolerance limits permitted or, where no tolerance is laid down, the quantity which has been proved harmless in accordance with scientific knowledge and on which the Scientific Veterinary Committee has given its opinion. 4. If the milk examined does not comply with this Directive and in particular shows traces of residues which exceed the permitted tolerances, the heat-treated milk must be excluded from intra-Community trade. Such examinations for residues must be carried out in accordance with proven methods which are scientifically recognized, in particular those laid down in Community Directives or other international standards. It must be possible to assess the results of the examination for residues using reference methods laid down pursuant to Article 10. For the purpose of inspecting producting holdings and in accordance with the procedure laid in Article 14, a general code of hygiene shall be drawn up which shall specify the general conditions of hygiene to be complied with in production holdings, in particular the conditions for the upkeep of premises and those relating to milking operations. The Commission will effect the publication of that code. 5. Where there is good reason to suspect that the requirements of this Directive are not being satisfied, the official department shall carry out the necessary checks and, if that suspicion is confirmed, take appropriate measures, in particular the suspension of approval. 6. Acting by a qualified majority on a proposal from the Commission, within two years of the notification of this Directive the Council shall lay down the detailed arrangements for and the frequency of the checks provided for in paragraphs 1 and 2 and the tolerances provided for in paragraph 3. In accordance with the same procedure, a decision may be taken to extend the examinations to substances other than those referred to in paragraph 3. 7. Until the entry into force of the implementing measures for this Article, national rules shall remain applicable subject to compliance with the general provisions of the Treaty. Article 12 1. A Member State may take the following measures with due regard for the general provisions of the Treaty: (a) in the event of an outbreak of foot-and-mouth disease in another Member State, it may temporarily prohibit or restrict the introduction into its territory of pasteurized milk obtained in an approved establishment which collects untreated milk in the protection area, to be determined pursuant to Directive 64/432/EEC, or which is situated in that area; (b) if that epizootic disease becomes widespread or if there is an outbreak of a further infectious animal disease of a serious nature, it may temporarily prohibit or restrict the introduction into its territory of pasteurized milk and UHT milk from the whole of the territory of that State. 2. Every Member State must immediately inform the other Member States and the Commission of any outbreak within its territory of a disease covered by paragraph 1 (b) and not covered by Directive 82/894/EEC (1) and of the measures which it has taken to combat it. It must also notify them without delay of the disappearance of the disease. 3. The measures taken by the Member States under paragraph 1 and the repeal of any such measures must be communicated without delay to the other Member States and to the Commission, together with the reasons for such action. It may be decided, in accordance with the procedure laid down in Article 13, that the measures should be amended, in particular in order to ensure their coordination with those adopted by the other Member States, or abolished. 4. If the situation provided for in paragraph 1 arises and if it appears necessary for other Member States also to take measures under that paragraph, possibly amended in accordance with paragraph 3, the appropriate measures shall be decided on in accordance with the procedure defined in Article 14. Article 13 1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (hereinafter referred to as 'the Committee') by its Chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The Chairman shall not vote. 3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within two days. Opinions shall be delivered by a majority of 45 votes. 4. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If 15 days after the proposal was submitted to it the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority. Article 14 1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Committee by its Chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The Chairman shall not vote. 3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within a time limit which the Chairman may set according to the urgency of the matter submitted. Opinions shall be delivered by a majority of 45 votes. 4. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit a proposal to the Council concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If three months after the proposals was submitted to it the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority. Article 15 Pending the adoption of a Community system governing the importation of heat-treated milk from non-member countries, the provisions of national law applicable to such imports must not be more favourable than those governing intra-Community trade. Article 16 The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 1 January 1989. Article 17 This Directive is addressed to the Member States.

31985L0433

1985

Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49 and 57 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, pursuant to the Treaty, all discriminatory treatment based on nationality with regard to establishment and provision of services is prohibited as from the end of the transitional period; whereas the principle of such treatment based on nationality applies, in particular, to the grant of any authorization required for the practice of certain activities, and also to registration with or membership of professional organizations or bodies; Whereas it nevertheless seems desirable that certain provisions be introduced to facilitate the effective exercise of the right of establishment; Whereas, pursuant to Article 54 (3) (h) of the Treaty, the Member States are required not to grant any form of aid likely to distort the conditions of establishment; Whereas Article 57 (1) of the Treaty provides that Directives be adopted for mutual recognition of diplomas, certificates and other evidence of formal qualifications; Whereas, in view of the present disparities in training in pharmacy given in the Member States, it is necessary to lay down certain coordinating provisions to enable the Member States to introduce mutual recognition of diplomas, certificates and other evidence of formal qualifications; whereas such coordination has been established by Council Directive 85/432/EEC of 16 September 1985, concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy (4); Whereas in certain Member States access to certain activities in the field of pharmacy is, apart from the award of the relevant diploma, certificate or other formal qualification, subject to the requirement of additional professional experience; whereas, since there is as yet no convergence of views among the Member States on this point, it is advisable, in order to obviate any difficulties, to recognize as a sufficient condition appropriate practical experience of equal duration acquired in another Member State; Whereas, under their national policies in the sphere of public health, which seek inter alia to ensure the satisfactory dispensing of medicinal products over their entire territories, certain Member States restrict the number of new pharmacies that may be established, while others have adopted no such provisions; whereas in these circumstances it is premature to provide that the effects of the recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy must also extend to the pursuit of the activities of pharmacist as the controller of a pharmacy open to the public for less than three years; whereas this problem must be re-examined by the Commission and the Council within a certain period; Whereas, with regard to the possession of a formal certificate of training, since a Directive on the mutual recognition of diplomas does not necessarily imply equivalence in the training covered by such diplomas, the use of such qualifications should be authorized only in the language of the Member State of origin or of the Member State from which the foreign national comes; Whereas, to facilitate the application of this Directive by the national authorities, Member States may prescribe that, in addition to formal certificates of training, the person who satisfies the conditions of training required by this Directive must provide a certificate from the competent authorities of his country of origin or of the country from which he comes stating that these certificates of training are those covered by the Directive; Whereas this Directive does not affect the provisions laid down by law, regulation or administrative action in the Member States which prohibit companies from practising certain activities or impose on them certain conditions for such practice; Whereas it is difficult to assess the extent to which rules aimed at facilitating freedom of pharmacists to provide services could at present be appropriate; whereas, in these circumstances, it is not advisable to adopt such rules for the time being; Whereas, with regard to good character and good repute, a distinction should be drawn between the requirements to be satisfied on first taking up the profession and those to be satisfied in order to practise it; Whereas, as far as the activities of employed persons are concerned, Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1) lays down no specific provisions relating to good character or good repute, professional discipline or use of title for the professions covered; whereas, depending on the individual Member State, such rules are or may be applicable both to employed and self-employed persons; whereas the activities subject in the Member States to possession of a diploma, certificate or other evidence of formal qualification in pharmacy are pursued by both employed and self-employed persons, or by the same persons in both capacities in the course of their professional career; whereas, in order to encourage as far as possible the free movement of those professional persons within the Community, it therefore appears necessary to extend the application of this Directive to employed persons. CHAPTER I Scope Article 1 This Directive applies to activities, the access to and pursuit of which is subject to conditions of professional qualification in one or more Member States, and which are open to holders of one of the diplomas, certificates or other formal qualifications in pharmacy referred to in Article 4. CHAPTER II Diplomas, certificates and other evidence of formal qualifications in pharmacy Article 2 1. Each Member State shall recognize the diplomas, certificates and other formal qualifications listed in Article 4 awarded to nationals of Member States by other Member States in accordance with Article 2 of Directive 85/432/EEC by giving such qualifications, as regards the right of access to and pursuit of the activities referred to in Article 1, the same effect in its territory as those diplomas, certificates and other formal qualifications, listed in Article 4, which it itself awards. 2. However, Member States need not give effect to the diplomas, certificates and other formal certificates referred to in paragraph 1 with respect to the establishment of new pharmacies open to the public. For the purposes of applying this Directive, pharmacies which have been in operation for less than three years shall also be regarded as new. Five years after the date stipulated in Article 19 (1), the Commission shall submit a report to the Council on the way in which Member States have implemented the preceding subparagraph and on the possibility of extending the effects of mutual recognition of the diplomas, certificates and other formal certificates referred to in paragraph 1. It shall make any appropriate proposals. Article 3 1. By way of derogation from Article 2 and without prejudice to Article 45 of the 1979 Act of Accession, the Hellenic Republic shall not be required to give effect as laid down in Article 2 to the diplomas, certificates and other formal qualifications awarded by other Member States except in the case of the pursuit as an employed person in accordance with Regulation (EEC) No 1612/68 of the activities referred to in Article 1. As long as the Hellenic Republic makes use of this derogation and without prejudice to Article 45 of the 1979 Act of Accession, the other Member States shall not be required to give effect as provided for in Article 2 to the certificates referred to in Article 4 (d) except in the case of the pursuit as an employed person in accordance with Regulation (EEC) No 1612/68 of the activities referred to in Article 1. 2. Ten years after the date stipulated in Article 19, the Commission shall submit to the Council appropriate proposals in order to extend the effects of mutual recognition of diplomas, certificates and other formal qualifications with a view to facilitating the effective exercise of the right of establishment between the Hellenic Republic and the other Member States. The Council shall act on these proposals in accordance with the procedure laid down in the EEC Treaty. Article 4 The diplomas, certificates and other evidence of formal qualifications referred to in Article 2 are the following: (a) in Belgium: Le diplôme légal de pharmacien/het wettelijk diploma van apoteker (the legal diploma in pharmacy) awarded by the faculties of medicine and pharmacy of the Universities, by the Central examining board or by the State examining boards for university education; (b) in Denmark: Bevis for bestaaet farmaceutisk kandidateksamen (the university pharmacy certificate); (c) in the Federal Republic of Germany: (1) Zeugnis ueber die staatliche Pharmazeutische Pruefung (the State examination certificate in pharmacy) awarded by the competent authorities; (2) Certificates from the competent authorities the Federal Republic of Germany stating that the diplomas awarded after 8 May 1945 by the competent authorities of the German Democratic Republic are recognized as equivalent to those referred to in point 1 above; (d) in Greece: Piatopoiitikó ton armodíon archón, ikanótitas áskisis tis farmakeftikís, chorigoýmeno metá kratikí exétasi (the certificate attesting competence to pursue the activity of a pharmacist) issued by the competent authorities following a State examination; (e) in France: The State diploma in pharmacy awarded by the universities or the State diploma of Doctor in Pharmacy awarded by the universities; (f) in Ireland: The certificate of Registered Pharmaceutical Chemist; (g) in Italy: The diploma or certificate giving the right to practise pharmacy, obtained by passing a State examination; (h) in Luxembourg: The State pharmacy diploma awarded by the State Examining Board and signed by the National Minister of Education; (i) in the Netherlands: Het getuigschrift van met goed gevolg afgelegd apothekersexamen (the university pharmacy certificate); (j) in the United Kingdom: The certificate of Registered Pharmaceutical Chemist. Article 5 Where, in a Member State, access to or pursuit of one of the activities referred to in Article 1 is subject not only to the possession of a diploma, certificate or other formal qualification mentioned in Article 4 but also to the requirement of additional professional experience, that State shall accept as sufficient evidence in this respect a certificate issued by the competent authorities of the person's Member State of origin or of the Member State from which he comes, attesting that he has pursued the said activities for an equivalent period in his Member State of origin or in the Member State from which he comes. However, such recognition shall not apply with regard to the two-year period of professional experience required by the Grand Duchy of Luxembourg for the grant of a State public pharmacy concession. CHAPTER III Established rights Article 6 Diplomas, certificates and other university or equivalent qualifications in pharmacy which were awarded to nationals of Member States by Member States and which do not satisfy all the minimum training requirements laid down in Article 2 of Directive 85/432/EEC shall be treated as diplomas satisfying these requirements if: - they are evidence of training which was completed before the implementation of the said Directive, or - they are evidence of training which was completed after but which was commenced before the implementation of the said Directive, and, in each case, if: - they are accompanied by a certificate stating that their holders have been effectively and lawfully engaged in one of the activities referred to in Article 1 (2) of Directive 85/432/EEC in a Member State for at least three consecutive years during the five years preceding the award of the certificate, provided that this activity is regulated in that State. CHAPTER IV Use of academic title Article 7 1. Without prejudice to Article 14, host Member States shall ensure that nationals of Member States who fulfil the conditions laid down in Articles 2, 5 and 6 have the right to use the lawful academic title and, where appropriate, the abbreviation thereof, of their Member State of origin or of the Member State from which they come, in the language of that State. Host Member States may require this title to be followed by the name and location of the establishment or examining board which awarded it. 2. If the academic title used in the Member State of origin, or in the Member State from which a foreign national comes, can be confused in the host Member State with a title requiring in that State additional training which the person concerned has not undergone, the host Member State may require such a person to use the title employed in the Member State of origin or the Member State from which he comes in suitable wording to be indicated by the host Member State. CHAPTER V Provisions to facilitate the effective exercise of the right of establishment Article 8 1. A host Member State which requires of its nationals proof of good character or good repute when they take up for the first time any of the activities referred to in Article 1 shall accept as sufficient evidence, in respect of nationals of other Member States, a certificate issued by a competent authority in the Member State of origin or in the Member State from which the foreign national comes, attesting that the requirements of the Member State as to good character or good repute for taking up the activity in question have been met. 2. Where the Member State of origin or the Member State from which the foreign national comes does not require proof of good character or good repute of persons wishing to take up the activity in question for the first time, the host Member State may require of nationals of the Member State of origin or of the Member State from which the foreign national comes an extract from the judicial record or, failing this, an equivalent document issued by a competent authority in the Member State of origin or the Member State from which the foreign national comes. 3. If the host Member State has detailed knowledge of a serious matter which, prior to the establishment in that State of the person in question, has occurred outside its territory and is likely to affect the taking up within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes. The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts if they are likely to affect the taking up of the activity in question in that Member State. The authorities in that State shall decide on the nature and extent of the investigations to be made and shall inform the host Member State of any consequential action which they take with regard to the certificates or documents they have issued. 4. Member States shall ensure the confidentiality of the information which is forwarded. Article 9 1. Where, in a host Member State, provisions laid down by law, regulation or adminsitrative action are in force laying down requirements as to good character or good repute, including provisions for disciplinary action in respect of serious professional misconduct or conviction for criminal offences and relating to the pursuit of any of the activities referred to in Article 1, the Member State of origin or the Member State from which the foreign national comes shall forward to the host Member State all necessary information regarding measures or disciplinary action of a professional or administrative nature taken in respect of the person concerned, or criminal penalties imposed on him when pursuing his profession in the Member State of origin or in the Member State from which he came. 2. If the host Member State has detailed knowledge of a serious matter which, prior to the establishment in that State of the person in question, has occurred outside its territory and is likely to affect the pursuit within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes. The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts if they are likely to affect in that Member State the pursuit of the activity in question. The authorities in that State shall decide on the nature and extent of the investigations to be made and shall inform the host Member State of any consequential action which they take with regard to the information they have forwarded in accordance with paragraph 1. 3. Member States shall ensure the confidentiality of the information which is forwarded. Article 10 Where a host Member State requires of its own nationals wishing to take up or pursue any of the activities referred to in Article 1, a certificate of physical or mental health, that State shall accept as sufficient evidence thereof the presentation of the document required in the Member State of origin or in the Member State from which the foreign national comes. Where the Member State of origin or the Member State from which the foreign national comes does not impose any requirements of this nature on those wishing to take up or pursue the activity in question, the host Member State shall accept from such nationals a certificate issued by a competent authority in that State corresponding to the certificates issued in the host Member State. Article 11 The documents referred to in Articles 8, 9 and 10 may not be presented more than three months after their date of issue. Article 12 1. The procedure for authorizing the person concerned to take up any of the activities referred to in Article 1, pursuant to Articles 8, 9 and 10, must be completed as soon as possible and not later than three months after submission of all the documents relating to such person, without prejudice to delays resulting from any appeal that may be made upon the completion of this procedure. 2. In the cases referred to in Articles 8 (3) and 9 (2), a request for re-examination shall suspend the period stipulated in paragraph 1. When consulted, the Member State of origin or the Member State from which the foreign national comes shall give its reply within three months. On receipt of the reply or at the end of that period, the host Member State shall continue with the procedure referred to in paragraph 1. Article 13 Where a host Member State requires its own nationals wishing to take up or pursue one of the activities referred to in Article 1 to take an oath or make a solemn declaration and where the form of such oath or declaration cannot be used by nationals of other Member States, that Member State shall ensure that an appropriate and equivalent form of oath or declaration is offered to the persons concerned. Article 14 Where in a host Member State, the use of the professional title relating to one of the activities referred to in Article 1 is regulated, nationals of Member States who fulfil the conditions of professional qualification laid down in Articles 2, 5 and 6 shall be entitled to the professional title of the host Member State which in that State corresponds to those conditions, and shall use the abbreviation thereof. Article 15 1. Member States shall take the necessary measures to enable the persons concerned to obtain information on the health and social security laws and, where applicable, on the professional ethics of the host Member State. For this purpose, Member States may set up information centres from which such persons may obtain the necessary information. The host Member States may require the persons concerned to contact these centres. 2. Member States may set up the centres referred to in paragraph 1 under the aegis of the competent authorities and bodies which they shall designate within the period laid down in Article 19 (1). 3. Member States shall see to it that, where appropriate, the persons concerned acquire, in their own interest and in that of their customers, the linguistic knowledge necessary for the practice of their profession in the host Member State. CHAPTER VI Final provisions Article 16 In the event of justified doubts, the host Member State may require of the competent authorities of another Member State confirmation of the authenticity of the diplomas, certificates and other formal qualifications issued in that other Member State and referred to in Chapters II and III, and also confirmation of the fact that the person concerned has fulfilled all the training requirements laid down in Directive 85/432/EEC. Article 17 Within the time limit laid down inArticle 19 (1), Member States shall designate the authorities and bodies competent to issue or receive the diplomas, certificates and other formal qualifications as well as the documents and information referred to in this Directive and shall forthwith inform the other Member States and the Commission thereof. Article 18 This Directive shall also apply to nationals of Member States who, in accordance with Regulation (EEC) No 1612/68, are pursuing or will pursue as employed persons one of the activities referred to in Article 1. Article 19 1. Member States shall bring into force the measures necessary to comply with this Directive before 1 October 1987. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 20 Where a Member State encounters major difficulties in certain fields when applying this Directive, the Commission shall examine these difficulties in conjunction with that State and shall request the opinion of the Pharmaceutical Committee set up under Decision 75/320/EEC (1). Where necessary, the Commission shall submit appropriate proposals to the Council. Article 21 This Directive is addressed to the Member States.

31985L0432

1985

Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down by Law, Regulation or Administrative Action in respect of certain activities in the field of pharmacy Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49 and 57 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 persons who hold a diploma, certificate or other formal qualification in pharmacy are for that reason specialists in the field of medicinal products and, in principle, must have access in all the Member States to a minimum range of activities in that field; whereas, in defining that minimum range, this Directive does not have the effect of limiting the activities accessible in the Member States to pharmacists, in particular with regard to medical biology analyses, and does not give them any monopoly, since the creation of a monopoly continues to be a matter for the Member States alone; Whereas, moreover, this Directive does not ensure coordination of all conditions of access to and pursuit of activities in the field of pharmacy; whereas, in particular, the geographical distribution of pharmacies and the monopoly of the supply of medicinal products continue to be matters for the Member States; Whereas, with a view to achieving mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, as required by Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy (4), the broad comparability of training courses in the Member States enables coordination in this field to be confined to the requirement that minimum standards be observed, thus leaving the Member States freedom of organization as regards teaching; Whereas this Directive does not prevent the Member States from requiring supplementary conditions of training for access to activities not included in the coordinated minimum range of activities; whereas for this reason a host Member State which lays down such conditions may subject thereto nationals of Member States who hold one of the diplomas referred to in Article 4 of Directive 85/433/EEC; Whereas the coordination provided for by this Directive covers professional qualifications; whereas, as regards such qualifications, most Member States do not at present distinguish between professional persons who pursue their activities as employed persons and those who are self-employed; whereas, for this reason, it appears necessary to extend the application of this Directive to employed professional persons; Whereas further training is being developed in the Member States in certain aspects of pharmacy which is intended to extend certain areas of knowledge acquired during the training of pharmacists; whereas, therefore, with a view to mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy specialities and in order to put all members of the profession who are nationals of the Member States on an equal footing within the Community, some coordination of the requirements for training in pharmacy specialities is necessary where there are specialized forms of training common to several Member States which can entitle a person to use a specialist title, without such training being a condition of access to the activities included in the coordinated minimum range of activities; whereas such coordination does not seem possible at this stage, but constitutes an objective to be attained as soon as possible together with the relevant mutual recognition, Article 1 1. Member States shall ensure that holders of a diploma, certificate or other university or equivalent qualification in pharmacy which meets the conditions laid down in Article 2 shall be entitled at least to access to the activities mentioned in paragraph 2 and to pursue such activities subject, where appropriate, to the requirement of additional professional experience. 2. The activities referred to in paragraph 1 are: - the preparation of the pharmaceutical form of medicinal products, - the manufacture and testing of medicinal products, - the testing of medicinal products in a laboratory for the of medicinal of medicinal products, - the storage, preservation and distribution of medicinal products at the wholesale stage, - the preparation, testing, storage and supply of medicinal products in pharmacies open to the public, - the preparation, testing, storage and dispensing of medicinal products in hospitals, - the provisions of information and advice on medicinal products. 3. Where at the time of adoption of this Directive a system of competition based on tests exists in a Member State for the purpose of selecting from among the holders referred to in paragraph 1 those to be appointed to control the new pharmacies to be set up under a national geographical distribution system, that Member State may, by way of derogation from paragraph 1, retain this competition system and may oblige nationals of the Member States holding the diplomas, certificates and other formal qualifications in pharmacy referred to in Article 2 (1) and Article 6 of Directive 85/433/EEC to take part in such a competition. Article 2 Member States shall subordinate the award of the diplomas, certificates and other formal qualifications referred to in Article 1 to the following minimum conditions: 1. Training leading to the award of the diploma, certificate or other formal qualification shall ensure: (a) adequate knowledge of medicines and the substances used in the manufacture of medicines; (b) adequate knowledge of pharmaceutical technology and the physical, chemical, biological and microbiological testing of medicinal products; (c) adequate knowledge of the metabolism and the effects of medicinal products and of the action of toxic substances, and of the use of medicinal products; (d) adequate knowledge to evaluate scientific data concerning medicines in order to be able to supply appropriate information on the basis of this knowledge; (e) adequate knowledge of the legal and other requirements associated with the practice of pharmacy. 2. In order to be accepted for such training, the candidate must have a diploma or a certificate which entitles him to be admitted for the course of study concerned to the universities of a Member State or to higher education institutions recognized as having equivalent status. 3. The diploma, certificate or other formal qualification shall testify to the completion of a course of training covering a period of at least five years and comprising: - at least four years of full-time theoretical and practical training in a university, in a higher education institution of a level recognized as having equivalent status, or under the supervision of a university, - at least six months of in-service training in a pharmacy open to the public or in a hospital under the supervision of the pharamaceutical department of that hospital. 4. By way of derogation from point 3: (a) if at the time of the adoption of this Directive two courses of training coexist in a Member State, one of which lasts five years and the other four years, the diploma, certificate or other formal qualification testifying to the completion of the four-year course of training, shall be considered to fulfil the condition concerning duration referred to in point 3 provided that the diplomas, certificates or other formal qualifications testifying to the completion of the two courses of training are recognized as equivalent by that State; (b) if, because, there are insufficient places in pharmacies open to the public and in hospitals near training establishments, a Member State is unable to provide six months of in-service training, it may, for a period of five years following the expiry of the time limit laid down in Article 5, make provision for no more than half of that training period to involve activities as a pharmacist in an undertaking which manufactures medicinal products. 5. The course of training referred to in point 3 shall comprise as a minimum theoretical and practical training in the following subjects: - Plant and animal biology, - Physics, - General and inorganic chemistry, - Organic chemistry, - Analytical chemistry, - Pharmaceutical chemistry, including analysis of medicinal products, - General and applied biochemistry (medical), - Anatomy and physiology; medical terminology, - Microbiology, - Pharmacology and pharmacotherapy, - Pharmaceutical technology, - Toxicology, - Pharmacognosy, - Legislation and, where appropriate, professional ethics. The balance between theoretical and practical training shall, in respect of each subject, give sufficient importance to theory to maintain the university character of the training. Article 3 Not more than three years after the expiry of the time limit laid down in Article 5, the Commission shall submit to the Council appropriate proposals on specializations in pharmacy and in particular hospital pharmacy. The Council shall examine these proposals within one year. Article 4 This Directive shall also apply to nationals of Member States who, in accordance with Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1), are pursuing or will pursue, as employed persons, one of the activities referred to in Article 1 of Directive 85/433/EEC. Article 5 1. Member States shall take the measures necessary to comply with this Directive before 1 October 1987. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 6 Where a Member State encounters major difficulties in certain fields when applying this Directive, the Commission shall examine these difficulties in conjunction with that State and shall request the opinion of the Pharmaceutical Committee set up by Council Decision 75/320/EEC (2). Where necessary, the Commission shall submit appropriate proposals to the Council. Article 7 This Directive is addressed to the Member States.

31985L0490

1985

FOURTH COMMISSION DIRECTIVE of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (85/490/EEC) 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 85/391/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 three steps towards the attainment of this objective having already been taken through the definition of certain methods in Commission Directive 80/1335/EEC (3), 82/434/EEC (4) and 83/514/EEC (5), the fourth step is to consist in the definition of methods for the identification and determination of glycerol 1-(4-aminobenzoate), the determination of chlorobutanol, the identification and determination of quinine, the identification and determination of inorganic sulphites and hydrogen sulphites, the identification and determination of chlorates of the alkali metals and the identification and determination of sodium iodate; 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: — identification and determination of glycerol l-(4-aminobenzoate), — determination of chlorobutanol, — identification and determination of quinine, — identification and determination of inorganic sulphites and hydrogen sulphites, — identification and determination of chlorates of the alkali metals, and — identification and determination of sodium iodate are performed in accordance with the methods described in the Annex. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1986. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0479

1985

Commission Directive 85/479/EEC of 14 October 1985 amending Directive 77/794/EEC laying down detailed rules for implementing certain provisions of Directive 76/308/EEC on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/308/EEC of 15 March 1976 on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties, and in respect of value added tax (1), as last amended by Directive 79/1071/EEC (2), and in particular Article 22 (1) thereof, Whereas detailed rules for implementing certain provisions of Directive 76/308/EEC were laid down by Commission Directive 77/794/EEC (3); whereas the title of Directive 76/308/EEC was amended by Directive 79/1071/EEC; whereas the title of Directive 77/794/EEC must be amended accordingly; Whereas Article 20 (2) of Directive 77/794/EEC provides that no request for assistance may be made if the amount of the relevant claim or claims is less than 750 ECU; Whereas Article 12 (2) of Council Regulation (EEC) No 3/84 of 19 December 1983 introducing arrangements for movement within the Community of goods sent from one Member State for temporary use in one or more other Member States (4) provides for mutual assistance between Member States for the recovery of charges due as a result of an irregularity committed in one of them; whereas, however, it is stipulated that the Member State which is recovering the debt may alternatively apply the provisions of Directive 76/308/EEC; Whereas Article 22 (5) of Commission Regulation (EEC) No 2364/84 of 31 July 1984 laying down detailed implementing provisions for the arrangements for movement within the Community of goods sent from one Member State for temporary use in one or more other Member States (5), provides that Article 12 (2) of Regulation (EEC) No 3/84 shall not apply where the amount to be recovered is less than 200 ECU; Whereas, in order to allow, in accordance with Article 12 (2) of Regulation (EEC) No 3/84, the provisions adopted in accordance with Directive 76/308/EEC to be applied in cases where the amount to be recovered is 200 ECU or more, it is necessary to derogate from the principle that no request or assistance may be made under that Directive if the amount of the relevant claim or claims is less than 750 ECU; Whereas Annex I to Directive 77/794/EEC, which contains the form to be used for requesting the information mentioned in Article 4 of Directive 76/308/EEC contains a material error which requires correcting; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on Recovery, Article 1 Directive 77/794/EEC is hereby amended as follows: 1. The title is replaced by the following: 'Commission Directive of 4 November 1977 laying down detailed rules for implementing certain provisions of Council Directive 76/308/EEC on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties, and in respect of value added tax'. 2. Article 20 (2) is replaced by the following: '2. No request for assistance may be made if the amount of the relevant claim or claims is less than 750 ECU. This amount shall be reduced to 200 ECU if the request relates to the recovery of a claim payable as a result of an irregularity committed in the course of or in connection with an operation carried out under arrangements for movement of goods within the Community introduced by Council Regulation (EEC) No 3/84.' 3. Annex I is replaced by the Annex to this Directive. Article 2 1. Member States shall take the measures necessary to comply with this Directive not later than 1 January 1986. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the measures which it takes in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31985L0503

1985

FIRST COMMISSION DIRECTIVE of 25 October 1985 on methods of analysis for edible caseins and caseinates (85/503/EEC) Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption (1), and in particular Article 9 (b) thereof; Whereas Article 9 (b) of Directive 83/417/EEC requires that Community methods of analysis be determined for checking the composition of certain edible caseins and caseinates; Whereas it is possible to adopt an initial series of methods in respect of which studies have been completed; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, Article 1 Member States shall take all measures necessary to ensure that the analyses necessary for verification of the criteria set out in Annex I are carried out in accordance with the methods described in Annex II. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 May 1987 at the latest. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31985L0511

1985

Council Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot- and-mouth disease Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas one of the Community's tasks in the veterinary field is to improve the state of health of livestock, thereby increasing the profitability of stockfarming; Whereas an outbreak of foot-and-mouth disease can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce sharply the profitability of farming of pigs and ruminants as a whole; Whereas action must be taken as soon as the presence of the disease is suspected so that immediate and effective control measures can be implemented as soon as its presence is confirmed; whereas such measures must be modulated by the competent authorities to take account of whether or not a country carries out a prophylactic vaccination programme on all or part of its territory; whereas, under certain conditions, the Member States which practise such a policy may authorize animals having sufficent immunization protection against the foot-and-mouth virus to be exempted from slaughter; Whereas it is necessary to prevent any spread of the disease as soon as an outbreak occurs, by carefully monitoring movements of animals and the use of products liable to be contaminated, and, where appropriate, by vaccination; Whereas diagnosis of the disease and identification of the relevant virus must be carried out under the auspices of responsible laboratories the coordination of which must be ensured by a reference laboratory appointed by the Community; Whereas the vaccine used for emergency vaccination must be verified both for efficacy and safety, with coordination being carried out by a specialized institute appointed by the Community; whereas, furthermore, special coordinated measures must be implemented where virus types or variants are detected against which the vaccines usually used in the Community do not provide sufficient protection; whereas it proves necessary, to this end, to make provision for the Member States which vaccinate to draw up multiannual vaccination plans which will be examined and, where appropriate, be the subject of Community coordination; Whereas provision must be made for a procedure for close cooperation between the Member States and the Commission; Whereas the arrangements introduced by this Directive are of an experimental nature and whereas they will have to be reviewed in keeping with developments in the situation, Article 1 This Directive defines the minimum Community control measures to be applied in the event of outbreaks of foot-and-mouth disease, whatever the type of virus concerned, without prejudice to the Community provisions governing intra-Community trade. This Directive does not affect Member States' prophylactic vaccination policies. Article 2 For the purposes of this Directive, the definitions given in Article 2 of Directive 64/432/EEC (1) shall apply as appropriate. The following definitions shall also apply: (a) 'animal of a susceptible species' means any domestic or wild ruminant or swine present on a holding; (b) 'receptive animal' means any animal of a susceptible species which is not vaccinated, or which is vaccinated but whose immunization cover is considered to be inadequate by the competent authority; (c) 'infected animal' means any animal of a susceptible species: - in which clinical symptoms or post-mortem lesions which may arise from foot-and-mouth disease have been ascertained, or - in which the presence of foot-and-mouth disease has been officially ascertained following a laboratory examination; (d) 'animal suspected of being infected' means any animal of a susceptible species showing clinical symptoms or post-mortem lesions which are such that the presence of foot-and-mouth disease may reeasonably be suspected; (e) 'animal suspected of being contaminated' means any animal of a suspectible species which may - according to the epizootiological information collected - have been directly or indirectly exposed to the foot-and-mouth virus. Article 3 Member States shall ensure that the presence, or suspected presence, of foot-and-mouth disease is compulsorily and immediately notifiable to the competent authority, in accordance with Directive 82/894/EEC (2). Article 4 1. Member States shall ensure that, where a holding contains one or more animals suspected of being infected or of being contaminated with foot-and-mouth disease, official means of investigation to confirm or rule out the presence of the disease are set in motion immediately and, in particular, that the official veterinarian takes the necessary samples, or has them taken, for laboratory examination. As soon as the suspected infection is notified, the competent authority shall have the holding placed under official surveillance and shall in particular order that: - a census be made of all categories of animals of susceptible species and that, in respect of each of these categories, the number of animals already dead, infected or liable to be infected or contaminated be recorded; the census must be kept up to date to take account of animals born or dying during the period of suspicion; the information in the census must be produced on request and may be checked at each visit; - all animals of susceptible species on the holding be kept in their living quarters or some other place where they can be isolated; - no animals of susceptible species enter or leave the holding; - no animals of other species enter or leave the holding without the authorization of the competent authority; - all movement from the holding of meat or carcases of animals of susceptible species or of animal feed, utensils, objects or other substance, such as wool or waste or rejected matter, liable to transmit foot-and-mouth disease be prohibited, unless authorized by the competent authority; - the movement of milk from the holding be prohibited; in the event of difficulties in storing the milk on the holding, the competent authority may authorize the milk to be moved from the holding under veterinary supervision to a treatment establishment in order that it may be given heat treatment ensuring the destruction of the foot-and-mouth virus; - the movement of persons to or from the holding be made subject to authorization by the competent authority; - the entry or exit of vehicles to or from the holding be made subject to authorization by the competent authority which shall lay down the conditions necessary in order to avoid propagation of the foot-and-mouth virus; - appropriate means of disinfection be used at the entrances and exits of buildings housing animals of susceptible species and of the holding itself; - an epizootiological inquiry be carried out in accordance with Articles 7 and 8. 2. The competent authority may extend the measures provided for in paragraph 1 to adjoining holdings should their location, their configuration, or contacts with animals from the holding where the disease is suspected give reason to suspect possible contamination. 3. The measures referred to in paragraphs 1 and 2 shall not be withdrawn until the suspicion of foot-and-mouth disease has been officially ruled out. Article 5 As soon as it has been confirmed that one or more of the animals defined in Article 2 (c) are on a holding, the competent authority shall introduce the following measures: 1) the official veterinarian takes adequate samples or has them taken for examination by the laboratory referred to in Annex I, where these samples and examinations have not been taken or carried out during the period of suspicion in accordance with the first subparagraph of Article 4 (1); 2) in addition to the measures listed in Article 4 (1), the following measures are taken without delay: (a) in Member States or regions where vaccination is prohibited: - all animals of susceptible species on the holding shall be slaughtered on the spot under official supervision in such a way as to avoid all risk of spreading the foot-and-mouth virus; - after being slaughtered, the aforementioned animals shall be destroyed under official supervision in such a way that there is no risk of spreading the foot-and-mouth virus; - meat of animals of susceptible species coming from the holding and slaughtered during the period between the probable introduction of the disease to the holding and the implementation of official measures shall, wherever possible, be traced and destroyed under official supervision in such a way as to avoid any risk of spreading the foot-and-mouth virus; - the carcases of animals of susceptible species which have died on the holding shall be destroyed under official supervision in such a way as to avoid any risk of spreading the foot-and-mouth virus; - any substance referred to in Article 4 (1), seond subparagraph, fifth indent shall be destroyed or treated in such a way as to ensure the destruction of any foot-and-mouth virus present; all treatment must be carried out in accordance with the instructions of the official veterinarian; - milk and milk products shall be destroyed in such a way as to avoid any risk of spreading the foot-and-mouth virus; - after elimination of the animals of susceptible species and of the substances referred to in Article 4 (1), second subparagraph, fifth indent, the buildings used for housing, their surroundings and the vehicles used for their transport and all equipment likely to be contaminated shall be cleaned and disinfected in accordance with Article 10; - no animals of susceptible species shall be reintroduced to the holding until at least 21 days after completion of the cleaning and disinfection operations carried out in accordance with Article 10; - an epizootiological inquiry shall be carried out in accordance with Articles 7 and 8; (b) in the Member States or regions where a vaccination policy is organized in compliance with the provisions of Article 14: (i) - all animals of susceptible species on the holding shall be slaughtered and destroyed under official supervision. When the animals are slaughtered and destroyed, Member States shall take the measures necessary to avoid any risk of the foot-and-mouth virus persisting and being spread and any harmful consequence for the environment; in particular when slaughtering is not carried out on the spot, the animals shall be transported in specially equipped vehicles to avoid any risk of spreading the foot-and-mouth virus; - when the type, sub-type or variant of the foot-and-mouth virus has been identified or when the epidemiological information and data make it possible to ascertain that the vaccines used provide immunization cover valid for the type of virus in question, Member States may: - restrict the slaughtering and destruction to receptive animals; - authorize meat and milk from animals not infected or not suspected of being infected to be given appropriate heat treatment under veterinary supervision; (ii) the measures provided for in (i) shall be accompanied by vaccination or re-vaccination of the remaining animals in accordance with Article 13 (1); (iii) the measures provided for under the third, fourth and fifth indents of (a) shall apply by analogy as well as, except in the case of the heat treatment referred to in (i), the measures provided for in the sixth indent of (a). 3) the provisions of paragraph 1 shall not apply in the case of appearance of a secondary source which is linked epidemiologically with a primary source for which samples have already been taken; 4. the competent authority may extend the measures provided for in paragraph 1 to adjoining holdings should their location, their configuration, or contacts with animals from the holding where the disease has been recorded give reason to suspect possible contamination. Article 6 1. In the case of holdings which consist of two or more separate production units, the competent authority may derogate from the requirements of Article 5 (2) (a), first and second indents and (2) (b) (i) as regards healthy production units of a holding which is infected, provided that the official veterinarian has confirmed that the structure and size of these units and the operations carried out there are such that they are completely separate as regards housing, keeping and feeding, so that the virus cannot spread from one to another. The same measures and the possibility of derogating from the requirements of the sixth indent of Article 5 (2) (a) may be extended to holdings producing milk, provided that, in addition, milking in each unit is carried out quite separately. 2. Where recourse is had to paragraph 1, the Member States shall lay down detailed rules for applying it in the light of the health guarantees offered. They shall notify the Commission thereof. 3. It may be decided, in accordance with the procedure laid down in Article 16, that the measures laid down in paragraph 2 shall be amended in order to ensure the coordination thereof with those adopted by the Member States. Article 7 The epizootiological inquiry shall deal with: - the length of time during which the foot-and-mouth disease may have existed on the holding before being notified or suspected; - the possible origin of the foot-and-mouth disease on the holding and the identification of other holdings on which there are anmals of susceptible species which may have become infected or contaminated from the same source; - the movement of persons, vehicles and substances referred to in Article 4 (1), second subparagraph, fifth indent, likely to have carried the foot-and-mouth virus to or from the holdings in question. Article 8 1. (a) Where the official veterinarian finds, or considers on the basis of confirmed data, that foot-and-mouth disease could have been introduced from other holdings on to the holding referred to in Article 4, or from the latter holding on to other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with Article 4 and this surveillance shall not be lifted until the suspected presence of foot-and-mouth disease on the holding referred to in Article 4 has been officially ruled out; (b) where the official veterinarian finds, or considers on the basis of confirmed data, that foot-and-mouth disease could have been introduced on to the holding referred to in Article 5 from other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with Article 4; (c) where the official veterinarian finds, or considers on the basis of confirmed data, that foot-and-mouth disease could have been introduced from the holding referred to in Article 5 on to other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall become subject to the provisions of Article 4. 2. When a holding holding has been subject to the provisions of paragraph 1, the competent authority shall prohibit removal of animals from the holding other than for transport directly to a slaughterhouse under official supervision for the purpose of emergency slaughter during a 15-day period in the case of holdings referred to in 1 (a) and (b) and a 21-day period in the case of holdings referred to in 1 (c) respectively. Prior to granting such authorization, the official veterinarian must have carried out an examination of the herd and confirmed that none of the animals is suspected of being infected. 3. Where it considers that conditions permit, the competent authority may limit the measures provided for in paragraph 1 (a) and (b) to a part of the holding and the animals contained therein, provided that the animals there have been housed, kept and fed completely separately. Article 9 1. Member States shall ensure that, once the diagnosis of foot-and-mouth disease has been officially confirmed, the competent authority establishes, around the infected holding, a protection zone based on a minimum radius of 3 km and a surveillance zone based on a minimum radius of 10 km. The establishment of zones must take account of natural boundaries and supervision facilities. 2. (a) The following measures shall be applied in the protection zones: - a census of all the holdings having animals of susceptible species and the animals shall be taken; these holdings shall be visited periodically; - the movement of animals of susceptible species on public or private roads, excluding the service roads of holdings, shall be prohibited; - animals of susceptible species may not be removed during the first 15 days from the holding on which they are kept except to be transported directly under official supervision for the purpose of emergency slaughter to a slaughterhouse located in that zone or, if that zone has no slaughterhouse under veterinary supervision, to a slaughterhouse designated by the competent authority. Such movement may be authorized by the competent authority only after examination by the official veterinarian of all the animals of susceptible species on the holding has ruled out the presence of suspected animals; - itinerant service for breeding shall be prohibited; - artificial insemination shall be prohibited during the first 15 days except where it is carried out by the farmer with sperm that is on the farm or with sperm delivered directly by an insemination centre; - fairs, markets, shows or other gatherings of susceptible animals, including collection and distribution, shall be prohibited; - without prejudice to the case provided for in the second sentence of the third indent, the transport of animals of susceptible species shall be prohibited, except for transit by major highways or mainline railways. (b) the measures applied in the protection zone shall be maintained for at least 15 days after elimination of all the animals referred to in Article 5 from the holding and the carrying out on that holding of preliminary cleaning and disinfection operations in accordance with Article 10. However, the measures described in paragraph 3 for the surveillance zone shall remain in force in the protection zone for the period provided for in paragraph 3 (b). 3. (a) The following measures shall be applied in the surveillance zone: - a census shall be taken of all holdings having animals of susceptible species; - the movement of animals of susceptible species on public roads shall be prohibited except for the purpose of leading them to pasture; - the transport of animals of susceptible species within the surveillance zone shall be subject to the authorization of the competent authority; - the animals may not be removed from the surveillance zone during the first 15 days. Between the 15th day and the 30th day the animals may not be removed from the said zone except to be transported under official supervision directly to a slaughterhouse for the purpose of emergency slaughter. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all the animals concerned and confirmed that none of the animals is suspected of being infected; - itinerant service for breeding shall be prohibited; - fairs, markets, shows and other gatherings of susceptible animals shall be prohibited. b) The measures in the surveillance zone shall be kept in force for at least 30 days after the elimination of all the animals referred to in Article 5 from the holding and the carrying out on that holding of preliminary cleaning and disinfection operations in accordance with Article 10. Article 10 Member States shall ensure that: - the disinfectants to be used and their concentrations are officially approved by the competent authority; - the cleaning and disinfection operations are carried out under official supervision, in accordance with the instructions given by the official veterinarian. Article 11 1. Member States shall ensure that: - laboratory testing to detect the presence of foot-and-mouth diesease are carried out by a national laboratory indicated in the Annex which may be amended or supplemented in accordance with the procedure laid down in Article 17. This laboratory testing should, if necessary and especially on the first appearance of the disease, show the type, sub-type or, where appropriate, the variant of the relevant virus which may be confirmed, if necessary, be a reference laboratory designated by the Community; - one of the national laboratories indicated in Annex I is responsible for coordinating standards and methods of diagnosis in each Member State; - the national laboratories referred to in the first indent liaise with a reference laboratory designated by the Community. 2. The Council, acting by a qualified majority on a proposal from the Commission, shall designate, before 1 January 1987, the reference laboratory referred to in paragraph 1 and shall determine its powers and the detailed rules for applying the second indent of paragraph 1. Article 12 Member States shall ensure that: - when animals of susceptible species are moved out of the holding on which they are kept, they are identified in such a way as to enable their holding of origin, or the holding from which they have come, and their movements to be traced rapidly. However, for certain categories of animals and without prejudice to Article 13 of Council Directive 80/217/EEC of 22 January 1980 introducing Community measures for the control of classical swine fever (1), as last amended by Directive 84/645/EEC (2), the competent authority may, in certain circumstances and having regard to the health situation, authorize other ways of rapidly tracing their holding of origin, or the holding from which they have come, and their movements. The arrangements for identifying the animals or for tracing the holding of origin shall be determined by the competent authority; - the owner or keeper of the animals is required to supply the competent authority, on request by that authority, with information concerning animals entering or leaving his holding; - all persons engaged in the transport or marketing of animals of susceptible species are able to supply the competent authority with information concerning the movements of animals which they have transported or marketed and to furnish all the details concerning such information. Article 13 1. When foot-and-mouth is diagnosed on a holding, the measures to control the disease may be supplemented by the vaccination of animals of susceptible species on holdings threatened with contamination in a territorial area specified by the competent authority. 2. In the case referred to in paragraph 1, Member States shall ensure that: (a) without prejudice to the exception provided for in Article 5 (2) (b) (i), second indent, and national arrangements where such arrangements provide for the prophylactic vaccination against foot-and-mouth disease of any or all of the animals of susceptible species on part or all of the territory, the vaccination or re-vaccination of animals of susceptible species on the holdings referred to in Article 4 is prohibited; (b) serum injection is prohibited; (c) the type of anti-foot-and-mouth disease vaccine and its method of use comply with the general recommendations decided on in accordance with the procedure in Article 16; (d) the vaccine used is authorized by the competent authority on the basis of the verification by national laboratories the activity of which is coordinated by the institute desginated in accordance with Article 14 (3); (e) any vaccine imported from a third country satisfies the requirements laid down in (c) and is checked as indicated in (d). The Council, acting by a qualified majority on a proposal from the Commission, shall adopt the procedure for coordinating standards and checking vaccines on the territory of the Community. 3. In the event of the appearance of types, sub-types or variants of foot-and-mouth virus against which the vaccines usually used provide no protection or insufficient protection, the Member State concerned shall immediately inform the Commission and the other Member States, stating what emergency measures it considers necessary for the adaptation of vaccine formulae and their use. 4. If, in the light of the national measures referred to above, the adoption of Community measures proves necessary, such measures shall be decided on by the procedure provided for in Article 16. Article 14 1. Member States which authorize vaccination against foot-and-mouth disease shall draw up a multiannual vaccination plan, which they shall submit to the Commission and the other Member States within the Standing Veterinary Committee. This plan must specify: (i) - the frequency of the vaccination, - the conditions and procedure for the production and checking of vaccines to be used in the various possible circumstances of outbreaks of foot-and-mouth disease, - the protective 'standard' rating, - the cross-immunity controls with variants, - the species and categories of animals which are to be subject to the vaccination programme, - the procedures for supervision of the distribution, conservation, storage and use of vaccines; (ii) - the types of virus used, - the characteristics and composition of each vaccine used. 2. The coordination of the measures adopted by Member States as part of their national anti-foot-and-mouth plans, and provided for in paragraph 1 (i), shall be decided upon according to the procedure provided for in Article 16, with a view to ensuring their effectiveness. 3. Before 1 January 1987 the Council, acting by a qualified majority on a proposal from the Commission, shall designate the laboratory referred to in Article 13 and shall determine its powers together with those of the institute responsible for vaccine and cross-immunity checks. 4. Before 1 January 1989 the Commission shall submit to the Council a report accompanied, where appropriate, by proposals on the rules relating to the production and distribution of anti-foot-and-mouth disease vaccines in the Community, together with proposals on the setting up of a Community reserve of anti-foot-and-mouth disease vaccines. Article 15 If foot-and-mouth disease assumes alarming proportions on the territory of a Member State and, despite the measures taken, particularly in application of Article 13, the epizootic becomes extensive and develops widely outside the limits of the vaccinated zone, a Member State which does not practise prophylactic vaccination on all or part of its territory may carry out such vaccination on all or part of its territory and apply the measures laid down in Article 5 (2) (b). It shall inform the Commission and the other Member States of this action. Article 16 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC (1) (hereinafter referred to as 'the Committee') by the committee chairman, either on his own initiative or at the request of a Member State. 2. The votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be adopted. The committee shall deliver its opinion on these measures within two days. Opinions shall be delivered by a majority of 54 votes. 4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the committee. Where they are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If the Council has not adopted any measures within 15 days of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately unless the Council has voted against the said measures by a simple majority. Article 17 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the committee without delay by its chairman, either on his own initiative or at the request of a Member State. 2. Within the committee the votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be adopted. The committee shall deliver its opinion by a date which the chairman may set in the light of the urgency of the matters submitted for examination. Opinions shall be delivered by a majority of 54 votes. 4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the committee. Where they are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If the Council has not adopted any measures within three months of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately unless the Council has voted against the said measures by a simple majority. Article 18 On the basis of a report from the Commission on the experience gained in controlling foot-and-mouth disease, accompanied by proposals where appropriate, the Council shall review the situation by 1 January 1990, with a view to further harmonization. Article 19 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1987 at the latest. Article 20 This Directive is addressed to the Member States.

31985L0536

1985

Council Directive 85/536/EEC of 5 December 1985 on crude-oil savings through the use of substitute fuel components in petrol Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas, pursuant to Article 2 of the Treaty, the Community has as its task to promote throughout the Community a harmonious development of economic activities, a continuous and balanced expansion and an increase in stability; Whereas, in the present energy situation, a reduction in the Community's dependence upon imported crude oil will contribute effectively to the attainment of these objectives; Whereas the reduction and elimination of lead in petrol may be partly offset by the use of substitute fuel components in petrol and whereas such components may also help to reduce over-consumption of crude oil necessary in refining to produce lead-free petrol; Whereas petrol used for the propulsion of vehicles powered by internal combustion spark-ignited engines is an important sector of oil consumption in the Community; Whereas the use of crude oil to manufacture petrol for vehicles propelled by internal combustion spark-ignited engines can be reduced through blending hydrocarbon petrol with substitute fuel components; Whereas the increasingly complex refining process and the creation of petro-chemical products require that such products be intended, as far as possible, for a proper use and whereas it is desirable to establish rules to that effect; Whereas these substitute fuel components can be produced from raw materials other than crude oil both inside and outside the Community, thereby broadening the raw materials base for the production of fuels for use in internal combustion spark-ignited engines; Whereas the distribution and use of petrol blended with substitute fuel components as defined by this Directive require no, or only minor, modifications to existing petrol distribution systems and no modification to existing vehicles propelled by internal combustion spark-ignited engines designed to operate on petrol; Whereas the distribution and combustion of blends as defined by this Directive carries no safety, health or environmental risks significantly different from those of petrol currently sold for motor vehicles in the Community; Whereas the objective of saving crude oil makes it desirable that no obstacles be placed in the way of the manufacture, distribution, sale and use of suitable blends for the propulsion of vehicles powered by internal combustion spark-ignited engines; Whereas cross-border traffic requires that motorists be offered suitable fuels for their motor vehicles everywhere in the Community and that potential users be able to distinguish between fuels covered by this Directive and others which can be used only in specifically designed or adapted vehicles; Whereas scientific and technical developments may make it appropriate to modify the Annex to this Directive; whereas a procedure should be set up so that such modifications may be made; Whereas the Treaty has not provided the necessary powers other than those of Article 235, Article 1 Member States shall not prevent, restrict or discourage, on the grounds of oxygenate content, the production, marketing and free movement of blended petrol containing organic oxygenate compounds which comply with the Annex and which do not exceed the limits stipulated in column A of Section II of that Annex. Such blended fuels must be usable in complete safety and with similar performance to petrol used in vehicles propelled by internal combustion spark-ignited engines currently in use or being offered for sale without requiring any modification to such vehicles. Article 2 For the purposes of this Directive, 'petrol' means any mixture consisting essentially of liquid hydrocarbons suitable for the operation of internal combustion spark-ignited engines. Article 3 Pumps for the sale of motor fuels to the general public which dispense motor fuels containing organic oxygenate compounds in proportions higher than the limits set in column B of Section II of the Annex shall be very clearly marked accordingly to take account in particular of variations in the calorific value of such fuels. Article 4 The Annex may be amended in accordance with the procedure laid down in Articles 5 and 6. Article 5 1. A Committee on the Adaptation of the Annex to Scientific and Technical Progress, hereinafter referred to as the 'Committee', shall be established. 2. The Committee shall also be empowered to examine substitute fuel components not covered by this Directive but without having recourse to the pocedure set out in Article 6. 3. The Committee shall consist of representatives of the Member States, with a Commission representative as chairman. It shall be convened by the chairman, either on his own initiative or at the request of the representative of a Member State. 4. The Committee shall adopt its own rules of procedure. Article 6 1. Where the procedure laid down in this Article is to be followed, 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. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. 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 a majority of 45 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. (a) The Commission shall adopt the intended measures when they are in accordance with the Committee's opinion; (b) Where the intended measures are not in accordance with the opinion of the Committee, or in the absence of any opinion, the Commission shall forthwith submit to the Council a proposal relating to the measures to be taken. The Council shall act on a qualified majority. If, on the expiry of three months from the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately. Article 7 1. Member States shall bring into force the laws, regulations and administrative provisions, including those referring to the test and measuring methods in the context of the Annex, necessary to comply with this Directive by 1 January 1988. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 8 This Directive is addressed to the Member States.

31985L0574

1985

Council Directive 85/574/EEC of 19 December 1985 amending Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas by its Directive 77/93/EEC (4), as last amended by Directive 84/378/EEC (5), the Council laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; Whereas, having regard to developments since then, certain of its provisions should be amended for the reasons given below; Whereas it is useful to give a detailed definition of certain terms used in connection with the term 'plants'; Whereas machinery should be established to determine, at Community level, acceptable tolerances for certain harmful organisms on products other than plants intended for planting; Whereas it is appropriate to lay down, with a view to the intended adoption in a standardized layout of the specimen certificates approved by the International Plant Protection Convention of 6 December 1951, as amended on 21 November 1979, certain rules concerning the conditions in accordance with which such certificates may be issued, certain rules for the use of previous models during a transitional period, and certification requirements in the case of the introduction of plants and plant products from third countries; Whereas the procedure applicable to certain types of amendments to be made to the Annexes to Directive 77/93/EEC should be simplified; Whereas, as a result of the adoption of certain new headings in the Annexes, the Member State concerned could impose the relevant prohibitions or restrictions also where the products concerned, originating in a third country, come from other Member States; Whereas certain provisions laid down in the enacting terms of that Directive should be deleted following the adoption, by Directive 84/378/EEC, of more appropriate provisions in the Annexes; Whereas derogations from the general provisions of Directive 77/93/EEC which have been granted in accordance with conditions determined on a Community basis pursuant to Article 14 (2) and (3) of that Directive have presented considerable advantages in that they have enabled specific situations to be taken into account; whereas the scope of such derogations should therefore be extended; Whereas, moreover, experience has shown that the same degree of urgency may attach to such derogations as attaches to the safeguard provisions laid down in Article 15 of that Directive; whereas therefore the urgency procedure specified in Article 17 of the said Directive should also be made applicable to these derogations, Article 1 Directive 77/93/EEC is hereby amended as follows: 1. Article 2 (1) (a) shall be replaced by the following:'(a) Plants shall be considered to mean living plants and living parts thereof, including seeds.Living parts of plants shall be considered to include: - fruit - in the botanical sense - other than that preserved by deep freezing, -vegetables, other than those preserved by deep freezing, -tubers, corms, bulbs, rhizomes, -cut flowers, -branches with foliage, -cut trees retaining foliage, -plant tissue cultures.' Seeds shall be considered to mean seeds in the botanical sense, other than those not intended for planting. 2.In Article 2 (1), the following shall be inserted after (c):'(d)plants intended for planting shall be considered to mean: -plants which are already planted and are intended to remain planted or to be replanted after their introduction, or -plants which are not planted at the time of introduction, but are intended to be planted thereafter.'Points (d) and (e) shall become points (e) and (f) respectively. 3. In Article 3:- paragraphs 2 and 3 shall be deleted,-former paragraph 4 shall become paragraph 2,-the following paragraph shall be inserted:'3. Paragraphs 1 and 2 shall not apply, in accordance with conditions which may be determined in accordance with the procedure laid down in Article 16, in the case of slight contamination of plants, other than those intended for planting, by harmful organisms listed in Annex I, Part A, or in Annex II, Part A, which have previously been selected in agreement with the authorities representing the Member States in the field of plant health.'-former paragraphs 5, 6 and 7 shall become 4, 5 and 6 respectively. 4.Article 7 (1) shall be replaced by the following:'1. Where it is considered, on the basis of the examination laid down in Article 6 (1) and (2), that the conditions therein are fulfilled, a phytosanitary certificate conforming to the model in Annex VIII, Part A, may be issued, drawn up in at least one of the official languages of the Community and filled in, except in respect of stamp and signature, either entirely in capital letters or entirely in typescript, and preferably in one of the official languages of the Member State of destination.The botanical names of plants shall be indicated in Latin characters. Uncertified alterations or erasures shall invalidate the certificate. Any copies of this certificate shall only be issued with the indication ''copy'' or ''duplicate'' printed or stamped thereon.By way of derogation from the first subparagraph, remaining stocks of phytosanitary certificates conforming to the original version of the model laid down in the Annex to the International Plant Protection Convention of 6 December 1951 may be used until 31 December 1986.' 5.In Article 7 (3), '31 December 1980' shall be replaced by '31 December 1986'. 6.In Article 8 (2), first subparagraph, second sentence, the passage 'reforwarding phytosanitary certificate in accordance with the specimen in Annex VIII, Part B, drawn up in at least one official Community language, preferably that of the Member State of destination' shall be replaced by 'reforwarding phytosanitary certificate, in one original copy only, conforming to the model laid down in Annex VIII, Part B, drawn up in at least one of the official languages of the Community, and filled in, except in respect of stamp and signature, either entirely in capital letters or entirely in typescript, and preferably in one of the official languages of the Member State of destination'. 7.In Article 8 (2), the following subparagraph shall be inserted after the first subparagraph:'Article 7 (1), second subparagraph, shall apply by analogy.' 8.In Article 8 (2), second subparagraph, '31 December 1980' shall be replaced by '31 December 1986'. 9.Article 10 shall be deleted. 10.In Article 12 (1) (b), second sentence, the words 'The certificates shall be issued' shall be replaced by 'The certificates prescribed in Articles 7, 8 or 9 shall contain information in accordance with the model defined in the Annex to the International Plant Protection Convention of 6 December 1951, as amended on 21 November 1979, irrespective of their layout, and shall be issued'. 11.In Article 12 (1) (b), the following subparagraph shall be added:'By way of derogation from the first subparagraph phytosanitary certificates issued in accordance with the original version of the model laid down in the Annex to the International Plant Protection Convention of 6 December 1951 may be used for a transitional period. The date of expiry of such period may be determined in accordance with the procedure laid down in Article 16.' 12. In Article 13 the following paragraph shall be added:'However, the following shall be adopted in accordance with the procedure laid down in Article 16:- headings additional to Annex III to this Directive in respect of certain plants, plant products or other objects originating in specified third countries, provided that: - these headings are introduced at the request of a Member State which already applies special prohibitions as regards the intro duction of such products from third countries, -harmful organisms occurring in the country of origin constitute a plant-health risk for the whole or part of the Community, and -their possible presence on the products in question cannot be detected effectively at the time of their introduction,-headings additional to the other Annexes to this Directive in respect of certain plants, plant products or other objects originating in specified third countries, provided that: -these headings are introduced at the request of a Member State which already applies special prohibitions or restrictions as regards the introduction of such products from third countries, and -harmful organisms occurring in the country of origin constitute a plant-health risk for the whole or part of the Community in respect of crops, the scale of possible damage to which is unforeseeable,-any amendment to part B of the Annexes to this Directive, in agreement with the Member State concerned,-any other amendment to the Annexes to this Directive to be made in the light of developments in scientific or technical knowledge.' 13. In Article 14 (1) (a), point (i) shall be deleted, points (ii), (iii) and (iv) shall become points (i), (ii) and (iii) respectively. 14.In Article 14 (1) (a):- in point (i), the reference to Article 10 shall be deleted,-in point (iii), the terms '5 to 10 and 12' shall be replaced by the terms '5 to 9 and 12'. 15. In Article 14 (1) (c) (i), the terms 'and 4 (1) with regard to requirements referred to in Annex III, Part A (8), and from Articles' shall be deleted. 16.In Article 14 (2) and (3), the terms 'or, in urgent cases, with that laid down in Article 17', shall be inserted after 'In accordance with the procedure laid down in Article 16'. 17.In Article 14 (3), second indent, the terms '1 to 8 and 10' shall be replaced by 'remaining items', and the words 'with regard to the requirements referred to in Annex IV, Part A, 2, 3 and 4' replaced by 'with regard to other requirements referred to in Annex IV, Part A'. 18.In Article 14 (3), the following indent shall be inserted after the second indent:'- from Articles 7 (2) and 12 (1) (b), in the case of wood, if equivalent safeguards are given.' Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 1 January 1987 at the latest. 2. Member States shall forthwith inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31985L0573

1985

Council Directive 85/573/EEC of 19 December 1985 amending Directive 77/436/EEC on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts Having regard to the Treaty establishing the European Economic Community , and in particular Article 100 thereof , 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 for sale to the ultimate consumer (1) , as amended by the Act of Accession of Greece , and in particular the second paragraph of Article 20 thereof , Having regard to the proposal from the Commission (2) , Having regard to the opinion of the European Parliament (3) , Having regard to the opinion of the Economic and Social Committee (4) , Whereas on the basis of technical progress and the need to improve the price/quality ratio of the products and to protect them from the risk of unfair competition from similar products manufactured in third countries , it is desirable to abolish any requirements as to the minimum quantity of raw coffee and the maximum content of insoluble substances used in coffee extract and to reduce the minimum dry-matter content required for coffee extract and chicory extract ; Whereas it is also desirable , in view of developments in the industry , to provide for the existence of a concentrated product in the case of chicory extract ; Whereas Directive 77/436/EEC (5) as amended by the Act of Accession of Greece should therefore be amended , Article 1 Directive 77/436/EEC is hereby amended as follows : 1 . The second indent of Article 3 (2) shall be deleted . 2 . Article 4 shall be replaced by the following : " Article 4 Products in solid or in paste form referred to in Article 1 , when put up in individual packages of a nominal weight of more than 25 g but not exceeding 10 kg , shall be offered for retail sale in packages of the following nominal weights only : 50 g , 100 g , 200 g , 250 g ( for mixtures of coffee and chicory extracts only and for coffee extracts intended exclusively for use in automatic vending machines ) , 300 g ( for coffee extracts only ) , 500 g , 750 g , 1 kg , 1,5 kg , 2 kg , 2,5 kg , 3 kg and multiples of a kilogram . " 3 . Article 6 shall be replaced by the following : " Article 6 1 . Directive 79/112/EEC shall apply in accordance with the following conditions to the products defined in the Annex to this Directive where they are intended to be supplied without further processing to the ultimate consumer : ( 1 ) ( a ) The name under which a product is sold , as referred to in Article 5 of Directive 79/112/EEC , shall be the description applied to the products concerned pursuant to Article 5 of this Directive ; ( b ) It may be supplemented by the term " concentrated " : ( i ) in the case of the product defined in point 1 ( c ) of the Annex , provided that the coffee-based dry matter content is more than 25 % by weight , ( ii ) in the case of the product defined in point 2 ( c ) of the Annex , provided that the chicory-based dry matter content is more than 45 % by weight . ( 2 ) The following particulars , in addition to those specified in Article 3 of Directive 79/112/EEC , shall be compulsory on the labelling : ( a ) the term " decaffeinated " in the case of the products defined in point 1 of the Annex provided that the anhydrous caffeine content does not exceed 0,3 % by weight of the coffee-based dry matter ; ( b ) in the case of the products defined in points 1 ( c ) and 2 ( c ) of the Annex : ( i ) the term " roasted with sugar " if the extract is obtained from the raw material roasted with sugar , ii ) the terms " with sugar " , " preserved with sugar " or " with added sugar " if the sugar has been added to the raw material after roasting . Where sugars of types other than sucrose are used this must be stated instead of the term " sugar " ; ( c ) the minimum coffee-based dry matter content , expressed as a percentage by weight of the finished product , in the case of the products defined in point 1 ( b ) and ( c ) of the Annex ; ( d ) the minimum chicory-based dry matter content , expressed as a percentage by weight of the finished product , in the case of the products defined in point 2 ( b ) and ( c ) of the Annex . ( 3 ) The particulars mentioned in point ( 2 ) ( a ) and ( b ) above shall appear in the same field of vision as those mentioned in Article 11 ( 3 ) ( a ) of Directive 79/112/EEC . 2 . The labelling of the products defined in the Annex where they are not intended to be supplied to the ultimate consumer shall include only the following compulsory information : - the name under wich the product is sold , as specified in paragraph 1 ( 1 ) ( a ) , - the nominal net quantity in units of mass or volume , except in the case of products put up for sale in bulk , - a means of identifying the batch , - the name or business name and address of the manufacturer or packager , or of a seller established within the Community . The particulars listed in the first subparagraph shall appear on the packaging or a label affixed to it , or on an accompanying document . " 4 . The Annex shall be replaced by the following : " ANNEX DESCRIPTIONS AND DEFINITIONS OF THE PRODUCTS 1 . Coffee extracts to which this Directive applies ( a ) " Soluble coffee " , " instant coffee " , " dried coffee extract " or " dried extract of coffee " means coffee extract in powder , granular , flake , cube or other solid form , of which the coffee-based dry matter content is not less than 95 % by weight . This product may not contain any substances other than those derived from its extraction . ( b ) " Coffee extract paste " means coffee extract , in paste form , of wich the coffee-based dry matter content is not more than 85 % and not less than 70 % by weight . This product may not contain substances other than those derived from its extraction . ( c ) " Liquid coffee extract " means coffee extract in liquid form , of wich the coffee-based dry matter content is not more than 55 % but greater than 15 % by weight . This product may not contain any substances other than those derived from its extraction . However , it may contain edible sugars , whether or not roasted , in a proportion not exceeding 12 % by weight . 2 . Chicory extracts to which this Directive applies ( a ) " Dried chicory extract " or " soluble chicory " or " instant chicory " means chicory extract in powder , granular , flake , cube or other solid form , the chicory-based dry matter content of which is not less than 95 % by weight . This product may not contain any substances other than those derived from its extraction . Substances wich are not derived from chicory may not exceed 1 % . ( b ) " Chicory extract paste " means chicory extract in paste form , of which the chicory-based dry matter content is not more than 85 % and not less than 70 % by weight . This product may not contain any substances other than those derived from its extraction . Substances which are not derived from chicory may not exceed 1 % . ( c ) " Liquid chicory extract " means chicory extract in liquid form , of which the chicory-based dry matter content is less than 55 % but greater than 25 % by weight . This product may not contain any substances other than those derived from its extraction . It may , however , contain sugars in a proportion not exceeding 35 % by weight . " Article 2 Member States shall take the measures necessary to comply with this Directive so as to permit , not later than 1 January 1987 , trade in products complying with this Directive and prohibit from 1 July 1988 trade in products which do not comply with this Directive . They shall forthwith inform the Commission thereof . Article 3 This Directive is addressed to the Member States .

31985L0572

1985

COUNCIL DIRECTIVE of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (85/572/EEC) Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs (1), and in particular Article 2 (3) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas, by virtue of Article 2 (3) of, together with the first indent of Chapter 1 (2) of the Annex to Directive 82/71 I/EEC, appropriate simulants to carry out migration tests should be indicated for plastic materials and articles intended to come into contact with a single foodstuff or a specific group of foodstuffs; Whereas the possibility should not be excluded, where necessary, of making use of methods for testing migration other than those laid down in this Directive; Whereas, in determining appropriate simulants, account must be taken in particular of the chemical composition of the foodstuff and its physical properties; Whereas, for some foodstuffs containing fat, the result obtained in migration tests with the simulant is higher than that obtained in migration tests with the foodstuff itself and whereas therefore the result should be corrected by applying a ‘reduction factor’ appropriate to the particular situation; whereas in certain specific cases, particularly that of materials and objects in contact with foodstuffs with fatty substances on the surface, the existence of appropriate methods of analysis is essential for implementation of this Directive; Whereas the adaptation of this Directive to technical progress constitutes an implementing measure, the adoption of which, in order to simplify and accelerate the procedure, should in principle be the responsibility of the Commission; Whereas in all cases in which the Council confers on the Commission authority to implement the provisions relating to plastic materials and articles intended to come into contact with foodstuffs, a procedure should be laid down establishing close cooperation between Member States and the Commission within the Standing Committee for Foodstuffs, set up under Decision 69/414/EEC (5), Article 1 Pursuant to Article 2 (3) of Directive 82/71 I/EEC, the simulants to be used for testing migration of the constituents of plastic materials and articles intended to come into contact with a single foodstuff or specific group of foodstuffs and the concentration of these simulants shall be those indicated in the Annex. Article 2 Notwithstanding Article 1, the list of substances or materials whose use is authorized to the exclusion of all others may lay down procedures testing migration of particular constituents of plastic materials and articles which differ from those laid down in the Annex where this is appropriate. Article 3 Adaptations to be made to the Annex to this Directive in the light of progress in scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC (6). Article 4 Member States shall take all measures necessary to comply with this Directive not later than such time as they take the measures to implement Directive 82/711/EEC Article 5 This Directive is addressed to the Member States.

31985L0591

1985

Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the production, manufacture, marketing and use of foodstuffs intended for human consumption are of considerable importance in the European Economic Community; Whereas the methods of sampling and analysis used for this purpose can have direct repercussions on the establishment and functioning of the common market; whereas they should, therefore, be harmonized; Whereas the laying down of these methods of sampling and analysis constitutes a measure of a purely scientific and technical nature; whereas a rapid procedure for developing, improving and supplementing such methods is necessary; whereas, in order to facilitate the adoption of such measures, a procedure should be introduced for close cooperation between the Member States and the Commission within the Standing Committee for Foodstuffs, Article 1 1. Where it is necessary to introduce Community methods of sampling or analysis for the purpose of determining the composition, conditions of manufacture, packaging or labelling of a foodstuff, such methods shall be adopted by the Commission or by the Council as appropriate in accordance with the procedure laid down in Article 4.2. Paragraph 1 shall be without prejudice to any specific provisions currently in force or hereafter adopted in the context of special Community rules. 3. For the purposes of determining whether it is necessary to introduce the measures provided for in paragraph 1, the following criteria in particular will be taken into consideration:(a) the need to ensure that Community law is uniformly applied;(b)the existence of barriers to intra-Community trade;(c)the permanent or recurrent nature of the criteria referred to in (a) or (b). Article 2 1. The Directives provided for in Article 1 shall take account of the state of scientific and technical knowledge, in particular of proven methods of sampling and analysis. 2. Such Directives shall specify appropriate time limits for Member States to implement them. 3. The introduction of the measures provided for in Article 1 (1) shall not preclude Member States from using other tested and scientifically valid methods provided that this does not hinder the free movement of products recognized as complying with the rules by virtue of Community methods. However, in the event of differences in the interpretation of results, those obtained by the use of Community methods shall be determinant. 4. The methods of analysis introduced shall comply with the criteria set out in the Annex. 5. Without prejudice to Article 3, the necesaary amendments to existing Directives in so far as appropriate in view of the advanced state of scientific and technological knowledge may, at the request of a Member State, be adopted by means of the procedure provided for in Article 4. Article 3 1. Where a Member State has detailed evidence that a measure adopted in accordance with Article 1 is inappropriate in a particular case for technical reasons or because it is insufficiently conclusive for the examination of an important health question, that Member State may temporarily suspend the measure in question in its territory but only for that particular case. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision. 2. The Commission shall examine as soon as possible the evidence given by the Member State and then consult the Member States within the Standing Committee for Foodstuffs referred to in Article 4, after which it shall deliver its opinion forthwith and take the appropriate measures. 3. If the Commission considers that amendments to the measure adopted in accordance with Article 1 are necessary in order to resolve the difficulties mentioned in paragraph 1, it shall initiate the procedure laid down in Article 4. The member State which has suspended the Community measure may, in that event, continue to do so until the amendments enter into force. Article 4 1. Where the procedure defined in this Article is invoked, the matter shall be referred to the Standing Committee for Foodstuffs set up by Decision 69/414/EEC (1) (hereinafter called 'the Committee') by its chairman, either on his own initiative or at the request of a representative of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its own opinion on that draft within a time limit set by the chairman having regard to the urgency of the matter. Opinions shall be delivered by a majority of 45 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. (a) Where the measures envisaged are in accordance with the opinion of the Committee, the Commission shall adopt them;(b)Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall act by a qualified majority;(c)If the Council has not acted within three months after submission of the proposal, the proposed measures shall be adopted by the Commission. Article 5 Member States shall, within a period of two years following notification thereof (2), bring into force by law, regulation or administrative action any provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. Article 6 This Directive is addressed to the Member States.

31985L0585

1985

Council Directive 85/585/EEC of 20 December 1985 amending Directive 64/54/EEC on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption Having regard to the Treaty establishing the European Economic Community , and in particular Article 100 thereof , Having regard to the proposal from the Commission (1) , Having regard to the opinion of the European Parliament (2) , Having regard to the opinion of the Economic and Social Committee (3) , Whereas Directive 64/54/EEC (4) , as last amended by Directive 85/172/EEC (5) , lays down a list of preservatives which may be used for the protection of foodstuffs intended for human consumption against deterioration caused by micro-organisms ; Whereas potassium acid sulphite ( potassium bisulphite ) may be used in wine production as an alternative to other sulphites already permitted by the said Directive , and therefore should be added to the list under No E 228 ; Whereas , without prejudice to future general Community rules on the surface treatment of fruit , in order to remove any uncertainty about the acceptability of thiabendazole ( E 233 ) , the deadline for its authorized use should be removed with effect from 16 September 1984 , Article 1 The Annex to Directive 64/54/CEE is hereby amended as follows : ( i ) the following shall be inserted under entry I : EEC No * Name * Conditions of use * E 228 * Potassium acid sulphite ( Potassium bisulphite ) * * ( ii ) Under E 233 in the column " Conditions of use " , point ( c ) shall be deleted with effect from 1 January 1986 . Article 2 Member States shall bring into force not later than 31 December 1986 the laws , regulations or administrative procedures necessary to comply with this Directive . They shall forthwith inform the Commission thereof . Article 3 This Directive is addressed to the Member States .

31985L0584

1985

Council Directive 85/584/EEC of 20 December 1985 amending, on account of the accession of Spain and Portugal, Directive 85/433/EEC concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy Having regard to the Act of Accession of Spain and Portugal, and in particular Article 396 thereof, Whereas, on account of the accession of Spain and Portugal, it is necessary to make certain amendments to Directive 85/433/EEC (1) to ensure its equal application by the Kingdom of Spain and the Portuguese Republic and the other Member States; Whereas pursuant to Article 2 (3), of the Treaty of Accession of Spain and Portugal the institutions of the Community can adopt before accession the measures referred to in Article 396 of the Act of Accession, the measures entering into force subject to and on the date of entry into force of the said Treaty, Article 1 As from 1 January 1986, subject to the entry into force of the Treaty of Accession of Spain and Portugal, the following shall be added to Article 4 of Directive 85/433/EEC: '(k) in Spain: título de licenciado en farmacia (university degree in pharmacy awarded by the Ministry of Education and Science or by the universities) (l)in Portugal: Carta de curso de licenciatura em Ciências Farmacêuticas (the certificate in pharmaceutical sciences awarded by the universities).' Article 2 The Member States shall bring into force the measures necessary to comply with this Directive within the time limit specified in Article 19 (1) of Directive 85/433/EEC. Article 3 This Directive is addressed to the Member States.

31985L0614

1985

Council Directive 85/614/EEC of 20 December 1985 amending, on account of the accession of Spain and Portugal, Directive 85/384/EEC on the mutual recognition of diplomas, certificates and other evidence of formal qualifications in architecture, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services Having regard to the Act of Accession of Spain and Portugal, and in particular Article 396 thereof, Whereas in view of the accession of Spain and Portugal, it is necessary to make certain amendments to Directive 85/384/EEC (1) to ensure its equal application by the Kingdom of Spain and the Portuguese Republic and the other Member States, Whereas pursuant to Article 2 (3) of the Treaty of Accession of Spain and Portugal the institutions of the Community may adopt before accession the measures referred to in Article 396 of the Act of Accession, the measures entering into force subject to and on the date of entry into force of the said Treaty, Article 1 With effect from 1 January 1986, subject to the entry into force of the Treaty of Accession of Spain and Portugal, Article 11 of Directive 85/384/EEC shall be amended by the addition of the following: '(j) in Spain- the official formal qualification of an architect (título oficial de arquitecto) awarded by the Ministry of Education and Science or by the universities, (k)in Portugal-the Diploma ''diploma do curso especial de arquitectura'' awarded by the Schools of Fine Arts of Lisbon and of Porto,-the Architects Diploma 'diploma de arquitecto' awarded by the Schools of Fine Arts of Lisbon and of Porto,-the Diploma ''diploma do curso de arquitectura'' awarded by the Higher Schools of Fine Arts of Lisbon and Porto,-the Diploma ''diploma de licenciatura em arquitectura'' awarded by the Higher School of Fine Arts of Lisbon,-the Diploma ''carta de curso de licenciatura em arquitectura'' awarded by the Technical University of Lisbon and the University of Porto.' Article 2 The Member States shall take the measures necessary to comply with this Directive within the time limit specified in Article 31 (1) of Directive 85/384/EEC. Article 3 This Directive is addressed to the Member States.

31985L0576

1985

Council Directive 85/576/EEC of 20 December 1985 amending Directive 78/1035/EEC on the exemption from taxes of imports of small consignments of goods of a non-commercial character from third countries Having regard to the Treaty establishing the European Economic Community, and in particular Article 99, 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 no adjustment has been made to the tax relief provided for in Directive 78/1035/EEC (4) as amended by Directive 81/933/EEC (5), as regards the importation of small consignments of goods of a non-commercial character from third countries since the adoption of Directive 81/933/EEC, resulting in a fall in the real value of the relief owing to the rise in consumer prices; whereas that situation should be remedied; Whereas tafia, saké and other similar beverages can be treated as beverages of an alcoholic strength of 22 % vol. or less for which there is currently a tax-free limit; whereas the list of beverages covered by this limit should therefore be extended; Whereas it should be specifically mentioned that the limit on the quantity of alcoholic beverages which can be exempted applies a fortiori to pure alcohol, Article 1 In the third indent of Article 1 (2) (a) of Directive 78/1035/EEC, '35 ECU' is hereby replaced by '45 ECU'. Article 2 Article 2 (b) first and second indents of Directive 78/1035/EEC shall be replaced by the following: '(b) alcohol and alcoholic beverages: - distilled beverages and spirits of an alcoholic strength exceeding 22 % vol.; undenatured ethyl alcohol of 80 % vol. and over: one standard bottle (up to 1 litre), or -distilled beverages and spirits, and aperitifs with a wine or alcohol base, tafia, saké or similar beverages of an alcoholic strength of 22 % vol. or less; sparkling wines, fortified wines: one standard bottle (up to 1 litre),'. Article 3 1. Member States shall take the measures necessary to comply with this Directive as from 1 July 1986. 2. Member States shall inform the Commission of the measures they take for the application of this Directive. Article 4 This Directive is addressed to the Member States.

31985L0610

1985

Council Directive 85/610/EEC of 20 December 1985 amending for the seventh time (asbestos) Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas asbestos is recognized to be a health hazard; Whereas the use of asbestos and even products containing it can, by releasing fibres, cause asbestosis and cancer ; whereas placing on the market and use should therefore be subject to the severest possible restrictions; Whereas Directive 76/769/EEC(4) as amended by Directive 83/478/EEC(5) already lays down initial measures of that kind by prohibiting, with a few exceptions, the placing on the market and use of crocidolite and by requiring specific labelling to draw attention to the hazards inherent in the use of products containing asbestos fibres; Whereas improved monitoring of the marketing and use of dangerous asbestos fibres is necessary to protect human health, especially as there are for certain uses substitution products regarded as less dangerous; Whereas it is necessary to deal with the marketing and the use of other products containing asbestos, and whereas in this context, the Council requests the Commission to undertake and in particular to continue with its work on the development of test methods for asbestos products as rapidly as possible ; Whereas some Member States have regulations on asbestos; whereas these differ in respect of the conditions for placing on the market and use; whereas these differences form a barrier to trade and have a direct impact on the establishment and operation of the common market; Whereas to eliminate certain of these differences it is therefore necessary to supplement the Annex to Directive 76/769/EEC, as last amended by Directive 85/467/EEC(6), Article 1 In Annex I to Directive 76/769/EEC, point 5 shall become point 6, and the following point shall be added: '6.3.Asbestos fibres Chrysotile, CAS N° 12001-29-5 Amosite, CAS N° 12172-73-5 Anthophyllite, CAS N° 77536-67-5 Actinolite, CAS N° 77536-66-4 Tremolite, CAS N° 77536-68-6 6.3.1.The placing on the market and the use of products containing these fibres shall be prohibited for: (a)toys; (b)materials or preparations intended to be applied by spraying; Member States may, however, allow on their territories butiminous compounds containing asbestos intended to be applied by spraying as vehicle undersealing for anti-corrosion protection; (c)finished products which are retailed to the public in powder form; (d)items for smoking such as tobacco pipes and cigarette and cigar holders; (e)catalytic filters and insulation devices for incorporation in catalytic heaters using liquefied gas; (f)paints and varnishes.' Article 2 1. Member States shall take the measures necessary to comply with this Directive not later than 31 December 1987. They shall forthwith inform the Commission thereof. 2. Member States shall communiciate to the Commission the text 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.

31985L0611

1985

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) Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas the laws of the Member States relating to collective investment undertakings differ appreciably from one state to another, particularly as regards the obligations and controls which are imposed on those undertakings ; whereas those differences distort the conditions of competition between those undertakings and do not ensure equivalent protection for unit-holders; Whereas national laws governing collective investment undertakings should be coordinated with a view to approximating the conditions of competition between those undertakings at Community level, while at the same time ensuring more effective and more uniform protection for unit-holders; whereas such coordination will make it easier for a collective investment undertaking situated in one Member State to market its units in other Member States; Whereas the attainment of these objectives will facilitate the removal of the restrictions on the free circulation of the units of collective investment undertakings in the Community, and such coordination will help to bring about a European capital market; Whereas, having regard to these objectives, it is desirable that common basic rules be established for the authorization, supervision, structure and activities of collective investment undertakings situated in the Member States and the information they must publish ; Whereas the application of these common rules is a sufficient guarantee to permit collective investment undertakings situated in Member States, subject to the applicable provisions relating to capital movements, to market their units in other Member States without those Member States' being able to subject those undertakings or their units to any provision whatsoever other than provisions which, in those states, do not fall within the field covered by this Directive; whereas, nevertheless, if a collective investment undertaking situated in one Member State markets its units in a different Member State it must take all necessary steps to ensure that unit-holders in that other Member State can exercise their financial rights there with ease and are provided with the necessary information, Whereas the coordination of the laws of the Member States should be confined initially to collective investment undertakings other than of the closed-ended type which promote the sale of their units to the public in the Community and the sole object of which is investment in transferable securities (which are essentially transferable securities officially listed on stock exchanges or similar regulated markets); whereas regulation of the collective investment undertakings not covered by the Directive poses a variety of problems which must be dealt with by means of other provisions, and such undertakings will accordingly be the subject of coordination at a later stage ; whereas pending such coordination any Member State may, inter alia, prescribe those categories of undertakings for collective investment in transferable securities (UCITS) excluded from this Directive's scope on account of their investment and borrowing policies and lay down those specific rules to which such UCITS are subject in carrying on their business within its territory; Whereas the free marketing of the units issued by UCITS authorized to invest up to 100 % of their assets in transferable securities issued by the same body (State, local authority, etc.) may not have the direct or indirect effect of disturbing the functioning of the capital market or the financing of the Member States or of creating economic situations similar to those which Article 68 (3) of the Treaty seeks to prevent; Whereas account should be taken of the special situations of the Hellenic Republic's and Portuguese Republic's financial markets by allowing those countries and additional period in which to implement this Directive, Section I General provisions and scope Article 1 1. The Member States shall apply this Directive to undertakings for collective investment in transferable securities (hereinafter referred to as UCITS) situated within their territories. 2. For the purposes of this Directive, and subject to Article 2, UCITS shall be undertakings: -the sole object of which is the collective investment in transferable securities of capital raised from the public and which operate on the principle of risk-spreading, and -the units of which are, at the request of holders, re-purchased or redeemed, directly or indirectly, out of those undertakings' assets. Action taken by a UCITS to ensure that the stock exchange value of its units does not significantly vary from their net asset value shall be regarded as equivalent to such re-purchase or redemption. 3. Such undertakings may be constituted according to law, either under the law of contract (as common funds managed by management companies) or trust law (as unit trusts) or under statute (as investment companies). For the purposes of this Directive 'common funds' shall also include unit trusts. 4. Investment companies the assets of which are invested through the intermediary of subsidiary companies mainly otherwise than in transferable securities shall not, however, be subject to this Directive. 5. The Member States shall prohibit UCITS which are subject to this Directive from transforming themselves into collective investment undertakings which are not covered by this Directive. 6. Subject to the provisions governing capital movements and to Articles 44, 45 and 52 (2) no Member State may apply any other provisions whatsoever in the field covered by this Directive to UCITS situated in another Member State or to the units issued by such UCITS, where they market their units within its territory. 7. Without prejudice to paragraph 6, a Member State may apply to UCITS situated within its territory requirements which are stricter than or additional to those laid down in Article 4 et seq. of this Directive, provided that they are of general application and do not conflict with the provisions of this Directive. Article 2 1. The following shall not be UCITS subject to this Directive: -UCITS of the closed-ended type; -UCITS which raise capital without promoting the sale of their units to the public within the Community or any part of it; -UCITS the units of which, under the fund rules or the investment company's instruments of incorporation, may be sold only to the public in non-member countries; -categories of UCITS prescribed by the regulations of the Member States in which such UCITS are situated, for which the rules laid down in Section V and Article 36 are inappropriate in view of their investment and borrowing policies. 2. Five years after the implementation of this Directive the Commission shall submit to the Council a report on the implementation of paragraph 1 and, in particular, of its fourth indent. If necessary, it shall propose suitable measures to extend the scope. Article 3 For the purposes of this Directive, a UCITS shall be deemed to be situated in the Member State in which the investment company or the management company of the unit trust has its registered office ; the Member States must require that the head office be situated in the same Member State as the registered office. SECTION II Authorization of UCITS Article 4 1. N° UCITS shall carry on activities as such unless it has been authorized by the competent authorities of the Member State in which it is situated, hereinafter referred to as 'the competent authorities'. Such authorization shall be valid for all Member States. 2. A unit trust shall be authorized only if the competent authorities have approved the management company, the fund rules and the choice of depositary. An investement company shall be authorized only if the competent authorities have approved both its instruments of incorporation and the choice of depositary. 3. The competent authorities may not authorize a UCITS if the directors of the management company, of the investment company or of the depositary are not of sufficiently good repute or lack the experience required for the performance of their duties. To that end, the names of the directors of the management company, of the investment company and of the depositary and of every person succeeding them in office must be communicated forthwith to the competent authorities. 'Directors' shall mean those persons who, under the law or the instruments of incorporation, represent the management company, the investment company or the depositary, or who effectively determine the policy of the management company, the investment company or the depositary. 4. Neither the management company nor the depositary may be replaced, nor may the fund rules or the investment company's instruments of incorporation be amended, without the approval of the competent authorities. SECTION III Obligations regarding the structure of unit trusts Article 5 A management company must have sufficient financial resources at its disposal to enable it to conduct its business effectively and meet its liabilities. Article 6 N° management company may engage in activities other than the management of unit trusts and of investment companies. Article 7 1. A unit trust's assets must be entrusted to a depositary for safe-keeping. 2. A depositary's liability as referred to in Article 9 shall not be affected by the fact that it has entrusted to a third party all or some of the assets in its safe-keeping. 3. A depositary must, moreover: (a)ensure that the sale, issue, re-purchase, redemption and cancellation of units effected on behalf of a unit trust or by a management company are carried out in accordance with the law and the fund rules; (b)ensure that the value of units is calculated in accordance with the law and the fund rules; (c)carry out the instructions of the management company, unless they conflict with the law or the fund rules; (d)ensure that in transactions involving a unit trust's assets any consideration is remitted to it within the usual time limits; (e)ensure that a unit trust's income is applied in accordance with the law and the fund rules. Article 8 1. A depositary must either have its registered office in the same Member State as that of the management company or be established in that Member State if its registered office is in another Member State. 2. A depositary must be an institution which is subject to public control. It must also furnish sufficient financial and professional guarantees to be able effectively to pursue its business as depositary and meet the commitments inherent in that function. 3. The Member States shall determine which of the categories of institutions referred to in paragraph 2 shall be eligible to be depositaries. Article 9 A depositary shall, in accordance with the national law of the State in which the management company's registered office is situated, be liable to the management company and the unit-holders for any loss suffered by them as a result of its unjustifiable failure to perform its obligations or its improper performance of them. Liability to unit-holders may be invoked either directly or indirectly through the management company, depending on the legal nature of the relationship between the depositary, the management company and the unit-holders. Article 10 1. N° single company shall act as both management company and depositary. 2. In the context of their respective roles the management company and the depositary must act independently and solely in the interest of the unit-holders. Article 11 The law or the fund rules shall lay down the conditions for the replacement of the management company and the depositary and rules to ensure the protection of unit-holders in the event of such replacement. SECTION IV Obligations regarding the structure of investment companies and their depositaries Article 12 The Member States shall determine the legal form which an investment company must take. It must have sufficient paid-up capital to enable it to conduct its business effectively and meet its liabilities. Article 13 N° investment company may engage in activities other than those referred to in Article 1 (2). Article 14 1. An investment company's assets must be entrusted to a depositary for safe-keeping. 2. A depositary's liability as referred to in Article 16 shall not be affected by the fact that it has entrusted to a third party all or some of the assets in its safe-keeping. 3. A depositary must, moreover: (a)ensure that the sale, issue, re-purchase, redemption and cancellation of untis effected by or on behalf of a company are carried out in accordance with the law and with the company's instruments of incorporation; (b)ensure that in transactions involving a company's assets any consideration is remitted to it within the usual time limits; (c)ensure that a company's income is applied in accordance with the law and its instruments of incorporation. 4. A Member State may decide that investment companies situated within its territory which market their units exclusively through one or more stock exchanges on which their units are admitted to official listing shall not be required to have depositaries within the meaning of this Directive. Articles 34, 37 and 38 shall not apply to such companies. However, the rules for the valuation of such companies' assets must be stated in law or in their instruments of incorporation. 5. A Member State may decide that investment companies situated within its territory which market at least 80 % of their-units through one or more stock exchanges designated in their instruments of incorporation shall not be required to have depositaries within the meaning of this Directive provided that their units are admitted to official listing on the stock exchanges of those Member States within the territories of which the units are marketed, and that any transactions which such a company may effect outwith stock exchanges are effected at stock exchange prices only. A company's instruments of incorporation must specify the stock exchange in the country of marketing the prices on which shall determine the prices at which that company will effect any transactions outwith stock exchanges in that country. A Member State shall avail itself of the option provided for in the preceding subparagraph only if it considers that unitholders have protection equivalent to that of unit-holders in UCITS which have depositaries within the meaning of this Directive. In particular, such companies and the companies referred to in paragraph 4, must: (a)in the absence of provision in law, state in their instruments of incorporation the methods of calculation of the net asset values of their units; (b)intervene on the market to prevent the stock exchange values of their units from deviating by more than 5 % from their net asset values; (c)establish the net asset values of their units, communicate them to the competent authorities at least twice a week and publish them twice a month. At least twice a month, an independent auditor must ensure that the calculation of the value of units is effected in accordance with the law and the company's instruments of incorporation. On such occasions, the auditor must make sure that the company's assets are invested in accordance with the rules laid down by law and the company's instruments of incorporation. 6. The Member States shall inform the Commission of the identities of the companies benefiting from the derogations provided for in paragraphs 4 and 5. The Commission shall report to the Contact Committee on the application of paragraphs 4 and 5 within five years of the implementation of this Directive. After obtaining the Contact Committee's opinion, the Commission shall, if need be, propose appropriate measures. Article 15 1. A depositary must either have its registered office in the same Member State as that of the investment company or be established in that Member State if its registered office is in another Member State. 2. A depositary must be an institution which is subject to public control. It must also furnish sufficient financial and professional guarantees to be able effectively to pursue its business as depositary and meet the commitments inherent in that function. 3. The Member States shall determine which of the categories of institutions referred to in paragraph 2 shall be eligible to be depositaries. Article 16 A depositary shall, in accordance with the national law of the State in which the investment company's registered office is situated, be liable to the investment company and the unit-holders for any loss suffered by them as a result of its unjustifiable failure to perform its obligations, or its improper performance of them. Article 17 1. N° single company shall act as both investment company and depositary. 2. In carrying out its role as depositary, the depositary must act solely in the interests of the unit-holders. Article 18 The law or the investment company's instruments of incorporation shall lay down the conditions for the replacement of the depositary and rules to ensure the protection of unit-holders in the event of such replacement. SECTION V Obligations concerning the investment policies of UCITS Article 19 1. The investments of a unit trust or of an investment company must consist solely of: (a)transferable securities admitted to official listing on a stock exchange in a Member State and/or; (b)transferable securities dealt in on another regulated market in a Member State which operates regularly and is recognized and open to the public and/or; (c)transferable securities admitted to official listing on a stock exchange in a non-member State or dealt in on another regulated market in a non-member State which operates regularly and is recognized and open to the public provided that the choice of stock exchange or market has been approved by the competent authorities or is provided for in law or the fund rules or the investment company's instruments of incorporation and/or; (d)recently issued transferable securities, provided that: -the terms of issue include an undertaking that application will be made for admission to official listing on a stock exchange or to another regulated market which operates regularly and is recognized and open to the public, provided that the choice of stock exchange or market has been approved by the competent authorities or is provided for in law or the fund rules or the investment company's instruments of incorporation; -such admission is secured within a year of issue. 2. However: (a)a UCITS may invest no more than 10 % of its assets in transferable securities other than those referred to in paragraph 1; (b)a Member State may provide that a UCITS may invest no more than 10 % of its assets in debt instruments which, for purposes of this Directive, shall be treated, because of their characteristics, as equivalent to transferable securities and which are, inter alia, transferable, liquid and have a value which can be accurately determined at any time or at least with the frequency stipulated in Article 34; (c)an investment company may acquire movable and immovable property which is essential for the direct pursuit of its business; (d)a UCITS may not acquire either precious metals or certificates representing them. 3. The total of the investments referred to in paragraph 2 (a) and (b) may not under any circumstances amount to more than 10 % of the assets of a UCITS. 4. Unit trusts and investment companies may hold ancillary liquid assets. Article 20 1. The Member States shall send to the Commission : (a)no later than date of implementation of this Directive, lists of the debt instruments which, in accordance with Article 19 (2) (b), they plan to treat as equivalent to transferable securities, stating the characteristics of those instruments and the reasons for so doing; (b)details of any amendments which they contemplate making to the lists of instruments referred to in (a) or any further instruments which they contemplate treating as equivalent to transferable securities, together with their reasons for so doing. 2. The Commission shall immediately forward that information to the other Member States together with any comments which it considers appropriate. Such communications may be the subject of exchanges of views within the Contact Committee in accordance with the procedure laid down in Article 53 (4). Article 21 1. The Member States may authorize UCITS to employ techniques and instruments relating to transferable securities under the conditions and within the limits which they lay down provided that such techniques and instruments are used for the purpose of efficient portfolio management. 2. The Member States may also authorize UCITS to employ techniques and instruments intended to provide protection against exchange risks in the context of the management of their assets and liabilities. Article 22 1. A UCITS may invest no more than 5 % of its assets in transferable securities issued by the same body. 2. The Member States may raise the limit laid down in paragraph 1 to a maximum of 10 %. However, the total value of the transferable securities held by a UCITS in the issuing bodies in each of which it invests more than 5 % of its assets must not then exceed 40 % of the value of its assets. 3. The Member States may raise the limit laid down in paragraph 1 to a maximum of 35 % if the transferable securities are issued or guaranteed by a Member State, by its local authorities, by a non-member State or by public international bodies of which one or more Member States are members. Article 23 1. By way of derogation from Article 22 and without prejudice to Article 68 (3) of the Treaty, the Member States may authorize UCITS to invest in accordance with the principle of risk-spreading up to 100 % of their assets in different transferable securities issued or guaranteed by any Member State, its local authorities, a non-member State or public international bodies of which one or more Member States are members. The competent authorities shall grant such a derogation only if they consider that unit-holders in the UCITS have protection equivalent to that of unit-holders in UCITS complying with the limits laid down in Article 22. Such a UCITS must hold securities from at least six different issues, but securities from any one issue may not account for more than 30 % of its total assets. 2. The UCITS referred to in paragraph 1 must make express mention in the fund rules or in the investment company's instruments of incorporation of the States, local authorities or public international bodies issuing or guaranteeing securities in which they intend to invest more than 35 % of their assets; such fund rules or instruments of incorporation must be approved by the competent authorities. 3. In addition each such UCITS referred to in paragraph 1 must include a prominent statement in its prospectus and any promotional literature drawing attention to such authorization and indicating the States, local authorities and/or public international bodies in the securities of which it intends to invest or has invested more than 35 % of its assets. Article 24 1. A UCITS may not acquire the units of other collective investment undertakings of the open-ended type unless they are collective investment undertakings within the meaning of the first and second indents of Article 1 (2). 2. A UCITS may invest no more than 5 % of its assets in the units of such collective investment undertakings. 3. Investment in the units of a unit trust managed by the same management company or by any other company with which the management company is linked by common management or control, or by a substantial direct or indirect holding, shall be permitted only in the case of a trust which, in accordance with its rules, has specialized in investment in a specific geographical area or economic sector, and provided that such investment is authorized by the competent authorities. Authorization shall be granted only if the trust has announced its intention of making use of that option and that option has been expressly stated in its rules. A management company may not charge any fees or costs on account of transactions relating to a unit trust's units where some of a unit trust's assets are invested in the units of another unit trust managed by the same management company or by any other company with which the management company is linked by common management or control, or by a substantial direct or indirect holding. 4. Paragraph 3 shall also apply where an investment company acquires units in another investment company to which it is linked within the meaning of paragraph 3. Paragraph 3 shall also apply where an investment company acquires units of a unit trust to which it is linked, or where a unit trust acquires units of an investment company to which it is linked. Article 25 1. An investment company or a management company acting in connection with all of the unit trusts which it manages and which fall within the scope of this Directive may not acquire any shares carrying voting rights which would enable it to exercise significant influence over the management of an issuing body. Pending further coordination, the Member States shall take account of existing rules defining the principle stated in the first subparagraph under other Member States' legislation. 2. Moreover, an investment company or unit trust may acquire no more than: -10 % of the non-voting shares of any single issuing body; -10 % of the debt securities of any single issuing body; -10 % of the units of any single collective investment undertaking within the meaning of the first and second indents of Article 1 (2). The limits laid down in the second and third indents may be disregarded at the time of acquisition if at that time the gross amount of the debt securities or the net amount of the securities in issue cannot be calculated. 3. A Member State may waive application of paragraphs 1 and 2 as regards: (a)transferable securities issued or guaranteed by a Member State or its local authorities; (b)transferable securities issued or guaranteed by a non-member State; (c)transferable securities issued by public international bodies of which one or more Member States are members; (d)shares held by a UCITS in the capital of a company incorporated in a non-member State investing its assets mainly in the securities of issuing bodies having their registered offices in that State, where under the legislation of that State such a holding represents the only way in which the UCITS can invest in the securities of issuing bodies of that State. This derogation, however, shall apply only if in its investment policy the company from the non-member State complies with the limits laid down in Articles 22, 24 and 25 (1) and (2). Where the limits set in Articles 22 and 24 are exceeded. Article 26 shall apply mutatis mutandis; (e)shares held by an investment company in the capital of subsidiary companies carrying on the business of management, advice or marketing exclusively on its behalf. Article 26 1. UCITS need not comply with the limits laid down in this Section when exercising subscription rights attaching to transferable securities which form part of their assets. While ensuring observance of the principle of risk-spreading, the Member States may allow recently authorized UCITS to derogate from Articles 22 and 23 for six months following the date of their authorization. 2. If the limits referred to in paragraph 1 are exceeded for reasons beyond the control of a UCITS or as a result of the exercise of subscription rights, that UCITS must adopt as a priority objective for its sales transactions the remedying of that situation, taking due account of the interests of its unit-holders. SECTION VI Obligations concerning information to be supplied to unit- holders A.Publication of a prospectus and periodical reports Article 27 1. An investment company and, for each of the trusts it manages, a management company must publish: -a prospectus, -an annual report for each financial year, and -a half-yearly report covering the first six months of the financial year. 2. The annual and half-yearly reports must be published within the following time limits, with effect from the ends of the periods to which they relate: -four months in the case of the annual report, -two months in the case of the half-yearly report. Article 28 1. A prospectus must include the information necessary for investors to be able to make an informed judgement of the investment proposed to them. It shall contain at least the information provided for in Schedule A annexed to this Directive, insofar as that information does not already appear in the documents annexed to the prospectus in accordance with Article 29 (1). 2. The annual report must include a balance-sheet or a statement of assets and liabilities, a detailed income and expenditure account for the financial year, a report on the activities of the financial year and the other information provided for in Schedule B annexed to this Directive, as well as any significant information which will enable investors to make an informed judgement on the development of the activities of the UCITS and its results. 3. The half-yearly report must include at least the information provided for in Chapters I to IV of Schedule B annexed to this Directive; where a UCITS has paid or proposes to pay an interim dividend, the figures must indicate the results after tax for the half-year concerned and the interim dividend paid or proposed. Article 29 1. The fund rules or an investment company's instruments of incorporation shall form an integral part of the prospectus and must be annexed thereto. 2. The documents referred to in paragraph 1 need not, however, be annexed to the prospectus provided that the unit-holder is informed that on request he or she will be sent those documents or be apprised of the place where, in each Member State in which the units are placed on the market, he or she may consult them. Article 30 The essential elements of the prospectus must be kept up to date. Article 31 The accounting information given in the annual report must be audited by one or more persons empowered by law to audit accounts in accordance with Council Directive 84/253/EEC of 10 April 1984 based on Article 54 (3) (g) of the EEC Treaty on the approval of persons responsible for carrying out the statutory audits of accounting documents(1). The auditor's report, including any qualifications, shall be reproduced in full in the annual report. Article 32 A UCITS must send its prospectus and any amendments thereto, as well as its annual and half-yearly reports, to the competent authorities. Article 33 1. The prospectus, the latest annual report and any subsequent half-yearly report published must be offered to subscribers free of charge before the conclusion of a contract. 2. In addition, the annual and half-yearly reports must be available to the public at the places specified in the prospectus. 3. The annual and half-yearly reports shall be supplied to unit-holders free of charge on request. B.Publication of other information Article 34 A UCITS must make public in an appropriate manner the issue, sale, re-purchase or redemption price of its units each time it issues, sells, re-purchases or redeems them, and at least twice a month. The competent authorities may, however, permit a UCITS to reduce the frequency to once a month on condition that such a derogation does not prejudice the interests of the unit-holders. Article 35 All publicity comprising an invitation to purchase the units of a UCITS must indicate that a prospectus exists and the places where it may be obtained by the public. SECTION VII The general obligations of UCITS Article 36 1. Neither: -an investment company, nor -a management company or depositary acting on behalf of a unit trust, may borrow. However, a UCTIS may acquire foreign currency by means of a 'back-to-back' loan. 2. By way of derogation from paragraph 1, a Member State may authorize a UCITS to borrow: (a)up to 10 % -of its assets, in the case of an investment company, or -of the value of the fund, in the case of a unit trust, provided that the borrowing is on a temporary basis; (b)up to 10 % of its assets, in the case of an investment company, provided that the borrowing is to make possible the acquisition of immovable property essential for the direct pursuit of its business; in this case the borrowing and that referred to in subparagraph (a) may not in any case in total exceed 15 % of the borrower's assets. Article 37 1. A UCITS must re-purchase or redeem its units at the request of any unit-holder. 2. By way of derogation from paragraph 1: (a)a UCITS may, in the cases and according to the procedures provided for by law, the fund rules or the investment company's instruments of incorporation, temporarily suspend the re-purchase or redemption of its units. Suspension may be provided for only in exceptional cases where circumstances so require, and suspension is justified having regard to the interests of the unit-holders; (b)the Member States may allow the competent authorities to require the suspension of the re-purchase or redemption of units in the interest of the unit-holders or of the public. 3. In the cases mentioned in paragraph 2 (a), a UCITS must without delay communicate its decision to the competent authorities and to the authorities of all Member States in which it markets its units. Article 38 The rules for the valuation of assets and the rules for calculating the sale or issue price and the re-purchase or redemption price of the units of a UCITS must be laid down in the law, in the fund rules or in the investment company's instruments of incorporation. Article 39 The distribution or reinvestment of the income of a unit trust or of an investment company shall be effected in accordance with the law and with the fund rules or the investment company's instruments of incorporation. Article 40 A UCITS unit may not be issued unless the equivalent of the net issue price is paid into the assets of the UCITS within the usual time limits. This provision shall not preclude the distribution of bonus units. Article 41 1. Without prejudice to the application of Articles 19 and 21, neither: -an investment company, nor -a management company or depositary acting on behalf of a unit trust may grant loans or act as a guarantor on behalf of third parties. 2. Paragraph 1 shall not prevent such undertakings from acquiring transferable securities which are not fully paid. Article 42 Neither: -an investment company, nor -a management company or depository acting on behalf of a unit trust may carry out uncovered sales of transferable securities. Article 43 The law or the fund rules must prescribe the remuneration and the expenditure which a management company is empowered to charge to a unit trust and the method of calculation of such remuneration. The law or an investment company's instruments of incorporation must prescribe the nature of the cost to be borne by the company. SECTION VIII Special provisions applicable to UCITS which market their units in Member States other than those in which they are situated Article 44 1. A UCITS which markets its units in another Member State must comply with the laws, regulations and administrative provisions in force in that State which do not fall within the field governed by this Directive. 2. Any UCITS may advertise its units in the Member State in which they are marketed. it must comply the provisions governing advertising in that State. 3. The provisions referred to in paragraphs 1 and 2 must be applied without discrimination. Article 45 In the case referred to in Article 44, the UCITS must, inter alia, in accordance with the laws, regulations and administrative provisions in force in the Member State of marketing, take the measures necessary to ensure that facilities are available in that State for making payments to unit-holders, re-purchasing or redeeming units and making available the information which UCITS are obliged to provide. Article 46 If a UCITS proposes to market its units in a Member State other than that in which it is situated, it must first inform the competent authorities and the authorities of that other Member State accordingly. It must simultaneously send the latter authorities: -an attestation by the competent authorities to the effect that it fulfils the conditions imposed by this Directive, -its fund rules or its instruments of incorporation, -its prospectus, -where appropriate, its latest annual report and any subsequent half-yearly report and -details of the arrangements made for the marketing of its units in that other Member State. A UCITS may begin to market its units in that other Member State two months after such communication unless the authorities of the Member State concerned establish, in a reasoned decision taken before the expiry of that period of two months, that the arrangements made for the marketing of units do not comply with the provisions referred to in Articles 44 (1) and 45. Article 47 If a UCITS markets its units in a Member State other than that in which it is situated, it must distribute in that other Member State, in at least one of that other Member State's official languages, the documents and information which must be published in the Member State in which it is situated, in accordance with the same procedures as those provided for in the latter State. Article 48 For the purpose of carrying on its activities, a UCITS may use the same generic name (such as investment company or unit trust) in the Community as it uses in the Member State in which it is situated. In the event of any danger of confusion, the host Member State may, for the purpose of clarification, require that the name be accompanied by certain explanatory particulars. SECTION IX Provisions concerning the authorities responsible for authorization and supervision Article 49 1. The Member States shall designate the authorities which are to carry out the duties provided for in this Directive. They shall inform the Commission thereof, indicating any division of duties. 2. The authorities referred to in paragraph 1 must be public authorities or bodies appointed by public authorities. 3. The authorities of the State in which a UCITS is situated shall be competent to supervise that UCITS. However, the authorities of the State in which a UCITS markets its units in accordance with Article 44 shall be competent to supervise compliance with Section VIII. 4. The authorities concerned must be granted all the powers necessary to carry out their task. Article 50 1. The authorities of the Member States referred to in Article 49 shall collaborate closely in order to carry out their task and must for that purpose alone communicate to each other all information required. 2. The Member States shall provide that all persons employed or formerly employed by the authorities referred to in Article 49 shall be bound by professional secrecy. This means that any confidential information received in the course of their duties may not be divulged to any person or authority except by virtue of provisions laid down by law. 3. Paragraph 2 shall not, however, preclude communications between the authorities of the various Member States referred to in Article 49, as provided for in this Directive. Information thus exchanged shall be covered by the obligation of professional secrecy on persons employed or formerly employed by the authorities receiving the information. 4. Without prejudice to cases covered by criminal law, an authority of the type referred to in Article 49 receiving such information may use it only for the performance of its duties or in the context of administrative appeals or legal proceedings relating to such performance. Article 51 1. The authorities referred to in Article 49 must give reasons for any decision to refuse authorization, and any negative decision taken in implementation of the general measures adopted in application of this Directive, and communicate them to applicants. 2. The Member States shall provide that decisions taken in respect of a UCITS pursuant to laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts; the same shall apply if no decision is taken within six months of its submission on an authorization application made by a UCITS which includes all the information required under the provisions in force. Article 52 1. Only the authorities of the Member State in which a UCITS is situated shall have the power to take action against it if it infringes any law, regulation or administrative provision or any regulation laid down in the fund rules or in the investment company's instruments of incorporation. 2. Nevertheless, the authorities of the Member State in which the units of a UCITS are marketed may take action against it if it infringes the provisions referred to in Section VIII. 3. Any decision to withdraw authorization, or any other serious measure taken against a UCITS, or any suspension of re-purchase or redemption imposed upon it, must be communicated without delay by the authorities of the Member State in which the UCITS in question is situated to the authorities of the other Member States in which its units are marketed. SECTION X Contact Committee Article 53 1. A Contact Committee, hereinafter referred to as 'the Committee', shall be set up alongside the Commission. Its function shall be: (a)to facilitate, without prejudice to Articles 169 and 170 of the Treaty, the harmonized implementation of this Directive through regular consultations on any practical problems arising from its application and on which exchanges of views are deemed useful; (b)to facilitate consultation between Member States either on more rigorous or additional requirements which they may adopt in accordance with Article 1 (7), or on the provisions which they may adopt in accordance with Articles 44 and 45; (c)to advise the Commission, if necessary, on additions or amendments to be made to this Directive. 2. It shall not be the function of the Committee to appraise the merits of decisions taken in individual cases by the authorities referred to in Article 49. 3. The Committee shall be composed of persons appointed by the Member States and of representatives of the Commission. The Chairman shall be a representative of the Commission. Secretarial services shall be provided by the Commission. 4. Meetings of the Committee shall be convened by its chairman, either on his own initiative or at the request of a Member State delegation. The Committee shall draw up its rules of procedure. SECTION XI Transitional provisions, derogations and final provisions Article 54 Solely for the purpose of Danish UCITS, pantebreve issued in Denmark shall be treated as equivalent to the transferable securities referred to in Article 19 (1) (b). Article 55 By way of derogation from Articles 7 (1) and 14 (1), the competent authorities may authorize those UCITS which, on the date of adoption of this Directive, had two or more depositaries in accordance with their national law to maintain that number of depositaries if those authorities have guarantees that the functions to be performed under Articles 7 (3) and 14 (3) will be performed in practice. Article 56 1. By way of derogation from Article 6, the Member States may authorize management companies to issue bearer certificates representing the registered securities of other companies. 2. The Member States may authorize those management companies which, on the date of adoption of this Directive, also carry on activities other than those provided for in Article 6 to continue those other activities for five years after that date. Article 57 1. The Member States shall bring into force no later than 1 October 1989 the measures necessary for them to comply with this Directive. They shall forthwith inform the Commission thereof. 2. The Member States may grant UCITS existing on the date of implementation of this Directive a period of not more than 12 months from that date in order to comply with the new national legislation. 3. The Hellenic Republic and the Portuguese Republic shall be authorized to postpone the implementation of this Directive until 1 April 1992 at the latest. One year before that date the Commission shall report to the Council on progress in implementing the Directive and on any difficulties which the Hellenic Republic or the Portuguese Republic may encounter in implementing the Directive by the date referred to in the first subparagraph. The Commission shall, if necessary, propose that the Council extend the postponement by up to four years. Article 58 The Member States shall ensure that the Commission is informed of the texts of the main laws, regulations and administrative provisons which they adopt in the field covered by this Directive. Article 59 This Directive is addressed to the Member States.

31986L0017

1986

Council Directive 86/17/EEC of 27 January 1986 amending, on account of the accession of Portugal, Directive 85/384/EEC on the mutual recognition of diplomas, certificates and other evidence of formal qualifications in architecture, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services Having regard to the Act of Accession of Spain and Portugal, and in particular Article 396 thereof, Whereas in view of the accession of Portugal, it is necessary to make certain further technical amendments to Directive 85/384/EEC (1) as amended by Directive 85/614/EEC (2) to ensure its equal application by the Portuguese Republic and the other Member States; Whereas pursuant to Article 2 (3) of the Treaty of Accession of Spain and Portugal the institutions of the Community may adopt the measures referred to in Article 396 of the Act of Accession, the measures entering into force on the date of entry into force of the said Treaty, Article 1 With effect from 1 January 1986, Article 11 (k) of Directive 85/384/EEC, shall be supplemented by the following: '- the university diploma in civil engineering awarded by the Higher Technical Institute of the Technical University of Lisbon (Licenciatura em engenharia civil), - the university diploma in civil engineering awarded by the Faculty of Science and Technology of the University of Porto (Licenciatura em engenharia civil), - the university diploma in civil engineering awarded by the Faculty of Science and Technology of the University of Coimbra (Licenciatura em engenharia civil), - the university diploma in civil engineering (production) awarded by the University of Minho (Licenciatura em engenharia civil (produção)).' Article 2 The Member States shall take the measures necessary to comply with this Directive within the time limit specified in Article 31 (1) of Directive 85/384/EEC. Article 3 This Directive is addressed to the Member States.

31986L0109

1986

Commission Directive 86/109/EEC of 27 February 1986 limiting the marketing of seed of certain species of fodder plants and oil and fibre plants to seed which has been officially certified as 'basic seed' or 'certified seed' Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Commission Directive 85/38/EEC (2), and in particular Article 3 (3) thereof, Having regard to Council Directive 69/208/EEC of 30 June 1969 on marketing the seed of oil and fibre plants (3), as last amended by Commission Directive 82/859/EEC (4), and in particular Article 3 (3) thereof, Whereas Directive 66/401/EEC allows the marketing of basic seed, certified seed and commercial seed of certain species of fodder plants; Whereas Directive 69/208/EEC allows the marketing of basic seed, certified seed of all kinds and commercial seed of certain species of oil and fibre plants; Whereas Article 3 (3) of each of the aforementioned Directives authorizes the Commission to prohibit the marketing of seed unless it has been officially certified as 'basic seed' or 'certified seed'; Whereas it has been established, on the basic of the information available at present, that Member States will be in a position to produce sufficient basic seed and certified seed to satisfy within the Community the demand for seed of some of the species referred to above with seed of those categories as from 1 July 1987 in the case of certain species, 1 July 1989 in the case of certain other species and 1 July 1991 in the case of certain further species; 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. Member States shall provide that from 1 July 1987 it shall not be permitted to place on the market seed of: 1.2 // - Vicia faba L. (partim) // - Field bean // - Papaver somniferum L. // - Opium poppy unless it has been officially certified as 'basic seed' or 'certified seed'. 2. Member States shall provide that from 1 July 1987 it shall not be permitted to place on the market seed of: 1.2 // - Glycine max (L.) Merr. // - Soya bean // - Linum usitatissimum L. // - Linseed Article 2 Member States shall provide that from 1 July 1989 it shall not be permitted to place on the market seed of: 1.2 // - Agrostis canina L. // - Velvet bent // - Agrostis gigantea Roth // - Redtop // - Agrostis stolonifera L. // - Creeping bent grass // - Agrostis tenuis Sibth. // - Brown top // - Alopecurus pratensis L. 357, 18. 12. 1982, p. 31. // - Arrhenatherum elatius (L.) Beauv. ex J. et K. Presl. // - Tall oatgrass // - Phleum bertolinii DC // - Timothy // - Poa nemoralis L. // - Wood meadowgrass // - Poa palustris L. // - Swamp meadowgrass // - Poa trivilialis L. // - Rough-stalked meadowgrass // - Trisetum flavescens (L.) Beauv. // - Golden oatgrass // - Lotus corniculatus L. // - Birdsfoot trefoil // - Lupinus albus L. // - White lupin // - Lupinus angustifolius L. // - Blue lupin // - Lupinus luteus L. // - Yellow lupin // - Medicago lupulina L. // - Black medick // - Trifolium hybridum L. // - Alsike clover // - Brassica juncea L. Czern. et Coss. in Czern. // - Brown mustard unless it has been officially certified as 'basic seed' or 'certified seed'. Article 3 Member States shall provide that from 1 July 1991 it shall not be permitted to place on the market seed of: 1.2 // - Festuca ovina L. // - Sheep's fescue // - Trifolium incarnatum L. // - Crimson clover // - Trifolium resupinatum L. // - Persian clover // - Vicia sativa L. // - Common vetch // - Vicia villosa Roth. // - Hairy vetch // - Sinapis alba L. // - White mustard unless it has been officially certified as 'basic seed' or 'certified seed'. Article 4 Member States shall bring into force: - not later than 1 July 1987 the laws, regulations or administrative provisions necessary to comply with Article 1, - not later than 1 July 1989 the laws, regulations or administrative provisions necessary to comply with Article 2, and - not later than 1 July 1991 the laws, regulations or administrative provisions necessary to comply with Article 3. They shall forthwith inform the Commission thereof. Article 4 This Directive is addressed to the Member States.

31986L0179

1986

Seventh Commission Directive 86/179/EEC of 28 February 1986 adapting to technical progress Annexes II, III, IV and V to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Having regard to the Treaty establishing the European Economic Community , Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1) , as last amended by Directive 85/391/EEC (2) , and in particular Articles 5 and 8 ( 2 ) thereof , Whereas , in order to protect public health , it is necessary to prohibit chloroform , 2,3,7,8-tetrachlorodibenzo-p-dioxin , 2,6-dimethyl-1,3-dioxan-4-yl acetate ( Dimethoxane ) and pyrithione sodium ( INNM ) in cosmetic products ; Whereas on the basis of the latest findings of scientific and technical research the use of 1,3-bis(hydroxymethyl)imidazolidine-2-thione may be authorized for nail care under certain conditions ; Whereas , on the basis of the available information , certain provisionally permitted colouring agents and substances may be definitively permitted , while others must be definitively prohibited or be permitted for a further specified period ; Whereas the measures laid down 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 numbers are added : " 366 . Chloroform 367 . 2,3,7,8-Tetrachlorodibenzo-p-dioxin except as an impurity of hexachlorophene , subject to the conditions laid down in Annex VI - Part 1 , under No 6 368 . 2,6-Dimethyl-1,3-dioxan-4-yl acetate ( Dimethoxane ) 369 . Pyrithione sodium ( INNM ) " . 2 . Annex III , Part 1 is amended as follows : " a * b * c * d * e * f * 44 * 1,3-Bis (hydroxymethyl)imidazolidine-2-thione * ( a ) Hair-care preparations * ( a ) Up to 2 % * ( a ) Prohibited in aerosol dispensers ( sprays ) * Contains 1,3-bis(hydroxymethyl)imidazolidine-2-thione * * * ( b ) Nail-care preparations * ( b ) Up to 2 % * ( b ) The pH of the product as applied must be less than 4 * * 51 * Quinolin-8-ol and bis ( 8-hydroxyquinolinium ) sulphate * Stabilizer for hydrogen peroxide in rinse-off hair-care preparations * 0,3 % calculated as base " * * * 3 . Annex III , Part 2 , Annex IV , Parts 2 and 3 , are replaced by Annexes 1 and 2 to this Directive . 4 . Annex V is amended as follows : - No 10 - Chloroform is deleted , - In Nos 5 and 6 , the footnote reference (5) is replaced by (3) . Article 2 1 . Member States shall take the necessary measures to ensure that from 1 January 1988 neither manufactures nor importers established in the Community place on the market products which do not satisfy the requirements of this Directive . 2 . Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 can no longer be sold or disposed of to the final consumer after 31 December 1989 . Article 3 1 . Member States shall bring into force the laws , regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 31 December 1986 . They shall forthwith inform the Commission thereof . 2 . Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive . Article 4 This Directive is addressed to the Member States .

31986L0102

1986

Council Directive 86/102/EEC of 24 March 1986 amending for the fourth time Directive 74/329/EEC on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 74/329/EEC (4), as last amended by Directive 85/6/EEC (5), lays down a list of emulsifiers, stabilizers, thickeners and gelling agents which may be authorized for use in foodstuffs; Whereas Annex II to Directive 74/329/EEC indicates the designations of the substances which may be temporarily authorized by Member States for use in foodstuffs, and whereas the validity of each authorization is limited to 30 September 1985; Whereas the period of temporary authorization for the polysorbates must be prolonged so that these substances may be re-evaluated in the light of any new information not previously assessed; Whereas the use of Tragacanth gum (E 413) should be re-evaluated after an enquiry by the Commission; Whereas, for Karaya gum and thermally oxidized soya bean oil interacted with mono- and di-glycerides of fatty acids, a further period of temporary authorization must be provided to permit the completion of certain toxicological and technological investigations so that a decision can be taken on the possibility of inclusion of these substances in Annex I to Directive 74/329/EEC or their deletion from the said Directive; Whereas in the light of the recent toxicological investigations, pectin and amidated pectin can be considered as equivalent; Whereas polyoxyethylene (8) stearate, polyoxyethylene (40) stearate, lactylated fatty acid esters of glycerol and propylene glycol, and dioctyl sodium sulphosuccinate must no longer be used in foodstuffs after a temporary period to allow the sale of foodstuffs containing these substances which are already on the market, Article 1 Directive 74/329/EEC is hereby amended as follows: 1. Paragraph 2 of Article 2 shall be replaced by the following: '2. However, as regards Tragacanth gum referred to in Annex I under E 413, the Commission shall make an enquiry and, on the basis of the results of this enquiry, propose where appropriate to the Council, that a decision be taken by not later than 31 December 1988, in accordance with the procedure provided for in Article 100 of the Treaty, to delete it form the Annex or otherwise change its status as appropriate.'; 2. Article 3 shall be replaced by the following: 'Article 3 1. By way of derogation from Article 2 (1), Member States may authorize until 31 December 1988 the use in foodstuffs of the substances listed in Annex II. However, as regards Karaya gum and thermally oxidized soya bean oil interacted with mono- and di-glycerides of fatty acids, the Council, acting in accordance with the procedure provided for in Article 100 of the Treaty, may decide, by 31 December 1988 and on the basis of a study by the Commission, to delete them from that Annex or otherwise change their status. Member States may authorize up to 31 March 1987 the marketing of foodstuffs containing the following substances: - Polyoxyethylene (8) stearate, - Polyoxyethylene (40) stearate, - Lactylated fatty acid esters of glycerol and propylene glycol, - Dioctyl sodium sulphosuccinate. 2. Where a Member State exercises the option under paragraph 1 other than by merely retaining the legislation in force at the time of notification of this Directive, it shall forthwith inform the other Member States and the Commission of the measures taken and shall furnish evidence which in its view justifies such measures. 3. Without prejudice to the first subparagraph of paragraph 1 and before the end of the period provided therein, the Council may, in accordance with the procedure laid down in Article 100 of the Treaty, include in Annex I the substances referred to in Annex II. In the case referred to in paragraph 2, the Council may, in accordance with the procedure laid down in Article 100 of the Treaty decide on any other appropriate measure.'; 3. In Annex I the designations E 440 a (pectin) and E 440 b (amidated pectin) shall be amended as follows: 'E 440 (i) pectin (ii) amidated pectin' 4. Annex II shall be replaced by the following: 'ANNEX II DENOMINATIONS Karaya gum (synonym: sterculia gum), Polyoxyethylene (20) sorbitan monolaurate (synonym: polysorbate 20), Polyoxyethylene (20) sorbitan monopalmitate (synonym: polysorbate 40), Polyoxyethylene (20) sorbitan monostearate (synonym: polysorbate 60), Polyoxyethylene (20) sorbitan tristearate (synonym: polysorbate 65), Polyoxyethylene (20) sorbitan monooleate (synonym: polysorbate 80), Thermally oxidized soya bean oil interacted with mono- and di-glycerides of fatty acids'. Article 2 Article 1 shall take effect as from 1 October 1985. Article 3 Member States shall, within one year of the notification of this Directive, amend their laws in accordance with the preceding provisions, and shall forthwith inform the Commission thereof. The laws thus amended shall be implemented two years after notification of this Directive. Article 4 This Directive is addressed to the Member States.

31986L0113

1986

Council Directive 86/113/EEC of 25 March 1986 laying down minimum standards for the protection of laying hens kept in battery cages Having regard to the Treaty establishing the European Economic Community, and in particular Articles 42 and 43 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas eggs are covered by a common organization of the market; whereas the rules on the conditions under which egg production takes place, in particular with regard to the keeping of hens, are of major importance as far as the operation of the market organization is concerned; whereas differences between the rules applied by Member States may lead to distortion of competition which may interfere with the smooth running of the market organization concerned; Whereas the keeping of laying hens in battery cages is the most widely used means of egg production in the Community and makes a very large contribution to the high productivity of this sector; whereas the fact that this means of housing may, in certain cases, lead to unnecessary and excessive suffering on the part of the animals has led Member States to introduce differing rules with regard to certain aspects of the type of production concerned, in particular the size of the cages; Whereas there is therefore a need to establish priority parameters and to define common minimum requirements applicable in order to overcome existing problems and enable the market organization to operate more satisfactorily, in particular with regard to Article 39 of the Treaty, while bearing in mind the need to protect animals; Whereas provision should be made for introducing Community control measures in order to ensure that the provisions of this Directive are effective; Whereas, to provide the basis for further Community measures, the studies on poultry protection must be continued, not only as regards the keeping of poultry in battery cages but also in possible alternative systems of housing; Whereas, in certain Member States, the adjustment of existing structures to the standards laid down by this Directive will entail a reduction in production; whereas such adjustment should therefore be facilitated under the conditions laid down in this Directive without creating structural and market imbalances, Article 1 This Directive lays down the minimum standards for the protection of laying hens kept in battery cages. Article 2 For the purpose of this Directive: 1. 'Laying hens' means adult hens of the species Gallus gallus which are kept for egg production. 2. 'Battery cage' means any enclosed space intended for laying hens in a battery system. 3. 'Battery system' means an arrangement of cages beside and/or on top of each other. Article 3 1. Member States shall ensure that from 1 January 1988: - all newly-built cages for use within the Community, - all cages brought into use for the first time, comply at least with the following requirements: (a) At least 450 cm2 of cage area, measured in a horizontal plane, which may be used without restriction, in particular not including non-waste deflection plates liable to restrict the area available, shall be provided for each laying hen; (b) A feed trough which may be used without restriction shall be provided. Its length shall be at least 10 cm multiplied by the number of animals in the cage; (c) Unless nipple drinkers or drinking cups are provided, each battery cage shall have a continuous drinking channel of the same length as the feed trough mentioned in point (b). Where drinking points are plumbed in, at least two nipple drinkers or two drinking cups shall be within reach of each cage; (d) Battery cages shall be at least 40 cm high over 65 % of the cage area and not less than 35 cm at any point; (e) Floors of battery cages must be constructed so as to support adequately each of the forward facing claws of each foot. Floor slope shall not exceed 14 % or 8 degrees. In the case of floors using other than rectangular wire mesh, Member States may permit steeper slopes. 2. Moreover, Member States shall ensure that from 1 January 1995 the minimum requirements laid down in points (a) to (e) of paragraph 1 apply to all battery cages. Article 4 Member States shall ensure that conditions for laying hens kept in battery cages are in accordance with the general requirements laid down in the Annex. Article 5 The provisions of the Annex may be amended in accordance with the procedure laid down in Article 8 in order to take account of scientific developments. Article 6 Member States shall arrange for inspections to be made by the competent authority to ensure that this Directive, including the Annex, is complied with. Article 7 1. Furthermore, in order to ensure that this Directive is complied with and that it is uniformly applied by the Member States, the Commission shall check on its application on the spot regularly and in an appropriate manner, in conjunction with the relevant national departments. 2. To that end, Commission experts shall carry out inspection operations jointly with national departments under inspection programmes adopted in cooperation with the competent authorities of the Member State concerned. Where it is established that this Directive is not being complied with the Commission will inform the relevant national authorities. The Commission will prepare periodical general reports on the results of the inspections carried out. Those reports shall be communicated to the Member States. 3. The Community shall in an appropriate manner bear the cost of participation by the Commission in the checks provided for in paragraph 1. 4. The general provisions for implementing this Article shall be determined in accordance with the procedure laid down in Article 8. In accordance with the same procedure, a code may be established containing the rules to be followed for the purpose of the checks provided for in paragraph 1 of this Article. Article 8 1. Where the procedure laid down in this Article is referred to, matters shall without delay be referred by the chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called 'Committee'). 2. Within the Committee the votes of Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within two days. Opinions shall be delivered by a qualified majority as provided in Article 148 (2) of the Treaty. 4. The Commission shall adopt the measures and apply them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal concerning the measures to be adopted. The Council shall adopt the measures by a qualified majority. If, within three months of the date on which the proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately save where the Council has decided by a simple majority against those measures. Article 9 Before 1 January 1993 the Commission shall submit a report on scientific developments regarding the welfare of hens under various systems of rearing and on the provisions in the Annex, accompanied by any appropriate adjustment proposals. Article 10 From the date on which this Directive takes effect until the end of the transitional period, national aid intended for the functional extension of buildings housing the battery cages necessary for rearing the same number of hens may be considered compatible with the common market, under Articles 92 to 94 of the Treaty, account being taken also of the depreciation of these buildings. Article 11 Member States shall bring into force the laws, regulations and administrative provisions required in order to comply with this Directive by 1 July 1987 at the latest. They shall immediately inform the Commission thereof. Article 12 This Directive is addressed to the Member States.

31986L0199

1986

Eighth Commission Directive 86/199/EEC of 26 March 1986 adapting to technical progress Annexes II, IV and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 86/179/EEC (2), and in particular Articles 5 and 8 (2) thereof, Whereas, in order to protect public health, it is necessary to lay down purity criteria for hexachlorophene and triclocarban; Whereas, on the basis of the available information, certain provisionally-permitted substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified period; Whereas the measures laid down 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, number 221 is replaced by: '221. Mercury and its compounds, except those special cases included in Annexes V and VI, Part 1'. 2. Annex IV, Part 1 and Annex VI, Parts 1 and 2, are replaced by Annexes 1 and 2 to this Directive. Article 2 1. Member States shall take the necessary measures to ensure that from 1 January 1988 neither manufacturers nor importers, established in the Community, place on the market products which do not satisfy the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 can no longer be sold or disposed of to the final consumer after 31 December 1989. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 31 December 1986 and shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States.

31986L0174

1986

Commission Directive 86/174/EEC of 9 April 1986 fixing the method of calculation for the energy value of compound poultryfeed Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (1), as last amended by Commission Directive 82/957/EEC (2), and in particular Article 10 thereof, Whereas, until Community methods have been introduced, the Member States may not, under the said Directive 79/373/EEC, require or permit declaration of the energy value of compound feedingstuffs except where such a declaration was required or permitted on their territory and official methods of calculation were, moreover, already in application at the time when the said Directive was adopted; Whereas scientific and technical knowledge is now such that the energy value of compound poultryfeed can be calculated by means of a uniform method in all Member States; whereas this method should therefore be adopted and made applicable not only in Member States which require or permit declaration of the energy value on the labels of compound poultryfeed but also in those Member States which had to wait for the adoption of a Community method before requiring or permitting such declarations; Whereas in case of differences between the result of the official findings for energy value and the value declared by the manufacturer, it is desirable to permit a minimum tolerance to allow for deviations due to the method used for sampling the feedingstuff, the manufacturing process or analytical divergences; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 In so far as, pursuant to the provisions of Article 5 (4) and (6) of Directive 79/373/EEC, the energy value of compound poultryfeed is declared, Member States shall require the said value to be calculated in accordance with the method described in the Annex to this Directive. Article 2 Member States shall bring into force by 30 June 1987 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0155

1986

Council Directive 86/155/EEC of 22 April 1986 amending, on account of the accession of Spain and Portugal, certain Directives concerning the marketing of seeds and plants Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Whereas the Council has established, by means of various Directives, a regime applicable to the marketing of seeds and propagating material; Whereas, in respect of Portugal, a transitional regime applicable in this field has been specified in the Act of Accession of Spain and Portugal; Whereas, in respect of Spain, adaptations should be made to the following Directives in accordance with the guidelines arrived at during the accession negotiations: - Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (2), as last amended by Regulation (EEC) No 3768/85 (3), - Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (4), as last amended by Regulation (EEC) No 3768/85, - Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (5), as last amended by Regulation (EEC) No 3768/85, - Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (6), as last amended by Regulation (EEC) No 3768/85, - Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (7), as last amended by Regulation (EEC) No 3768/85, - Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (8), as last amended by Regulation (EEC) No 3768/85; Whereas Bermuda grass, Harding grass (Phalaris), sorghum, Sudan grass, safflower, gourd and cardoon are important species for the production of agricultural or vegetable plants in the enlarged Community and should therefore be included in the scope of the said Directives; Whereas, in order to make it possible to take measures necessary to introduce a system of compulsory varietal certification for seed of lucerne, fodder kale and fodder radish, the Kingdom of Spain should be authorized, in respect of such seed, to postpone application of the obligation imposed by Directive 66/401/EEC to market exclusively seed which has been officially certified as 'basic seed' or 'certified seed'; Whereas the demand for cotton seed in the enlarged Community is such that Directive 69/208/EEC should be amended to allow the marketing of certified cotton seed of the second generation; Whereas, in order to enable the Kingdom of Spain to take the measures necessary to adapt its seed and propagating material production and marketing to the requirements of the catalogue of varieties set up in the Community system, that Member State should be authorized to postpone the application of certain provisions relating to the national catalogue of vine varieties, the Common Catalogue of Varieties of Agricultural Plant Species and the Common Catalogue of Varieties of Vegetable Species, either entirely or in respect of certain species, Article 1 Directive 66/401/EEC is hereby amended as follows: 1. In Article 2 (1) (A) (a): 1.2 // - the words 'Cynodon dactylon (L.) Pers. // Bermuda grass' // shall be inserted after 'Arrhenatherum elatius (L.) Beauv. ex. J. et K. Presl. // Tall oatgrass', // - the words // // 'Phalaris aquatica L. // Harding grass, Phalaris' // shall be inserted after 'Lolium × hybridum Hausskn // Hybrid ryegrass'. 2. The following paragraph shall be inserted in Article 3: '1a. Until 31 December 1989 the Kingdom of Spain may be authorized, in accordance with the procedure laid down in Article 21, to provide for exceptions to paragraph 1 in the case of seed of Medicago sativa, Brassica oleracea convar. acephala and Raphanus sativus.' 3. In Annex II (I) (2) (A) the following lines shall be inserted after the lines Arrhenatherum elatius and Lolium × hybridum respectively: 1.2.3.4.5.6.7.8.9.10.11.12.13.14.15 // // // // // // // / / // // // // // // // // 1 // 2 // 3 // 4 // 5 // 6 // 7 // 8 // 9 // 10 // 11 // 12 // 13 // 14 // 15 // // // // // // // // // // // // // // // // 'Cynodon dactylon // 70 (a) // // 90 // 2,0 // 1,0 // 0,3 // 0,3 // // // // 0 // 0 (j) (k) // 2 // ' // and // // // // // // // // // // // // // // // 'Phalaris aquatica L. // 75 (a) // // 96 // 1,5 // 1,0 // 0,3 // 0,3 // // // // 0 // 0 (j) (k) // 20 // '. // // // // // // // // // // // // // // // 4. In Annex II (II) (2) (A) the following lines shall be inserted after the lines Arrhenatherum elatius and Lolium × hybridum respectively: 1.2.3.4.5.6.7.8 // // // // // // // // // 1 // 2 // 3 // 4 // 5 // 6 // 7 // 8 // // // // // // // // // 'Cynodon dactylon // 0,3 // 20 (a) // 1 // 1 // 1 // // (j)' // and // // // // // // // // 'Phalaris aquatica L. // 0,3 // 20 // 5 // 5 // 5 // // (j)'. // // // // // // // // 5. In Annex III the following lines shall be inserted after the lines Arrhenatherum elatius and Lolium × hybridum respectively: 1.2.3.4 // // // // // 1 // 2 // 3 // 4 // // // // // 'Cynodon dactylon // 10 // 50 // 5' // and // // // // 'Phalaris aquatica L. // 10 // 100 // 50'. // // // // // // // // Article 2 Directive 66/402/EEC is hereby amended as follows: 1. In Article 2 (1) (A) the words 1.2 // 'Sorghum bicolor (L.) Moench // Sorghum // Sorghum sudanense (Piper) Stapf // Sudan grass' // shall be inserted after 'Secale cereale L. // Rye'. 2. In Article 2 (1) (B) the words 'and Sorghum spp.' shall be inserted after 'maize'. 3. In Article 2 (1) (D) the words 'Sorghum spp.' shall be inserted after 'maize'. 4. In Article 2 (2) (E) the words 'Sorghum spp.' shall be inserted after 'canary grass'. 5. In Annex I (2) the following words shall be inserted before the table: 'and in particular, in the case of sorghum, from sources of Sorghum halepense'. 6. In the table in Annex I (2) the following shall be inserted before the line Zea mays: 'Sorghum spp. 300 m'. 7. In the first and second paragraphs of Annex I (3), and in the introductory wording of the third paragraph the words 'Sorghum spp. and' shall be inserted in each case before 'Zea mays'. 8. In the third paragraph of Annex I (3), the following shall be added: 'C. Sorghum spp. (a) the percentage by number of plants of a Sorghum species other than the crop species or plants which are recognizable as obviously not being true to the inbred line or to the component shall not exceed: (aa) for the production of basic seed (i) at flowering: 0,1 %, (ii) at maturity: 0,1 %; (bb) for the production of certified seed (i) plants of the male component which have shed pollen when the plants of the female component have receptive stigmas: 0,1 %; (ii) plants of the female component - at flowering: 0,3 %, - at maturity: 0,1 %; (b) the following standards or other conditions shall be satisfied for the production of certified seed: (aa) sufficient pollen shall be shed by the plants of the male component while the plants of the female component have receptive stigmas; (bb) where plants of the female component have receptive stigmas, the percentage of plants of that component which have shed pollen or are shedding pollen shall not exceed 0,1 %'. 9. In Annex I (5) (B) (b) the words 'Sorghum spp. and' shall be inserted in each case before 'Zea mays'. 10. In the first and second sentences of Annex II (I), the words 'Sorghum spp. and' shall be inserted in each case before 'Zea mays'. 11. In Annex II (1) (B) the words 'Sorghum spp. and' shall be inserted before 'Zea mays'. 12. In Annex II (2) (A) the following shall be inserted after the line Secale cereale: 1.2.3.4.5.6.7.8.9.10 // // // // // // // // // // // 1 // 2 // 3 // 4 // 5 // 6 // 7 // 8 // 9 // 10 // // // // // // // // // // // 'Sorghum spp. // 80 // 98 // 0' // // // // // // // // // // // // // // // // 13. In Annex III the following shall be inserted after the line Oryza sativa: 1.2.3.4 // // // // // 1 // 2 // 3 // 4 // // // // // 'Sorghum spp. // 10 // 1 000 // 900'. // // // // 14. In Annex IV (A) (a) (5) the words 'and Sorghum spp.' shall be added. 15. In Annex IV (A) (a) (9) the words 'of maize' shall be deleted. Article 3 In Directive 68/193/EEC the following sentence shall be added to Article 5: 'With regard to the Kingdom of Spain, the date 31 December 1971 referred to above shall be replaced by 28 February 1986.' Article 4 Directive 69/208/EEC is hereby amended as follows: 1. In Article 2 (1) (A) the words 1.2 // 'Carthamus tinctorius L. // Safflower' // shall be inserted after 'Cannabis sativa L. // Hemp'. 2. In Article 2 (1) (C) the word 'safflower' shall be inserted after 'dioecious hemp'. 3. In Article 2 (1) (C) the word 'cotton' shall be deleted. 4. In Article 2 (1) (D) the word 'cotton' shall be inserted after 'soya'. 5. In Article 2 (1) (E) the word 'cotton' shall be inserted after 'soya'. 6. In Article 3 (1) the words 'Carthamus tinctorius L.' shall be inserted after 'Cannabis sativa L.'. 7. In column 1 of the table in Annex I (2) the words 'Carthamus tinctorius' shall be inserted after 'Cannabis sativa other than monoecious hemp'. 8. In Annex I (3) the words 'Carthamus tinctorius' shall be inserted after 'Cannabis sativa'. 9. In Annex II (I) (2) (A) the following line shall be inserted after the line Cannabis sativa: 1.2.3.4.5.6.7.8.9.10.11.12 // // // // // // // // // // // // // 1 // 2 // 3 // 4 // 5 // 6 // 7 // 8 // 9 // 10 // 11 // 12 // // // // // // // // // // // // // 'Carthamus tinctorius // 75 // 98 // - // 5 // 0 // 0 (c) // // // // // (e)'. // // // // // // // // // // // // 10. In Annex III the following line shall be inserted after the line Cannabis sativa: 1.2.3.4 // // // // // 1 // 2 // 3 // 4 // // // // // 'Carthamus tinctorius // 10 // 900 // 900'. // // // // Article 5 Directive 70/457/EEC is hereby amended as follows: 1. The following sentence shall be added to Article 3 (3): 'With regard to the Kingdom of Spain, the dates 1 July 1972 and 30 June 1980 referred to in the first sentence shall be replaced by the dates 1 March 1986 and 31 december 1990 respectively in respect of the following species: Agrostis stolonifera Agrostis tenuis Phleum pratense Poa Pratensis Hedysarum coronarium Lotus corniculatus Lupinus angustifolium Lupinus luteus Onobrychis viciifolia Trifolium alexandrinum Trifolium pratense Vicia villosa Brassica napus var. napobrassica Brassica oleracea convar. acephala Raphanus sativus ssp. oleifera and Arachis hypogaea'. 2. The following sentence shall be added to Article 15 (1): 'With regard to the Kingdom of Spain, the date 1 July 1972 referred to in the first sentence shall be replaced by the date 1 March 1986 in respect of varieties other than those which are officially included in the catalogue of that Member State on 1 March 1986 and which are also included on that date in the catalogue of one or more of the Member States of the Community of Ten, without prejudice to the particular provisions applicable to certain species referred to in the second and third sentences of paragraph 5. 3. The following sentence shall be added to Article 16: 'With regard to the Kingdom of Spain, the 1 July 1972 referred to in the first sentence shall be replaced by the date 1 March 1986.' 4. The following sentence shall be added to Article 17: 'With regard to the Kingdom of Spain, the date 1 July 1972 referred to in the first sentence shall be replaced by the date 1 March 1986.' Article 6 Directive 70/458/EEC is hereby amended as follows: 1. In Article 2 (1) (A) the words 1.2 // 'Cucurbita maxima Duchesne // Gourd' // shall be inserted after 'Cucumis sativus L. // Cucumber, gherkin' // and the words 'Cynara cardunculus L. shall be inserted after // Cardoon' // 'Cucurbita pepo L. // Marrow'. 2. In Article 2 (1) (F) (b) the word 'gourd' shall be inserted after 'water melon'. 3. The following sentence shall be added to Article 9 (1): 'With regard to the Kingdom of Spain the dates 1 July 1972 and 30 June 1975 referred to in the first sentence shall be replaced by the dates 1 March 1986 and 31 december 1988 respectively in respect of the following species: Apium graveolens Beta vulgaris var. esculenta Brassica oleracea Cichorium endivia Cucurbita pepo Petroselinum endivia crispum Phaseolus coccineus Raphanus sativus Scorzonera hispanica'. 4. The following sentence shall be added to Article 9 (2): 'With regard to the Kingdom of Spain, the dates 1 July 1972 and 30 June 1980 referred to in the first sentence shall be replaced by the dates 1 March 1986 and 31 December 1993 respectively in respect of the species referred to in the last sentence of paragraph 1.' 5. The following sentence shall be added to Article 9 (3): 'With regard to the Kingdom of Spain, the dates 30 June 1975 and 1 July 1972 referred to above shall be replaced by the dates 31 December 1988 and 1 March 1986 respectively in respect of the species referred to in the last sentence of paragraph 1.' 6. The following sentence shall be added to Article 12 (1): 'With regard to the Kingdom of Spain, the date 1 July 1970 referred to in the second sentence shall be replaced by the date 1 March 1986.' 7. The following sentence shall be added to Article 16 (4): 'With regard to the Kingdom of Spain, the date 1 July 1972 referred to in the first sentence shall be replaced by the date 1 March 1986.' 8. The following sentence shall be added to Article 26 (2): 'With regard to the Kingdom of Spain, the date 1 July 1970 referred to in the first sentence shall be replaced by the date 1 March 1986.' 9. In Annex II (3) (a) the following shall be inserted after the lines Cucumis sativus and Cucurbita pepo respectively: 1.2.3.4 // // // // // // // // // // // // // // / / // // 'Cucurbita maxima // 98 // 0,1 // 80' // and // // // // 'Cynara cardunculus // 96 // 0,5 // 65'. // // // // // // // // 10. In Annex III (2) the following lines shall be inserted after the lines Cucumis sativus and Cucurbita pepo respectively: 1.2 // // // // // // // // // 'Cucurbita maxima // 250' // and // // 'Cynara cardunculus // 50'. // // Article 7 Member States shall take the measures necessary to comply with: - Article 1 (2), Article 3, Article 4 (3), (4) and (5), Article 5 and Article 6 (3) to (8), with effect from 1 March 1986, - the other provisions of the Directive not later than 1 July 1987. They shall inform the Commission thereof forthwith. Article 8 This Directive is addressed to the Member States.

31986L0188

1986

Council Directive 86/188/EEC of 12 May 1986 on the protection of workers from the risks related to exposure to noise at work Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, drawn up after consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work (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 resolutions of 29 June 1978 and 27 February 1984 on action programmes of the European Communities on safety and health at work (4) provide for the implementation of specific harmonized procedures for the protection of workers exposed to noise; whereas the measures adopted in this field vary from State to State and it is recognized that they urgently need to be approximated and improved; Whereas exposure to high noise levels is encountered in a large number of situations and therefore many workers are exposed to a potential safety and health hazard; Whereas a reduction of exposure to noise reduces the risk of hearing impairment caused by noise; Whereas, where the noise level at the workplace involves a risk for the health and safety of workers, limiting exposure to noise reduces that risk without prejudice to the applicable provisions on the limitation of noise emission; Whereas the most effective way of reducing noise levels at work is to incorporate noise prevention measures into the design of installations and to choose materials, procedures and working methods which produce less noise; whereas the priority aim must be to achieve the said reduction at source; Whereas the provision and use of personal ear protectors is a necessary complementary measure to the reduction of noise at source, where exposure cannot reasonably be avoided by other means; Whereas noise is an agent to which Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (5) applies; whereas Articles 3 and 4 of the said Directive provide for the possibility of laying down limit values and other special measures in respect of the agents being considered; Whereas certain technical aspects must be defined and may be reviewed in the light of experience and progress made in the technical and scientific field; Whereas the current situation in the Member States does not make it possible to fix a noise-exposure value below which there is no longer any risk to workers' hearing; Whereas current scientific knowledge about the effects that exposure to noise may have on health, other than on hearing, does not enable precise safety levels to be set; whereas, however, reduction of noise will lower the risk of illnesses unrelated to auditory complaints; whereas this Directive contains provisions which will be reviewed in the light of experience and developments in scientific and technical knowledge in this field, Article 1 1. This Directive, which is the third individual Directive within the meaning of Directive 80/1107/EEC, has as its aim the protection of workers against risks to their hearing and, in so far as this Directive expressly so provides, to their health and safety, including the prevention of such risks arising or likely to arise from exposure to noise at work. 2. This Directive shall apply to all workers, including those exposed to radiation covered by the scope of the EAEC Treaty, with the exception of workers engaged in sea transport and in air transport. For the purpose of this Directive, the expression 'workers engaged in sea transport and in air transport' shall refer to personnel on board. On a proposal from the Commission the Council shall examine, before 1 January 1990, the possibility of applying this Directive to workers engaged in sea transport and in air transport. 3. This Directive shall not prejudice the right of Member States to apply or introduce, subject to compliance with the Treaty, laws, regulations or administrative provisions ensuring, where possible, greater protection for workers and/or intended to reduce the level of noise experienced at work by taking action at source, particularly in order to achieve exposure values which prevent unnecessary nuisance. Article 2 For the purposes of this Directive, the following terms shall have the meaning hereby assigned to them: 1. Daily personal noise exposure of a worker L EP, d The daily personal noise exposure of a worker is expressed in dB (A) using the formula: 1.2.3 // L EP, d = LAeq, Te + 10 log10 // Te To // where: 1.2.3.4.5.6.7.8.9.10.11.12 // LAeq, Te = 10 log10 // { // 1 Te // l // Te o // [ // pA (t ) po // ] // 2 // dt // } // 1.2 // Te = // daily duration of a worker's personal exposure to noise, // To = // 8 h = 28 800 s, // po = // 20 mPa, // pA = // 'A'-weighted instantaneous sound pressure in pascals to which is exposed, in air at atmospheric pressure, a person who might or might not move from one place to another while at work; it is determined from measurements made at the position occupied by the person's ears during work, preferably in the person's absence, using a technique which minimizes the effect on the sound field. // // If the microphone has to be located very close to the person's body, appropriate adjustments should be made to determine an equivalent undisturbed field pressure. The daily personal noise exposure does not take account of the effect of any personal ear protector used. 2. Weekly average of the daily values L EP, w The weekly average of the daily values is found using the following formula: 1.2.3.4.5.6.7 // L EP, w = 10 log10 // [ // 1 5 // m S k=1 // 100,1 ( L EP, d ) k // ] // where (L EP, d ) k are the values of L EP, d for each of the m working days in the week being considered. Article 3 1. Noise experienced at work shall be assessed and, when necessary, measured in order to identify the workers and workplaces referred to in this Directive and to determine the conditions under which the specific provisions of this Directive shall apply. 2. The assessment and measurement mentioned in paragraph 1 shall be competently planned and carried out at suitable intervals under the responsibility of the employers. Any sampling must be representative of the daily personal exposure of a worker to noise. The methods and apparatus used must be adapted to the prevailing conditions in the light, particularly, of the characteristics of the noise to be measured, the length of exposure, ambient factors and the characteristics of the measuring apparatus. These methods and this apparatus shall make it possible to determine the parameters defined in Article 2 and to decide whether, in a given case, the values fixed in this Directive have been exceeded. 3. Member States may lay down that personal exposure to noise shall be replaced by noise recorded at the workplace. In that event the criterion of personal exposure to noise shall be replaced, for the purposes of Articles 4 to 10, by that of noise exposure during the daily work period, such period being at least eight hours, at the places where the workers are situated. Member States may also lay down that, when the noise is measured, special consideration shall be given to impulse noise. 4. The workers and/or their representatives in the undertaking or establishment shall be associated, according to national law and practice, with the assessment and measurement provided for in paragraph 1. These shall be revised where there is reason to believe that they are incorrect or that a material change has taken place in the work. 5. The recording and preservation of the data obtained pursuant to this Article shall be carried out in a suitable form, in accordance with national law and practice. The doctor and/or the authority responsible and the workers and/or their representatives in the undertaking shall have access to these data, in accordance with national law and practice. Article 4 1. Where the daily personal exposure of a worker to noise is likely to exceed 85 dB (A) or the maximum value of the unweighted instantaneous sound pressure is likely to be greater than 200 Pa (1), appropriate measures shall be taken to ensure that: (a) workers and/or their representatives in the undertaking or establishment receive adequate information and, when relevant, training concerning: - potential risks to their hearing arising from noise exposure, - the measures taken in pursuance of this Directive, - the obligation to comply with protective and preventive measures, in accordance with national legislation, - the wearing of personal ear protectors and the role of checks on hearing in accordance with Article 7; (b) workers and/or their representatives in the undertaking or establishment have access to the results of noise assessments and measurements made pursuant to Article 3 and can be given explanations of the significance of those results. 2. At workplaces where the daily personal noise exposure of a worker is likely to exceed 85 dB (A), appropriate information must be provided to workers as to where and when Article 6 applies. At workplaces where the daily personal noise exposure of a worker is likely to exceed 90 dB (A) or where the maximum value of the unweighted instantaneous sound pressure is likely to exceed 200 Pa, the information provided for in the first subparagraph must, where reasonably practicable, take the form of appropriate signs. The areas in question must also be delimited and access to them must be restricted, where the risk of exposure so justifies and where these measures are reasonably practicable. Article 5 1. The risks resulting from exposure to noise must be reduced to the lowest level reasonably practicable, taking account of technical progress and the availability of measures to control the noise, in particular at source. 2. Where the daily personal noise exposure of a worker exceeds 90 dB (A), or the maximum value of the unweighted instantaneous sound pressure is greater than 200 Pa: (a) the reasons for the excess level shall be identified and the employer shall draw up and apply a programme of measures of a technical nature and/or of organization of work with a view to reducing as far as reasonably practicable the exposure of workers to noise; (b) workers and their representatives in the undertaking or establishment shall receive adequate information on the excess level and on the measures taken pursuant to subparagraph (a). Article 6 1. Without prejudice to Article 5, where the daily personal noise exposure of a worker exceeds 90 dB (A) or the maximum value of the unweighted instantaneous sound pressure is greater than 200 Pa, personal ear protectors must be used. 2. Where the exposure referred to in paragraph 1 is likely to exceed 85 dB (A), personal ear protectors must be made available to workers. 3. Personal ear protectors must be supplied in sufficient numbers by the employer, the models being chosen in association, according to national law and practice, with the workers concerned. The ear protectors must be adapted to the individual worker and to his working conditions, taking account of his safety and health. They are deemed, for the purposes of this Directive, suitable and adequate if, when properly worn, the risk to hearing can reasonably be expected to be kept below the risk arising from the exposure referred to in paragraph 1. 4. Where application of this Article involves a risk of accident, such risk must be reduced as far as is reasonably practicable by means of appropriate measures. Article 7 1. Where it is not reasonably practicable to reduce the daily personal noise exposure of a worker to below 85 dB (A), the worker exposed shall be able to have his hearing checked by a doctor or on the responsibility of the doctor and, if judged necessary by the doctor, by a specialist. The in which this check is carried out shall be established by the Member States in accordance with national law and practice. 2. The purpose of the check shall be the diagnosis of any hearing impairment by noise and the preservation of hearing. 3. The results of checks on workers' hearing shall be kept in accordance with national law and practice. Workers shall have access to the results which apply to them in so far as national law and practice allow. 4. Member States shall take the necessary measures with a view to the doctor and/or the authority responsible giving, as part of the check, appropriate indications on any individual protective or preventive measures to be taken. Article 8 1. Member States shall take appropriate measures to ensure that: (a) the design, building and/or construction of new plant (new factories, plant or machinery, substantial extensions or modifications to existing factories or plant and replacement of plant or machinery) comply with Article 5 (1); (b) where a new article (tool, machine, apparatus, etc.) which is intended for use at work is likely to cause, for a worker who uses it properly for a conventional eight-hour period, a daily personal noise exposure equal to or greater than 85 dB (A) or an unweighted instantaneous sound pressure the maximum value of which is equal to or greater than 200 Pa, adequate information is made available about the noise produced in conditions of use to be specified. 2. The Council shall establish, on a proposal from the Commission, requirements according to which, so far as is reasonably practicable, the articles referred to in paragraph 1 (b), when properly used, do not produce noise likely to constitute a risk to hearing. Article 9 1. In the case of workplaces where the noise exposure of a worker varies markedly from one working day to the next, Member States may, for workers performing special operations, exceptionally grant derogations from Article 5 (2), Article 6 (1) and Article 7 (1), but only on condition that the average weekly noise exposure of a worker, as shown by adequate monitoring, complies with the value laid down in these provisions. 2. (a) In exceptional situations where it is not reasonably practicable, by technical measures or organization of work, to reduce daily personal noise exposure to below 90 dB (A) or to ensure that the personal ear protectors provided for in Article 6 of this Directive are suitable and adequate within the meaning of the second subparagraph of Article 6 (3), the Member States may grant derogations from this provision for limited periods, such derogations being renewable. In such a case, however, personal ear protectors affording the highest degree of protection which is reasonably practicable must be used. (b) In addition, for workers performing special operations, Member States may exceptionally grant derogations from Article 6 (1) if its application involves an increase in the overall risk to the health and/or safety of the workers concerned and if it is not reasonably practicable to reduce this risk by any other means. (c) The derogations referred to in (a) and (b) shall be subject to conditions which, in view of the individual circumstances, ensure that the risks resulting from such derogations are reduced to a minimum. The derogations shall be reviewed periodically and be revoked as soon as is reasonably practicable. (d) Member States shall forward to the Commission every two years an adequate overall account of the derogations referred to in (a) and (b). The Commission shall inform the Member States thereof in an appropriate manner. Article 10 The Council, acting on a proposal from the Commission, shall re-examine this Directive before 1 January 1994, taking into account in particular progress made in scientific knowledge and technology as well as experience gained in the application of this Directive, with a view to reducing the risks arising from exposure to noise. In the context of this re-examination, the Council, acting on a proposal from the Commission, shall endeavour to lay down indications for measuring noise which are more precise than those given in Annex I. Article 11 Member States shall see to it that workers' and employers' organizations are consulted before the provisions for the implementation of the measures referred to in this Directive are adopted, and that where workers' representatives exist in the undertaking or establishments they can check that such provisions are applied or can be involved in their application. Article 12 1. For the measurement of noise and checking workers' hearing, any methods may be used which at least satisfy the provisions contained in Articles 3 and 7. 2. Indications for measuring noise and for checking workers' hearing are given in Annexes I and II. Annexes I and II shall be adapted to technical progress in accordance with Directive 80/1107/EEC and under the procedure set out in Article 10 thereof. Article 13 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1990. They shall forthwith inform the Commission thereof. However, in the case of the Hellenic Republic and the Portuguese Republic the relevant date shall be 1 January 1991. 2. Member States shall communicate to the Commission the 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 This Directive is addressed to the Member States.

31986L0297

1986

Council Directive 86/297/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to the power take-offs of wheeled agricultural and forestry tractors and their protection Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas the technical requirements with which wheeled agricultural or forestry tractors must comply pursuant to national laws relate, inter alia, to the power take-off and its protection;Whereas those requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements, either in addition to, or in place of, their existing rules, in particular in order to allow the EEC type-approval procedure which was the subject of Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (4), as last amended by the Act of Accession of Spain and Portugal, to be applied in respect of each tractor type;Whereas the Council Resolution of 29 June 1978 concerning an action programme of the European Communities on safety and health at work (5) provides for the application of the principles of accident prevention in the design and creation of plant and machinery, including the agricultural sector; whereas the provisions concerning power take-offs and their protection constitute safety factors;Whereas the approximation of the national laws relating to wheeled agricultural or forestry tractors entails reciprocal recognition by Member States of the checks carried out by each of them on the basis of common requirements, Article 1 1. 'Agricultural or forestry tractors' means any motor vehicle, fitted with wheels or endless tracks, having at least two axles, the main function of which lies in its tractive power and which is specially designed to tow, push, carry or power certain tools, machinery or trailers intended for agricultural or forestry use. It may be equipped to carry a load or passengers.2. This Directive shall apply only to the tractors defined in paragraph 1, which are fitted with pneumatic tyres and have at least two axles and a maximum design speed of between 6 and 30 km/h. Article 2 N° Member State may refuse to grant EEC type-approval or national type-approval in respect of a tractor, or refuse or prohibit its sale, registration, entry into service or use, on grounds relating to the power take-off and its protection if the latter satisfy the requirements set out in Annex I. Article 3 This Directive shall not affect the right of Member States to specify, with due observance of the Treaty, the requirements they deem necessary to ensure that workers are protected when using the tractors in question, provided this does not mean that the power take-off and its protection are modified in a way unspecified in this Directive. Article 4 Any amendments necessary to adapt the requirements of Annex I and the model Annex to the EEC type-approval certificate shown in Annex II to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 74/150/EEC. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within 18 months of its adoption. They shall forthwith inform the Commission thereof. However, the requirements of section 5.2 of Annex I shall not apply until 1 October 1995. 2. Member States shall ensure that the text of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission. Article 6 This Directive is addressed to the Member States.

31986L0217

1986

COUNCIL DIRECTIVE of 26 May 1986 on the approximation of the laws of the Member States relating to tyre pressure gauges for motor vehicles (86/217/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas in several Member States the construction and the methods of control of pressure gauges intended to measure the inflation pressure of motor vehicle tyres are subject to mandatory provisions which differ from one Member State to another and consequently hinder trade in such instruments; whereas it is therefore necessary to approximate those provisions; Whereas Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to commom provisions for both measuring instruments and methods of metrological control (4), as last amended by Directive 83/575/EEC (5), defined the EEC pattern approval and initial verification procedures; whereas, in accordance with that Directive, it is necessary to lay down the technical specifications in respect of manufacture and operation which tyre pressure gauges for motor vehicles must satisfy in order that they may be imported, marketed and used freely after they have undergone the controls and had affixed the marks and signs provided for, Article 1 This Directive shall apply to pressure gauges intended to measure the inflation pressure of motor-vehicle tyres, as defined in section 1 of the Annex. Article 2 The tyre-inflation equipment eligible for EEC marks and signs is described in the Annex. It shall be subject to EEC pattern approval and EEC initial verification under the conditions laid down in the Annex. Article 3 No Member State may refuse, prohibit or restrict the placing on the market and entry into service of tyre-inflation equipment on grounds relating to its metrological qualities if it bears the EEC pattern approval sign and the EEC initial verification mark. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 18 months after notification of the Directive (6). Article 5 This Directive is addressed to the Member States.

31986L0197

1986

Council Directive 86/197/EEC of 26 May 1986 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 Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 79/112/EEC (4) has not yet provided for, as part of the compulsory wording on labels, any indication of the alcoholic strength of alcoholic beverages; Whereas an indication of such strength is necessary in order to ensure that consumers are given adequate information; Whereas the rules concerning indication of alcoholic strength are measures of a technical nature the adoption of which should be entrusted to the Commission in accordance with the procedures governing the various beverages concerned, Article 1 Directive 79/112/EEC is hereby amended as follows: 1. The following point is added to Article 3 (1): '(9) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume.' 2. In Article 6 (3), 'and, possibly, indicating the alcoholic strength' is deleted. 3. The following Article is inserted: 'Article 10a The rules concerning indication of the alcoholic strength by volume shall, in the case of products covered by tariff heading Nos 22.04 and 22.05, be those laid down in the specific Community provisions applicable to such products. In the case of other beverages containing more than 1,2 % by volume of alcohol, these rules shall be laid down in accordance with the procedure provided for in Article 17.' 4. The first subparagraph of Article 11 (3) (a) is replaced by the following: '(a) The particulars listed in Article 3 (1), points (1), (3), (4) and (9) shall be simultaneously visible.' Article 2 1. Member States shall, where necessary, amend their legislation to comply with this Directive and shall forthwith inform the Commission thereof; legislation thus amended shall be applied in such a manner as to: - permit trade in products which comply with this Directive by 1 May 1988 at the latest; - prohibit trade in products which do not comply with this Directive as from 1 May 1989. 2. However, trade in beverages which do not comply with this Directive, labelled before the date in the second indent of paragraph 1, shall be permitted until stocks are exhausted. Article 3 This Directive is addressed to the Member States.

31986L0296

1986

Council Directive 86/296/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to falling-object protective structures (FOPS) for certain construction plant Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas in some Member States the design, construction and testing of falling-object protective structures for certain categories of construction plant under certain conditions of use are the subject of national provisions requiring these protective structures to comply with special technical criteria and undergo specific tests; whereas this situation is likely to create barriers to intra-Community trade; whereas it is therefore necessary to approximate these provisions;Whereas Council Directive 84/532/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to common provisions for construction plant and equipment (4) has defined a series of joint procedures - in particular, EEC type-approval, EEC-type examination and EEC self-certification - for the placing on the market and bringing into service of such construction plant; whereas provision should be made for the EEC type-examination procedure, coupled with an EEC inspection procedure, in respect of falling-object protective structures for certain construction plant; whereas, moreover, it is necessary to make provision for this construction plant to be designed with attachment points, so that it can be fitted with the corresponding EEC protective structures;Whereas this Directive is a separate Directive within the meaning of the second paragraph of Article 3 of Directive 84/532/EEC;Whereas the laboratory tests, performance criteria and deflection-limiting volume are laid down by ISO international standards; whereas reference should therefore be made to these existing standards; Whereas technical progress necessitates rapid adaptation of the technical requirements; whereas the procedure laid down in Article 24 of Directive 84/532/EEC should therefore be adopted for such adaptations of this Directive, Article 1 This Directive applies to falling-object protective structures (FOPS) for the construction plant listed under 2.1 in ISO standard 3449, third edition of 15 April 1984, hereinafter referred to as ISO standard 3449/3. Article 2 1. Member States shall take all necessary steps to ensure that:(afalling-object protective structures cannot be placed on the market unless they comply with this Directive and the type of structure which has satisfied EEC type-examination in accordance with Directive 84/532/EEC.These protective structures shall hereinafter be referred to as EEC protective structures;(bthe construction plant referred to in Article 1 cannot be placed on the market unless it is designed to be fitted with an EEC protective structure. Plant shall be considered to be designed to be fitted with an EEC protective structure if it is provided with a roll-over protective structure (ROPS) to which the aforesaid EEC protective structure can be fitted.2. Member States may stipulate that, when used in certain normal conditions where the use of a falling-object protective structure is justified, the construction plant referred to in Article 1 may not be put into service or used unless fitted with an EEC protective structure. Article 3 1. The approved bodies referred to in Article 9 of Directive 84/532/EEC shall not issue an EEC type-exami- nation certificate unless the type of EEC protective structure complies with the provisions of Annex I to this Directive.The EEC type-examination tests may be performed in the manufacturer's laboratory under the supervision of the approved body.2. All applications for EEC type-examination in respect of an EEC protective structure shall be accompanied by an information document conforming to the model in Annex II to this Directive.3. For each type of EEC protective structure that has undergone the tests and examinations provided for in Annex I to this Directive, the approved body shall draw up a test report conforming to the model in Annex III to this Directive and shall issue an EEC type-examination certificate conforming to the model in Annex V to this Directive, by way of derogation from Directive 84/532/EEC.4. By way of derogation from section 4.2 of Annex I to Directive 84/532/EEC, only Member States and the Commission may obtain the test report, part A, referred to in Annex III to this Directive, and, where appropriate, the technical data in part B.The approved body which has issued the EEC type-examination certificate shall forward the above document upon a duly substantiated request by a Member State or the Commission. Article 4 1. Each EEC protective structure shall be accompanied by a certificate of conformity in accordance with Article 18 (1) of Directive 84/532/EEC.2. The manufacturer of the EEC protective structure shall affix to each structure a legible, permanent and indelible EEC conformity mark, a model of which is contained in Annex IV, and shall attach to the structure a label in accordance with section 8 of ISO standard 3449/3. Article 5 1. When it is proposed to commence production of protective structures for which an EEC type-examination certificate has been issued, the manufacturer or his authorized representative established in the Community shall:(ainform the approved body which issued the EEC type-examination certificate of:the place of manufacture, and/or the place of warehousing within the Community,the date of commencement of production and/or import;(ballow representatives of the approved body access for the purpose of checking to the said places of manufacture or warehousing and provide all necessary information relevant to such checks; (cmake available, at the request of the approved body and within a reasonable period, a sample selected by that body for checking purposes.2. The holder of the EEC mark shall arrange for production to be checked so as to verify on a continuous and adequate basis that the EEC protective structures manufactured conform to the type tested as regards the materials used and the quality of workmanship. Article 6 1. Each approved body shall, if appropriate in accordance with instructions from the Member State which approved it, carry out spot checks to see whether the EEC protective structures being manufactured conform to the type for which it issued the EEC type-examination certificate.These checks shall enable the approved body to ascertain whether the manufacturer is in fact carrying out the conformity check referred to in Article 5 (2).The approved body may also request and itself select a sample for checking purposes. A second test in accordance with Annex I, involving destroying the EEC protective structure and possibly the chassis, shall be performed only if there are reasonable grounds for assuming that the structure does not comply with the performance requirements for the approved type.2. If the place of manufacture is situated in a Member State other than that of the approved body which granted the EEC type-examination certificate, that body may collaborate with the approved body in the Member State in which the abovementioned checks are to take place.The same shall apply to warehouses.3. Each approved body may on its own responsibility delegate the task of performing the checking tests and operations to one or more laboratories. Article 7 1. If the checks referred to in Article 6 reveal that EEC protective structures do not conform to the type for which the EEC type-examination certificate was granted, or that not all the requirements of this Directive have been fulfilled, the approved body shall take one of the following measures against the holder of the EEC mark:(aa warning, with a request that the infringements noted shall cease within a given period;(ba warning as referred to in (a), but accompanied by a larger number of checks; (ctemporary suspension of the EEC type-examination certificate;(dwithdrawal of the EEC type-examination certificate.These measures may be taken only by the approved body which granted the EEC type-examination certificate.2. The first two measures shall be taken where the disparities do not affect the basic design of the EEC protective structures or where the infringements are minor ones and in no way impair safety.One of the last two measures shall be taken where the disparities or infringements noted are substantial and in all cases where they represent a safety hazard.3. Temporary suspension or withdrawal of the EEC type-examination certificate shall be notified without delay to the other approved bodies and to the Member States. Article 8 1. N° Member State may, on grounds relating to the requirements laid down in this Directive, refuse, prohibit or restrict the marketing, placing into service or use of EEC protective structures.2. N° Member State may, on grounds relating to the requirements laid down in this Directive, refuse, prohibit or restrict the marketing, placing into service or use of construction plant as defined in Article 1 if it is fitted or designed to be fitted with an appropriate EEC protective structure. Article 9 1. Any amendments necessary to adapt the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure laid down in Article 24 of Directive 84/532/EEC.2. The procedure laid down in Article 21 of Directive 84/532/EEC shall not be applicable. Article 10 The provisions of this Directive shall not affect the Member States' entitlement to lay down, with due observance of the Treaty, the requirements they deem necessary to ensure that workers are protected when using the equipment in question, provided that this does not mean that the equipment is modified in a way not specified in the Directive. Article 11 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive within 36 months of its notification (1) and shall forthwith inform the Commission thereof.They shall bring these provisions into force 48 months after notification of this Directive.2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 12 This Directive is addressed to the Member States.

31986L0298

1986

Council Directive 86/298/EEC of 26 May 1986 on rear- mounted roll-over protection structures of narrow-track wheeled agricultural and forestry tractors Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (4), as last amended by the Act of Accession of Spain and Portugal, lays down that the necessary provisions for the implementation of the EEC type-approval procedure in respect of individual tractor parts or characteristics should be specified in special directives; whereas the provisions relating to roll-over protection structures and their attachments to tractors were laid down by Directives 77/536/EEC (5) and 79/622/EEC (6), as last amended by the Act of Accession of Spain and Portugal; whereas these two Directives cover respectively dynamic and static testing procedures - either of which may be employed by manufacturers for the present - and relate to standard tractors, that is, tractors having a maximum ground clearance of 1 000 mm and a fixed or adjustable track width of one of the driving axles of not less than 1 150 mm and weighing between 1,5 and 4,5 tonnes in the case of tractors covered by the 'dynamic testing' Directive and not less than 800 kilograms in the case of tractors covered by the 'static testing' Directive;Whereas the tractors covered by this Directive have a maximum ground clearance of 600 mm, a minimum track width of both axles of less than 1 150 mm and a mass greater than 600 kilograms; whereas the roll-over protection structures of these tractors, which are used for specific activities, can be made subject to specific requirement or requirements other than those of Directive 77/536/EEC and 79/622/EEC; Whereas the technical requirements with which such 'narrow-track' tractors must comply pursuant to national laws relate inter alia to roll-over protection structures and to their attachment to the tractor; whereas those requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements either in addition to or in place of their existing rules in order, in particular, to allow the EEC type-approval procedure which was the subject of Directive 74/150/EEC to be introduced in respect of each type of tractor;Whereas this Directive covers roll-over protection structures of the rear-mounted rollbar, frame or cab type having a zone of clearance whose upper limit is 900 mm above the seat reference point in order to provide a sufficiently large area or unobstructed space for the protection of the driver; whereas another special Directive will be adopted in respect of roll-over protection structures having two pillars mounted in front of the driver;Whereas a harmonized component type-approval procedure for roll-over protection structures and their attachment to the tractor makes it possible for each Member State to check compliance with the common construction and testing requirements and to inform the other Member States of its findings by sending them copies of the component type-approval certificate completed for each type of roll-over protection structure and its attachment to the tractor; whereas the placing of an EEC component type-approval mark on all structures manufactured in conformity with the approved type obviates any need for technical checks on those structures in the other Member States; whereas common requirements concerning other elements and characteristics of the roll-over protection structure, in particular, devices to prevent continuous roll-over if the tractor overturns, and protection of occupants, will be laid down at a later date;Whereas the harmonized requirements are intended principally to ensure safety on the road and at work throughout the Community; whereas, for this reason, it is necessary to introduce the obligation for tractors covered by this Directive to be fitted with roll-over protection structures;Whereas the approximation of the national laws relating to these tractors entails reciprocal recognition by Member States of the checks carried out by each of them on the basis of the common requirements, Article 1 This Directive shall apply to tractors as defined in Article 1 of Directive 74/150/EEC having the following characteristics:ground clearance of not more than 600 mm measured beneath the lowest points of the front or rear axles, allowing for the differential,fixed or adjustable minimum track width of one of the two axles less than 1 150 mm; under no circumstances must the outer edge of the tyres on the other axle go beyond the outer edge of the tyres on the axle of 1 150 mm minimum track width,mass greater than 600 kilograms and corresponding to the unladen weight of the tractor as defined in section 2.4 of Annex I to Directive 74/150/EEC, including the roll-over protection structure fitted in compliance with this Directive and tyres of the largest size recommended by the manufacturer. Article 2 1. Each Member State shall grant EEC component type-approval for any type of roll-over protection structure and its tractor attachment which satisfies the construction and testing requirements laid down in Annexes I to IV.2. A Member State which has granted EEC component type-approval shall take the measures required to verify, in so far as is necessary and if need be in cooperation with the competent authorities in the other Member States, that production models conform to the approved type. Such verification shall be limited to spot checks. Article 3 Member States shall, for each type of roll-over protection structure and its tractor attachment which they approve pursuant to Article 2, issue to the manufacturer of the tractor or of the roll-over protection structure, or to his authorized representative, an EEC component type-approval mark conforming to the model shown in Annex VI.Member States shall take all appropriate measures to prevent the use of marks liable to create confusion between roll-over protection structures which have been component type-approved pursuant to Article 2 and other devices. Article 4 1. N° Member State may prohibit the placing on the market of roll-over protection structures or their attachment to the tractors for which they are intended on grounds relating to their construction if they bear the EEC component type-approval mark.2. Nevertheless, a Member State may prohibit the placing on the market of roll-over protection structures bearing the EEC component type-approval mark which consistently fail to conform to the approved type.That State shall forthwith inform the other Member States and the Commission of the measures taken, specifying the reasons for its decision. Article 5 The competent authorities of each Member State shall, within one month, send to the competent authorities of the Member State a copy of the component type-approval certificates, an example of which is given in Annex VII, completed for each type of roll-over protection structure which they approve or refuse to approve. Article 6 1. If the Member State which has granted EEC component type-approval finds that a number of roll-over protection structures and their tractor attachments bearing the same EEC component type-approval mark do not conform to the type which it has approved, it shall take the necessary measures to ensure that production models conform to the approved type. The competent authorities of that State shall advise those of the other Member States of the measures taken which may, if necessary, where there is serious and repeated failure to conform, extend to withdrawal of EEC component type-approval. The said authorities shall take the same measures if they are informed by the competent authorities of another Member State of such failure to conform.2. The competent authorities of the Member States shall within one month inform each other of any withdrawal of EEC component type-approval and of the reasons for any such measure. Article 7 Any decision taken pursuant to the provisions adopted in implementation of this Directive to refuse or withdraw component type-approval for roll-over protection structures and their tractor attachments, or to prohibit their placing on the market or their use, shall set out in detail the reasons on which it is based. Such decisions shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 8 N° Member State may refuse to grant EEC type-approval or national type-approval in respect of a tractor on grounds relating to roll-over protection structures or their tractor attachment if these bear the EEC component type-approval mark and if the requirements laid down in Annex VIII have been satisfied. Article 9 N° Member State may refuse or prohibit the sale, registration, entry into service or use of any tractor on grounds relating to the roll-over protection structure and its tractor attachment if these bear the EEC component type-approval mark and if the requirements laid down in Annex VIII have been met. Article 10 This Directive shall not affect the right of Member States to specify - in due compliance with the Treaty - the requirements they deem necessary to ensure that workers are protected when using the tractors in question, provided this does not mean that the protection structures are modified in a way unspecified in this Directive. Article 11 1. In connection with EEC type-approval, any tractor to which Article 1 refers must be fitted with a roll-over protection structure.2. Where the protection structure is not one having two pillars mounted in front of the driver's seat, the structure referred to in paragraph 1 must comply with the requirements laid down in Annexes I to IV to this Directive or to Directives 77/536/EEC or 79/622/EEC. Article 12 Any amendments necessary in order to adapt the requirements of the Annexes to this Directive so as to take account of technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 74/150/EEC. Article 13 Within 18 months of the notification of this Directive, the Council, acting on a proposal from the Commission, on the basis of the provisions of the Treaty, shall adopt a Directive supplementing this Directive by means of provisions introducing the additional impact tests in the dynamic test procedure. Article 14 1. Member States shall bring into force the provisions necessary in order to comply with this Directive within 24 months of its notification (1). They shall forthwith inform the Commission thereof.2. Member States shall ensure that the texts of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission. Article 15 This Directive is addressed to the Member States.

31986L0299

1986

Fourth Commission Directive 86/299/EEC of 3 June 1986 amending the Annex to Council Directive 74/63/EEC on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (1) as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 6 thereof, Whereas Directive 74/63/EEC provides for regular amendment of its Annex to take account of advances in scientific and technical knowledge; Whereas, in so far as there are no special provisions for complementary feedingstuffs, theses may not, allowing for the dilutions prescribed for their use, contain levels of undesirable substances and products in excess of those fixed in the Annex to the Directive for complete feedingstuffs; Whereas it appears that keeping to this rule does not always permit the prescribed maximum levels for complete feedingstuffs to be respected, in cases where complementary feedingstuffs are taken into the daily ration with other feedingstuffs that are also contaminated; whereas it is suitable therefore to limit the presence of certain undesirable substances or products in complementary feedingstuffs by fixing appropriate maximum levels; Whereas the measures provided for in this Directive are in accordance with the opinion on the Standing Committee for Feedingstuffs: Article 1 The Annex to Directive 74/63/EEC is amended according to the Annex of the present Directive. Article 2 The Member States shall bring into force, on 31 December 1987 at the latest, the laws, regulations and administrative provisions necessary to comply with Article 1. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0300

1986

Commission Directive 86/300/EEC of 4 June 1986 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 86/29/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular adaptation of the content of its Annexes to the evolution of scientific and technical knowledge; whereas the Annexes were consolidated by Commission Directive 85/429/EEC (3); Whereas the maximum content of copper needs to be decreased for sheep feedingstuffs, in order that the real physiological need (requirements) of the animals is satisfied without causing any adverse effect for their health; 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 hereto. Article 2 Member States shall, by 31 December 1987, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive, and shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0280

1986

Council Directive 86/280/EEC of 12 June 1986 on limit values and quality objectives for discharges of certain dangerous substances included in List I of the Annex to Directive 76/464/EEC Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to Council Directive 76/464/EEC of 4 May 1976 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community(1), and in particular Article 6 thereof, Having regard to the proposal from the Commission(2), Having regard to the opinion of the European Parliament(3), Having regard to the opinion of the Economic and Social Committee(4), Whereas, in order to protect the aquatic environment of the Community against pollution by certain dangerous substances, Article 3 of Directive 76/464/EEC introduces a system of prior authorization laying down emission standards for discharges of the substances in List I in the Annex thereto; whereas Article 6 of the said Directive provides that limit values shall be laid down for such emission standards and also quality objectives for the aquatic environment affected by discharges of these substances; Whereas Member States are required to apply the limit values except in cases where they may employ quality objectives; Whereas the dangerous substances covered by this Directive have been chosen mainly on the basis of the criteria adopted in Directive 76/464/EEC; Whereas, since pollution due to the discharge of these substances into the aquatic environment is caused by a large number of industries, it is necessary to lay down specific limit values for discharges according to the type of industry concerned and to lay down quality objectives for the aquatic environment into which these substances are discharged; Whereas the purpose of the limit values and quality objectives is to eliminate pollution of the various parts of the aquatic environment which might be affected by discharges of these substances; Whereas such limit values and quality objectives must be laid down for this purpose and not with the intention of establishing rules pertaining to consumer protection or to the marketing of products from the aquatic environment; Whereas, to enable Member States to demonstrate that the quality objectives are being met, provision should be made for reports to the Commission for each quality objective chosen and applied; Whereas Member States should seek to ensure that the measures taken pursuant to this Directive do not have the effect of increasing soil or air pollution; Whereas, moreover, for the purposes of effective implementation of this Directive, provision should be made for the monitoring by the Member States of the aquatic environment affected by discharges of the substances in question; whereas the powers to introduce such monitoring are not provided by Directive 76/464/EEC; whereas, since the specific powers have not been provided for in the Treaty, recourse should be had to Article 235 thereof; Whereas, in the case of certain significant sources of pollution by these substances other than sources subject to Community limit values or national emission standards, specific programmes should be devised to eliminate the pollution; whereas the necessary powers to that effect have not been provided by Directive 76/464/EEC; whereas, since the specific powers have not been provided for in the EEC Treaty, recourse should be had to Article 235 thereof; Whereas ground water can be excluded from the scope of this Directive since it is the subject of Directive 80/68/EEC(5); Whereas, for the purposes of effective implementation of this Directive, it is important that the Commission should forward to the Council, every five years, a comparative assessment of its implementation by the Member States; Whereas this Directive will have to be amended and supplemented, on proposals from the Commission, in line with developments in scientific knowledge relating principally to the toxicity, persistence and accumulation of the substances referred to in living organisms and sediments, or in the event of an improvement in the best technical means available; whereas it is necessary, for that purpose, to provide for additions to this Directive, relating to measures in respect of other dangerous substances, and for amendments to the content of the Annexes, Article 1 1. This Directive: -lays down, pursuant ot Article 6 (1) of Directive 76/464/EEC, limit values for emission standards for the substances referred to in Article 2 (a) in discharges from industrial plants as defined in Article 2 (e) of this Directive, -lays down, pursuant to Article 6 (2) of Directive 76/464/EEC, quality objectives for the substances referred to in Article 2 (a) of this Directive in the aquatic environment, -lays down, pursuant to Article 6 (4) of Directive 76/464/EEC, the time limits for compliance with the conditions specified in the authorizations granted by the competent authorities of Member States in respect of existing discharges, -lays down, pursuant to Article 12 (1) of Directive 76/464/EEC, the reference methods of measurement enabling the content of the substances referred to in Article 2 (a) of this Directive in discharges and in the aquatic environment to be determined, -establishes, pursuant to Article 6 (3) of Directive 76/464/EEC, a monitoring procedure, -requires Member States to cooperate with one another in the case of discharges affecting the waters of more than one Member State, -requires Member States to draw up programmes to avoid or eliminate pollution arising from the sources referred to in Article 5, -lays down in Annex I a set of general provisions applicable to all the substances referred to in Article 2 (a) and relating, in particular, to limit values for emission standards (heading A), quality objectives (heading B) and reference methods of measurement (heading C), -lays down in Annex II a set of specific provisions which amplify and supplement those headings in respect of individual substances. 2. This Directive applies to the waters referred to in Article 1 of Directive 76/464/EEC, with the exception of ground water. Article 2 For the purposes of this Directive: (a)'substances' means: those dangerous substances, belonging to the families and groups of substances appearing in List I in the Annex to Directive 76/464/EEC, which are specified in Annex II to this Directive; (b)'limit values' means: the values specified in Annex II, under heading A, in respect of the substances referred to in (a); (c)'quality objectives' means: the requirements specified in Annex II, under heading B, in respect of the substances referred to in (a); (d)'handling of substances' means: any industrial process involving the production, the processing or use of the substances referred to in (a), or any other industrial process in which the presence of such substances is inherent; (e)'industrial plant' means: a plant at which the substances referred to in (a), or any other substances containing them, are handled; (f)'existing plant' means: an industrial plant which is operational at a date 12 months after the date of notification of this Directive or, where applicable, at a date 12 months after the date of notification of any Directive amending it that relates to such plant; (g)'new plant' means: -an industrial plant which becomes operational later than 12 months after the date of notification of this Directive or, where applicable, later than 12 months after the date of notification of any Directive amending it that relates to such plant, -an existing industrial plant whose capacity for handling the substances is substantially increased later than 12 months after the date of notification of this Directive or, where applicable, later than 12 months after the date of notification of any Directive amending it that relates to such plant. Article 3 1. The limit values, the time limits for compliance therewith and the procedures for monitoring discharges are laid down in the Annexes, under heading A. 2. The limit values shall normally apply at the point where waste waters containing the substances referred to in Article 2 (a) leave the industrial plant. Should it be considered necessary in the case of certain substances to lay down other points where the limit values shall apply, these points shall be listed in Annex II. When waste waters containing these substances are treated outside the industrial plant at a treatment plant intended for their removal, the Member State may permit the limit values to be applied at the point where the waste waters leave the treatment plant. 3. The authorizations referred to in Article 3 of Directive 76/464/EEC must contain provisions as stringent as those set out under heading A in the Annexes to this Directive, except where a Member State is complying with Article 6 (3) of Directive 76/464/EEC on the basis of heading B in the Annexes to this Directive. Authorizations shall be reviewed at least every four years. 4. Without prejudice to their obligations arising from paragraphs 1, 2 and 3 and to Directive 76/464/EEC, Member States may grant authorizations for new plants only if those plants apply the standards corresponding to the best technical means available when that is necessary for the elimination of pollution in accordance with Article 2 of the said Directive or for the prevention of distortions of competition. Whatever method it adopts, the Member State concerned shall, where for technical reasons the measures envisaged do not correspond to the best technical means available, provide the Commission, before any authorization, with evidence in support of those reasons. The Commission shall immediately forward such evidence to the other Member States and shall send all Member States a report, at the earliest opportunity, giving its opinion on the derogation referred to in the second subparagraph. If necessary, it shall at the same time submit appropriate proposals to the Council. 5. The reference method of analysis to be used in determining the presence of the substances referred to in Article 2 (a) is given under heading C in Annex II. Other methods may be used provided that the limits of detection, precision and accuracy of such methods are at least as good as those laid down under heading C in Annex II. 6. Member States shall seek to ensure that the measures taken pursuant to this Directive do not result in an increase in the pollution of other media, notably soil and air, by these substances. Article 4 The Member States concerned shall be responsible for monitoring the aquatic environment affected by discharges from industrial establishments and by other sources of significant discharges. In the case of discharges affecting the waters of more than one Member State, the Member States concerned shall cooperate with a view to harmonizing monitoring procedures. Article 5 1. As regards substances to which specific reference is made in Annex II, the Member States shall draw up specific programmes to avoid or eliminate pollution from significant sources of these substances (including multiple and diffuse sources) other than sources of discharges subject to Community limit value rules or national emission standards. 2. The programmes shall include the most appropriate measures and techniques for the replacement, retention and/or recycling of the substances referred to in para- graph 1. 3. The specific programmes must be implemented not later than five years after the date of notification of the Directive which relates specifically to the substance concerned. Article 6 1. The Commission shall make a comparative assessment of the implementation of this Directive by Member States on the basis of information supplied to it by them pursuant to Article 13 of Directive 76/464/EEC at its request, which it must submit case by case. The information concerned shall, in particular, comprise: -details of authorizations laying down emission standards for discharges of the substances, -the inventory of the substances discharged into the waters referred to in Article 1 (2), -compliance with either the limit values or the quality objectives set out under headings A and B of Annex II, -the results of the monitoring referred to in Article 4 of the area of the aquatic environment which is affected by discharges, -the specific elimination programmes referred to in Article 5. 2. The Commission shall forward the comparative assessment referred to in paragraph 1 to the Council every five years, and for the first time four years after notification of this Directive. 3. Should there be a change in scientific knowledge relating principally to the toxicity, persistence and accumulation of the substances referred to in Article 2 (a) in living organisms and sediments, or in the event of an improvement in the best technical means available, the Commission shall submit appropriate proposals to the Council with the aim of making the limit values and the quality objectives more stringent, if appropriate, or of establishing new limit values and additional quality objectives. Article 7 1. Member States shall bring into force the measures necessary to comply with this Directive by 1 January 1988. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission, immediately after adoption, the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 8 This Directive is addressed to the Member States.

31986L0278

1986

Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission(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 aim of this Directive is to regulate the use of sewage sludge in agriculture in such a way as to prevent harmful effects on soil, vegetation, animals and man, while encouraging its correct use; Whereas the disparity between the Member States' provisions on the agricultural applications of sewage sludge might affect the functioning of the common market; whereas in this field the approximation of laws provided for under Article 100 of the Treaty should therefore be instigated; Whereas sewage sludge used in agriculture is not covered by Council Directive 75/442/EEC of 15 July 1975 on waste(4); Whereas the measures for which provision is made in Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste(5) also apply to sewage sludge containing or contaminated by substances or materials listed in the Annex to that Directive which are of such a nature or are present in such quantities or concentrations that they represent a hazard to human health or to the environment; Whereas special arrangements should be made to ensure that man, animals, plants and the environment are fully safeguarded against the harmful effects arising from the uncontrolled use of sludge; Whereas this Directive also aims at establishing certain initial Community measures in connection with soil protection; Whereas sludge can have valuable agronomic properties and it is therefore justified to encourage its application in agriculture provided it is used correctly; whereas the use of sewage sludge must not impair the quality of the soil and of agricultural products; Whereas some heavy metals may be toxic to plants and also to man through their presence in crops and whereas it is necessary to lay down mandatory limit values for these elements in the soil; Whereas the use of sludge should be prohibited when the concentration of these metals in the soil exceeds these limit values; Whereas, moreover, it is necessary to prevent these limit values from being exceeded as a result of the use of sludge; whereas, to this end, it is necessary to limit the amount of heavy metals added to cultivated soil either by setting maximum quantities for the amounts of sludge used per annum and ensuring that the limit values for the concentration of heavy metals in the sludge used are not exceeded or by seeking to ensure that limit values for the quantities of heavy metals that can be added to the soil on the basis of a 10-year average are not exceeded; Whereas sludge must be treated before being used in agriculture; whereas Member States may nevertheless authorize, on certain conditions, the use of untreated sludge, without risk to human or animal health, if it is injected or worked into the soil; Whereas a certain period must elapse between using the sludge and putting stock out to pasture or harvesting fodder crops or certain crops which are normally in direct contact with the soil and normally consumed raw; whereas the use of sludge on fruit and vegetable crops during the growing season, except for fruit-tree crops, must be prohibited; Whereas sludge should be used under conditions which ensure that the soil and the surface and ground water are protected, in accordance with Directives 75/440/EEC(1) and 80/68/EEC(2); Whereas to this end it is necessary to monitor the quality of sludges and of the soils on which they are used and hence to make analyses and to communicate certain results to the users; Whereas a certain amount of essential information should be kept to ensure better awareness of the use of sludge in agriculture and whereas such information should be forwarded in the form of periodic reports to the Commission; whereas, in the light of these reports, the Commission will if necessary draw up proposals to ensure greater protection for the soil and the environement; Whereas sludge from small sewage-treatment plants which treat primarily domestic waste water represents little danger to human, animal and plant health and to the environment and should therefore be exempt from some of the obligations laid down relating to information and analysis; Whereas Member States should be able to draw up more stringent provisions than those laid down in this Directive; whereas such provisions should be communicated to the Commission; Whereas technical and scientific progress may make necessary the rapid adaptation of certain of the requirements laid down in this Directive; whereas, in order to facilitate the introduction of the measures required for this purpose, a procedure should be laid down whereby close cooperation could be established between the Member States and the Commission; whereas such cooperation should take place within a Committee on Adaptation to Technical and Scientific Progress; Whereas the Treaty has not provided the necessary powers, other than those of Article 235, Article 1 The purpose of this Directive is to regulate the use of sewage sludge in agriculture in such a way as to prevent harmful effects on soil, vegetation, animals and man, thereby encouraging the correct use of such sewage sludge. Article 2 For the purposes of this Directive: (a)'sludge' means: (i)residual sludge from sewage plants treating domestic or urban waste waters and from other sewage plants treating waste waters of a composition similar to domestic and urban waste waters; (ii)residual sludge from septic tanks and other similar installations for the treatment of sewage; (iii)residual sludge from sewage plants other than those referred to in (i) and (ii); (b)'treated sludge' means: sludge which has undergone biological, chemical or heat treatment, long-term storage or any other appropriate process so as significantly to reduce its fermentability and the health hazards resulting from its use; (c)'agriculture' means: the growing of all types of commercial food crops, including for stock-rearing purposes; (d)'use' means: the spreading of sludge on the soil or any other application of sludge on and in the soil. Article 3 1. The sludge referred to in Article 2 (a) (i) may only be used in agriculture in accordance with this Directive. 2. Without prejudice to Directives 75/442/EEC and 78/319/EEC: -the sludge referred to in Article 2 (a) (ii) may be used in agriculture subject to any conditions that the Member State concerned may deem necessary for the protection of human health and the environment, -the sludge referred to in Article 2 (a) (iii) may be used in agriculture only if its use is regulated by the Member State concerned. Article 4 Values for concentrations of heavy metals in soil to which sludge is applied, concentrations of heavy metals in sludge and the maximum annual quantities of such heavy metals which may be introduced into soil intended for agriculture are given in Annexes I A, I B and I C. Article 5 Without prejudice to Article 12: 1.Member States shall prohibit the use of sludge where the concentration of one or more heavy metals in the soil exceeds the limit values which they lay down in accordance with Annex I A and shall take the necessary steps to ensure that those limit values are not exceeded as a result of the use of sludge. 2.Member States shall regulate the use of sludge in such a way that the accumulation of heavy metals in the soil does not lead to the limit values referred to in paragraph 1 being exceeded. To achieve this, they shall apply one or other of the procedures provided for in (a) and (b) below: (a)Member States shall lay down the maximum quantities of sludge expressed in tonnes of dry matter which may be applied to the soil per unit of area per year while observing the limit values for heavy metal concentration in sludge which they lay down in accordance with Annex I B; or (b)Member States shall ensure observance of the limit values for the quantities of metals introduced into the soil per unit of area and unit of time as set out in Annex I C. Article 6 Without prejudice to Article 7: (a)sludge shall be treated before being used in agriculture. Member States may nevertheless authorize, under conditions to be laid down by them, the use of untreated sludge if it is injected or worked into the soil; (b)sewage-sludge producers shall regularly provide users with all the information referred to in Annex II A. Article 7 Member States shall prohibit the use of sludge or the supply of sludge for use on: (a)grassland or forage crops if the grassland is to be grazed or the forage crops to be harvested before a certain period has elapsed. This period, which shall be set by the Member States taking particular account of their geographical and climatic situation, shall under no circumstances be less than three weeks; (b)soil in which fruit and vegetable crops are growing, with the exception of fruit trees; (c)ground intended for the cultivation of fruit and vegetable crops which are normally in direct contact with the soil and normally eaten raw, for a period of 10 months preceding the harvest of the crops and during the harvest itself. Article 8 The following rules shall be observed when using sludge: -the sludge shall be used in such a way that account is taken of the nutrient needs of the plants and that the quality of the soil and of the surface and ground water is not impaired, -where sludge is used on soils of which the pH is below 6, Member States shall take into account the increased mobility and availability to the crop of heavy metals and shall, if necessary, reduce the limit values they have laid down in accordance with Annex I A. Article 9 Sludge and soil on which it is used shall be analyzed as outlined in Annexes II A and II B. The reference methods for sampling and analysis are indicated in Annex II C. Article 10 1. Member States shall ensure that up-to-date records are kept, which register: (a)the quantities of sludge produced and the quantities supplied for use in agriculture; (b)the composition and properties of the sludge in relation to the parameters referred to in Annex II A; (c)the type of treatment carried out, as defined in Article 2 (b); (d)the names and addresses of the recipients of the sludge and the place where the sludge is to be used. 2. The records shall be available to the competent authorities and shall provide a basis for the consolidated report referred to in Article 17. 3. Information on the methods of treatment and the results of the analyses shall be released upon request to the competent authorities. Article 11 Member States may exempt from Article 6 (b) and Article 10 (1) (b), (c) and (d) and paragraph 2, sludge from sewage treatment plants with a treatment capacity below 300 kg BOD5 per day, corresponding to 5 000 person equivalents, which are designed primarily for the treatment of domestic waste water. Article 12 Where conditions so demand, Member States may take more stringent measures than those provided for in this Directive. Any decision of this nature shall be communicated to the Commission in accordance with existing agreements. Article 13 Adaptation to technical and scientific progress, in accordance with the procedure referred to in Article 15, shall cover the provisions of the Annexes to the Directive, except for the parameters and values listed in Annexes I A, I B and I C, any factors likely to affect the evaluation of the values, and the parameters for analysis referred to in Annexes II A and II B. Article 14 1. A committee for adapting this Directive to technical and scientific progress (hereinafter called 'the Committee') is hereby set up. It shall consist of representatives of the Member States with a representative of the Commission as chairman. 2. The Committee shall draw up its own rules of procedure. Article 15 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the 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 adopted. The Committee shall deliver its opinion on the draft within a period to be determined by the chairman according to the urgency of the matter. It shall decide by a majority of 54 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3.(a)The Commission shall adopt the measures envisaged where these are in accordance with the opinion of the Committee. (b)Where the measures envisaged are not in accordance with the opinion of the Committee or if no opinion has been given, the Commission shall forthwith propose to the Council the measures to be adopted. The Council shall act by a qualified majority. (c)If, within three months of the proposal being submitted to it, the Council has not acted, the measures proposed shall be adopted by the Commission. Article 16 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within three years of its notification. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 17 Five years after notification of this Directive, and every four years thereafter, Member States shall prepare a consolidated report on the use of sludge in agriculture setting out the quantities used, the criteria followed and any difficulties encountered; they shall forward this report to the Commission, which shall publish the information contained therein. In the light of that report, the Commission shall if necessary submit appropriate proposals for increased protection of the soil and the environment. Article 18 This Directive is addressed to the Member States.

31986L0279

1986

Council Directive 86/279/EEC of 12 June 1986 amending Directive 84/631/EEC on the supervision and control within the European Community of the transfrontier shipment of hazardous waste Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission(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 programme of action of the European Communities on the environment, approved by the Council on 22 N°vember 1973(4), the continuation and implementation of which are the subject of the resolutions of 17 May 1977(5) and 7 February 1983(6), provides for Community action aimed at controlling the disposal of hazardous wastes; Whereas, pursuant to Directive 78/319/EEC(7), Member States are required to take the necessary measures to ensure that toxic and dangerous waste is disposed of without endangering human health and without harming the environment; Whereas for this purpose Directive 84/631/EEC(8) organizes the supervision and control within the Community of the transfrontier shipment of hazardous waste; Whereas, in connection with protecting the environment against dangers arising out of such waste, account must be taken of the risk of pollution occurring outside the Community; Whereas, therefore, in the case of waste being transferred outside the Community the holder must, when notifying the transfer, furnish satisfactory information in respect of the agreement of the non-member State of destination and whereas the consignee of the waste must possess adequate technical capacity for the disposal of the waste; Whereas, moreover, experience has shown that, in the case of waste being transferred outside the Community, it would be more fitting for the right to issue the acknowledgement of receipt of the notification or to raise objections to the transfer to be given to the dispatching Member State; whereas, however, in certain circumstances, the Member State of final transit of the waste should be able to exercise that right; Whereas, in order to take account of these various requirements, Directive 84/631/EEC should be amended, Article 1 Articles 3, 4, 5, 7 and 17 of Directive 84/631/EEC are replaced by the following: 'Article 3 1. Where the holder of the waste intends to ship it or to have it shipped from one Member State to another, to have it routed through one or more Member States, or to ship it to a Member State from a third State or from a Member State to a third State, he shall notify the competent authority of the Member State responsible for issuing the acknowledgement of receipt, with a copy to the competent authorities of the other Member States concerned and, where applicable, to the third State of destination and/or the third State(s) of transit. 2. N°tification shall be effected by means of a uniform consignment note, hereinafter referred to as the 'consignment note', to be drawn up in accordance with Article 15 and the contents of which are set out in Annex I. 3. When so notifying the competent authority of the Member State responsible for issuing the acknowledgement of receipt, the holder of the waste shall provide it with satisfactory information on the following in particular: -the source and composition of the waste, including the producer's identity, and in the case of waste from various sources, a detailed inventory of the waste and, where such information exists, the identity of the original producers, -the provision made for routes and insurance against damage to third parties, -the measures to be taken to ensure safe transport and, in particular, compliance by the carrier with the conditions laid down by the Member States concerned for the exercise of such transport operations, -the existence of a contractual agreement with the consignee of the waste, who should possess adequate technical capacity for the disposal of the waste in question under conditions presenting no danger to human health or the environment. Where the waste is stored, treated or dumped in a Member State, the consignee must also possess a permit in accordance with Article 9 of Directive 78/319/EEC or Article 6 of Directive 76/403/EEC. 4. In the case of a shipment from a Member State to a third State, the holder of the waste shall obtain the agreement of the third State of destination before embarking upon the notification procedure provided for in paragraph 3. The notification must include satisfactory information on such agreement. Article 4 1. Transfrontier shipment may not be effected before the competent authorities of the Member States referred to in paragraph 2 (a), (b) or (c) have acknowledged receipt of the notification. The acknowledgement shall be entered on the consignment note. 2. N°t later than one month after receipt of the notification, the acknowledgement of receipt or any objection raised in accordance with paragraph 3 shall be forwarded to the holder of the waste: (a)either by the competent authorities of the Member State of destination; or (b)in the case of shipments of waste from a third State in transit through the Community for disposal outside the Community, by the competent authorities of the last Member State through which the shipment is due to pass; or (c)in the case of shipments of waste from a Member State for disposal outside the Community in a third State, by the competent authorities of the Member State of dispatch, except in the case provided for in the last subparagraph of this paragraph with a copy to the consignee of the waste and to the competent authorities of the other Member States concerned, and where applicable, to the third State of destination and the third State(s) of transit. Where the waste is disposed of in a third State bordering on the last Member State of transit, the latter shall be entitled to issue the acknowledgement of receipt or to raise any objection in place of the Member State referred to in (c). A Member State of transit intending to exercise the right conferred upon it in this subparagraph shall communicate it to the Commission and other Member States. It may not exercise this right earlier than three months following such communication. 3. Objections must be substantiated on the basis of laws and regulations relating to environmental protection, public policy and public security or health protection which are in conformity with this Directive, with other Community instruments or with international conventions on this subject concluded by the Member State concerned prior to notification of this Directive. 4. Once the competent authorities of the Member State referred to in paragraph 2 are satisfied that the problems giving rise to their objections have been resolved, they shall immediately send an acknowledgement to the holder of the waste with a copy to the consignee of the waste and to the competent authorities of the other Member States concerned, and, where applicable, to the third State of destination and the third State(s) of transit. 5. The acknowledgement forwarded by the competent authorities of the Member State referred to in paragraph 2 to the holder of the waste pursuant to this Article shall not release the producer of such waste or any other person from his obligations under existing national and Community provisions. 6. Without prejudice to paragraphs 1 and 2, the competent authorities of the Member State of dispatch, and those of the Member State or States of transit, if any, shall have 15 days following the notification in which to lay down, if appropriate, conditions in respect of the shipment of waste in their national territory. These conditions, which shall be forwarded to the holder of the waste, with a copy to the competent authorities of the Member States concerned, may not be more stringent than those laid down in respect of similar shipments effected wholly within the Member State in question and shall take due account of existing agreements. The holder of the waste must comply with these conditions to be able to carry out shipment. N°t later than 20 days after receipt of the notification, the competent authorities of the Member State of dispatch may raise objections on the grounds that the shipment of waste adversely affects the implementation of plans drawn up pursuant to Article 12 of Directive 78/319/EEC or Article 6 of Directive 76/403/EEC or that it conflicts with obligations resulting from international agreements on this subject concluded by it prior to notification of this Directive. Such objections shall be forwarded to the holder of the waste with a copy to the competent authorities of the Member States concerned. Article 5 1. The holder of the waste may use a general nofitication procedure where waste having the same physical and chemical characteristics is shipped regularly to the same consignee via the same customs office of exit of the Member State of dispatch, via the same customs office of entry of the Member State of destination and, in the case of transit, via the same customs offices of entry and exit of the Member State or States of transit. 2. The competent authorities of the Member State referred to in Article 4 (2) and, where applicable, those of the Member State or States of transit, may make their agreement to the use of this general notification procedure subject to the supply of certain information, such as the exact quantities or periodical lists of waste to be shipped. 3. Under a general notification procedure, a single acknowledgement within the meaning of Article 4 (1) may cover several shipments of waste during a maximum period of one year. 4. General notification shall be by means of the consignment note. Article 7 1. By way of derogation from Article 6 (4), when waste leaves the Community for disposal outside the Community, the customs service in the last Member State through which the shipment passes shall forward a copy of the consignment note to the competent authorities in that Member State, which, in the case referred to in Article 4 (2) (c), shall also forward a copy to the competent authorities in the Member State of dispatch. These copies shall be kept for at least two years. 2. The holder of the waste shall also declare or certify to the competent authorities of the Member State referred to in Article 4 (2) (b) or (c), not later than six weeks after the waste has left the Community, that the waste has reached its proper destination and shall indicate the last customs post in the Community through which the shipment passed. Article 17 Waste (including in particular waste, scrap, sludge, ash and dust) from non-ferrous metals which is intended for re-use, regeneration or recycling on the basis of a contractual agreement relating to such operations shall be exempt from the provisions of this Directive provided that the following conditions are fulfilled: (a)the holder must make a declaration on a uniform document, the contents of which are set out in Annex III and which must accompany the shipment, to the effect that the materials concerned are intended for the operations in question and must forward a copy of this document to the competent authorities of the Member State referred to in Article 4 (2); (b)the consignee must declare in that same document, which he shall forward to the competent authorities of the Member State referred to in (a) not more than 15 days after receipt of the materials, that these operations will actually be carried out.' Article 2 1. Member States shall bring into force, not later than 1 January 1987, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31986L0431

1986

Seventh Commission Directive 86/431/EEC of 24 June 1986 adapting to technical progress Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(1), as last amended by Directive 79/831/EEC(2), and in particular Article 19 thereof, (1)OJ N 196, 16. 8. 1967, p. 1. (2)OJ N L 259, 15. 10. 1979, p. 10. Whereas Annex I to Directive /548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance; whereas examination of the list of dangerous substances has shown that this list needs to be adapted in the light of present scientific and technical knowledge or, more precisely, that it is necessary to change the classification and labelling of certain substances, to clarify certain names, to correct certain CAS-numbers (Chemical Abstract Service) and to enter other substances in the list; Whereas Annex II to Directive 67/548/EEC illustrates the symbols and indications of danger; whereas, in view of the advances in knowledge, a certain indication of danger can be better formulated in the German language; Whereas Annexes III and IV to Directive 67/548/EEC define the indications of special risks (R-phrases) and safety advice (S-phrases); whereas certain R- and S-phrases can be better formulated in the Danish language; whereas in view of the advances in knowledge it is necessary to introduce new safety advice; Whereas Annex VI, D, to Directive 67/548/EEC contains a guide to the classification and labelling of dangerous substances and preparations; whereas it is necessary to correct in this Annex some criteria for the choice of phrases indicating the special risks (R phrases) and to define the criteria for the choice of a new safety advice phrase (S phrase); Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Directive 67/548/EEC is hereby amended as follows: 1. Annex I (list of dangerous substances): 1. The following Note E is added after Note D in the foreword to Annex I: 'Note E For substances ascribed Note E the risk phrases R 20, R 21, R 22, R 23, R 24, R 25, R 26, R 27 and R 28 and all combinations of these risk phrases shall be preceded by the word "also". Examples: R 23: 'Also toxic by inhalation.' R 27 / R 28: 'Also very toxic in contact with skin and if swallowed.' 2. The designation, CAS-number, classification and labelling of the substances of Annex I detailed below are replaced by those listed in Annex I to this Directive. No 016-023-00-4 No 016-027-00-6 No 048-008-00-3 No 601-020-00-8 No 602-010-00-6 No 602-021-00-6 No 603-026-00-6 No 603-046-00-5 No 603-070-00-6 No 608-003-00-4 No 609-002-00-1 No 612-022-00-3 No 612-042-00-2 3. The substances listed in Annex II to this Directive are added to Annex I. 2. Annex II (Symbols and indications of danger): In the German language the term 'Gesundheitsschädlich' next to the symbol 'Xn' of Annex II is replaced by the term 'Mindergiftig (Gesundheitsschädlich)'. 3. Annex III (Nature of special risks attaching to dangerous substances): 1. In the Danish language the following R-phases replace those listed in Annex III: 'R 21 Farlig ved hudkontakt R 24 Giftig ved hudkontakt R 27 Meget giftig ved hudkontakt R 33 Kan ophobes i kroppen efter gentagen brug R 39 Fare for varig skade på helbred R 40 Mulighed for varig skade på helbred R 42 Kan give allergi ved indånding R 43 Kan give allergi ved kontakt med huden'. 2. In the Danish language the following combinations of R-phrases replace those listed in Annex III: 'R 20 / 21 Farlig ved indånding og ved hudkontakt R 21 / 22 Farlig ved hudkontakt og ved indtagelse R 20 / 21 / 22 Farlig ved indånding, ved hudkontakt og ved indtagelse R 23 / 24 Giftig ved indånding og ved hudkontakt R 24 / 25 Giftig ved hudkontakt og ved indtagelse R 23 / 24 / 25 Giftig ved indånding, ved hudkontakt og ved indtagelse R 26 / 27 Meget giftig ved indånding og ved hudkontakt R 27 / 28 Meget giftig ved hudkontakt og ved indtagelse R 26 / 27 / 28 Meget giftig ved indånding, ved hudkontakt og ved indtagelse R 42 / 43 Kan give allergi ved indånding og ved kontakt med huden.' 4. Annex IV (Safety advice concerning dangerous chemical substances): 1. The following phrase is added to Annex IV: 'S 53: ES: Evitese la exposición - recábense instrucciones especiales antes del uso DA: Undgå enhver kontakt - indhent særlige anvisninger før brug DE: Exposition vermeiden - vor Gebrauch besondere Anweisungen einholen GR: Áðïöåýãåôå ôçí Ýêèåóç - åöïäéáóôåßôå ìå åéäéêÝò ïäçãßåò ðñéí ôçí ÷ñçóéìïðïßçóç EN: Avoid exposure - obtain special instruction before use FR: Éviter l'exposition - se procurer des instructions spéciales avant l'utilisation IT: Evitare l'esposizione - procurarsi speciali istruzioni prima dell'uso NL: Blootstelling vermijden - vóór gebruik speciale aanwijzingen raadplegen PT: Evitar a exposição - obter instruções especiais antes da utilização'. 2. In the Danish language the following S-phrases replace those listed in Annex IV: 'S 26 Kommer stoffet i øjnene, skylles straks grundigt med vand og læge kontaktes S 28 Kommer stof på huden vaskes straks med store mængder...(angives af producenten eller importøren) S 30 Hæld aldrig vand på eller i produktet S 36 Brug særligt arbejdstøj S 37 Brug egnede beskyttelseshandsker under arbejdet S 38 Brug egnet åndedrætsværn, his effektiv ventilation ikke er mulig S 39 Brug beskyttelsesbriller/ansigtsskærm under arbejdet S 41 Undgå at indånde røgen ved brand eller eksplosion S 43 Brug...ved brandslukning (Den nøjagtige type brandslukningsudstyr angives af producenten eller importøren. Såfremt vand ikke må bruges tilføjes:'Brug ikke vand') S 45 Ved ulykkestilfælde eller ved ildebefindende er omgående lægebehandling nødvendig; vis etiketten, hvis det er muligt'. 3. In the Danish language the following combinations of S-phrases replace those listed in Annex IV: 'S 20 / 21 Der må ikke spises, drikkes eller ryges under brugen S 36 / 37 Brug særligt arbejdstøj og egnede beskyttelses-handsker S 36 / 39 Brug særligt arbejdstøj og egnede beskyttelses-briller/ensigtsskærm S 37 / 39 Brug egnede beskyttelseshandsker og -briller/ansigtsskærm under arbejdet S 36 / 37 / 39 Brug særligt arbejdstøj, egnede beskyttelses-handsker og -briller/ansigtsskærm'. 5. Annex VI, D (Guide to the classification and labelling of dangerous substances and preparations): 1. In chapter 2.4.10 (irritant), second indent (criteria for use of R 36 Irritating to eyes) the last seven words of the final sentence 'the value should be equal to three' are replaced by the words 'the value should be 2,5 or more'. 2. The following general criteria for the choice of safety advice phrase S 53 are added after the general criteria for S 52 at the end of chapter 4: 'S 53: Avoid exposure - obtain special instructions before use - Applicability - Carci genic, mutagenic and/or teratogenic substances and preparations - Criteria for use - Obligatory for substances and preparations mentioned above to which R 45, R 46 and/or R 47 have been ascribed'. Article 2 Member States shall adopt and publish before 1 july 1987 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these provisions by 31 December 1987. Article 3 This Directive is addressed to the Member States.

31986L0424

1986

FIRST COMMISSION DIRECTIVE of 15 July 1986 laying down methods of sampling for chemical analysis of edible caseins and caseinates (86/424/EEC) Having regard to the Treaty establishing the European Economic Community, Having regard to the Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) included for human consumption (1) and in particular Article 9 thereof, Whereas under Article 9 of Directive 83/417/EEC, caseins and caseinates are required to be sampled according to Community procedures; Whereas it is desirable to adopt an initial series of methods of sampling for chemical analysis in request of which studies are completed; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 The sampling requirements referred to in Article 9, paragraph (b) of Directive 83/417/EEC shall be those outlined in the Annex to the present Directive. Article 2 Member States shall take all necessary measures in order to comply with the present Directive by 15 January 1988 (2) at the latest. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to all the Member States.

31986L0354

1986

Council Directive 86/354/EEC of 21 July 1986 amending Directive 74/63/EEC on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs, Directive 77/101/EEC on the marketing of straight feedingstuffs and Directive 79/373/EEC on the marketing of compound feedingstuffs Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the definitions of straight feedingstuffs and the various types of compound feedingstuffs in Directives 74/63/EEC (4), 77/101/EEC (5) and 79/373/EEC (6), as last amended by Directives 86/299/EEC (7), 83/87/EEC (8) and 82/957/EEC (9) respectively, should be aligned on the new definitions in Council Directive 84/587/EEC of 29 November 1984 amending Directive 70/524/EEC concerning additives in feedingstuffs (10); whereas 'milk replacer feeds' should also be defined; Whereas it should be made clear that the provisions of Directives 74/63/EEC, 77/101/EEC and 79/373/EEC are without prejudice to the provisions of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (11); Whereas Directive 74/63/EEC concerns undesirable substances and products in feedingstuffs; whereas, therefore, the maximum permitted levels laid down in the Annex to that Directive do not apply to the raw materials used for preparing compound feedingstuffs; Whereas the fixing of maximum levels or the limiting of the presence of certain undesirable substances and products in raw materials is at the moment governed by divergent provisions in the Member States; Whereas the consequences of the presence, above a certain level, of these substances or products are likely to prove harmful to human health and whereas it is therefore necessary to guarantee, in an appropriate and uniform manner,the safe use of these products and substances throughout the Community; Whereas, moreover, the divergent provisions in the national legislation of Member States leads to substantial barriers in intra-Community trade and whereas it is desirable to adopt appropriate measures within the context of Directive 74/63/EEC; Whereas, in addition, Directives 77/101/EEC and 79/373/EEC should be adopted to better facilitate the marketing of straight and compound feedingstuffs; Whereas it is desirable to define the concept of raw materials in order to set clear limits to the scope of the measures relating to that class of products, which is also referred to by the term 'ingredients' in other Directives on animal feedingstuffs; Whereas the provisions in question apply exclusively to raw materials intended for animal feed which are to be entered into circulation in the form of straight feedingstuffs or as carriers of premixtures of additives or, after being mixed with other products, as compound feedingstuffs; Whereas, in order to ensure that certain particularly undesirable substances are not present in feedingstuffs, it is necessary not only to limit their presence in raw materials to an acceptable level but also to restrict the use of those raw materials to persons who have the requisite skill, apparatus and equipment for the diluting operations which ensure that the maximum levels laid down in the Directive for compound feedingstuffs are observed; Whereas the minimum conditions laid down in Annex III to Council Directive 70/524/EEC for a person to be entered on a national list of manufacturers of compound feedingstuffs must also be applied to manufacturers of compound feedingstuffs using raw materials which contain a level of undesirable substances and products higher than that permitted in straight feedingstuffs; whereas it is desirable, however, that Member States should be able to confine the delivery of such highly contaminated raw materials to those manufacturers who produce compound feedingstuffs for sale where their inspection services are unable to monitor at farm level those manufacturers of compound feedingstuffs who are also livestock farmers and who use all or part of their production for their own requirements; Whereas, for certain raw materials whose level of undesirable substances and products is not restricted in Annex II (A), provision should be made for the possibility of imposing appropriate labelling provisions if the quantity of the undesirable substance or product present in the raw materials exceeds the maximum level laid down for the corresponding straight feedingstuffs; whereas this measure is indispensable in order to ensure that such raw materials are not delivered to livestock farmers and to inform manufacturers of the nature and quantity of the undesirable substance or product present; Whereas the Member States should provisionally be authorized to retain the national provisions which they have adopted concerning raw materials contaminated by aflatoxin other than those referred to in Annex II (A) or relating to undesirable substances or products other than aflatoxin affecting the quality of the raw materials; whereas a Community decision should be taken before 3 December 1990 so that by that date uniform Community rules exist regarding the presence of undesirable substances and products in raw materials used in the preparation of feedingstuffs; Whereas, in order to guarantee the safety of feedingstuffs, rules should be laid down governing the presence of undesirable substances and products and processes sought for decontaminating raw materials; whereas, on the basis of the results obtained, the criteria should be laid down with which products subject to certain decontamination processes must comply; Whereas the procedure introducing close cooperation between the Member States and the Commission within the Standing Committee for Feedingstuffs should be applied in order to facilitate implementation of the measures proposed and to make, inter alia, amendments and additions concerning the fixing of maximum levels or labelling rules for raw materials contaminated by certain undesirable substances or products and the establishment of acceptability criteria for decontaminated raw materials; Wheras an information procedure must be established for notifying Member States of cases of non-compliance with Community provisions in order to facilitate supervision of the application of Directive 74/63/EEC; Whereas the experience gained in the implementation of Directive 79/373/EEC shows the need to improve or supplement the labelling of compound feedingstuffs in certain cases; Whereas, in particular, an indication of the name or business name and address of the manufacturer must be stipulated where the latter is not responsible for the labelling particulars; whereas, however, account must be taken of the particular control systems in certain Member States and whereas such Member States should be authorized, for feedingstuffs produced and marketed in their territory, to replace these particulars by the official code number given to each manufacturer, Article 1 Directive 74/63/EEC is hereby amended as follows: 1. The title of the Directive shall be replaced by the following: 'Council Directive on undesirable substances and products in animal nutrition.' 2. In Article 1: (a) paragraph 1 shall be replaced by the following: '1. This Directive deals with undesirable substances and products in animal nutrition.' (b) The following point (e) shall be added to paragraph 2: '(e) certain products used in animal nutrition.' 3. In Article 2: (a) points (a), (b) and (h) shall be replaced by the following: '(a) feedingstuffs: 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) straight feedingstuffs: the various vegetable or animal products in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and various organic or inorganic substances, whether or not containing additives, intended as such for oral animal feeding: (h) compound feedingstuffs: mixtures of products of vegetable or animal origin in the 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;' (b) the following point shall be added: '(i) raw materials (ingredients); various 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, whether or not containing additives, which are intended to be entered for circulation as straight feedingstuffs or for the preparation of compound feedingstuffs or as carriers of premixtures;' 4. Article 3 shall be replaced by the following: 'Article 3 1. Member States shall prescribe that the substances and products listed in Annex I shall be tolerated in feedingstuffs only under the conditions therein set out. 2. Member States may authorize the maximum permitted levels provided for in Annex I in respect of feedingstuffs to be exceeded in the case of fodder which is produced and used in the same state on the same agricultural holding, where this is necessary for particular local reasons. The Member States concerned shall ensure that neither animal nor human health can suffer harm thereby.' 5. The following Articles shall be inserted: 'Article 3a 1. Member States shall prescribe that the raw materials listed in Annex II (A) may be marketed only if their content of the undesirable substance or product mentioned in column 1 of the said Annex does not exceed the maximum level laid down in column 3 of that Annex. 2. Where the content of the undesirable substance or product listed in column 1 of Annex II (A) exceeds the level laid down in column 3 of Annex I in respect of the straight feedingstuff, the raw material listed in column 2 of Annex II (A) may, without prejudice to paragraph 1, be marketed only if: (a) it is intended for use by manufacturers of compound feedingstuffs entered on a national list as provided for in Article 13 (3) of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), and (b) it is accompanied by a document stating: - that the raw material is intended for manufacturers of compound feedingstuffs who fulfil the conditions laid down in paragraph (a), - that the raw material may not be fed unprocessed to livestock, - the amount of the undesirable substance or product contained in the raw material. 3. Member States shall prescribe that paragraph 2 (a) and (b) shall also apply to the raw materials and undesirable substances or products listed in Annex II (B) the maximum level of which is not restricted in Annex II (A), if the level of the undesirable substance or product present in the raw material exceeds that laid down in column 3 of Annex I for the corresponding straight feedingstuffs. 'Article 3b Member States may restrict the application of Article 3a (2) (a) to those manufacturers of compound feedingstuffs who use the materials in question for the production and marketing of compound feedingstuffs.' (1) OJ No L 270, 14. 12. 1970, p. 1.' 6. In Article 4, 'in this Directive' shall be replaced by 'in Annex I.' 7. In Article 5: (a) the text of paragraph 1 shall be replaced by the following: '1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that a maximum content fixed in Annex I or II or a substance or product not listed therein constitutes a danger to animal or human health or the environment, that Member State may provisionally reduce that content, fix a maximum content or prohibit the presence of that substance or product in feedingstuffs or raw materials. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.' (b) in paragraph 2, 'the Annex' shall be replaced by 'the Annexes'. 8. Article 6 shall be replaced by the following: 'Article 6 In accordance with the procedure laid down in Article 9 and in the light of developments in scientific and technical knowledge: (a) the amendments to be made to the Annexes shall be adopted; (b) a consolidated version of the Annexes shall be drawn up periodically incorporating the successive amendments made pursuant to (a); (c) criteria for the acceptability of raw materials which have undergone certain decontamination processes may be defined.' 9. The following Article shall be added: 'Article 6a 1. Until a Community decision is taken, Member States may retain measures governing the importation and entry for circulation within their territories of: (a) raw materials contaminated by aflatoxin other than the raw materials referred to in Annex II (A), and (b) raw materials contaminated by undesirable substances or products other than aflatoxin. 2. Not later than the 31 January 1987, Member States shall notify the Commission of the national provisions which they intend to retain by virtue of paragraph 1. 3. The amendments to be made to Annex II to remove discrepancies resulting from the application of paragraph 1 shall be adopted by 3 December 1990 at the latest.' 10. In Article 7, 'and raw materials' shall be inserted after 'feedingstuffs'. 11. In Article 8: (a) paragraph 1 shall be replaced by the following: '1. Member States shall take all necessary measures to ensure that feedingstuffs and raw materials are officially controlled, at least by random sampling, to verify whether the conditions laid down in this Directive are satisfied.' (b) the following paragraph 3 shall be added: '3. If a consignment of raw material is likely to be sent to a Member State after it has been judged not to comply with the provisions of this Directive on account of an excessive content of undesirable substances or products in another Member State, the latter Member State shall immediately give the other Member States and the Commission any useful information concerning that consignment of raw material.' 12. In Article 11, 'and raw materials' shall be inserted after 'feedingstuffs', 13. The Annex shall be amended as follows: (a) 'I' shall be added after the word 'ANNEX'; (b) the three columns of Annex I shall be numbered 1, 2 and 3 respectively; (c) in Annex I (B), the heading of column 3 shall be replaced by the following: 'Maximum content in mg/kg (ppm) of feedingstuffs referred to a moisture content of 12 %'. 14. The following shall be added as Annex II: ANNEX II A 1.2.3 // // // // Substances, products // Raw materials // Maximum content in mg/kg (ppm) of raw material, referred a moisture content of 12 % // // // // (1) // (2) // (3) // // // // 1. Aflatoxin B1 // Groudnut, copra, palm-kernel, cotton seed, babassu, maize and products derived from the processing thereof // 0,2 // // // B 1.2 // // // Substances, products // Raw materials // // // (1) // (2)' // // // // // // 15. 'Alimenti per animali' throughout the Directive in the Italian text shall be replaced by 'mangimi'. Article 2 Directive 77/101/EEC is hereby amended as follows: 1. In Article 1 (2): (a) point (b) shall be replaced by the following: '(b) undesirable substances and products in animal nutrition;' (b) the following point shall be added: '(d) certain products used in animal nutrition.' 2. Article 2 shall be replaced by the following: 'Article 2 For the purposes of this Directive, straight feedingstuffs shall mean the various vegetable or animal products in their natural state, fresh or preserved, and products derived from the industrial processing thereof, as well as various organic or inorganic substances, whether or not containing additives, intended as such for oral animal feeding.' 3. 'Alimenti per animali' throughout the Directive in the Italian text shall be replaced by 'mangimi'. Article 3 Directive 79/373/EEC is hereby amended as follows: 1. In Article 1 (2): (a) point (c) shall be replaced by the following: '(c) undesirable substances and products in animal nutrition;' (b) the following point shall be added: '(f) certain products used in animal nutrition.' 2. In Article 2: (a) the text of points (a) and (b) shall be replaced by the following: '(a) Feedingstuffs: 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: 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.' (b) the following points shall be added: '(j) Milk replacer feeds: compound feedingstuffs administered in dry form or after dilution in a given quantity of liquid for feeding young animals as a supplement to, or substitute for, post-colostral milk or for feeding calves intended for slaughter. (k) Ingredients (raw materials): various 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, whether or not containing additives, which are intended to be entered for circulation as straight feedingstuffs or for the preparation of compound feedingstuffs or as carriers of premixtures.' 3. In Article 5: (a) paragraph 1, point (a) shall be replaced by the following: '(a) the description "complete feedingstuff", "complementary feedingstuff", "mineral feedingstuff", "molassed feedingstuff", "complete milk replacer feed", "complementary milk replacer feed", as appropriate;' (b) in paragraph 4 the following point shall be added: '(g) the name or business name and address or registered place of business of the producer, where the latter is not responsible for the labelling particulars;' (c) the following paragraph shall be inserted: '4a. Member States shall be authorized, for feedingstuffs produced and marketed in their territory, to prescribe instead of the particulars referred to in Article 5 (4) (g) indication of an official code number corresponding to the producers established in their territory.' (d) in paragraph 5 the following point shall be added: '(h) an indication of the physical condition of the feedingstuff or the specific processing it has undergone.' (e) the following paragraph shall be inserted: '7a. Paragraph 7 shall not apply where ingredients (raw materials) must be mentioned on the label of compount feedingstuffs pursuant to Directive 82/471/EEC.' (f) paragraph 8 shall be supplemented by the following subparagraph: 'Such information - may not mislead the purchaser in particular by attributing to the feedingstuff effects or properties that it does not possess or by suggesting that it possesses special characteristics when in fact all similar feedingstuffs possess such characteristics, - must relate to objective or quantifiable factors which can be substantiated.' 4. The following Articles shall be inserted: 'Article 5a In English, 'complementary feedingstuff' and 'complete feedingstuff' may be replaced, in the case of feedingstuff for pets, respectively by 'complementary pet food' and 'complete pet food'. Article 5b Without prejudice to the provisions of Article 5, Member States shall stipulate that the labelling of compound feedingstuffs for pet animals may draw particular attention to the presence or low content of one or more ingredients that are essential for the characteristics of the feedingstuff. In such case the minimum or maximum content, expressed in terms of the percentage by weight of the ingredient(s) incorporated, must be clearly indicated either opposite the statement drawing particular attention to it or them or in the list of ingredients or by mentioning it or them and the percentage(s) by weight concerned opposite the corresponding category of ingredients.' 5. 'Alimenti per animali' throughout the Directive in the Italian text shall be replaced by 'mangimi'. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 3 December 1988. They shall forthwith inform the Commission thereof. Article 5 This Directive is addressed to the Member States.

31986L0355

1986

Council Directive 86/355/EEC of 21 July 1986 amending Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (1), as last amended by Directive 86/214/EEC (2), and in particular Article 6 thereof, Whereas that Directive provides for the contents of the Annex to be regularly amended to take account of the development of scientific and technical knowledge; Whereas it has now been established that the use of ethylene oxide as a plant protection product, in particular for the fumigation of plants or plant products in storage, leaves residues in foodstuffs which may give rise to harmful effects on human or animal health; Whereas alternative treatments are available for plant protection except for certain minor commodities; Whereas the marketing and use of ethylene oxide as a plant protection product should therefore be prohibited; Whereas, however, temporary national exceptions from this prohibition may be permitted for certain minor commodities, where special need exists, until other methods of treatment become available, Article 1 The following entry is hereby added to the Annex to Directive 79/117/EEC: 1.2 // // // 'C. Ethylene oxide // (a) pathogen reduction of the following dried vegetables, intended for incorporation in food preparations which do not undergo full cooking treatment prior to consumption // // - asparagus // // - onions // // - leeks // // - mushrooms // // (b) pathogen reduction of dried herbs and spices (1) // // (c) pathogen reduction of dried herbs intended exclusively for marketing without further processing as medicinal products // // (d) pathogen reduction of cocoa powder and cake // // (e) fumigation of tobacco leaf // // These derogations shall expire on 31 December 1989 at the latest // // (1) Plants and plant products rich in essential oils and aromatic principles mainly used as condiments because of their characteristic taste'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1987. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0388

1986

Commission Directive 86/388/EEC of 23 July 1986 amending Council Directive 83/229/EEC on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/893/EEC of 23 November 1976 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 6 (3) thereof, Whereas, under heading B.1 of the First Part of its Annex II, Council Directive 83/229/EEC (2) authorizes the use of bis (2-hydroxyethyl) ether [= diethyleneglycol] and ethanediol [= monoethyleneglycol] as softeners, provided that the total amount contained does not exceed 20 % and that the film in question is to be coated and used exclusively for packaging foodstuffs which are not moist, i.e. which do not contain water that is physically free at the surface; Whereas, on the basis of the safeguard clause in Article 6 of Directive 76/893/EEC, the Federal Republic of Germany has communicated to the Commission that it intends to prohibit the use of bis (2-hydroxethyl) ether and ethanediol as a preventive measure in the interests of public health, on the grounds that these substances have been observed to migrate extensively to certain foodstuffs; Whereas consultation of the Member States within the Standing Committee for Foodstuffs, in accordance with Article 6 (2) of Directive 76/893/EEC, and other inquiries have proved inconclusive as regards the migration phenomena in question; Whereas the rates of migration observed are very variable, ranging from a few milligrams to several hundred milligrams per kilogram of foodstuff; whereas it has not yet been possible to identify the foodstuffs or ingredients most likely to be affected by this migration; whereas, furthermore, it appears that sources other than regenerated cellulose packaging, which have not yet been identified with any certainty, contribute to the presence of these two softeners in foodstuffs; Whereas, in the light of these observations, the possibility of a risk to human health cannot be ruled out; Whereas, however, a total and immediate prohibition of the two substances as envisaged by the Federal Republic of Germany would be a measure disproportionate to the possible risk; whereas, as a preventive measure, it is more appropriate to establish a maximum amount of such substances in foodstuffs in contact with regenerated cellulose film; Whereas this amount must be calculated on the basis of toxicological data and be consistent with the principle of the inertia of materials embodied in the second indent of Article 2 of Directive 76/893/EEC; Whereas this restriction should be regarded as a temporary measure until such time as the research on migration of these two substances to different types of foodstuffs has been completed; Whereas, in any case, it can be concluded that use of the two substances in regenerated cellulose film does not constitute any immediate danger to human health; whereas, therefore, provision can be made for a deadline for implementation of the preventive measure contained in this Directive which will allow stocks of both packages and foodstuffs that have already been packaged to be run down; Whereas the Member States should be left to determine the deadline for implementation in the light of both the levels of contamination observed and the dietary habits of their consumers in relation to those levels; whereas, however, a maximum deadline of 31 March 1987 is in any case adequate; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, Article 1 In the First Part of Annex II, heading B.1, the text opposite the first two indents, in the column entitled 'Restrictions' in Directive 83/229/EEC is replaced by the following: 'Only for films intended to be glazed and then used for foodstuffs which are not moist, i.e. which do not contain water which is physically free at the surface. The total amount of bis (2-hydroxyethyl) ether and ethanediol present in a foodstuff in contact with films of this type may not exceed 50 mg/kg of the foodstuff'. Article 2 Member States shall amend their laws, regulations and administrative provisions in order to apply the limit laid down in Article 1 as from 1 April 1987 at the latest. Article 3 This Directive is addressed to the Member States.

31986L0363

1986

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 Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas crop and animal production play a very important role in the Community; Whereas the yield from that production is continually affected by harmful organisms and weeds; Whereas it is absolutely essential to protect plants, plant products and livestock against these organisms, not only to prevent a reduction in yield but also to increase agricultural productivity; Whereas one of the most important methods of protecting plants, plant products and livestock from the effects of these harmful organisms is the use of chemical pesticides; Whereas, however, these pesticides do not have only a favourable effect on plant and animal production, since they are generally toxic substances or preparations with dangerous side-effects; Whereas a large number of these pesticides and of their metabolites or breakdown products may have harmful effects on consumers of plant and animal products; Whereas these pesticides and the contaminants which may accompany them can present dangers for the environment and indirectly affect humans through animal products; Whereas, in order to deal with these dangers, several Member States have already fixed maximum levels for certain pesticide residues in and on foodstuffs of animal origin; Whereas the differences which exist between Member States with regard to the maximum permissible levels for pesticide residues can help to create barriers to trade and thus hinder the free movement of goods within the Community; Whereas, for this reason, in an initial stage, maximum levels should be fixed for certain organochlorine compounds in meat and meat products and milk and milk products, which must be observed when these products are put into circulation; Whereas, moreover, observance of the maximum levels will ensure that the goods can circulate freely and that the health of consumers is properly protected; Whereas at the same time the Member States should be enabled to authorize the monitoring of levels of pesticide residues in foodstuffs of animal origin produced and consumed in their territory by a monitoring system and related measures so as to provide safeguards equivalent to those resulting from the levels laid down; Whereas it is normally sufficient to apply check sampling to fresh milk or frozen cream at the dairy or when it is put on sale to the final consumer; whereas, however, Member States should be authorized also to apply check sampling to fresh milk and fresh cream at an earlier stage; Whereas it is not necessary to apply this Directive to products intended for export to third countries; Whereas Member States should be allowed to reduce temporarily the levels laid down if they unexpectedly prove to be dangerous to human or animal health; Whereas it is appropriate in that case to establish close cooperation between the Member States and the Commission within the Standing Committee on Plant Health; Whereas, in order to guarantee compliance with this Directive when the foodstuffs in question are put into circulation, the Member States must provide for suitable control measures; Whereas Community methods of sampling and analysis should be established to be used at least as reference methods; Whereas methods of sampling and analysis are technical and scientific matters, which should be determined by means of a procedure involving close cooperation between the Member States and the Commission within the Standing Committee on Plant Health; Whereas Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (1), as last amended by Regulation (EEC) No 3768/85 (2), Council Directive 72/462/EEC of 12 December 1972 on health and veterinary problems upon importation of bovine animals and swine and fresh meat from third countries (3), as last amended by Regulation (EEC) No 3768/85, and Council Directive 85/397/EEC of 5 August 1985 on health and animal-health problems affecting intra-Community trade in heat-treated milk (4), as amended by Regulation (EEC) No 3768/85, provide for the fixing of permitted limits for pesticides with regard respectively to fresh meat sent from one Member State to another, fresh meat imported from third countries and heat-treated milk sent from one Member State to another, and for the laying down of the required methods of analysis; and whereas maximum residue levels laid down in this Directive should also apply for the purposes of those three Directives; Whereas it is appropriate that Member States make an annual report to the Commission on the results of their control measures so as to enable information concerning levels of pesticide residues to be collected for the Community as a whole; Whereas the Council should review this Directive before 30 June 1991 with the aim of attaining a uniform Community system, Article 1 This Directive concerns foodstuffs of animal origin listed in Annex I in so far as those foodstuffs may contain residues of pesticides listed in Annex II, and without prejudice to Community or national provisions concerning dietary or children's food. Article 2 1. For the purposes of this Directive, 'pesticide residues' means residues of the pesticides and of their metabolites, and breakdown or reaction products listed in Annex II, which are present in or on the products referred to in Article 1. 2. For the purposes of this Directive, 'putting into circulation' means any handing over, whether or not for a consideration, of the products referred to in Article 1. Article 3 1. Member States shall ensure that the products referred to in Article 1 do not, from the time they are put into circulation, present a danger to human health as a result of the presence of pesticide residues. 2. Member States may not prohibit or impede the putting into circulation within their territories of the products referred to in Article 1 on the grounds that they contain pesticide residues if the quantity of such residues does not exceed the maximum levels specified in Annex II. Article 4 1. Member States shall prescribe that the products referred to in Article 1 may not contain, from the time they are put into circulation, levels of pesticide residues greater than those specified in Annex II. 2. Member States shall take all necessary measures to ensure, at least by check sampling, compliance with the maximum levels laid down in accordance with paragraph 1. Article 5 1. In the case of the products referred to in Article 1 other than those imported from third countries or intended for other Member States, Member States may, by way of derogation from Article 4, continue to apply a system of monitoring already in force on their territory for the presence of pesticide residues together with any other measure in order to ensure that an effect equivalent to the levels of pesticide residues laid down in Annex II is obtained and to assess the total dietary exposure of their population to these residues, whatever their source. Such measures shall include regular representative surveys of the levels of these pesticide residues in typical diets. 2. Member States shall inform the other Member States and the Commission of any implementation of paragraph 1. Article 6 Notwithstanding the provisions of Article 4, in the case of the products referred to in Annex I falling within heading No 04.01 of the Common Customs Tariff, the check sampling provided for shall be carried out at the dairy or, if they are not delivered to a dairy, at the point of supply to the consumer. Member States may nevertheless provide also for check sampling from the time these products are first put into circulation. Article 7 Member States shall make a report to the Commission, before 1 August each year, on the results of the official checks, the monitoring carried out and the other measures taken pursuant to Article 4 and, where appropriate, Article 5, during the previous year. Article 8 1. The methods of sampling and analysis necessary for carrying out the checks, monitoring and other measures provided for in Article 4 and, where appropriate, Article 5, shall be determined in accordance with the procedure laid down in Article 12. The existence of Community analysis methods, to be used in cases of dispute, shall not preclude the use by Member States of other scientifically valid methods capable of achieving comparable results. 2. Member States shall inform the other Member States and the Commission of the use of other methods pursuant to paragraph 1. 3. Paragraphs 1 and 2 shall apply without prejudice to Community veterinary inspection measures for checking pesticide residues in products referred to in Article 1, in particular those adopted pursuant to Directives 64/433/EEC, 72/462/EEC and 85/397/EEC. Article 9 1. Where a Member State considers that a maximum level set in Annex II endangers human health, and therefore requires swift action to be taken, that Member State may temporarily reduce the level in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures taken, attaching a statement of the reasons therefor. 2. If the situation envisaged in paragraph 1 arises, it shall be decided in accordance with the procedure laid down in Article 13 whether the maximum levels laid down in Annex II should be altered. Until such time as a decision is taken by the Council or the Commission in accordance with the abovementioned procedure, the Member State may maintain the measures which it has implemented. Article 10 Without prejudice to Article 9, amendments to the maximum levels set in Annex II as a result of developments in scientific or technical knowledge shall be adopted by the Council acting by a qualified majority on a proposal from the Commission. Article 11 The Council, acting unanimously on a proposal from the Commission, shall adopt, by means of Directives, any new list of products or any new list of pesticide residues in and on the products referred to in Article 1, and their maximum values. Article 12 1. Where the procedure laid down in this Article is to be followed, the matters shall be referred without delay to the Standing Committee on Plant Health, hereinafter referred to as the 'Committee', by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on these measures within a time limit set by the chairman, having regard to the urgency of the matters to be examined. Opinions shall be delivered by a majority of 54 votes. 4. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. If the measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If, within three months following the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures, except where the Council has voted by a simple majority against the said measures. Article 13 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Committee by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on these measures within two days. Opinions shall be delivered by a majority of 54 votes. 4. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If, within 15 days of the date onwhich the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures, except where the Council has voted by a single majority against the said measures. Article 14 This Directive shall not apply to the products referred to in Article 1 where it can be established at least by appropriate evidence that they are intended for export to third countries. Article 15 In order to improve upon the Community system introduced by this Directive, the Council, on the basis of a Commission report accompanied, if appropriate, by suitable proposals, shall re-examine this Directive by 30 June 1991 at the latest. Article 16 Member States shall bring into force not later than 30 June 1988 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 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 17 This Directive is addressed to the Member States.

31986L0378

1986

Council Directive 86/378/EEC of 24 July 1986 on the implementation of the principle of equal treatment for men and women in occupational social security schemes Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission (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 Treaty provides that each Member State shall ensure the application of the principle that men and women should receive equal pay for equal work; whereas 'pay' should be taken to mean the ordinary basic or minimum wage or salary and any other consideration, whether in cash or in kind, which the worker receives, directly of indirectly, from his employer in respect of his employment; Whereas, although the principle of equal pay does indeed apply directly in cases where discrimination can be determined solely on the basis of the criteria of equal treatment and equal pay, there are also situations in which implementation of this principle implies the adoption of additional measures which more clearly define its scope; Whereas Article 1 (2) of Council Directive 76/207/EEC of 9 February 1976 on the implementation of the principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions (4) provides that, with a view to ensuring the progressive implementation of the principle of equal treatment in matters of social security, the Council, acting on a proposal from the Commission, will adopt provisions defining its substance, its scope and the arrangements for its application; whereas the Council adopted to this end Directive 79/7/EEC of 19 December 1978 on the progressive implementation of the principle of equal treatment for men and women in matters of social security (5); Whereas Article 3 (3) of Directive 79/7/EEC provides that, with a view to ensuring implementation of the principle of equal treatment in occupational schemes, the Council, acting on a proposal from the Commission, will adopt provisions defining its substance, its scope and the arrangements for its application; Whereas the principle of equal treatment should be implemented in occupational social security schemes which provide protection against the risks specified in Article 3 (1) of Directive 79/7/EEC as well as those which provide employees with any other consideration in cash or in kind within the meaning of the Treaty; Whereas implementation of the principle of equal treatment does not prejudice the provisions relating to the protection of women by reason of maternity, Article 1 The object of this Directive is to implement, in occupational social security schemes, the principle of equal treatment for men and women, hereinafter referred to as 'the principle of equal treatment'. Article 2 1. 'Occupational social security schemes' means schemes not governed by Directive 79/7/EEC whose purpose is to provide workers, whether employees or self-employed, in an undertaking or group of undertakings, area of economic activity or occupational sector or group of such sectors with benefits intended to supplement the benefits provided by statutory social security schemes or to replace them, whether membership of such schemes is compulsory or optional. 2. This Directive does not apply to: (a) individual contracts, (b) schemes having only one member, (c) in the case of salaried workers, insurance schemes offered to participants individually to guarantee them: - either additional benefits, or - a choice of date on which the normal benefits will start, or a choice between several benefits. Article 3 This Directive shall apply to members of the working population including self-employed persons, persons whose activity is interrupted by illness, matrnity, accident or involuntary unemployment and persons seeking employment, and to retired and disabled workers. Article 4 This Directive shall apply to: (a) occupational schemes which provide protection against the following risks: - sickness, - invalidity, - old age, including early retirement, - industrial accidents and occupational diseases, - unemployment; (b) occupational schemes which provide for other social benefits, in cash or in kind, and in particular survivors' benefits and family allowances, if such benefits are accorded to employed persons and thus constitute a consideration paid by the employer to the worker by reason of the latter's employment. Article 5 1. Unter the conditions laid down in the following provisions, the principle of equal treatment implies that there shall be no discrimination on the basis of sex, either directly or indirectly, by reference in particular to marital or family status, especially as regards: - the scope of the schemes and the conditions of access to them; - the obligation to contribute and the calculation of contributions; - the calculation of benefits, including supplementary benefits due in respect of a spouse or dependants, and the conditions governing the duration and retention of entitlement to benefits. 2. The principle of equal treatment shall not prejudice the provisions relating to the protection of women by reason of maternity. Article 6 1. Provisions contrary to the principle of equal treatment shall include those based on sex, either directly or indirectly, in particular by reference to marital or family for: (a) determining the persons who may participate in an occupational scheme; (b) fixing the compulsory or optional nature of participation in an occupational scheme; (c) laying down different rules as regards the age of entry into the scheme or the minimum period of employment or membership of the scheme required to obtain the benefits thereof; (d) laying down different rules, except as provided for in subparagraphs (h) and (i), for the reimbursement of contributions where a worker leaves a scheme without having fulfilled the conditions guaranteeing him a deferred right to long-term benefits; (e) setting different conditions for the granting of benefits of restricting such benefits to workers of one or other of the sexes; (f) fixing different retirement ages; (g) suspending the retention or acquisition of rights during periods of maternity leave or leave for family reasons which are granted by law or agreement and are paid by the employer; (h) setting different levels of benefit, except insofar as may be necessary to take account of actuarial calculation factors which differ according to sex in the case of benefits designated as contribution-defined; (i) setting different levels of worker contribution; setting different levels of employer contribution in the case of benefits designated as contribution-defined, except with a view to making the amount of those benefits more nearly equal; (j) laying down different standards or standards applicable only to workers of a specified sex, except as provided for in subparagraphs (h) and (i), as regards the guarantee or retention of entitlement to deferred benefits when a worker leaves a scheme. 2. Where the granting of benefits within the scope of this Directive is left to the discretion of the scheme's management bodies, the latter must take account of the principle of equal treatment. Article 7 Member States shall take all necessary steps to ensure that: (a) provisions contrary to the principle of equal treatment in legally compulsory collective agreements, staff rules of undertakings or any other arrangements relating to occupational schemes are null and void, or may be declared null and void or amended; (b) schemes containing such provisions may not be approved or extended by administrative measures. Article 8 1. Member States shall take all necessary steps to ensure that the provisions of occupational schemes contrary to the principle of equal treatment are revised by 1 January 1993. 2. This Directive shall not preclude rights and obligations relating to a period of membership of an occupational scheme prior to revision of that scheme from remaining subject to the provisions of the scheme in force during that period. Article 9 Member States may defer compulsory application of the principle of equal treatment with regard to: (a) determination of pensionable age for the purposes of granting old-age or retirement pensions, and the possible implications for other benefits: - either until the date on which such equality is achieved in statutory schemes, - or, at the latest, until such equality is required by a directive. (b) survivors' pensions until a directive requires the principle of equal treatment in statutory social security schemes in that regard; (c) the application of the first subparagraph of Article 6 (1) (i) to take account of the different actuarial calculation factors, at the latest until the expiry of a thirteen-year period as from the notification of this Directive. Article 10 Member States shall introduce into their national legal systems such measures as are necessary to enable all persons who consider themselves injured by failure to apply the principle of equal treatment to pursue their claims before the courts, possibly after bringing the matters before other competent authorities. Article 11 Member States shall take all the necessary steps to protect worker against dismissal where this constitutes a response on the part of the employer to a complaint made at undertaking level or to the institution of legal proceedings aimed at enforcing compliance with the principle of equal treatment. Article 12 1. Member States shall bring into force such laws, regulations and administrative provisions as are necessary in order to comply with this Directive at the latest three years after notification thereof (1). They shall immediately inform the Commission thereof. 2. Member States shall communicate to the Commission at the latest five years after notification of this Directive all information necessary to enable the Commission to draw up a report on the application of this Directive for submission to the Council. Article 13 This Directive is addressed to the Member States.

31986L0362

1986

Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas crop production plays a very important role in the Community; Whereas the yield from that production is continually affected by harmful organisms and weeds; Whereas it is absolutely essential to protect plants and plant products against these organisms, not only to prevent a reduction in yield or damage to the products harvested but also to increase agricultural productivity; Whereas one of the most important methods of protecting plants and plant products from the effect of these harmful organisms is the use of chemical pesticides; Whereas, however, these pesticides do not have only a favourable effect on plant production, since they are generally toxic substances or preparations with dangerous side-effects; Whereas a large number of these pesticides and of their metabolites or breakdown products may have harmful effects on consumers of plant products; Whereas these pesticides and the contaminants which may accompany them can present dangers for the environment; Whereas, in order to deal with these dangers, several Member States have already fixed maximum levels for certain residues in and on cereals; Whereas the differences which exist between Member States as regards the maximum permissible levels for pesticide residues can help to create barriers to trade and thus hinder the free movement of goods within the Community; Whereas, for this reason, in an initial stage, maximum levels should be fixed for certain active substances in cereals, which must be observed when these products are put into circulation; Whereas, moreover, observance of the maximum levels will ensure that the cereals can circulate freely and that the health of consumers is properly protected; Whereas at the same time the Member States should be enabled to authorize the monitoring of levels of pesticide residues in cereals produced and consumed in their territory by a system of surveillance and related measures so as to provide safeguards equivalent to those resulting from the levels laid down; Whereas, in special cases, particularly of volatile liquid or gaseous fumigants, Member States should be authorized to permit for cereals, not intended for immediate consumption, higher maximum levels than those laid down, provided that a suitable check is made to ensure that these products are not placed at the disposal of the end user or consumer until the residue content thereof no longer exceeds the maximum permissible levels; Whereas it is not necessary to apply this Directive to products intended for export to third countries, for the manufacture of products other than foodstuffs or for sowing; Whereas Member States should be allowed the reduce temporarily the levels laid down if they unexpectedly prove to be dangerous to human or animal health; Whereas it is appropriate in that case to establish close cooperation between the Member States and the Commission within the Standing Committee on Plant Health; Whereas, in order to guarantee compliance with this Directive when the products in question are put into circulation, the Member States must provide for suitable control measures; Whereas Community methods of sampling and analysis should be established to be used at least as reference methods; Whereas methods of sampling and analysis are technical and scientific matters, which should be determined by means of a procedure involving close cooperation between the Member States and the Commission within the Standing Committee on Plant Health; Whereas it is appropriate that Member States make an annual report to the Commission on the results of their control measures so as to enable information concerning levels of pesticide residues to be collected for the Community as a whole; Whereas the Council should review this Directive before 30 June 1991 with the aim of attaining a uniform Community system, Article 1 This Directive shall apply, without prejudice to the provisions of Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (1), as last amended by Directive 86/354/EEC (2) to the cereals listed in Annex I, in so far as these products may contain residues of pesticides listed in Annex II. Article 2 1. For the purposes of this Directive, 'pesticide residues' means residues of the pesticides and of their metabolites, and breakdown or reaction products listed in Annex II, which are present in or on the products referred to in Article 1. 2. For the purposes of this Directive, 'putting into circulation' means any handing over, whether or not for a consideration, of the products referred to in Article 1. Article 3 1. Member States shall ensure that the products referred to in Article 1 do not, from the time they are put into circulation, present a danger to human health as a result of the presence of pesticide residues. 2. Member States may not prohibit or impede the putting into circulation within their territories of the products referred to in Article 1 on the grounds that they contain pesticide residues, if the quantity of such residues does not exceed the maximum levels specified in Annex II. Article 4 1. Member States shall prescribe that the products referred to in Article 1 may not contain, from the time they are put into circulation, levels of residues of pesticides greater than those specified in Annex II. 2. Member States shall take all necessary measures to ensure, at least by check sampling, compliance with the maximum levels laid down in accordance with paragraph 1. Article 5 1. In the case of the products referred to in Article 1, other than those imported from third countries or intended for other Member States, Member States may, by way of derogation from Article 4, continue to apply a system of monitoring already in force on their territory for the presence of pesticide residues together with any other measure in order to ensure that an effect equivalent to the levels of pesticide residues laid down in Annex II is obtained, and to assess the total dietary exposure of their population to these residues, whatever their source. Such measures shall include regular representative surveys of the levels of these pesticide residues in typical diets. 2. Member States shall inform the other Member States and the Commission of any implementation of paragraph 1. Article 6 Member States may authorize the presence in and on the products referred to in Article 1 of the pesticide residues listed in Part B of Annex II in greater quantities than those specified therein, provided that those products are not intended for immediate consumption and an appropriate control system ensures that they cannot be made available to the end user or to the consumer, if they are supplied directly to the latter, until the residues no longer exceed the maximum levels specified in Part B. They shall inform the other Member States and the Commission of the measures taken. These measures shall be applicable to all products covered thereby, irrespective of the origin of the products. Article 7 Member States shall make a report to the Commisson before 1 August each year on the results of the official checks, the monitoring carried out and the other measures taken pursuant to Article 4 and, where appropriate Article 5, during the previous year. Article 8 1. The methods of sampling and analysis necessary for carrying out the checks, monitoring and other measures provided for in Article 4 and, where appropriate, Article 5, shall be determined in accordance with the procedure laid down in Article 12. The existence of Community analysis methods, to be used in cases of dispute, shall not preclude the use by Member States of other scientifically valid methods capable of achieving comparable results. 2. Member States shall inform the other Member States and the Commission of the other methods used pursuant to paragraph 1. Article 9 1. Where a Member State considers that a maximum level fixed in Annex II endangers human health, and therefore requires swift action to be taken, that Member State may temporarily reduce the level in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures, attaching a statement of the reasons therefor. 2. If the situation envisaged in paragraph 1 arises, it shall be decided in accordance with the procedure laid down in Article 13 whether the maximum levels laid down in Annex II should be altered. Until such time as a decision is taken by the Council or the Commission in accordance with the abovementioned procedure, the Member State may maintain the measures which it has implemented. Article 10 Without prejudice to Article 9, amendments to the maximum levels set in Annex II as a result of developments in scientific or technical knowledge shall be adopted by the Council acting by a qualified majority on a proposal from the Commission. Article 11 The Council, acting unanimously on a proposal from the Commission, shall adopt, by means of Directives, any new list of products or any new list of pesticide residues in and on the products referred to in Article 1, and their maximum values. Article 12 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Committee on Plant Health, hereinafter referred to as the 'Committee', by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on these measures within a time limit set by the chairman, having regard to the urgency of the matters to be examined. Opinions shall be delivered by a majority of 54 votes. 4. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. Where the measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If, within three months following the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures except where the Council has voted by a simple majority againt the said measures. Article 13 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Committee by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on these measures within two days. Opinions shall be delivered by a majority of 54 votes. 4. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If, within 15 days of the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures except where the Council has voted by a simple majority against the said measures. Article 14 This Directive shall not apply to the products referred to in Article 1 where it can be established at least by appropriate evidence that they are intended for: (a) export to third countries; (b) the manufacture of products other than foodstuffs; (c) sowing. Article 15 In order to improve upon the Community system introduced by this Directive, the Council, on the basis of a Commission report accompanied, if appropriate, by suitable proposals, shall re-examine this Directive by 30 June 1991 at the latest. Article 16 Member States shall bring into force not later than 30 June 1988 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 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 17 This Directive is addressed to the Member States.

31986L0415

1986

Council Directive 86/415/EEC of 24 July 1986 on the installation, location, operation and identification of the controls of wheeled agricultural or forestry tractors Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas the technical requirements with which wheeled agricultural or forestry tractors must comply pursuant to national laws relate, inter alia, to the installation, location, operation and identification of controls; Whereas those requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements, either in addition to or in place of their existing rules, in particular in order to allow the EEC type-approval procedure which was the subject of Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (3) as last amended by the Act of Accession of Spain and Portugal to be applied in respect of each tractor type; Whereas the harmonization of these requirements is an obvious safety factor and, where the location of the controls and the symbols used for them are concerned, makes it possible to surmount the problem associated with indications in the various languages; Whereas the approximation of the national laws relating to wheeled agricultural or forestry tractors entails recognition (1) OJ N° C 172, 13. 7. 1981, p. 108. (2) OJ N° C 189, 30. 7. 1981, p. 15. (3) OJ N° L 84, 28. 3. 1974, p. 10. by Member States of the checks carried out by each of them on the basis of common requirements, Article 1 1. 'Agricultural or forestry tractors' means any motor vehicle, fitted with wheels or endless tracks, having at least two axles, the main function of which lies in its tractive power and which is specially designed to tow, push, carry or power certain tools, machinery or trailers intended for agricultural or forestry use. It may be equipped to carry a load or passengers. 2. This Directive shall apply only to the tractors defined in paragraph 1, which are fitted with pneumatic tyres and have at least two axles and a maximum design speed of between 6 and 30 kilometres per hour. Article 2 N° Member State may refuse to grant EEC type-approval or national type-approval in respect of a tractor, or refuse or prohibit its sale, registration, entry into service or use on grounds relating to the installation, location, operation and identification of controls if the latter satisfy the requirements set out in Annexes I, II, III and IV. Article 3 This Directive shall not affect the right of Member States to specify - with due observance of the Treaty - the requirements they deem necessary to ensure that workers are protected when using the tractors in question, provided this does not mean that the tractors are modified in a way unspecified in this Directive. Article 4 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 74/150/EEC. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 October 1987. They shall forthwith inform the Commission thereof. 2. Member States shall ensure that the text of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission. Article 6 This Directive is addressed to the Member States.

31986L0364

1986

Council Directive 86/364/EEC of 24 July 1986 relating to proof of compliance of vehicles with Directive 85/3/EEC on the weights, dimensions and certain other technical characteristics of certain road vehicles Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 85/3/EEC of 19 December 1984 on the weights, dimensions and certain other technical characteristics of certain road vehicles (1), and in particular Article 5 thereof, Having regard to the proposal from the Commission, Whereas Article 5 of Directive 85/3/EEC provides for the adoption, of detailed provisions on proof of compliance of vehicles with the provisions of that Directive; Whereas Council Directive 76/114/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to statutory plates and inscriptions for motor vehicles and their trailers, and their location and method of attachment (2), as amended by Commission Directive 78/507/EEC (3), already provides for such proof of compliance in the form of the manufacturer's plate; whereas that plate must be supplemented by a plate bearing vehicle dimensions also established and attached in accordance with Directive 76/114/EEC; Whereas the form and content of these two plates as well as the provisions of their mutual recognition by Member States as prescribed in those two Directives and in this Directive offer sufficient information and guarantees to the competent authorities for the control of the requirements of Directive 85/3/EEC as regards vehicles at the time of manufacture; Whereas provision should be made that proof of compliance may also be furnished either by a single plate established and attached in accordance with Directive 76/114/EEC and containing the information on the two abovementioned plates, or by a single document issued by the competent authority of the Member State where the vehicle is registered or put into circulation bearing the same headings and information as those appearing on the said plates; Whereas where the vehicle characteristics no longer correspond to those entered on the proof of compliance, the Member State in which the vehicle is registered should take the necessary measures to ensure that the proof of compliance is amended; Whereas it may be useful to show on the abovementioned plate(s) or document the maximum vehicle weights authorized by national legislation in a Member State which differ from those provided for by Directive 85/3/EEC and the technically permissible weights, Article 1 1. Member States shall take the necessary measures to ensure that the vehicles referred to in Article 2 of Directive 85/3/EEC and complying with that Directive carry one of the proofs referred to in (a), (b) and (c): (a) a combination of the following two plates: - the 'manufacturer's plate' established and attached in accordance with Directive 76/114/EEC, - the plate relating to dimensions, in accordance with the Annex and established and attached in accordance with Directive 76/114/EEC; (b) a single plate established and attached in accordance with Directive 76/114/EEC and containing the information on the two plates referred to in (a); (c) a single document issued by the competent authorities of the Member State in which the vehicle is registered or put into circulation. Such document shall bear the same headings and information as the plates referred to in (a). It shall be kept in a place easily accessible to inspection and shall be adequately protected. 2. If the characteristics of the vehicle no longer correspond to those indicated on the proof of compliance, the Member State in which the vehicle is registered shall take the necessary steps to ensure that the proof of compliance is altered. 3. The plates and documents referred to in paragraph 1 shall be recognized by the Member States as the proof of vehicle compliance provided for in Article 5 of Directive 85/3/EEC. 4. Vehicles carrying proof of compliance may be subject: - as regards common standards on weights, to random checks, - as regards common standards on dimensions, only to checks where there is a suspicion of non-compliance with Directive 85/3/EEC. Article 2 1. The middle column of the proof of compliance relating to weights shall contain, where appropriate, the Community weight standards applicable to the vehicle in question. As regards vehicles referred to in section 2.2.2 (c) of Annex I of Directive 85/3/EEC, the entry '(44 tonnes)' shall be included in brackets under the maximum authorized weight of the combined vehicle. 2. Each Member State may decide, in respect of any vehicle registered or put into circulation in its territory, that the maximum weights authorized by its national legislation shall be indicated in the proof of compliance in the left-hand column and the technically permissible weights indicated in the right-hand column. Article 3 Member States shall take the measures necessary to comply with this Directive wihin one year at the latest following its notification (1). They shall forthwith inform the Commission thereof. Article 4 This Directive is addressed to the Member States.

31986L0360

1986

Council Directive 86/360/EEC of 24 July 1986 amending Directive 85/3/EEC on the weights, dimensions and certain other technical characteristics of certain road vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas Directive 85/3/EEC (3) provides that the weight per driving axle of five or six-axle combined vehicles circulating in international traffic between Member States should be fixed as soon as possible; Whereas the state of certain portions of the road network in Ireland and the United Kingdom does not make it possible at the present stage to apply all the provisions of that Directive; whereas the application of some of these provisions in those Member States should therefore be temporarily deferred under arrangements to be laid down by the Council by the end of June 1988 at the latest; whereas it is not possible to lay down those arrangements in this Directive; whereas in view of the need for substantial improvements to the relevant portions of the road networks which will take some years to complete, the conditions referred to in Article 75 (3) of the Treaty are at present fulfilled in those Member States and are expected to remain so when the Council takes its Decision; whereas in consequence that Decision will then be adopted unanimously, Article 1 Council Directive 85/3/EEC is hereby amended as follows: 1. Article 7 shall be replaced by the following: 'Article 7 After consulting the Commission, Member States shall take the measures necessary to comply with this Directive: - as from 1 July 1986 as regards application of all provisions other than Article 4 and Annex II, as well as point 3.4 of Annex I, - as from 1 January 1990 as regards the application of Article 4 and Annex II, - as from 1 January 1992 as regards the application of point 3.4 of Annex I, Member States shall inform the Commission of the measures they take to implement this Directive.'; 2. the following two paragraphs shall be added to Article 8: '3. The provisions of Article 3 as regards the standard referred to in point 3.4 of Annex I shall temporarily not apply to Ireland and the United Kingdom. However, these two Member States shall apply Article 3 to the combined vehicles referred to in point 2.2 of Annex I where the weight per driving axle does not exceed 10,5 tonnes. 4. Before the end of 1987, the Commission shall submit to the Council a report on the development of the circumstances which have justified the derogation referred to in paragraph 3. This report shall be accompanied by a proposal concerning: (i) the duration of the derogation, and (ii) the procedure for periodic reviews of the circumstances justifying continuation of the derogation. The Council shall decide on this proposal by 30 June 1988, in accordance with the procedures laid down in the Treaty.'; 3. the following point shall be inserted in Annex I: 1.2.3 // '3.4. // Driving axle of vehicles referred to in point 2.2 // 11,5 tonnes.' Article 2 This Directive is addressed to the Member States.

31986L0403

1986

Commission Directive 86/403/EEC of 28 July 1986 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 86/300/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; Whereas the Annexes were consolidated by Commission Directive 85/429/EEC (3); Whereas the use of certain additives for certain purposes hitherto authorized at national level has been widely tested; whereas the experience gained and the studies carried out indicate that the use of these additives for the said purposes may now be authorized throughout the Community; 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 specified period; 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 shown in the Annex to this Directive. Article 2 Member States shall, by 3 December 1986, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1, and shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0457

1986

Council Directive 86/457/EEC of 15 September 1986 on specific training in general medical practice Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57 and 66 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 75/362/EEC (4), as last amended by the 1985 Act of Accession, and Council Directive 75/363/EEC (5), as last amended by Directive 82/76/EEC (6), on freedom of movement for medical practitioners, contain no provisions regarding the mutual recognition of diplomas attesting to specific training in general medical practice or the criteria to which such training should conform; Whereas, although the Council did not consider that the time was right to take appropriate measures on the matter at Community level, it nevertheless noted that in a number of Member States there was a growing tendency to emphasize the general medical practitioner's role and the importance of his training; whereas it accordingly requested the Commission to study the problems connected with this development; Whereas the point has now been reached where it is almost universally recognized that there is a need for specific training for the general medical practitioner to enable him better to fulfil his function; whereas this function, which depends to a great extent on the doctor's personal knowledge of his patients' environment, consists of giving advice on the prevention of illness and on the protection of the patient's general health, besides giving appropriate treatment; Whereas this need for specific training in general medical practice has emerged mainly as a result of the development of medical science, which has increasingly widened the gap between medical research and teaching on the one hand and general medical practice on the other, so that important aspects of general medical practice can no longer be taught in a satisfactory manner within the framework of the Member States' current basic medical training; Whereas, apart from the benefit to patients, it is also recognized that improved training for the specific function of general medical practitioner would contribute to an improvement in health care, particularly by developing a more selective approach to the consultation of specialists, use of laboratories and other highly specialized establishments and equipment; Whereas improved training for general medical practice will upgrade the status of the general medical practitioner; Whereas, although this situation seems irreversible, it has developed at different rates in the various Member States; whereas it is desirable to ensure that the various trends converge in successive stages, without however forcing the pace, with a view to appropriate training for every general medical practitioner in order to satisfy the specific requirements of general medical practice; Whereas, to ensure the gradual introduction of this reform, it is necessary in an initial stage to institute in each Member State specific training in general medical practice which satisfies minimum quality and quantity requirements, and supplements the minimum basic training which medical practitioners must receive in accordance with Directive 75/363/EEC; whereas it is immaterial whether this training in general medical practice is received as part of, or separately from, basic medical training as laid down nationally; whereas, in a second stage, provision should be made to subject the exercise of general medical practice under a social security scheme to completion of specific training in general medical practice; whereas further proposals to complete the reform should subsequently be put forward; Whereas this Directive does not affect the power of the Member States to organize their national social security schemes and to determine what activities are to be carried out under those schemes; Whereas the coordination, pursuant to this Directive, of the minimum conditions governing the issue of diplomas, certificates or other evidence of formal qualifications certifying completion of specific training in general medical practice will render possible the mutual recognition of these diplomas, certificates or other evidence of formal qualifications by the Member States; Whereas, under Directive 75/362/EEC, a host Member State is not entitled to require medical practitioners, in possession of diplomas obtained in another Member State and recognized under that Directive, to complete any additional training in order to practise within its social security scheme, even where such training is required of holders of diplomas of medicine obtained in its own territory; whereas this consequence of Directive 75/362/EEC will remain in effect as regards the exercise of general medical practice under social security schemes until 1 January 1995, from which date the present Directive requires all Member States to make the exercise of general medical practice in the context of their social security schemes subject to the possession of specific training in general medical practice; whereas medical practitioners established in practice before that date under Directive 75/362/EEC must have an acquired right to practise as general medical practitioners under the national social security scheme of the host country even if they have not completed specific training in general medical practice, Article 1 Each Member State which dispenses the complete training referred to in Article 1 of Directive 75/363/EEC within its territory shall institute specific training in general medical practice meeting requirements at least as stringent as those laid down in Articles 2 and 3 of this Directive, in such a manner that the first diplomas, certificates or other evidence of formal qualifications awarded on completion of the course are issued not later than 1 January 1990. Article 2 1. The specific training in general medical practice referred to in Article 1 must meet the following minimum requirements: (a) entry shall be conditional upon the successful completion of at least six years' study within the framework of the training course referred to in Article 1 of Directive 75/363/EEC; (b) it shall be a full-time course lasting at least two years, and shall be supervised by the competent authorities or bodies; (c) it shall be practically rather than theoretically based; the practical instruction shall be given, on the one hand, for at least six months in an approved hospital or clinic with suitable equipment and services and, on the other hand, for at least six months in an approved general medical practice or in an approved centre where doctors provide primary care; it shall be carried out in contact with other health establishments or structures concerned with general medical practice; however, without prejudice to the aforesaid minimum periods, the practical instruction may be given for a maximum period of six months in other approved health establishments or structures concerned with general medical practice; (d) it shall entail the personal participation of the trainee in the professional activities and responsibilities of the persons with whom he works. 2. Member States shall be entitled to defer application of the provisions of paragraph 1 (c) relating to minimum periods of instruction until 1 January 1995 at the latest. 3. Member States shall make the issue of diplomas, certificates, or other evidence of formal qualifications awarded after specific training in general medical practice, conditional upon the candidate's holding one of the diplomas, certificates or other evidence of formal qualifications referred to in Article 3 of Directive 75/362/EEC. 4. Member States shall designate the authorities or bodies competent to issue the diplomas, certificates or other evidence of formal qualifications awarded after specific training in general medical practice. Article 3 If, at the date of notification of this Directive, a Member State provides training in general medical practice by means of experience in general medical practice acquired by the medical practitioner in his own surgery under the supervision of an authorized training supervisor, that Member State may retain this type of training on an experimental basis on condition that: - it complies with Article 2 (1) (a) and (b), and Article 2 (3), - its duration is equal to twice the difference between the period laid down in Article 2 (1) (b) and the sum of the periods laid down in the third indent hereof, - it involves a period in an approved hospital or clinic with suitable equipment and services and a period in an approved general medical practice or in an approved centre where doctors provide primary care; as from 1 January 1995, each of these periods shall be of at least six months' duration. Article 4 On the basis of experience acquired, and in the light of developments in training in general medical practice, the Commission shall submit to the Council, by 1 January 1996 at the latest, a report on the implementation of Articles 2 and 3 and suitable proposals in order to achieve further harmonization of the training of general medical practitioners. The Council shall act on these proposals in accordance with procedures laid down by the Treaty before 1 January 1997. Article 5 1. Without prejudice to the principle of full-time training laid down in Article 2 (1) (b), Member States may authorize specific part-time training in general medical practice in addition to full-time training where the following particular conditions are met: - the total duration of training may not be shortened because it is being followed on a part-time basis, - the weekly duration of part-time training may not be less than 60 % of weekly full-time training, - part-time training must include a certain number of full-time training periods, both for the training conducted at a hospital or clinic and for the training given in an approved medical practice or in an approved centre where doctors provide primary care. These full-time training periods shall be of sufficient number and duration as to provide adequate preparation for the effective exercise of general medical practice. 2. Part-time training must be of a level of quality equivalent to that of full-time training. It shall lead to a diploma, certificate or other evidence of formal qualification, as referred to in Article 1. Article 6 1. Irrespective of any acquired rights they recognize, Member States may issue the diploma, certificate or other evidence of formal qualification referred to in Article 1 to a medical practitioner who has not completed the training referred to in Articles 2 and 3 but who holds a diploma, certificate or other evidence of formal qualification issued by the competent authorities of a Member State, attesting to completion of another additonal training course; however, the Member States may issue such diploma, certificate or other evidence of formal qualification only if it attests to a level of skill equivalent to that reached on completion of the training referred to in Articles 2 and 3. 2. In adopting their rules in accordance with paragraph 1, Member States shall specify the extent to which the additional training already completed by the candidate and his professional experience may be taken into account in place of the training referred to in Articles 2 and 3. Member States may issue the diploma, certificate or other evidence of formal qualification referred to in Article 1 only if the candidate has acquired at least six months' experience in general medical practice in a general medical practice or a centre where doctors provide primary care, as referred to in Article 2 (1) (c). Article 7 1. From 1 January 1995, and subject to the acquired rights it has recognized, each Member State shall make the exercise of general medical practice under its national social security scheme conditional on possession of a diploma, certificate or other evidence of formal qualification as referred to in Article 1. However, Member States may exempt from this condition persons who are undergoing specific training in general medical practice. 2. Each Member State shall specify the acquired rights that it recognizes. However, it shall recognize the right to exercise the activities of gneral medical practitioner under its national social security scheme without the diploma, certificate or other evidence of formal qualification referred to in Article 1 as having been acquired by all those doctors who on 31 December 1994 possess such a right under Directive 75/362/EEC and who are established on its territory on that date by virtue of Article 2 or Article 9 (1) of that Directive. 3. Each Member State may apply paragraph 1 before 1 January 1995, subject to the condition that any doctor who has completed the training referred to in Article 1 of Directive 75/363/EEC in another Member State shall be able to establish himself in practice on its territory until 31 December 1994 and to practise under its national social security scheme by virtue of Article 2 or Article 9 (1) of Directive 75/362/EEC. 4. The competent authorities of each Member State shall issue on request a certificate granting doctors possessing acquired rights by virtue of paragraph 2 the right to practise as general medical practitioners under its national social security scheme without the diploma, certificate or other evidence of formal qualifications referred to in Article 1. 5. Paragraph 1 shall in no way prejudice the possibility, which is open to Member States, of granting, in accordance with their own rules and in respect of their own territory, the right to practise as general practitioners under a social security scheme to persons who do not possess diplomas, certificates or other formal evidence of medical training and of specific training in general medical practice obtained in both cases in a Member State, but who possess diplomas, certificates or other evidence of either or both of these types of training obtained in a non-member country. Article 8 1. Each Member State shall recognize under its national social security scheme, for the purposes of the exercise of the activities of general medical practitioner, the diplomas, certificates, or other evidence of formal qualifications referred to in Article 1, issued to nationals of Member States by other Member States in accordance with Articles 2, 3, 5 and 6. The certificates from the competent authorities of the Federal Republic of Germany, stating that the diplomas, certificates or other evidence of formal qualifications awarded by the competent authorities of the German Democratic Republic are recognized as equivalent to those listed in the first subparagraph, shall also be recognized. 2. Each Member State shall recognize the certificates referred to in Article 7 (4) issued to nationals of Member States by other Member States, and shall consider them as equivalent within its territory to the diplomas, certificates or other evidence of formal qualifications which it issues itself, and which permit the exercise of the activities of general medical practitioner under its national social security scheme. Article 9 Nationals of Member States to whom a Member State has issued the diplomas, certificates or other evidence of formal qualifications referred to in Article 1 or Article 7 (4) shall have the right to use in the host Member State the professional title existing in that State and the abbreviation thereof. Article 10 1. Without prejudice to Article 9, host Member States shall ensure that the nationals of Member States covered by Article 8 have the right to use the lawful academic title, or, where appropriate, the abbreviation thereof, of their Member State of origin or of the Member State from which they come, in the language of that Member State. Host Member States may require this title to be followed by the name and location of the establishment or examining board which awarded it. 2. If the academic title of the Member State of origin, or of the Member State from which a national comes, can be confused in the host Member State with a title requiring, in that State, additional training which the person concerned has not undergone, the host Member State concerned may require such person to use the title of the Member State of origin or of the Member State from which he comes in a suitable form to be indicated by the host Member State. Article 11 On the basis of experience acquired, and in the light of developments in training in general medical practice, the Commission shall submit to the Council by 1 January 1997 at the latest a report on the implementation of this Directive and, if necessary, suitable proposals with a view to appropriate training for every general medical practitioner in order to satisfy the specific requirements of general medical practice. The Council shall act on those proposals in accordance with the procedures laid down in the Treaty. Article 12 1. Member States shall take the measures necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall also notify the Commission of the date of entry into force of these measures. 2. As soon as a Member State has notified the Commission of the date of entry into force of the measures it has taken in conformity with Article 1, the Commission shall publish an appropriate notice in the Official Journal of the European Communities, indicating the designations adopted by that Member State for the diploma, certificate or other evidence of formal qualifications and, where appropriate, the professional title in question. Article 13 This Directive is addressed to the Member States.

31986L0469

1986

Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 4 thereof, Having regard to Council Directive 81/602/EEC of 31 July 1981 concerning the prohibition of certain substances having a hormonal action and of any substance having a thyrostatic action (3), Having regard to the proposals from the Commission (4), Having regard to the opinions of the European Parliament (5), Having regard to the opinions of the Economic and Social Committee (6), Whereas Article 4 (2) of Directive 64/433/EEC lays down as regards examination of animals or meat for residues that the Council shall adopt: - the detailed arrangements for controls, - the tolerances for the substances referred to in the second subparagraph of Article 4 (1) (b) of that Directive, - the frequency of sampling; Whereas, on 16 July 1985, the Council, by Directive 85/358/EEC supplementing Directive 81/602/EEC concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action (7), adopted certain rules of control with a view to guaranteeing the uniform application of Directive 81/602/EEC; whereas supplementary measures would appear to be appropriate; Whereas the detailed arrangements for controls of animals and fresh meat for residues, for the frequency of sampling of animals or meat, for examination for residues, and for the establishment of maximum permitted limits of residues of substances having a pharmacological action and of the conversion products thereof and other substances transmitted to meat are regulated in a differing fashion in the Member States; whereas the consequences of such residues for human health are assessed differently in such regulations; whereas these differences lead to major obstacles in intra-Community trade and to a distortion in the conditions of competition between products that are the subject of common organizations of the market; Whereas it is therefore necessary to adopt a general solution concerning controls in the Community of farm animals and meat and meat products obtained therefrom for the presence of residues, whether these products are intended for the national market of Member States or intra-Community trade; Whereas it is desirable that Member States should draw up plans which take account of their situation; whereas these plans must be approved and, if necessary, amended or amplified by means of a Community procedure; Whereas it is appropriate to provide that sampling be carried out officially in the Member States in accordance with common criteria for the different groups of substances of concern; whereas it is appropriate that samples are subject to examination at officially authorized laboratories; Whereas it is appropriate that the national reference laboratories designated in accordance with Article 4 (1) (b) of Directive 64/433/EEC should coordinate the standards and methods of analysis used in their respective territories; whereas it is appropriate that for each residue or group of residues of concern a Community laboratory should be designated for liaison with the national reference laboratories; Whereas further details of the criteria of operation of laboratories should be established later; Whereas, when an examination reveals the presence of residues, it is necessary that common control measures are taken to ascertain and eliminate the cause of the residue, and which ensure that meat showing residues which exceed the permitted level is excluded from consumption; Whereas, in order to make it easier to implement the provisions envisaged, provision should be made for a procedure which establishes close cooperation between the Member States and the Commission within the Standing Veterinary Committee set up by Decision 68/361/EEC (1); Whereas it is necessary to keep under review the details of the controls carried out in particular in terms of the results which are found; Whereas it is necessary to provide for the amendment and, where necessary, supplementation of technical provisions concerning controls and frequency of sampling to take account of new knowledge and scientific and technical developments; Whereas it is desirable that Community control measures be introduced to guarantee uniform application in all Member States of the provisions of this Directive; Whereas provision should be made for a procedure designed to settle any conflict which might arise between Member States on the efficiency of the controls provided for by this Directive; Whereas the adoption of a harmonized set of rules in the Community leads to the setting-up of arrangements for imports from third countries, offering equivalent guarantees; whereas, in this connection, Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries (2) should be amended; Whereas the decisions necessary to set up the arrangements for imports from third countries must be adopted both in the framework of Directive 72/462/EEC and that established by this Directive; Whereas it is desirable to entrust the Commission with the task of taking certain measures for the application of this Directive; whereas, with this in mind, provision should be made for a procedure which establishes close and efficient cooperation between the Commission and the Member States within the Standing Veterinary Committee, Article 1 Member States shall ensure that examination of animals, their excrement and body fluids and of tissues and fresh meat for the presence of residues is carried out in accordance with the requirements of this Directive or provisions to be added at a later date, in particular those which will be adopted in accordance with Article 16. Article 2 The definitions given in Article 2 of Directive 64/433/EEC and, where necessary, those given in Article 1 of Directive 85/649/EEC (3) shall apply for the purposes of this Directive. In addition: (a) 'official sample' means a sample, taken by the competent authority, which bears, for the examination of the residue concerned, a reference to the species, the type, the amount and the method of collection and the identification of the origin of the animal and the meat; this sample is to be taken without prior warning; (b) 'approved laboratory' means a laboratory approved by the competent authorities of a Member State to make an examination of an official sample in order to detect the presence of residues; (c) 'residue' means residue of substances having a pharmacological action and of conversion products thereof and other substances transmitted to meat and which are likely to be dangerous to human health. Article 3 Member States shall assign a central department or body to coordinate implementation of the inspections provided for in this Directive. In particular, that department or body shall be responsible for: - drawing up the plans provided for in Article 4 enabling the competent departments to carry out the required inspections, - coordinating the activities of regional departments responsible for carrying out inspections for different residues, - collecting the results of those inspections and the data which must be sent to the Commission. Article 4 1. Member States shall submit to the Commission: - by 31 May 1987, a plan setting out the national measures to be taken to achieve the stated objective of this Directive in respect of the substances referred to in Annex I, Group A, I and II, - by 31 May 1988, a plan stating the measures relating to the examination for residues in substances from the other groups. Both of these plans will have to take into account the specific situation of each Member State and specify inter alia: - legislation on the use of substances, and in particular on their prohibition or authorization, distribution, placing on the market and rules for administration, - the infrastructure of the services (in particular giving details of the authorities associated with the implementation of the plans, and the type and size of the bodies involved in such implementation), - a list of approved laboratories indicating their capacity for processing samples, - whether there is a total or partial ban on using the substances referred to in Annex I, Group A, in particular in the absence of Community regulations, - a list of the substances investigated, the methods of analysis and standards for interpreting the findings, - the number of official samples to be taken in conjunction with the number of animals slaughtered with regard to the species concerned during preceding years, - a list of the substances referred to in Annex I, Group B, indicating the number of samples and the reasons for this number, - details of the rules observed when official samples are collected, in particular the rules permitting the indication of the details specified in point (a) of the second paragraph of Article 2, - the type of measures laid down by the competent authorities with regard to products in which the presence of residues has been detected. 2. The Commission shall examine the plans communicated in accordance with paragraph 1, in order to determine whether they conform to the provisions laid down in this Directive. 3. In accordance with the procedure provided for in Article 15, the Commission shall approve the plans referred to in paragraph 1. In accordance with the same procedure, the Commission may decide that the Member State concerned must amend or supplement the plan which it has submitted. The abovementioned decisions must be adopted by 30 September 1987 for plans relating to inspection for the substances referred to in Annex I, Group A, I and II and by 30 September 1988 for plans relating to inspection for the other residues. 4. At the request of the Member State concerned, and in order to take account of developments in the situation in that Member State or in one of its regions, the Commission may decide, in accordance with the procedure provided for in Article 14, to approve any amendment or addition to a plan previously approved pursuant to paragraph 3. 5. In accordance with the procedure provided for in Article 14, the Commission may decide that a Member State must amend or supplement a plan previously approved pursuant to paragraph 3 in order to take account of the developments in the situation in that State or of findings established under Articles 5, 11 and 12. Article 5 1. Veterinary experts from the Commission may, in cooperation with the competent authorities of the Member States, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of this Directive. A Member State within whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member State concerned of the results of the investigation. The Member State concerned shall take any measures which may prove necessary to take account of the results of the investigation. If the Member State does not take those measures, the Commission may, after the situation has been examined by the Standing Veterinary Committee, have recourse to the provisions of Article 4 (5). 2. The general provisions for implementing this Article, especially as regards the frequency and method of carrying out the checks referred to in the first subparagraph of paragraph 1, shall be laid down in accordance with the procedure set out in Article 15. Article 6 Member States shall ensure that during examination for the presence of residues: - the minimum frequencies for inspections, as laid down in Annex II, are complied with. However: (i) Luxembourg shall be authorized to inspect 0,01 and 0,2 % of animals instead of a random statistical frequency of 300 and 700 official samples respectively. (ii) In the case of the substances referred to in Annex I, Group A, I and II: - for the initial stage Denmark shall be authorized to carry out inspections using 750 official samples, - until the total ban on the use of anabolic substances in production for the national market is extended, the United Kingdom shall be authorized to inspect only 0,15 % of animals slaughtered in slaughterhouses approved and inspected in accordance with Articles 8 (1) and 9 of Directive 64/433/EEC, the rest of the bovine population being officially sampled annually at a frequency which gives 99,9 % assurance that in the absence of positive findings, the proportion of the bovine fattening population liable to contain residues will be less than 1 %, - the inspections are applied in accordance with the procedures to be specified in the plan which will be approved, amended or supplemented pursuant to Article 4. Article 7 1. The following shall be inserted in Article 3 (2) of Directive 72/462/EEC: '(f ) that country's legislation on the use of substances, in particular legislation concerning the prohibition or authorization of substances, their distribution, release on to the market and their rules covering administration and inspection;'. 2. Admission to, or retention on, the list referred to in Article 3 of Directive 72/462/EEC shall be subject to the submission, by the third country concerned, of a plan giving details of the guarantees afforded by the said country for the checking of residues. The effect of these guarantees must be at least equivalent to that resulting from the guarantees provided for by this Directive. In accordance with the procedure provided for in Article 14, the Commission shall approve the plans in question. Likewise in accordance with this procedure, guarantees alternative to these resulting from the application of this Directive may be allowed. Decisions to be taken in this context must be adopted: (i) not later than 31 December 1987 as regards the substances referred to in Annex I, Group A, I and II; (ii) not later than 31 December 1988 as regards the substances referred to in Annex I, Group A, III and Group B, I and II. 3. Where no decision within the meaning of paragraph 2 is taken with regard to a given third country by the said dates, entry of that country on the list referred to in Article 3 of Directive 72/462/EEC shall be suspended in accordance with the procedure provided for in Article 14. 4. Compliance by the competent authorities of third countries with the execution of the plans shall be verified when the inspections referred to in Article 5 of Directive 72/462/EEC are carried out. Article 8 1. Member States shall seek to ensure, when implementing this Directive, that: (a) official samples are taken from animals, their excrement and body fluids and from tissues and fresh meat for examination at approved laboratories for residues in accordance with Annex II; (b) the national reference laboratories designated in accordance with Article 4 (1) (b) of Directive 64/433/EEC coordinate standards and methods of analysis for each residue or group of residues concerned, including the arrangement of periodic comparative tests of split samples by approved laboratories, and compliance with the limits laid down. 2. The Council, acting by a qualified majority on a proposal from the Commission, shall designate for each residue or group of residues a Community reference laboratory which shall be responsible for coordinating inspections, to be selected from among the various national reference laboratories, and shall determine, according to the needs of this Directive, the powers and conditions of operation of those reference laboratories. 3. The analysis of samples referred to in paragraph 1 must be carried out in accordance with methods which are applied by the Member States and have been submitted to the Commission under their inspection plans. All positive findings must, if challenged, be confirmed by a laboratory officially approved for that purpose by the competent authorities, using the reference methods established pursuant to Article 4 (1) (b) of Directive 64/433/EEC. Article 9 1. Where an examination of an official sample taken in accordance with Annex II reveals the presence of residues of prohibited substances or quantities of authorized substances exceeding the levels set by Community law or, in their absence, national levels permitted on 16 September 1986 the competent authorities shall seek to ensure that it obtains without delay: (a) all information, to be established according to the procedure laid down in Article 15, needed to identify the animal and the farm of origin; (b) the result of the examination. Where the results of the controls carried out in one Member State indicate the need for investigation or action in one or more other Member States or in one or more third countries, the Member State concerned shall inform the other Member States and the Commission thereof. Member States in which an investigation or action proves to be necessary shall take the appropriate measures. 2. The competent authorities shall thereupon ensure that: (a) an investigation is carried out at the farm of origin to determine the reasons for the presence of residues; (b) an investigation of the source or sources of the substances concerned is carried out as necessary at the levels of manufacture, handling, storage, transport, administration, distribution or sale. 3. The competent authorities shall also ensure that: (a) the herd or animals at the farm of origin and herds which, as a result of the investigations referred to in paragraph 2 may be regarded as containing the residues in question, bear an official marking and are subjected to appropriate examinations; (b) if the examination reveals the presence of prohibited substances, the animals may not be placed on the market for human or animal consumption; (c) if the conditions of use of an authorized substance have not been respected and, in particular, if the examination reveals the presence of residues of authorized substances above the permitted levels referred to in paragraph 1, the slaughter of animals for human consumption is prohibited until it can be ensured that the amount of residue no longer exceeds the permissible levels. This period may under no circumstances be shorter than the waiting period prescribed for the substances in question; (d) during the period of examination, the animals are disposed of to other persons only subject to the control of the official veterinarian. 4. By way of derogation from paragraph 3 (c), animals whose slaughter is prohibited may be slaughtered before the end of the prohibition period if the competent authority has been informed before the envisaged slaughter date, and the place of slaughter has been indicated to it. The officially marked animals must be accompanied to the place of slaughter by an official veterinary certificate containing the information required under paragraph 1 (a). The meat of each animal whose slaughter is notified pursuant to the first subparagraph shall be officially sampled for the residue concerned and shall be detained until the result of the examination is known. Meat in which the presence of residues is confirmed must be excluded from human consumption. 5. The competent authorities shall also ensure that the production establishment or animal holdings in the same region or locality supplying the establishment are subject to additional monitoring for the substance concerned. 6. For the effective application of this Directive, a Member State may require that, within its own territory, a register be kept, in particular, on the farm, at the slaughterhouse or at markets. Article 10 Without prejudice to Article 4, the competent authority may - where there is suspicion that residues are present - subject the animals of the species concerned or the fresh meat in question to examinations to establish the presence of such residues in its national production. Article 11 1. Where a Member State considers that, in another Member State, the checks provided for in this Directive are not being, or have ceased to be, carried out, it shall inform the competent central authority of that State accordingly. Following an investigation in accordance with Article 9 (2), that authority shall take all necessary measures and shall, at the earliest opportunity, notify the competent central authority of the first Member State of the decisions taken and the reasons for such decisions. If the first Member State fears that such measures are not being taken or are inadequate, it shall, together with the Member State which has been challenged, seek ways and means of remedying the situation; if appropriate, this may involve a visit. Member States shall inform the Commission of disputes and of solutions arrived at. If the Member States involved are unable to reach agreement, one of them shall bring the matter to the notice of the Commission within a reasonable period of time and the latter shall entrust one or more experts with delivering an opinion. Pending the experts' conclusions, the Member States of destination may carry out checks on products coming from the establishment or establishments or from a holding or holdings challenged by the dispute and, if the result is positive, take measures similar to those provided for in Article 10 (4) of Directive 64/433/EEC. In the light of the experts' opinion, appropriate measures may be taken in accordance with the procedure provided for in Article 15. These measures may be reviewed in accordance with the same procedure should the experts deliver a new opinion within a period of 15 days. 2. The general rules for the application of this Article shall be adopted in accordance with the procedure set out in Article 15. Article 12 Every year the Member States shall inform the Commission and the other Member States of the implementation of the plans approved in accordance with Article 4. In the light of that information, Article 4 (5) may be invoked. Within the Standing Veterinary Committee the Commission will inform the Member States periodically - and at all events whenever it sees fit on public health grounds - of the development of the situation in the various regions of the Community. Article 13 The Annexes may be amended or supplemented by the Council acting by a qualified majority on a proposal from the Commission. Article 14 1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (hereinafter referred to as 'the Committee') by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within two days. Opinions shall be delivered by a majority of 54 votes. 4. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If, 15 days after the proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority. Article 15 1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Committee by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within a time limit which the chairman may set according to the urgency of the matter submitted. Opinions shall be delivered by a majority of 54 votes. 4. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit a proposal to the Council concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If, three months after the proposals were submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority. Article 16 Acting on a proposal from the Commission, to be submitted before 1 January 1989, the Council shall, as a first stage, lay down the measures to be taken for the examination of residues in poultry and poultrymeat and, subsequently, the measures for fish-farming products. Article 17 In accordance with the procedure laid down in Article 14, possible transitional measures may be decided on for a maximum duration of one year. Article 18 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply: (a) with the provisions of Articles 3 and 4 not later than 1 April 1987; (b) with the provisions of Articles 5, 11 and 12 not later than 31 December 1987; (c) with the remaining provisions (i) not later than 31 December 1987 as regards the substances referred to in Annex I, Group A, I and II; (ii) not later than 31 December 1988 as regards the substances referred to in Annex I, Group A, III and Group B, I and II. Article 19 This Directive is addressed to the Member States.

31986L0489

1986

Commission Directive 86/489/EEC of 24 September 1986 amending Directive 77/794/EEC laying down detailed rules for implementing certain provisions of Directive 76/308/EEC on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties, and in respect of value added tax Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/308/EEC of 15 March 1976 on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties, and in respect of value added tax (1), as last amended by the Act of Accession of Spain and Portugal, and in particular Article 22 (1) thereof, Whereas Commission Directive 77/794/EEC (2), as amended by Directive 85/479/EEC (3), laid down detailed rules for implementing certain provisions of Directive 76/308/EEC; whereas Article 20 (2) laid down that no request for assistance may be made if the amount claimed is less than 750 ECU unless the request related to the recovery of a claim payable as a result of an irregularity committed in the course of, or in connection with, an operation carried out under arrangements for movement of goods within the Community introduced by Council Regulation (EEC) No 3/84 (4), as last amended by the Act of Accession of Spain and Portugal, in which case that amount is reduced to 200 ECU; Whereas, having regard to the increase in administrative costs since 1977, the threshold for the submission of requests for assistance should be increased to 1 500 ECU, except in the specific case referred to above where the threshold must remain 200 ECU so as to ensure the correct implementation of the provisions of Regulation (EEC) No 3/84; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on Recovery, Article 1 The first sentence of Article 20(2) of Directive 77/794/EEC is replaced by the following: 'From 1 January 1987 no request for assistance may be made if the amount of the relevant claim of claims is less than 1 500 ECU.' Article 2 Member States shall take the measures necessary to comply with this Directive not later than 1 January 1987. Article 3 Each Member State shall inform the Commission of the measures which it takes for implementing this Directive. The Commission shall communicate such information to the other Member States. Article 4 This Directive addressed to the Member States.

31986L0508

1986

Commission Directive 86/508/EEC of 7 October 1986 adapting to technical progress for the second time Council Directive 77/728/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/728/EEC of 7 November 1977 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products (1), as last amended by Directive 83/265/EEC (2) and in particular Article 11 thereof; Whereas the reference made to the ISO standard in Explanatory Note 6 to Annex I to Directive 77/728/EEC should be changed; Whereas Annex II to Directive 77/728/EEC lays down special provisions concerning the labelling of certain preparations, particularly paints and varnishes containing lead; whereas it is necessary to inform users of the harmful effects of lead on human health, especially in the case of children, and to minimize the lead content of the paints and varnishes available to them; whereas, under these circumstances, the numerical value laid down in point 1 of Annex II should be revised; Whereas it will be necessary to revise this numerical value within a reasonable period; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaption to Technical Progress of Directives relating to the removal of technical barriers to trade in dangerous substances and preparations, Article 1 Directive 77/728/EEC is hereby amended as follows: 1. The reference number of the ISO standard in Explanatory Note 6 to Annex I is replaced by 'ISO 6713-1984'. 2. Point 1 of Annex II is replaced by the following: '1. Paints and varnishes containing lead Labels of packages of paints and varnishes containing lead in quantities exceeding 0,25 % expressed as weight of metal, of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984 shall show the following particulars: "Contains lead. Should not be used on surfaces liable to be chewed or sucked by children." In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows: "Warning. Contains lead."' Article 2 The numerical value in Article 1 (2) is a reflection of the current situation. Given the continuing developments in knowledge and technology, it will be necessary to revise it within a period of 24 months from the date of adoption of this Directive, and in any case not later than 31 December 1988. Article 3 Member States shall adopt and publish the provisions necessary to comply with the Directive before 1 September 1987. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 June 1988 at the latest. Article 4 This Directive is addressed to the Member States.

31986L0525

1986

Commission Directive 86/525/EEC of 27 October 1986 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 86/403/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes were consolidated by Commission Directive 85/429/EEC (3); Whereas the use of certain additives hitherto authorized at national level has been widely tested; whereas the studies carried out and the experience gained indicate that these additives may be authorized throughout the Community for the uses specified; Whereas the manufacture of pet foods requires the use of acidity regulators to modulate the pH of such feedingstuffs; whereas, therefore, this group of additives should be added to the Annexes to the Directive while specifying, on the basis of the intended use, which substances are authorized for use throughout the Community and which are to remain for the time being subject to national authorization; Whereas it is appropriate to authorize at national level, for a limited period of time, the use of colouring matter 'Brilliant Blue FCF', for the identification of cereals used as feedingstuffs; whereas a decision on the authorization of this additive at Community level should be taken before the expiry of that period; 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 hereto. Article 2 Member States shall, by 30 November 1987 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0530

1986

Commission Directive 86/530/EEC of 28 October 1986 amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (1), as last amended by Commission Directive 85/509/EEC (2), and in particular Article 6 thereof, Whereas Directive 82/471/EEC provides for regular amendment of the content of the Annexes thereto as a result of developments in scientific or technical knowledge; Whereas the study of three new products belonging to the proteins, non-protein nitrogenous compounds and amino acids groups has shown that these products fulfil the requirements of Directive 82/471/EEC; whereas the use of these products in animal nutrition should, therefore, be permitted under certain conditions; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 The Annex to Directive 82/471/EEC is amended as set out in the Annex hereto. Article 2 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 not later than 30 June 1988. They shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0546

1986

Second Commission Directive 86/546/EEC of 29 October 1986 amending the Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 13, paragraph two, indents three and four thereof, Whereas Directive 77/93/EEC lays down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; Whereas developments in scientific and technical knowledge have shown that protection of Community forests should be improved, wherever they are at risk; Whereas the current provisions include measures to protect certain Member States against harmful bark beetles such as Dendroctonus micans and certain Ips species; Whereas these measures should be extended so as to protect other Member States where these organisms do not occur and to include additional safeguards in order to face means of spread which were not taken into account hitherto; Whereas the Community should also be protected against the introduction of certain organisms affecting Pinus or Acer saccharum, which are not yet referred to in the current provisions; Whereas new sources of infection by canker stain of plane (Ceratocystis fimbriata var. platani) should be prevented and spread within the Community should be limited; Whereas the relevant Annexes to Directive 77/93/EEC should therefore be amended accordingly; Whereas these amendments are made in agreement with the Member States concerned; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annex I to Directive 77/93/EEC is hereby amended as follows: In Part A (a), the following is inserted after (7b): '7c. Pissodes spp. (non-European)'. Article 2 Annex II to Directive 77/93/EEC is hereby amended as follows: 1. In Part A (a) the following is inserted before (2): 1.2 // // // '1. Bursaphelenchus xylophilus (Steier and Buhrer) Nickle // Coniferous plants other than fruit and seeds and coniferous wood' // // 2. In Part A (c), the following is inserted after (1): 1.2 // // // '1a. Ceratocystis coerulescens (Muench) Back. // Plants of Acer saccharum other than fruit or seeds, originating in the United States of America, wood of Acer saccharum, originating in the United States of America // 1b. Ceratocystis fimbriata var. platani Walt. // Plants of Platanus L. other than fruit or seeds, wood of Platanus // 1c. Cercoseptoria pini-densiflorae (Hori and Nambu) Deighton (= Cercospora pini-densiflorae Hori and Nambu) // Plants of Pinus other than fruit or seeds, wood of Pinus'. // // 3. In Part A (c), the following is added: 1.2 // // // '16. Scirrhia acicola (Dearn.) Siggers // Plants of Pinus other than fruit or seeds, wood of Pinus // 17. Scirrhia pini Funk and Parker // Plants of Pinus other than fruit or seeds, wood of Pinus'. // // 4. The texts in Part B (a) (2), (6), (7), (8), (9) and (10), central column are replaced respectively by the following: 'Coniferous plants, or coniferous wood with bark'. 5. In Part B (a) (2), (6), (7), (8) and (10), right-hand column, the following are added respectively: 'Greece, Spain, Italy, Portugal'. 6. In Part B (a) (9), right-hand column, the following are added: 'Greece, Italy'. 7. In Part B (a), the following is inserted after (10a): 1.2.3 // // // // '10b. Pissodes spp. (European) // Coniferous plants or coniferous wood with bark // Ireland, UK (Northern Ireland)'. // // // Article 3 Annex III to Directive 77/93/EEC is hereby amended as follows: 1. In Part A, the following is inserted after (6a): 1.2 // // // '6b. Isolated bark of Acer saccharum // United States of America' // // 2. In Part B (5), right-hand column, the words '(Northern Ireland)' are deleted. 3. In Part B, item (6) is replaced by the following: 1.2 // // // '6. Cut trees of conifers retaining foliage, of more than 3 m height // Ireland, United Kingdom'. // // Article 4 Annex IV to Directive 77/93/EEC is hereby amended as follows: 1. In Part (A), the following is inserted after (1): 1.2 // // // '1a. Sawn wood of Acer saccharum, originating in the USA // There shall be evidence by a mark 'Kiln-dried', 'K. D.' or another internationally recognized mark, put on the wood or in its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule'. // // 2. In Part A (2), right-hand column, the following is added: 'or in the case of sawn wood with or without residual bark attached, there shall be evidence by a mark 'Kiln-dried' 'K. D.' or another internationally recognized mark, put on the wood or in its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule'. 3. In Part A, the following is inserted after (4): 1.2 // // // '4a. Sawn wood of Platanus, originating in the USA // There shall be evidence by a mark 'Kiln-dried', 'K. D.' or another internationally recognized mark, put on the wood or in its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule // 4b. Sawn wood of Platanus, originating in countries other than USA, where Ceratocystis fimbriata var. platani is known to occur // (a) Official statement that the wood originates in regions which have been recognized in accordance with the procedure laid down in Article 16, to be free of Ceratocystis fimbriata, // // or // // (b) there shall be evidence by a mark 'Kiln-dried', 'K. D.' or another internationally recognized mark, input on the wood or in its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule // // 4. In Part A (8), right-hand column, the words 'Cronartium quercumm' are replaced by the words 'Cronartium quercuum, Scirrhia acicola or Scirrhia pini'. 5. In Part A, the following is inserted after (14): 1.2 // // // '14a. Plants of Platanus, other than fruit or seeds, originating in the USA or other countries where Ceratocystis fimbriata var. platani is known to occur // Official statement that no symptoms of Ceratocystis fimbriata var. platani have been observed at the place of production or in its immediate vicinity since the beginning of the last complete cycle of vegetation'. // // 6. In Part B (1), the text of the central column is replaced by the following: '(a) The wood shall be stripped of its bark, or (b) there shall be evidence by a mark 'Kiln-dried' 'K. D.' or another internationally recognized mark, put on the wood or in its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule' 7. In Part B (1), right-hand column, the words '(Northern Ireland)' are deleted. 8. In Part B (3), the text is replaced by the following: 1.2.3 // // // // '3. Plants of conifers over 3 m height, intended for planting // Official statement that the plants have been produced in nurseries and that the place of production is free from Dendroctonus micans and from Ips species referred to Annex II (B) (a) (6), (8) or (10) // Greece, Spain, Ireland, Italy, Portugal, United Kingdom // 3a. Plants of conifers over 3 m height, intended for planting // Official statement that the plants have been produced in nurseries and that the place of production is free from Ips species referred to in Annex II (B) (a) (7) // Greece, Spain, Ireland, Italy, Portugal, United Kingdom (Northern Ireland) // 3b. Plants of conifers over 3 m height, intended for planting // Official statement that the plants have been produced in nurseries and that the place of production is free from Ips species referred to in Annex II (B) (a) (9) // Greece, Ireland, Italy, United Kingdom (Northern Ireland) // 3c. Cut trees of conifers retaining foliage, of 3 m height or less // Official statement that the plants do not derive from the tops of trees which have grown in places other than nurseries, and which have been over 3 m height // Ireland, United Kingdom'. // // // Article 5 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive by 1 January 1987 at the latest. The Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof. Article 6 This Directive is addressed to the Member States.

31986L0547

1986

Third Commission Directive 86/547/EEC of 29 October 1986 amending Annex III B to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 13, paragraph two, indent one thereof, Having regard to the requests made by Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom, Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas those measures include measures to be taken by Member States in respect of plants, plant products and other objects coming from third countries; Whereas certain Member States have stricter measures in respect of those plants and plant products; Whereas those stricter measures include, in the requesting Member States, prohibitions of certain products originating in a third country; Whereas, if Annex III to the aforementioned Directive is amended appropriately, the Member States concerned could also impose the relevant prohibitions where the products concerned, originating in a third country, come from other Member States; Whereas, following the intentions declared by the Commission and all Member States at the time of adoption amending Council Directive 85/574/EEC (3), Annex III (B) to Directive 77/93/EEC should be amended accordingly, as an interim protective measures for a period of three years; Whereas during that period the Commission will study these protective measures in relation to the plant health situation existing in the various third countries concerned, in order to arrive, at the end of the period, at more permanent provisions; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In Annex III B to Directive 77/93/EEC the following are hereby added: 1.2 // // // // // '11. Plants of the following genera, other than seeds, originating in third countries where Erwinia amylovora is known to occur; Chaenomeles Lindl., Cydonia Mill., Malus Mill, Pyracantha M.J. Roem, Pyrus L., Sorbus L., Stranvaesia // Greece, Spain, Portugal // 12. Plants vine (Vitis L. partim) and any other plant which can be a vector of the organism causing Pierce's disease, originating in the USA (states where Pierce's disease is known to occur) or other third countries where Pierce's disease is known to occur // Greece, Portugal 1.2 // // // // // 13. Plants of vine (Vitis L. partim), other than fruit and seeds, originating in third countries // Spain, France // 14. Fruits of the genera Cydonia Mill., Malus Mill., Prunus L., Pyrus L., Ribes L. and other fruits primarily grown in tropical regions, originating in non-European countries where relevant fruit-infesting Trypetidae (non-European) are known to occur // Spain, Portugal // 15. Without prejudice to the prohibitions applicable to plants under points 9 and 10, plants of Chaenomeles Lindl., Cydonia Mill., Malus Mill., Pyracantha M.J. Roem, Pyrus L., Sorbus L. and Stranvaesia, other than fruit and seeds, originating in third countries // Ireland // 16. Without prejudice to the prohibitions applicable to plants under Annex III A: plants of the order Coniferales other than seeds, originating in third countries // Ireland // 17. Plants, other than seeds, of Apium L., Beta L., Brassica L., Cichorium L., Cynara, Daucus L., Foeniculum Mill., Lactuca L., Nasturtium officinale R. Br., Petroselinum Hill, Raphanus L. and Spinaceae with foliage, originating in third countries // Ireland // 18. Plants and plant products with growing medium attached, originating in third countries // Ireland // 19. Wood chips and sawdust originating in third countries // Ireland // 20. Plants of the following genera, other than seeds, originating in third countries: Acacia Tourn., ex I., Acer L., Med., Chaenomeles Lindl., Cydonia Mill., Fagus L., Malus Mill., Populus L., Prunus L., Pyracantha M.R. Roem, Pyrus L., Rosa L., Salix L., Sorbus L., Stranvaesia, Ulmus L., Vitis L. // Italy // 21. Plants of Fragaria, other than fruit and seeds originating in non-European countries // Italy // 22. From 1 April to 30 November plants of Solanaceae, other than tubers and seeds, originating in third countries // Italy // 23. From 1 April to 30 November fruit of melon and water-melon, originating in non-European countries // Italy // 24. From 1 June to 30 November fruits of Ananas originating in third countries // Italy // 25. Plants of Solanaceae for planting, other than tubers of potatoes and seeds, other than from European or Mediterranean countries // United Kingdom // // // // 26. Annual and biennial plants for planting, other than seeds, other than from European or Mediterranean countries // United Kingdom // 27. Plants of Beta L. for planting originating in third countries // United Kingdom // 28. Plants of Dendranthema (DC.) Desmoul. for planting, other than seeds, originating in third countries // United Kingdom // 29. Plants of Gramineae for planting, other than seeds, originating in third countries // United Kingdom // 30. Herbaceous perennial plants, for planting, of Caryophyllaceae, Compositae, Cruciferae, Leguminosae and Rosaceae, other than seeds, other than plants of Dianthus caryophyllus L., Dendranthema (DC.) Desmoul. and Fragaria L., other than from European or Mediterranean countries // United Kingdom // 31. Plants of Cydonia Mill, Malus Mill, Prunus L., and Pyrus L. for planting, other than seeds, originating in third countries other than Algeria, Egypt, Finland, Israel, Libya, Morocco, Norway, Sweden and Tunisia // United Kingdom // 32. Plants of Fragaria L. for planting, other than seeds, originating in non-European countries other than African states, Australia, Canada, Cyprus, Israel, Lebanon, New Zealand, Syria, Turkey and Continental States of the United States of America // United Kingdom // 33. Plants of trees and shrubs for planting, other than seeds, other than plants of certain families intended for use as indoor or glasshouse ornamentals, other than from European or Mediterranean countries and other than Canada and Continental States of the United States of America // United Kingdom // 34. Soil originating in third countries // United Kingdom // 35. Potato tubers for planting from third countries, other than those originating in Austria or Switzerland officially certified as seed potatoes pursuant to Directive 66/403/EEC // United Kingdom // 36. Potato tubers for consumption originating in third countries, other than Algeria, Austria, Cyrus, Egypt, Israel, Libya, Malta, Morocco, Switzerland and Tunisia // United Kingdom // // // // 37. Seeds of Medicago sativa L., for planting, originating in third countries where Corynebacterium michiganense pv insidiosum is known to occur, other than Australia, Austria, Canada, Czechoslovakia, Finland, Israel, Romania, Republic of South Africa, Sweden and the United States of America // United Kingdom // 38. Plants of Castanea Mill., Larix Mill., Populus L. with or without leaves, Pseudotsuga Carr., Quercus L., Tsuga Carr. and Ulmus L., other than fruit and seeds originating in non-European countries // United Kingdom // 39. Plants of Zelkova Spach originating in non-European countries // Ireland, United Kingdom (Northern Ireland) // 40. Isolated bark of conifers (Coniferae) originating in third countries // Ireland, Portugal, United Kingdom'. // // Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall apply until 31 December 1989. Article 4 This Directive is addressed to the Member States.

31986L0545

1986

First Commission Directive 86/545/EEC of 29 October 1986 amending the Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 13, paragraph two, indents three and four thereof, Whereas Directive 77/93/EEC lays down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; Whereas the relevant harmful organisms are listed either in Annex I or in Annex II to the aforementioned Directive; Whereas developments in scientific and technical knowledge have shown that the risks presented by Anarsia lineatella and Laspeyresia molesta, two organisms listed in the aforementioned Annexes, are lower than initially assessed; Whereas in this respect protection should be restricted only to certain fruit plants other than fruit, and only for certain Member States where substantial production of plants at risk takes place; Whereas Annexes I and II to Directive 77/93/EEC should therefore be amended accordingly; Whereas these amendments are made in agreement with the Member States concerned; 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 follows: 1. In Annex I Part A (a) item 7 is deleted 2. Annex II is amended as follows: (a) In Part A (a) item 1 is deleted. (b) In Part B (a) the following are inserted 1.2.3 // // // // '01a Anarsia lineatella // Cydonia Mill., Malus Mill., Prunus L. and Pyrus L., other than fruit or seeds // Belgium, Denmark, Luxembourg, Netherlands, United Kingdom' // // // // // // // '10aa Laspeyresia molesta (Busck) // Cydonia Mill., Malus Mill., Prunus L. and Pyrus L., other than fruit or seeds // Belgium, Denmark, Luxembourg, Netherlands, United Kingdom' // // // Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 1 January 1987 at the latest. Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31986L0562

1986

Commission Directive 86/562/EEC of 6 November 1986 adapting to technical progress Council Directive 71/127/EEC on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles 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 Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 80/1267/EEC (2), and in particular Article 11 thereof, Having regard to Council Directive 71/127/EEC of 1 March 1971 on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles (3), as last amended by Commission Directive 85/205/EEC (4); Whereas all rear-view mirrors EEC component typeapproved after 1 October 1986 must bear the EEC component type-approval mark with the sequence number 02; whereas sequence number 01 may still be used for Class I, II and III mirrors for so long as the requirements for those three classes of rear-view mirrors remain unchanged; Whereas a great many rear-view mirrors incorporate protective plastic casings and whereas a change to a single digit of the component type-approval mark would involve a major, if not complete modification of the moulding equipment used; whereas the cost of these modifications wuold be unjustifiably out of proportion to the intended aim; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the removal of technical barriers to trade in the motor vehicles sector, Article 1 Directive 71/127/EEC is hereby amended as follows: 1. The following is added to the end of item 4.2 of Appendix 2 in Annex II: 'Sequence number 01 may, however, be retained for Class I, II and III rear-view mirrors if the requirements relating to these three classes of mirror remain unchanged.' 2. A new item 1.3 as follows is added to Annex III: '1.3. Vehicles having received EEC type-approval in respect of the fitting of their rear-view mirrors in pursuance of this Directive may, either fully or in part, be fitted with Class I, II or III rear-view mirrors bearing within their EEC component type-approval number sequence number 01, on condition that the requirements relating to these three classes of rear-view mirror remain unchanged.' Article 2 Member States shall bring into force the provisions necessary to comply with this Directive by 31 December 1986. They forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0560

1986

THIRTEENTH COUNCIL DIRECTIVE of 17 November 1986 on the harmonization of the laws of the Member States relating to turnover taxes — Arrangements for the refund of value added tax to taxable persons not established in Community territory (86/560/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof, Having regard to 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 (1), and in particular Article 17 (4) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas Article 8 of Directive 79/1072/EEC (5) on the arrangements for the refund of value added tax to taxable persons not established in the territory of the country provides that in the case of taxable persons not established in the territory of the Community, Member States may refuse refunds or impose special conditions; Whereas there is a need to ensure the harmonious development of trade relations between the Community and third countries based on the provisions of Directive 79/1072/EEC, while taking account of the varying situations encountered in third countries; Whereas certain forms of tax evasion or avoidance should be prevented, Article 1 For the purposes of this Directive: 1. ‘A taxable person not established in the territory of the Community’ shall mean a taxable person as referred to in Article 4 (1) of Directive 77/388/EEC who, during the period referred to in Article 3 (1) of this Directive, has had in that territory neither his business nor a fixed establishment from which business transactions are effected, nor, if no such business or fixed establishment exists, his permanent address or usual place of residence, and who, during the same period, has supplied no goods or services deemed to have been supplied in the Member State referred to in Article 2, with the exception of: (a) transport services and services ancillary thereto, exempted pursuant to Article 14 (1) (i), Article 15 or Article 16 (1), B, C and D of Directive 77/388/EEC; (b) services provided in cases where tax is payable solely by the person to whom they are supplied, pursuant to Article 21 (1) (b) of Directive 77/388/EEC; 2. ‘Territory of the Community’ shall mean the territories of the Member States in which Directive 77/388/EEC is applicable. Article 2 1. Without prejudice to Articles 3 and 4, each Member State shall refund to any taxable person not established in the territory of the Community, subject to the conditions set out below, any value added tax charged in respect of services rendered or moveable property supplied to him in the territory or the country by other taxable persons or charged in respect of the importation of goods into the country, in so far as such goods and services are used for the purposes of the transactions referred to in Article 17 (3) (a) and (b) of Directive 77/388/EEC or of the provision of services referred to in point 1 (b) of Article 1 of this Directive. 2. Member States may make the refunds referred to in paragraph 1 conditional upon the granting by third States of comparable advantages regarding turnover taxes. 3. Member States may require the appointment of a tax representative. Article 3 1. The refunds referred to in Article 2 (1) shall be granted upon application by the taxable person. Member States shall determine the arrangements for submitting applications, including the time limits for doing so, the period which applications should cover, the authority competent to receive them and the minimum amounts in respect of which applications may be submitted. They shall also determine the arrangements for making refunds, including the time limits for doing so. They shall impose on the applicant such obligations as are necessary to determine whether the application is justified and to prevent fraud, in particular the obligation to provide proof that he is engaged in an economic activity in accordance with Article 4 (1) of Directive 77/388/EEC. The applicant must certify, in a written declaration, that, during the period prescribed, he has not carried out any transaction which does not fulfil the conditions laid down in point 1 of Article 1 of this Directive. 2. Refunds may not be granted under conditions more favourable than those applied to Community taxable persons. Article 4 1. For the purposes of this Directive, eligibility for refunds shall be determined in accordance with Article 17 of Directive 77/388/EEC as applied in the Member State where the refund is paid. 2. Member States may, however, provide for the exclusion of certain expenditure or make refunds subject to additional conditions. 3. This Directive shall not apply to supplies of goods which are or or may be exempted under point 2 of Article 15 of Directive 77/388/EEC. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1988 at the latest. This Directive shall apply only to applictions for refunds concerning value added tax charged on purchases of goods or services invoiced or on imports effected on or after that date. 2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive and shall inform the Commission of the use they make of the option afforded by Article 2 (2). The Commission shall inform the other Member States thereof. Article 6 Within three years of the date referred to in Article 5, the Commission shall, after consulting the Member States, submit a report to the Council and to the European Parliament on the application of this Directive, particularly as regards the application of Article 2 (2). Article 7 As from the date on which this Directive is implemented, and at all events by the date mentioned in Article 5, the last sentence of Article 17 (4) of Directive 77/388/EEC and Article 8 of Directive 79/1072/EEC shall cease to have effect in each Member State. Article 8 This Directive is addressed to the Member States.

31986L0587

1986

Council Directive 86/587/EEC of 18 November 1986 amending Annex I to Directive 64/433/EEC on health problems affecting intra-Community trade in fresh meat Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 64/433/EEC (1) of 26 June 1964 on health problems affecting intra-Community trade in fresh meat, as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 12 thereof, Having regard to the proposal from the Commission, Whereas, in order to take into account recent advances in slaughter technology, it is opportune to lay down rules of hygiene under which the stomach can be emptied in the slaughterrooms, without any risk of contaminiation of fresh meat; Whereas it is appropriate to consolidate the rules for post mortem health inspection for the different species of slaughter animals, Article 1 Annex I to Directive 64/433/EEC is hereby amended as follows: (1) the following shall be added to Chapter I, point 13 c) first indent: 'Separate rooms will not, however, be necessary if these operations involving stomachs are carried out by means of closed-circuit mechanical equipment having an apporpiate system of ventilation and satisfying the following requirements: (i) the equipment must be installed and arranged in such a manner that operations for separating intestines from the stomach and for the emptying and cleaning of stomachs are carried out hygienically. It must be located in a special place which is clearly separated from any exposed fresh meat by a partition stretching from the floor to a height of at least three metres and surrounding the area where these operations are carried out; (ii) the design and operation of the machine must effectively prevent any contamination of the fresh meat; (iii) an air extractor must be installed and must function in such a fashion as to eliminate odours and any risk of aerosol contamination; (iv) the machine must be equipped with a device permitting closed-circuit evacuation of the residual water and the content of stomachs to the drainage system; (v) the circuit followed by stomachs to and from the machine must be both clearly separated and at a distance from the circuit followed by other fresh meat. Immediately after they have been emptied and cleaned, the stomachs must be removed in a hygienic manner; (vi) stomach must not be handled by staff handling other fresh meat. Staff handling stomachs must not have access to other fresh meat.'; (2) in Chapter V point 25: (a) the first sentence shall be replaced by the following: '25. Animals must undergo ante-mortem inspection on the day of their arrival at the slaughterhouse or before the beginning of daily slaughtering.' (b) the two following paragraphs shall be added: 'The operator of the slaughterhouse or his agent must facilitate operations for performing ante-mortem health inspections and in particular any handling which is considered necessary. Each animal which must be slaughtered shall bear an identifying mark allowing the competent authority to determine its origin;'; (3) in Chapter VI: (a) the end of the first sentence of point 31 shall be replaced by the following: '31. . . . except for pigs, without prejudice to the derogation provided for in point 40 D a) second sentence.' (b) point 32: - the end of the third sentence shall be supplemented by the following: '. . . and any other part of the animal required for inspection or possibly required for the execution of checks laid down in Directive 86/469/EEC (1). (1) OJ No L 275, 26. 9. 1986, p. 36.'; - the following sentence shall be inserted after the fourth sentence: 'However, provided it shows no pathological symptom or lesion, the penis may be discarded immediately.'; (4) in Chapter VII, point 40 shall be replaced by the following: '40. The official veterinarian must proceed in particular in the following way: A. Bovine animals over six weeks old (a) visual inspection of the head and the throat; the submaxillary, retro-pharyngeal and parotid lymph nodes (lnn. retropharyngiales, mandibulares and parotidei) must be incised and examined. The external masseters, in which two incisions must be made parallel to the mandible, and the internal masseters (internal pterygoid muscles), which must be incised along one plane, must be examined; The tongue, having been freed to permit a detailed visual inspection of the mouth and the fauces, must be visually inspected and palpated. The tonsils must be removed; (b) inspection of the trachea; visual examination and palpation of the lungs and the oesophagus; the bronchial and mediastinal lymph nodes (lnn. bifurcationes, eparteriales and mediastinales) must be incised and examined. The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption; (c) visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and to cut through the interventricular septum; (d) visual inspection of the diaphragm; (e) visual inspection and palpation of the liver and the hepatic and pancreatic lymph nodes (lnn. portales); incision of the gastric surface of the liver and at the base of the caudate lobe to examine the bile ducts; inspection and palpation of the pancreatic lymph nodes; (f) visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (lnn. gastrici, mesenterici, craniales and caudales) palpation of the gastric and mesenteric lymph nodes, and, if necessary, incision of those lymph nodes; (g) visual inspection and, if necessary, palpation of the spleen; (h) visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (lnn. renales); (i) visual inspection of the pleura and the peritoneum; (j) visual inspection of the genital organs; (k) visual inspection, and, if necessary, palpation and incision of the udder and its lymph nodes (lnn. supramammarii). In cows the udder must be opened by a long, deep incision as far as the lactiferous sinuses (Sinus galactophores), unless it is excluded from human consumption. Where incision of the above lymph nodes is obligatory, they must be systematically subjected to multiple incisions and a visual inspection. B. Bovine animals under six weeks old (a) visual inspection of the head and the throat. The retro pharyngeal lymph nodes (lnn. retropharyngiales) must be incised and examined. The mouth and the fauces must be inspected and the tongue must be palpated. The tonsils must be removed; (b) visual inspection of the lungs, the trachea and the oesophagus; palpation of the lungs; the bronchaial and mediastinal lymph nodes (lnn. bifurcationes, eparteriales and mediastinales) must be incised and examined. The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption; (c) visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and to cut through the interventricular septum; (d) visual inspection of the diaphragm; (e) visual inspection of the liver and the hepatic and pancreatic lymph nodes (lnn. portales); palpation and, if necessary, incision of the liver and its lymph nodes; (f) visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (lnn. gastrici, mesenterici, craniales and caudales); palpation of the gastric and mesenteric lymph nodes and, if necessary, incision of those lymph nodes; (g) visual inspection and, if necessary, palpation of the spleen; (h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (lnn. renales), (i) visual inspection of the pleura and the peritoneum; (j) visual inspection and palpation of the umbilical region and the joints; in case of doubt, the umbilical region must be incised and the joints opened. The synovial fluid must be examined. C. Swine (a) visual inspection of the head and the throat; the submaxillary (lnn. mandibulares) lymph nodes must be examined and incised. The mouth, the fauces and the tongue must be visually inspected. The tonsils must be removed; (b) visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and of the bronchial and mediastinal lymph nodes (lnn. bifurcationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption; (c) visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and to cut through the inter-ventricular septum; (d) visual inspection of the diaphragm; (e) visual inspection of the liver and the hepatic and pancreatic lymph nodes (lnn. portales); palpation of the liver and its lymph nodes; (f) visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (lnn. gastrici, mesenterici, caniales and caudales); palpation of the gastric and mesenteric lymph nodes and, if necessary, incision of those lymph nodes; (g) visual inspection and palpation of the spleen; (h) visual insepction of the kidneys, if necessary, of the kidneys and the lymph nodes (lnn. renales); (i) visual inspection of the pleura and the peritoneum; (j) visual inspection of the genital organs; (k) visual inspection of the udder and its lymph nodes (lnn. supramammarii), incision of the supramammary lymph nodes in sows; (l) visual inspection and palpation of the umbilical region and joints of young animals; in the case of doubt, the umbilical region must be incised and the joints opened. D. Sheep and goats (a) visual inspection of the head after flaying and, in case of doubt, examination of the throat, the mouth, the tongue and the retro-pharyngeal and parotid lymph nodes. Without prejudice to animal health conditions, these examinations are not necessary if the competent authority is able to guarantee that the head - including the tongue and the brains - is excluded from human consumption; (b) visual inspection of the lungs, the trachea and the oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (lnn. bifurcationes, eparteriales and mediastinales); in case of doubt, these organs and lymph nodes must be incised and examined; (c) visual inspection of the pericardium and the heart; in case of doubt the heart must be incised and examined; (d) visual inspection of the diaphragm; (e) visual inspection of the liver and the hepatic and pancreatic lymph nodes (lnn. portales); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts; (f) visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (lnn. gastrici, mesenterici, craniales and caudales); (g) visual inspection and palpation of the spleen; (h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (lnn. renales); (i) visual inspection of the pleura and the peritoneum; (j) visual inspection of the genital organs; (k) visual inspection of the udder and its lymph nodes; (l) visual inspection and palpation of the umbilical region and joints of young animals; in case of doubt, the umbilical region must be incised and the joints opened. E. Domestic solipeds (a) visual inspection of the head, and after freeing the tongue, the throat; the submaxillary retro-pharyngeal and parotid lymph nodes (lnn. retroharyngiales, mandibulares and parotidei) must be palpated and, if necessary, incised. The tongue, having been freed to permit a detailed inspection of the mouth and the fauces, must be visually examined and palpated. The tonsils must be inspected; (b) visual inspection of the lungs, the trachea and the oesophagus; palpation of the lungs; the bronchial and mediastinal lymph nodes (lnn. bifurcationes, eparteriales and mediastinales) must be palpated and, if necessary, incised. The trachea and the main branches of the bronchi must be opened lengthwise and the lungs incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption; (c) visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and to cut through the interventricular septum; (d) visual inspection of the diaphragm; (e) visual inspection of the liver and the hepatic and pancreatic lymph nodes (lnn. portales); palpation of the liver and its lymph nodes; if necessary, incision of the liver and the hepatic and pancreatic lymph nodes; (f) visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (lnn. gastrici, mesenterici, craniales and caudales); incision, if necessary, of the gastric and mesenteric lymph nodes; (g) visual inspection and palpation of the spleen; (h) visual inspection of the kidneys, palpation of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (lnn. renales); (i) visual inspection of the pleura and the peritonium; (j) visual inspection of the genital organs of stallions and mares; (k) visual inspection of the udder and its lymph nodes (lnn. supramammarii) and, if necessary, incision of the supramammary lymph nodes; (l) visual inspection and palpation of the umbilical region and joints of young animals; in case of doubt, the umbilical region must be incised and the joints opened; (m) all grey or white horses must be inspected for melanosis and melanomata as regards the muscles and lymph nodes (lnn. lymphonodi subrhomboidei) of the shoulders beneath the scapular cartilage by loosening the attachment of one shoulder. The kidneys must be exposed and examined by incision through the entire kidney. F. In case of doubt, the official veterinarian may perform the further cuts and inspections of the relevant parts of the animals necessary in order to reach a final decision.'; (5) in Chapter VII, point 41: (a) Point A shall be replaced by the following: 'A. An investigation for cystercosis in swine: this investigation must include examination of the directly visible muscular surfaces, in particular the thigh muscles, the pillars of the diaphragm, the intercostal muscles, the heart, the tongue and the larynx and, if necessary, the abdominal wall and the psoas muscles freed from fatty tissue.' (b) Point B shall be deleted. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 April 1987 and shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0609

1986

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas there exist between the national laws at present in force for the protection of animals used for certain experimental purposes disparities which may affect the functioning of the common market; Whereas, in order to eliminate these disparities, the laws of the Member States should be harmonized; whereas such harmonization should ensure that the number of animals used for experimental or other scientific purposes is reduced to a minimum, that such animals are adequately cared for, that no pain, suffering, distress or lasting harm are inflicted unnecessarily and ensure that, where unavoidable, these shall be kept to the minimum; Whereas, in particular, unnecessary duplication of experiments should be avoided, (1) OJ N° C 351, 31. 12. 1985, p. 16. (2) OJ N° C 255, 13. 10. 1986, p. 250. (3) OJ N° C 207, 18. 8. 1986, p. 3. Article 1 The aim of this Directive is to ensure that where animals are used for experimental or other scientific purposes the provisions laid down by law, regulation or administrative provisions in the Member States for their protection are approximated so as to avoid affecting the establishment and functioning of the common market, in particular by distorsions of competition or barriers to trade. Article 2 For the purposes of this Directive the following definitions shall apply: (a) 'animal' unless otherwise qualified, means any live non-human vertebrate, including free-living larval and/or reproducing larval forms, but excluding foetal or embryonic forms; (b) 'experimental animals' means animals used or to be used in experiments; (c) 'bred animals' means animals specially bred for use in experiments in facilities approved by, or registered with, the authority; (d) 'experiment' means any use of an animal for experimental or other scientific purposes which may cause it pain, suffering, distress or lasting harm, including any course of action intended, or liable, to result in the birth of an animal in any such condition, but excluding the least painful methods accepted in modern practice (i.e. 'humane' methods) of killing or marking an animal; an experiment starts when an animal is first prepared for use and ends when no further observations are to be made for that experiment; the elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia or analgesia or other methods does not place the use of an animal outside the scope of this definition. Non experimental, agricultural or clinical veterinary practices are excluded; (e) 'authority' means the authority or authorities designated by each Member State as being responsible for supervising the experiments within the meaning of this Directive; (f) 'competent person' means any person who is considered by a Member State to be competent to perform the relevant function described in this Directive; (g) 'establishment' means any installation, building, group of buildings or other premises and may include a place which is not wholly enclosed or covered and mobile facilities; (h) 'breeding establishment' means any establishment where animals are bred with a view to their use in experiments; (i) 'supplying establishment' means any establishment, other than a breeding establishment, from which animals are supplied with a view to their use in experiments; (j) 'user establishment' means any establishment where animals are used for experiments; (k) 'properly anaesthetized' means deprived of sensation by methods of anaesthesia (whether local or general) as effective as those used in good veterinary practice; (l) 'humane method of killing' means the killing of an animal with a minimum of physical and mental suffering, depending on the species. Article 3 This Directive applies to the use of animals in experiments which are undertaken for one of the following purposes: (a) the development, manufacture, quality, effectiveness and safety testing of drugs, foodstuffs and other substances or products: (i) for the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in man, animals or plants; (ii) for the assessment, detection, regulation or modification of physiological conditions in man, animals or plants; (b) the protection of the natural environment in the interests of the health or welfare of man or animal. Article 4 Each Member State shall ensure that experiments using animals considered as endangered under Appendix I of the Convention on International Trade in Endangered Species of Fauna and Flora and Annex C.I. of Regulation (EEC) N° 3626/82 (1) are prohibited unless they are in conformity with the above Regulation and the objects of the experiment are: - research aimed at preservation of the species in question, or - essential biomedical purposes where the species in question exceptionally proves to be the only one suitable for those purposes. Article 5 Member States shall ensure that, as far as the general care and accommodation of animals is concerned: (a) all experimental animals shall be provided with housing, an environment, at least some freedom of movement, food, water and care which are appropriate to their health and well-being; (b) any restriction on the extent to which an experimental animal can satisfy its physiological and ethological needs shall be limited to the absolute minimum; (c) the environmental conditions in which experimental animals are bred, kept or used must be checked daily; (d) the well-being and state of health of experimental animals shall be observed by a competent person to prevent pain or avoidable suffering, distress or lasting harm; (e) arrangements are made to ensure that any defect or suffering discovered is eliminated as quickly as possible. For the implementation of the provisions of paragraphs (a) and (b), Member States shall pay regard to the guidelines set out in Annex II. Article 6 1. Each Member State shall designate the authority or authorities responsible for verifying that the provisions of this Directive are properly carried out. 2. In the framework of the implementation of this Directive, Member States shall adopt the necessary measures in order that the designated authority mentioned in paragraph 1 above may have the advice of experts competent for the matters in question. (1) OJ N° L 384, 31. 12. 1982, p. 1. Article 7 1. Experiments shall be performed solely by competent authorized persons, or under the direct responsibility of such a person, or if the experimental or other scientific project concerned is authorized in accordance with the provisions of national legislation. 2. An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available. 3. When an experiment has to be performed, the choice of species shall be carefully considered and, where necessary, explained to the authority. In a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected. Experiments on animals taken from the wild may not be carried out unless experiments on other animals would not suffice for the aims of the experiment. 4. All experiments shall be designed to avoid distress and unnecessary pain and suffering to the experimental animals. They shall be subject to the provisions laid down in Article 8. The measures set out in Article 9 shall be taken in all cases. Article 8 1. All experiments shall be carried out under general or local anaesthesia. 2. Paragraph 1 above does not apply when: (a) anaesthesia is judged to be more traumatic to the animal than the experiment itself; (b) anaesthesia is incompatible with the object of the experiment. In such cases appropriate legislative and/or administrative measures shall be taken to ensure that no such experiment is carried out unnecessarily. Anaesthesia should be used in the case of serious injuries which may cause severe pain. 3. If anaesthesia is not possible, analgesics or other appropriate methods should be used in order to ensure as far as possible that pain, suffering, distress or harm are limited and that in any event the animal is not subject to severe pain, distress or suffering. 4. Provided such action is compatible with the object of the experiment, an anaesthetized animal, which suffers considerable pain once anaesthesia has worn off, shall be treated in good time with pain-relieving means or, if this is not possible, shall be immediately killed by a humane method. Article 9 1. At the end of any experiment, it shall be decided whether the animal shall be kept alive or killed by a humane method, subject to the condition that it shall not be kept alive if, even though it has been restored to normal health in all other respects, it is likely to remain in lasting pain or distress. 2. The decisions referred to in paragraph 1 shall be taken by a competent person, preferably a veterinarian. 3. Where, at the end of an experiment: (a) an animal is to be kept alive, it shall receive the care appropriate to its state of health, be placed under the supervision of a veterinarian or other competent person and shall be kept under conditions conforming to the requirements of Article 5. The conditions laid down in this subparagraph may, however, be waived where, in the opinion of a veterinarian, the animal would not suffer as a consequence of such exemption; (b) an animal is not to be kept alive or cannot benefit from the provisions of Article 5 concerning its well-being, it shall be killed by a humane method as soon as possible. Article 10 Member States shall ensure that any re-use of animals in experiments shall be compatible with the provisions of this Directive. In particular, an animal shall not be used more than once in experiments entailing severe pain, distress or equivalent suffering. Article 11 Notwithstanding the other provisions of this Directive, where it is necessary for the legitimate purposes of the experiment, the authority may allow the animal concerned to be set free, provided that it is satisfied that the maximum possible care has been taken to safeguard the animal's well-being, as long as its state of health allows this to be done and there is no danger for public health and the environment. Article 12 1. Member States shall establish procedures whereby experiments themselves or the details of persons conducting such experiments shall be notified in advance to the authority. 2. Where it is planned to subject an animal to an experiment in which it will, or may, experience severe pain which is likely to be prolonged, that experiment must be specifically declared and justified to, or specifically authorized by, the authority. The authority shall take appropriate judicial or administrative action if it is not satisfied that the experiment is of sufficient importance for meeting the essential needs of man or animal. Article 13 1. On the basis of requests for authorization and notifications received, and on the basis of the reports made, the authority in each Member State shall collect, and as far as possible periodically make publicly available, the statistical information on the use of animals in experiments in respect of: (a) the number and kinds of animals used in experiments; (b) the number of animals, in selected categories, used in the experiments referred to in Article 3; (c) the number of animals, in selected categories, used in experiments required by legislation. 2. Member States shall take all necessary steps to ensure that the confidentiality of commercially sensitive information communicated pursuant to this Directive is protected. Article 14 Persons who carry out experiments or take part in them and persons who take care of animals used for experiments, including duties of a supervisory nature, shall have appropriate education and training. In particular, persons carrying out or supervising the conduct of experiments shall have received instruction in a scientific discipline relevant to the experimental work being undertaken and be capable of handling and taking care of laboratory animals; they shall also have satisfied the authority that they have attained a level of training sufficient for carrying out their tasks. Article 15 Breeding and supplying establishments shall be approved by or registered with, the authority and comply with the requirements of Articles 5 and 14 unless an exemption is granted under Article 19 (4) or Article 21. A supplying establishment shall obtain animals only from a breeding or other supplying establishment unless the animal has been lawfully imported and is not a feral or stray animal. General or special exemption from this last provision may be granted to a supplying establishment under arrangements determined by the authority. Article 16 The approval or the registration provided for in Article 15 shall specify the competent person responsible for the establishment entrusted with the task of administering, or arranging for the administration of, appropriate care to the animals bred or kept in the establishment and of ensuring compliance with the requirements of Articles 5 and 14. Article 17 1. Breeding and supplying establishments shall record the number and the species of animals sold or supplied, the dates on which they are sold or supplied, the name and address of the recipient and the number and species of animals dying while in the breeding or supplying establishment in question. 2. Each authority shall prescribe the records which are to be kept and made available to it by the person responsible for the establishments mentioned in paragraph 1; such records shall be kept for a minimum of three years from the date of the last entry and shall undergo periodic inspection by officers of the authority. Article 18 1. Each dog, cat or non-human primate in any breeding, supplying or user establishment shall, before it is weaned, be provided with an individual identification mark in the least painful manner possible except in the cases referred to in paragraph 3. 2. Where an unmarked dog, cat or non-human primate is taken into an establishment for the first time after it has been weaned it shall be marked as soon as possible. 3. Where a dog, cat or non-human primate is transferred from one establishment as referred to in paragraph 1 to another before it is weaned, and it is not practicable to mark it beforehand, a full documentary record, specifying in particular its mother, must be maintained by the receiving establishment until it can be so marked. 4. Particulars of the identity and origin of each dog, cat or non-human primate shall be entered in the records of each establishment. Article 19 1. User establishments shall be registered with, or approved by, the authority. Arrangements shall be made for user establishments to have installations and equipment suited to the species of animals used and the performance of the experiments conducted there; their design, construction and method of functioning shall be such as to ensure that the experiments are performed as effectively as possible, with the object of obtaining consistent results with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm. 2. In each user establishment: (a) the person or persons who are administratively responsible for the care of the animals and the functioning of the equipment shall be identified; (b) sufficient trained staff shall be provided; (c) adequate arrangements shall be made for the provision of veterinary advice and treatment; (d) a veterinarian or other competent person should be charged with advisory duties in relation to the well-being of the animals. 3. Experiments may, where authorized by the authority, be conducted outside user establishments. 4. In user establishments, only animals from breeding or supplying establishments shall be used unless a general or special exemption has been obtained under arrangements determined by the authority. Bred animals shall be used whenever possible. Stray animals of domestic species shall not be used in experiments. A general exemption made under the conditions of this paragraph may not extend to stray dogs and cats. 5. User establishments shall keep records of all animals used and produce them whenever required to do so by the authority. In particular, these records shall show the number and species of all animals acquired, from whom they were acquired and the date of their arrival. Such records shall be kept for a minimum of three years and shall be submitted to the authority which asks for them. User establishments shall be subject to periodic inspection by representatives of the authority. Article 20 When user establishments breed animals for use in experiments on their own premises, only one registration or approval is needed for the purposes of Article 15 and 19. However, the establishments shall comply with the relevant provisions of this Directive concerning breeding and user establishments. Article 21 Animals belonging to the species listed in Annex I which are to be used in experiments shall be bred animals unless a general or special exemption has been obtained under arrangements determined by the authority. Article 22 1. In order to avoid unnecessary duplication of experiments for the purposes of satisfying national or Community health and safety legislation, Member States shall as far as possible recognize the validity of data generated by experiments carried out in the territory of another Member State unless further testing is necessary in order to protect public health and safety. 2. To that end, Member States shall, where practicable and without prejudice to the requirements of existing Community Directives, furnish information to the Commission on their legislation and administrative practice relating to animal experiments, including requirements to be satisfied prior to the marketing of products; they shall also supply factual information on experiments carried out in their territory and on authorizations or any other administrative particulars pertaining to these experiments. 3. The Commission shall establish a permanent consultative committee within which the Member States would be represented, which will assist the Commission in organizing the exchange of appropriate information, while respecting the requirements of confidentiality, and which will also assist the Commission in the other questions raised by the application of this Directive. Article 23 1. The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The Commission and Member States shall monitor trends in experimental methods. 2. The Commission shall report before the end of 1987 on the possibility of modifying tests and guidelines laid down in existing Community legislation taking into account the objectives referred to in paragraph 1. Article 24 This Directive shall not restrict the right of the Member States to apply or adopt stricter measures for the protection of animals used in experiments or for the control and restriction of the use of animals for experiments. In particular, Member States may require a prior authorization for experiments or programmes of work notified in accordance with the provisions of Article 12 (1). Article 25 1. Member States shall take the measures necessary to comply with this Directive by 24 November 1989. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 26 At regular intervals not exceeding three years, and for the first time five years following notification of this Directive, Member States shall inform the Commission of the measures taken in this area and provide a suitable summary of the information collected under the provisions of Article 13. The Commission shall prepare a report for the Council and the European Parliament. Article 27 This Directive is addressed to the Member States.

31986L0594

1986

Council Directive 86/594/EEC of 1 December 1986 on airborne noise emitted by household appliances Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the European Communities' 1973 (4) and 1977 (5) action programmes on the environment highlight the importance of the problem of noise pollution and, in particular, the need to take action with regard to the source of the noise; Whereas the public should be informed, in a way which is as readily understandable and uniform as possible, of the level of noise emitted by household appliances; whereas accurate, pertinent and comparable information may serve to guide the public towards selecting less noisy household appliances; whereas manufacturers will then be driven, as a result, to take measures to reduce the sound emissions of the household appliances they manufacture; Whereas, for practical reasons and in order to avoid the appearance of a profusion of labels on household appliances, information on noise level should be included on the label provided for by the implementing Directives adopted under Council Directive 79/530/EEC of 14 May 1979 on the indication by labelling of the energy consumption of household appliances (6) where the same family of household appliance is concerned; Whereas, in the present case, legislative harmonization must be confined to those requirements necessary to measure the airborne noise emitted by household appliances and to carry out checks on the declared level; whereas such requirements must replace the national provisions in this field; Whereas this Directive defines only the requirements strictly necessary; whereas it will be presumed that these requirements are complied with as long as the harmonized standards are applied; whereas it is therefore indispensable to have available these standards concerning the measurement and checking of the declared level of airborne noise emitted by household appliances while they are being operated; Whereas the Comité européen de normalisation (CEN) (European Standardization Committee) and the Comité européen de normalisation électrotechnique (CENELEC) (European Electrotechnical Standardization Committee) are acknowledged to be the bodies competent to lay down and adopt the harmonized standards (European standards or harmonization documents), on instruction from the Commission, in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (7) and with general guidelines for cooperation between the Commission and both these bodies, signed on 13 November 1984; Whereas, pending adoption of harmonized standards, free circulation of goods will be assured by the acceptance of products which comply with national standards and technical regulations which are recognized, by means of a monitoring procedure, as satisfying the requirements of this Directive; Whereas the Standing Committee set up by Article 5 of Directive 83/189/EEC would be ideally designated to ensure the checking for conformity of harmonized standards and national standards and technical regulations, Article 1 1. This Directive shall cover provisions relating to: - the general principles regarding the publication of information on the airborne noise emitted by household appliances, - the measuring methods for determining the airborne noise emitted by household appliances, - the arrangements for monitoring the levels of airborne noise emitted by household appliances. 2. This Directive shall not apply to: - appliances, equipment or machines designed exclusively for industrial or professional purposes, - appliances which are integrated parts of a building or its installations such as equipment for air conditioning, heating and ventilating (except household fans, cooker hoods and free-standing heating appliances), oil burners for central heating and pumps for water supply and for sewage systems, - equipment components such as motors, - electroacoustic appliances. Article 2 For the purposes of this Directive: (a) 'household appliance' means any machine, portion of a machine or installation manufactured principally for use in dwellings, including cellars, garages and other outbuildings, in particular household appliances for upkeep, cleaning purposes, preparation and storage of foodstuffs, production and distribution of heat and cold, air conditioning, and other appliances used for non-professional purposes; (b) 'family' of household appliances means all models (or types) of various household appliances designed for the same purpose and powered by the same principal energy source. Generally, a family includes several models (or types); (c) 'series' of household appliances means all household appliances belonging to the same model (or type), which have defined characteristics and are produced by the same manufacturer; (d) 'batch' of household appliances means a specified quantity of a given series manufactured or produced under uniform conditions; (e) 'airborne noise emitted' means the A-weighted sound power level, LWA, of the household appliance, expressed in decibels (dB) with reference to the sound power of one picowatt (1 pW), transmitted by the air. Article 3 1. Member States may require the publication, for certain families of appliances, of information on the airborne noise emitted by such appliances. This information shall be supplied by the manufacturer or, where the manufacturer is established outside the Community, by the importer established in the Community. When this is so: (a) the level of noise subject to the information procedure shall be determined in accordance with the conditions set out in Article 6 (1); (b) the information may be subject to spot checks on the basis of the principles set out in Article 6 (2). The Member State concerned may take every appropriate step to ensure that the information supplied complies with the requirements of this Directive; (c) the manufacturer or importer shall be responsible for the accuracy of the information supplied. 2. When a Member State does not require information on the airborne noise emitted to be published, the manufacturer or importer may nevertheless publish such information but (a), (b) and (c) of the third subparagraph of paragraph 1 shall continue to apply. Article 4 Where, for the same family of household appliance, provision is made for a label relating to various types of information, such as those provided for pursuant to a separate Directive adopted under Directive 79/530/EEC, the information on the airborne noise emitted shall be given on that label. Article 5 1. Member States may not refuse, prohibit or restrict the marketing of household appliances on grounds relating to information on the airborne noise emitted by such appliances where the information in respect of such appliances is given in accordance with the requirements of this Directive. 2. Without prejudice to the outcome of any spot checks which may be carried out once the household appliances have been offered for sale, Member States shall regard publication of information on the airborne noise emitted as complying with this Directive. Article 6 1. (a) The general test method used to determine the airborne noise emitted by household appliances must be accurate enough for the measurement uncertainties to produce standard deviations not exceeding 2 dB in the case of A-weighted sound power levels. The standard deviations referred to in the first subparagraph shall represent the cumulative effects of all causes of uncertainty in the measurements, except for variations in the noise level of the appliance from one test to another. (b) The general test method referred to in (a) shall be supplemented, for each family of appliances, by a description of the location, mounting, load and operation of the appliances under test conditions to stimulate normal use and ensure adequate repeatability and reproducibility. The standard deviation of reproducibility must be specified for each family of appliances. 2. The statistical method used to verify the declared noise level of appliances in a batch shall be sampling measurement on isolated batches of appliances using unilateral tests. The fundamental statistical parameters of the statistical method referred to in the first subparagraph shall be such that the acceptance probability is 95 % if 6,5 % of the noise emission levels of a batch are higher than the level claimed. The size of a simple or equivalent sample must be 3. The statistical method chosen requires the use of a total reference standard deviation of 3,5 dB. By 1 January 1991 the Council, acting on a proposal from the Commission, shall fix new sample sizes and reference standard deviations for each family of household appliances. Article 7 Member States shall take all necessary steps to ensure that the manufacturer or importer, if he does not choose to withdraw the defective batch from the market, corrects the information without delay should it appear from monitoring in accordance with Article 6 (2) that the level of airborne noise emitted by a batch of appliances exceeds the declared level. Article 8 1. Member States shall presume that the indication of airborne noise emitted by a household appliance is in accordance with the requirements of this Directive and that the checks have been performed adequately by Member States if the measurements for determining the level of airborne noise and the relevant checks have been carried out in accordance with: (a) national standards incorporating harmonized standards the references of which have been published in the Official Journal of the European Communities. Member States shall publish the references for these national standards; or (b) the national standards and technical regulations referred to in paragraph 2 in so far as no harmonized standards exist in the areas covered by these national standards and regulations. 2. Member States shall communicate to the Commission the texts of their national standards and technical regulations as referred to in paragraph 1 (b) which they consider meet the requirements of Article 6. The Commission shall forward these texts forthwith to the other Member States. In accordance with the procedure laid down in Article 9 (2), it shall notify the Member States of those national standards and technical regulations which are presumed to conform to the requirements of Article 6. Member States shall arrange for the references of these national standards and technical regulations to be published. The Commission shall ensure that they are also published in the Official Journal of the European Communities. Article 9 1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 8 (1) (a) do not fully satisfy the requirements of Article 6, that Member State or the Commission shall bring the matter before the Standing Committee set up by Directive 83/189/EEC, hereinafter referred to as the 'Committee', setting out its reasons for doing so. The Committee shall deliver an opinion as a matter of urgency. In the light of the Committee's opinion, the Commission shall notify the Member States as to whether or not the standards concerned should be withdrawn from the publications referred to in Article 8 (1) (a). 2. With regard to the national standards and technical regulations referred to in Article 8 (2), the Committee shall act in accordance with the following procedure: (a) The Commission representative shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit which the chairman may fix on the basis of the urgency of the matter. It shall take a decision by a majority of 54 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. (b) The Commission shall adopt the intended measures where they are in accordance with the Committee's opinion. (c) Where the measures intended are not in keeping with the opinion of the Committee, or where there is no such opinion, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall take a decision by qualified majority. (d) If, on the expiry of a period of three months of the date on which the matter was brought before it, the Council has not reached a decision, the proposed measures shall be adopted by the Commission. Article 10 1. Member States shall take the measures necessary to comply with this Directive within 36 months of its notification (1). They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. Article 11 This Directive is adressed to the Member States.

31986L0604

1986

Council Directive 86/604/EEC of 8 December 1986 amending Directive 65/66/EEC laying down specific criteria of purity for the preservatives authorized for use in foodstuffs intended for human consumption Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (1), as last amended by Directive 85/585/EEC (2), and in particular Article 8 thereof, Having regard to the proposal from the Commission, Whereas Council Directive 65/66/EEC (3), as last amended by Directive 76/463/EEC (4), laid down specific criteria of purity for the preservatives listed in the Annex to Directive 64/54/EEC; whereas that Annex was supplemented by Directive 85/585/EEC, which added potassium acid sulphite (potassium bisulphite) to the list of authorized preservatives; Whereas it is necessary to lay down specific criteria of purity for this preservative, Article 1 The following specifications are hereby inserted between Nos E 227 and E 230 of the Annex to Directive 65/66/EEC: E 228 - Potassium acid sulphite (potassium bisulphite) 1.2 // Appearance: // Clear colourless solution prepared by bubbling sulphur dioxide (SO2) (E 220) in an aqueous solution of potassium hydroxide (KOH) as used in foodstuffs // Chemical formula: // KHSO3 in aqueous solution (1) // Content: // Not less than 280 g KHSO3 per litre (or 150 g SO2 per litre) // Sodium: // Not more than 1 % of the SO2 content // Selenium: // Not more than 10 mg/kg of the SO2 content // Chloride: // Not more than 1 000 mg/kg expressed as Cl. (1) Other potassium salts of sulphur dioxide may be present following deterioration due to storage in open containers.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1988. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31986L0635

1986

Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions Having regard to the Treaty establishing the European Community, and in particular Article 54 (3) (g) thereof, Having regard to the proposal from the Commission (1), (1) OJ No C 130, 1.6.1981, p. 1, OJ No C 83, 24.3.1984, p. 6 and OJ No C 351, 31.12.1985, p. 24. Having regard to the opinion of the European Parliament (2), (2) OJ No C 242, 12.9.1983, p. 33 and OJ No C 163, 10.7.1978, p. 60. Having regard to the opinion of the Economic and Social Committee (3), (3) OJ No C 112, 3.5.1982, p. 60. Whereas Council Directive 78/660/EEC of 25 July 1978, based on Article 54 (3) (g) of the Treaty, on the annual accounts of certain types of companies (4), as last amended by Directive 84/569/EEC (5), need not be applied to banks and other financial institutions, hereafter referred to as 'credit institutions', pending subsequent coordination; whereas in view of the central importance of these undertakings in the Community, such coordination is necessary; (4) OJ No L 222, 14.8.1978, p. 11. (5) OJ No L 314, 4.12.1984, p. 28. Whereas Council Directive 83/349/EEC of 13 June 1983, based on Article 54 (3) (g) of the Treaty, on consolidated accounts (6), provides for derogations for credit institutions only until expiry of the deadline imposed for the application of this Directive; whereas this Directive must therefore also include provisions specific to credit institutions in respect of consolidated accounts; (6) OJ No L 193, 18.7.1983, p. 1. Whereas such coordination has also become urgent because more and more credit institutions are operating across national borders; whereas for creditors, debtors and members and for the general public improved comparability of the annual accounts and consolidated accounts of these institutions is of crucial importance; Whereas in virtually all the Member States of the Community credit institutions within the meaning of Council Directive 77/780/EEC of the 12 December 1977 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions (7), having many different legal forms, are in competition with one another in the banking sector; whereas it therefore seems advisable not to confine coordination in respect of these credit institutions to the legal forms covered by Directive 78/660/EEC but rather to opt for a scope which includes all companies and firms as defined in the second paragraph of Article 58 of the Treaty; (7) OJ No L 322, 17.12.1977, p. 30. Whereas as far as financial institutions are concerned the scope of this Directive should however be confined to those financial institutions taking one of the legal forms referred to in Directive 78/660/EEC; whereas financial institutions which are not subject to that Directive must automatically come under this Directive; Whereas a link with coordination in respect of credit institutions is necessary because aspects of the provisions governing annual accounts and consolidated accounts will have an impact on other areas of that coordination, such as authorization requirements and the indicators used for supervisory purposes; Whereas although, in view of the specific characteristics of credit institutions, it would appear appropriate to adopt a separate Directive on the annual accounts and consolidated accounts of such institutions, this does not imply a new set of rules separate from those under Directives 78/660/EEC and 83/349/EEC; whereas such separate rules would be neither appropriate nor consistent with the principles underlying the coordination of company law since, given the important role which they play in the Community economy, credit institutions cannot be excluded from a framework of rules devised for undertakings generally; whereas, for this reason, only the particular characteristics of credit institutions have been taken into account and this Directive deals only with exceptions to the rules contained in Directives 78/660/EEC and 83/349/EEC; Whereas the structure and content of the balance sheets of credit institutions differ in each Member State; whereas this Directive must therefore prescribe the same layout, nomenclature and terminology for the balance sheets of all credit institutions in the Community; whereas derogations should be allowed if necessitated by the legal form of an institution or by the especial nature of its business; Whereas, if the annual accounts and consolidated accounts are to be comparable, a number of basic questions regarding the disclosure of various transactions in the balance sheet and off the balance sheet must be settled; Whereas, in the interests of greater comparability, it is also necessary that the content of the various balance sheet and off-balance sheet items be determined precisely; Whereas the same applies to the layout and definition of the items in the profit and loss account; Whereas the comparability of figures in the balance sheet and profit and loss account also depends crucially on the values at which assets and liabilities are entered in the balance sheet; Whereas, in view of the particular risks associated with banking and of the need to maintain confidence, provision should be made for the possibility of introducing a liabilities item in the balance sheet entitled 'Fund for general banking risks'; whereas it would appear advisable for the same reasons that the Member States be permitted, pending subsequent coordination, to allow credit institutions some discretion, especially in the valuation of loans and advances and of certain securities; whereas, however, in this last case the Member States should allow these same credit institutions to create the «Fund for general banking risks» mentioned above; whereas it would also appear appropriate to permit the Member States to allow credit institutions to set of certain charges and income in the profit and loss account; Whereas, in view of the special nature of credit institutions, certain changes are also necessary with regard to the notes on the accounts; Whereas, in the desire to place on the same footing as many credit institutions as possible, as was the case with Directive 77/780/EEC, the relief under Directive 78/660/EEC is not provided for in the case of small and medium-sized credit institutions; whereas, nevertheless, if in the light of experience such relief were to prove necessary it would be possible to provide for it in subsequent coordination; whereas for the same reasons the scope allowed the Member States under Directive 83/349/EEC to exempt parent undertakings from the consolidation requirement if the undertakings to be consolidated do not together exceed a certain size has not been extended to credit institutions; Whereas the application of the provisions on consolidated accounts to credit institutions requires certain adjustments to some of the rules applicable to all industrial and commercial companies; whereas explicit rules have been provided for in the case of mixed groups and exemption from subconsolidation may be made subject to additional conditions; Whereas, given the scale on which banking networks extend beyond national borders and their constant development, the annual accounts and consolidated accounts of a credit institution having its head office in one Member State should be published in all the Member States in which it is established; Whereas the examination of problems which arise in connection with the subject matter of this Directive, notably concerning its application, requires the cooperation of representatives of the Member States and the Commission in a contact committee; whereas, in order to avoid the proliferation of such committees, it is desirable that such cooperation take place in the Committee provided for in Article 52 of Directive 78/660/EEC; whereas, nevertheless, when examining problems concerning credit institutions the Committee will have to be appropriately constituted; Whereas, in view of the complexity of the matter, the credit institutions covered by this Directive must be allowed a longer period than usual to implement its provisions; Whereas provision should be made for the review of certain provisions of this Directive after five years' experience of its application, in the light of the aims of greater transparency and harmonization, SECTION 1 PRELIMINARY PROVISIONS AND SCOPE Article 1 1. Articles 2, 3, 4 (1), (3) to (5), 6, 7, 13, 14, 15 (3) and (4), 16 to 21, 29 to 35, 37 to 41, 42 first sentence, 45 (1), 46, 48 to 50, 51 (1), 54, 56 to 59 and 61 of Directive 78/660/EEC shall apply to the institutions mentioned in Article 2 of this Directive, except where this Directive provides otherwise. 2. Where reference is made in Directives 78/660/EEC and 83/349/EEC to Articles 9 and 10 (balance sheet) or to Articles 23 to 26 (profit and loss account) of Directive 78/660/EEC, such references shall be deemed to be references to Articles 4 (balance sheet) or to Articles 27 and 28 (profit and loss account) of this Directive. 3. References in Directives 78/660/EEC and 83/349/EEC to Articles 31 to 42 of Directive 78/660/EEC shall be deemed to references to those Articles, taking account of Articles 35 to 39 of this Directive. 4. Where reference is made in the aforementioned provisions of Directive 78/660/EEC to balance sheet items for which this Directive makes no equivalent provision, such references shall be deemed to be references to the items in Article 4 of this Directive which include the assets and liabilities in question. Article 2 1. The coordination measures prescribed by this Directive shall apply to (a) credit institutions within the meaning of the first indent of Article 1 of Directive 77/780/EEC which are companies or firms as defined in the second paragraph of Article 58 of the Treaty; (b) financial institutions having one of the legal forms referred to in Article 1 (1), of Directive 78/660/EEC which, on the basis of paragraph 2 of that Article, are not subject to that Directive. For the purposes of this Directive 'credit institutions' shall also include financial institutions unless the context requires otherwise. 2. The Member States need not apply this Directive to: (a) the credit institutions listed in Article 2 (2) of Directive 77/780/EEC; (b) institutions of the same Member State which, as defined in Article 2 (4) (a) of Directive 77/780/EEC, are affiliated to a central body in that Member State. In that case, without prejudice to the application of this Directive to the central body, the whole constituted by the central body and its affiliated institutions must be the subject of consolidated accounts including an annual report which shall be drawn up, audited and published in accordance with this Directive; (c) the following credit institutions: - in Greece: ETEBA (National Investment Bank for Industrial Development) and ******* ***** ***** (Investment Bank), - in Ireland: Industrial and Provident Societies, - in the United Kingdom: Friendly Societies and Industrial and Provident Societies. 4. Without prejudice to Article 2 (3) of Directive 78/660/EEC and pending subsequent coordination, the Member States may: (a) in the case of the credit institutions referred to in Article 2 (1) (a) of this Directive which are not companies of any of the types listed in Article 1 (1) of Directive 78/660/EEC, lay down rules derogating from this Directive where derogating rules are necessary because of such institutions' legal form; (b) in the case of specialized credit institutions, lay down rules derogating from this Directive where derogating rules are necessary because of the special nature of such institutions' business. Such derogating rules may provide only for adaptations to the layout, nomenclature, terminology and content of items in the balance sheet and the profit and loss account; they may not have the effect of permitting the institutions to which they apply to provide less information in their annual accounts than other institutions subject to this Directive. The Member States shall inform the Commission of those credit institutions, possibly by category, within six months of the end of the period stipulated in Article 47 (2). They shall inform the Commission of the derogations laid down to that end. These derogations shall be reviewed within 10 years of the notification of this Directive. The Commission shall, if appropriate, submit suitable proposals. It shall also submit an interim report within five years of the notification of this Directive. SECTION 2 GENERAL PROVISIONS CONCERNING THE BALANCE SHEET AND THE PROFIT AND LOSS ACCOUNT Article 3 In the case of credit institutions the possibility of combining items pursuant to Article 4 (3) (a) or (b) of Directive 78/660/EEC shall be restricted to balance sheet and profit and loss account sub-items preceded by lower-case letters and shall be authorized only under the rules laid down by the Member States to that end. SECTION 3 LAYOUT OF THE BALANCE SHEET The Member States shall prescribe the following layout for the balance sheet. Assets 1. Cash in hand, balances with central banks and post office banks. 2. Treasury bills and other bills eligible for refinancing with central banks: (a) Treasury bills and similar securities (b) Other bills eligible for refinancing with central banks (unless national law prescribes that such bills be shown under Assets items 3 and 4) 3. Loans and advances to credit institutions: (a) repayable on demand (b) other loans and advances 4. Loans and advances to customers 5. Debt securities including fixed- income securities: (a) issued by public bodies (b) issued by other borrowers, showing separately: - own-debt securities (unless national law requires their deduction from liabilities). 6. Shares and other variable-yield securities 7. Participating interests, showing separately: - participating interests in credit institutions (unless national law requires their disclosure in the notes on the accounts) 8. Shares in affiliated undertakings, showing separately: - shares in credit institutions (unless national law requires their disclosure in the notes on the accounts) 9. Intangible assets as described under Assets headings B and C.I of Article 9 of Directive 78/660/EEC, showing separately: - formation expenses, as defined by national law and in so far as national law permits their being shown as an asset (unless national law requires their disclosure in the notes on the accounts) - goodwill, to the extent that it was acquired for valuable consideration (unless national law requires its disclosure in the notes on the accounts) 10. Tangible assets as described under Assets heading C.II of Article 9 of Directive 78/660/EEC, showing separately: - land and buildings occupied by a credit institution for its own activities (unless national law requires their disclosure in the notes on the accounts) 11. Subscribed capital unpaid, showing separately: - called-up capital (unless national law provides for called-up capital to be included liabilities, in which case capital called but not yet paid must be included either in this Assets item or in Assets item 14) 12. Own shares (with an indication of their nominal value or, in the absence of a nominal value, their accounting par value to the extend that national law permits their being shown in the balance sheet) 13. Other assets 14. Subscribed capital called but not paid (unless national law requires that called-up capital be shown under Assets item 11 15. Prepayments and accrued income 16. Loss for the financial year (unless national law provides for its inclusion under Liabilities item 14) Total assets Liabilities 1. Amounts owed to credit institutions: (a) repayable on demand (b) with agreed maturity dates or periods of notice 2. Amounts owed to customers: (a) savings deposits, showing separately: - those repayable on demand and those with agreed maturity dates or periods of notice where national law provides for such a breakdown (unless national law provides for such information to be given in the notes on the accounts) (b) other debts (ba) repayable on demand (bb) with agreed maturity dates or periods of notice 3. Debts evidenced by certificates: (a) debt securities in issue (b) others 4. Other liabilities 5. Accruals and deferred income 6. Provisions for liabilities and charges: (a) provisions for pensions and similar obligations (b) provisions for taxation (c) other provisions 7. Profit for the financial year (unless national law provides for its inclusion under Liabilities item 14) 8. Subordinated liabilities 9. Subscribed capital (unless national law provides for called-up capital to be shown under this item. In that case, the amounts of subscribed capital and paid-up capital must be shown separately) 0. Share premium account 1. Reserves 2. Revaluation reserve 3. Profit or loss brought forward 4. Profit or loss for the financial year (unless national law requires that this item be shown under Assets item 16 or Liabilities item 7) Total liabilities Off-balance sheet items 1. Contingent liabilities, showing separately: - acceptances and endorsements - guarantees and assets pledged as collateral security 2. Commitments, showing separately: - commitments arising out of sale and repurchase transactions Article 5 The following must be shown separately as sub-items of the items in question: - claims, whether or not evidenced by certificates, on affiliated undertakings and included in Assets items 2 to 5, - claims, whether or not evidenced by certificates, on undertakings with which a credit institution is linked by virtue of a participating interest and included in Assets items 2 to 5, - liabilities, whether or not evidenced by certificates, to affiliated undertakings and included in Liabilities items 1, 2, 3 and 8. - liabilities, whether or not evidenced by certificates, to undertakings with which a credit institution is linked by virtue of a participating interest and included in Liabilities items 1, 2, 3 and 8. Article 6 1. Subordinated assets shall be shown separately as sub-items of the items of the layout and the sub-items created in accordance with Article 5. 2. Assets, whether or not evidenced by certificates, are subordinated if, in the event of winding up or bankruptcy, they are to be repaid only after the claims of other creditors have been met. Article 7 The Member States may permit the disclosure of the information referred to in Articles 5 and 6, duly broken down into the various relevant items, in the notes on the accounts. Article 8 1. Assets shall be shown under the relevant balance sheet headings even where the credit institution drawing up the balance sheet has pledged them as security for its own liabilities or for those of third parties or has otherwise assigned them as security to third parties. 2. A credit institution shall not include in its balance sheet assets pledged or otherwise assigned to it as security unless such assets are in the form of cash in the hands of that credit institution. Article 9 1. Where a loan has been granted by a syndicate consisting of a number of credit institutions, each credit institution participating in the syndicate shall disclose only that part of the total loan which it has itself funded. 2. If in the case of a syndicated loan such as described in paragraph 1 the amount of funds guaranteed by a credit institution exceeds the amount which it has made available, any additional guarantee portion shall be shown as a contingent liability (in Off-balance sheet item 1, second indent). Article 10 1. Funds which a credit institution administers in its own name but on behalf of third parties must be shown in the balance sheet if the credit institution acquires legal title to the assets concerned. The total amount of such assets and liabilities shall be shown separately or in the notes on the accounts, broken down according to the various Assets and Liabilities items. However, the Member States may permit the disclosure of such funds off the balance sheet provided there are special rules whereby such funds can be excluded from the assets available for distribution in the event of the winding-up of a credit institution (or similar proceedings). 2. Assets acquired in the name of and on behalf of third parties must not be shown in the balance sheet. Article 11 Only those amounts which can at any time be withdrawn without notice or for which a maturity or period of notice of 24 hours or one working day has been agreed shall be regarded as repayable on demand. Article 12 1. Sale and repurchase transactions shall mean transactions which involve the transfer by a credit institution or customer (the 'transferor') to another credit institution or customer (the 'transferee') of assets, for example, bills, debts or transferable securities, subject to an agreement that the same assets will subsequently be transferred back to the transferor at a specified price. 2. If the transferee undertakes to return the assets on a date specified or to be specified by the transferor, the transaction in question shall be deemed to be a genuine sale and repurchase transaction. 3. If, however, the transferee is merely entitled to return the assets at the purchase price or for a different amount agreed in advance on a date specified or to be specified, the transaction in question shall be deemed to be a sale with an option to repurchase. 4. In the case of the sale and repurchase transactions referred to in paragraph 2, the assets transferred shall continue to appear in the transferor's balance sheet; the purchase price received by the transferor shall be shown as an amount owed to the transferee. In addition, the value of the assets transferred shall be disclosed in a note in the transferor's accounts. The transferee shall not be entitled to show the assets transferred in his balance sheet; the purchase price paid by the transferee shall be shown as an amount owed by the transferor. 5. In the case of the sale and repurchase transactions referred to in paragraph 3, however, the transferor shall not be entitled to show in his balance sheet the assets transferred; those items shall be shown as assets in the transferee's balance sheet. The transferor shall enter under Off-balance sheet item 2 an amount equal to the price agreed in the event of repurchase. 6. No forward exchange transactions, options, transactions involving the issue of debt securities with a commitment to repurchase all or part of the issue before maturity of any similar transactions shall be regarded as sale and repurchase transactions within the meaning of this Article. SECTION 4 SPECIAL PROVISIONS RELATING TO CERTAIN BALANCE SHEET ITEMS Article 13 Assets: Item 1 - Cash in hand, balances with central banks and post office banks 1. Cash in hand shall comprise legal tender including foreign notes and coins. 2. This item may include only balances with the central banks and post office banks of the country or countries in which a credit institution is established. Such balances must be a readily available at all times. Other claims on such bodies must be shown as loans and advances to credit institution (Assets item 3) or as loans and advances to customers (Assets item 4). Article 14 Assets: Item 2 - Treasury bills and other bills eligible for refinancing with central banks 1. This item shall comprise, under (a), treasury bills and similar securities, i. e. treasury bills, treasury certificates and similar debt instruments issued by public bodies which are eligible for refinancing with the central banks of the country or countries in which a credit institution is established. Those debt instruments issued by public bodies which fail to meet the above condition shall be shown under Assets sub-item 5 (a). 2. This item shall comprise, under (b), bills eligible for refinancing with central banks, i. e. all bills held in portfolio what were purchased from credit institutions or from customers to the extent that they are eligible, under national law, for refinancing with the central banks of the country or countries in which a credit institution is established. Article 15 Assets: Item 3 - Loans and advances to credit Institutions 1. Loans and advances to credit institutions shall comprise all loans and advances arising out of banking transactions to domestic or foreign credit institutions by the credit institution drawing up the balance sheet, regardless of their actual designations. The only exception shall be loans and advances represented by debt securities or any other security, which must be shown under Assets item 5. 2. For the purposes of this Article credit institutions shall comprise all undertakings on the list published in the Official Journal of the European Communities pursuant to Article 3 (7) of Directive 77/780/EEC, as well as central banks and official domestic and international banking organizations and all private and public undertakings which are not established in the Community but which satisfy the definition in Article 1 of Directive 77/780/EEC. Loans and advances to undertakings which do not satisfy the above conditions shall be shown under Assets item 4. Article 16 Assets: Item 4 - Loans and advances to customers Loans and advances to customers shall comprise all types of assets in the form of claims on domestic and foreign customers other than credit institutions, regardless of their actual designations. The only exception shall be loans and advances represented by debt securities or any other security, which must be shown under Assets item 5. Article 17 Assets: Item 5 - Debt securities including fixed-income securities 1. This item shall comprise negotiable debt securities including fixed-income securities issued by credit institutions, by other undertakings or by public bodies; such securities issued by the latter, however, shall be included only if they are not to be shown under Assets item 2. 2. Securities bearing interest rates that vary in accordance with specific factors, for example the interest rate on the inter-bank market or on the Euromarket, shall also be regarded as debt securities including fixed-income securities. 3. Only repurchase and negotiable own-debt securities may be included in sub-item 5 (b). Article 18 Liabilities: Item 1 - Amounts owed to credit institutions 1. Amounts owed to credit institutions shall include all amounts arising out of banking transactions owed to other domestic or foreign credit institutions by the credit institution drawing up the balance sheet, regardless of their actual designations. The only exception shall be liabilities represented by debt securities or by any other security, which must be shown under Liabilities item 3. 2. For the purposes of this Article credit institutions shall comprise all undertakings on the list published in the Official Journal of the European Communities pursuant to Article 3 (7) of Directive 77/780/EEC, as well as central banks and official domestic and international banking organizations and all private and public undertakings which are not established in the Community but which satisfy the definition in Article 1 of Directive 77/780/EEC. Article 19 Liabilities: Item 2 - Amounts owed to customers 1. Amounts owed to customers shall include all amounts owed to creditors that are not credit institutions within the meaning of Article 18, regardless of their actual designations. The only exception shall be liabilities represented by debt securities or by any other security, which must be shown under Liabilities item 3. 2. Only deposits which satisfy the conditions laid down in national law shall be treated as savings deposits. 3. Savings bonds shall be shown under the corresponding sub-item only if they are not represented by negotiable certificates. Article 20 Liabilities: Item 3 - Debts evidenced by certificates 1. This item shall include both debt securities and debts for which negotiable certificates have been issued, in particular deposit receipts, «bons de caisse» and liabilities arising out of own acceptances and promissory notes. 2. Only acceptances which a credit institution has issued for ist own refinancing and in respect of which it is the first party liable ('drawee') shall be treated as own acceptances. Article 21 Liabilities: Item 8 - Subordinated liabilities Where it has been contractually agreed that, in the event of winding up or of bankruptcy, liabilities, whether or not evidenced by certificates, are to be repaid only after the claims of all other creditors have been met, the liabilities in question shall be shown under this item. Article 22 Liabilities: Item 9 - Subscribed capital This item shall comprise all amounts, regardless of their actual designations, which, in accordance with the legal structure of the institution concerned, are regarded under national law as equity capital subscribed by the shareholders or other proprietors. Article 23 Liabilities: Item 11 - Reserves This item shall comprise all the types of reserves listed in Article 9 of Directive 78/660/EEC under Liabilities item A.IV, as defined therein. The Member States may also prescribe other types of reserves if necessary for credit institutions the legal structures of which are not covered by Directive 78/660/EEC. The types of reserve referred to in the first paragraph shall be shown separately, as sub-items of Liabilities item 11, in the balance sheets of the credit institutions concerned, with the exception of the revaluation reserve which shall be shown under item 12. Article 24 Off-balance sheet: Item 1 - Contingent liabilities This item shall comprise all transactions whereby an institution has underwritten the obligations of a third party. Notes on accounts shall state the nature and amount of any type of contingent liability which is material in relation to an institution's activities. Liabilities arising out of the endorsement of rediscounted bills shall be included in this item only if national law does not require otherwise. The same shall apply to acceptances other than own acceptances. Sureties and assets pledged as collateral security shall include all guarantee obligations incurred and assets pledged as collateral security on behalf of third parties, particularly in respect of sureties and irrevocable letters of credit. Article 25 Off-balance sheet: Item 2 - Commitments This item shall include every irrevocable commitment which could give rise to a risk. Notes on accounts shall state the nature and amount of any type of commitment which is material in relation to an institution's activities. Commitments arising out of sale and repurchase transactions shall include commitments entered into by a credit institution in the context of sale and repurchase transactions (on the basis of firm agreements to sell with options to repurchase) within the meaning of Article 12 (3). SECTION 5 LAYOUT OF THE PROFIT AND LOSS ACCOUNT Article 26 For the presentation of the profit and loss account, the Member States shall prescribe one or both of the layouts provided for in Articles 27 and 28. If a Member State prescribes both layouts it may allow undertakings to choose between them. Article 27 Vertical layout 1. Interest receivable and similar income, showing separately that arising from fixed-income securities 2. Interest payable and similar charges 3. Income from securities: (a) Income from shares and other variable-yield securities (b) Income from participating interests (c) Income from shares in affiliated undertakings 4. Commissions receivable 5. Commissions payable 6. Net profit or net loss on financial operations 7. Other operating income 8. General administrative expenses: (a) Staff costs, showing separately: - wages and salaries - social security costs, with a separate indication of those relating to pensions (b) Other administrative expenses 9. Value adjustments in respect of Assets items 9 and 10 10. Other operating charges 11. Value adjustments in respect of loans and advances and provisions for contingent liabilities and for commitments. 12. Value re-adjustments in respect of loans and advances and provisions for contingent liabilities and for commitments. 13. Value adjustments in respect of transferable securities held as financial fixed assets, participating interests and shares in affiliated undertakings 14. Value re-adjustments in respect of transferable securities held as financial fixed assets, participating interests and shares in affiliated undertakings 15. Tax on profit or loss on ordinary activities 16. Profit or loss on ordinary activities after tax 17. Extraordinary income 18. Extraordinary charges 19. Extraordinary profit or loss 20. Tax on extraordinary profit or loss 21. Extraordinary profit or loss after tax 22. Other taxes not shown under the preceeding items 23. Profit or loss for the financial year Article 28 Horizontal layout A. Charges 1. Interest payable and similar charges 2. Commissions payable 3. Net loss on financial operations 4. General administrative expenses: (a) Staff costs, showing separately: - wages and salaries - social security costs, with a separate indication of those relating to pensions (b) Other administrative expenses 5. Value adjustments in respect of Assets items 9 and 10 6. Other operating charges 7. Value adjustments in respect of loans and advances and provisions for contingent liabilities and for commitments 8. Value adjustments in respect of transferable securities held as financial fixed assets, participating interests and shares in affiliated undertakings 9. Tax on profit or loss on ordinary activities 10. Profit or loss on ordinary activities after tax 11. Extraordinary charges 12. Tax on extraordinary profit or loss 13. Extraordinary loss after tax 14. Other taxes not shown under the preceding items 15. Profit for the financial year B. Income 1. Interest receivable and similar income, showing separately that arising from fixed-income securities 2. Income from securities: (a) Income from shares and other variable-yield securities (b) Income from participating interests (c) Income from shares in affiliated undertakings 3. Commissions receivable 4. Net profit on financial operations 5. Value re-adjustments in respect of loans and advances and provisions for contingent liabilities and for commitments 6. Value re-adjustments in respect of transferable securities held as financial fixed assets, participating interests and shares in affiliated undertakings 7. Other operating income 8. Profit or loss on ordinary activities after tax 9. Extraordinary income 10. Extraordinary profit after tax 11. Loss for the financial year SECTION 6 SPECIAL PROVISIONS RELATING TO CERTAIN ITEMS IN THE PROFIT AND LOSS ACCOUNT Article 29 Article 27, items 1 and 2 (vertical layout) Article 28, items A 1 and B 1 (horizontal layout) Interest receivable and similar income and interest payable and similar charges. These items shall include all profits and losses arising out of banking activities, including: (1) all income from assets entered under Assets items 1 to 5 in the balance sheet, however calculated. Such income shall also include income arising from the spreading on a time basis of the discount on assets acquired at an amount below, and liabilities contracted at an amount above, the sum payable at maturity; (2) all charges arising out of liabilities entered under Liabilities items 1, 2, 3 and 8, however calculated. Such charges shall also include charges arising from the spreading on a time basis of the premium on assets acquired at an amount above, and liabilities contracted at an amount below, the sum payable at maturity; (3) income and charges resulting from covered forward contracts, spread over the actual duration of the contract and similar in nature to interest; (4) fees and commission similar in nature to interest and calculated on a time basis or by reference to the amount of the claim or liability. Article 30 Article 27, item 3 (vertical layout) Article 28, item B 2 (horizontal layout) Income from shares and other variable-yield securities, from participating interests, and from shares in affiliated undertakings This item shall comprise all dividends and other income from variable-yield securities, from participating interests and from shares in affiliated undertakings. Income from shares in investment companies shall also be included under this item. Article 31 Article 27, items 4 and 5 (vertical layout) Article 28, items A 2 and B 3 (horizontal layout) Commissions receivable and commissions payable Without prejudice to Article 29, commissions receivable shall include income in respect of all services supplied to third parties, and commissions payable shall include charges for services rendered by third parties, in particular - commissions for guarantees, loans administration on behalf of other lenders and securities transactions on behalf of third parties, - commissions and other charges and income in respect of payment transactions, account administration charges and commissions for the safe custody and administration of securities, - commissions for foreign currency transactions and for the sale and purchase of coin and precious metals on behalf of third parties, - commissions charges for brokerage services in connection with savings and insurance contracts and loans. Article 32 Article 27, item 6 (vertical layout) Article 28, item A 3 or item B 4 (horizontal layout) Net profit or net loss on financial operations. This item covers: 1. the net profit or loss on transactions in securities which are not held as financial fixed assets together with value adjustments and value re-adjustments on such securities, taking into account, where Article 36 (2) has been applied, the difference resulting from application of that article; however, in those Member States which exercise the option provided for in Article 37, these net profits or losses and value adjustments and value re-adjustments shall be included only in so far as they relate to securities included in a trading portfolio; 2. the net profit or loss on exchange activities, without prejudice to Article 29, point 3; 3. the net profits and losses on other buying and selling operations involving financial instruments, including precious metals. Article 33 Article 27, items 11 and 12 (vertical layout) Article 28, items A 7 and B 5 (horizontal layout) Value adjustments in respect of loans and advances and provisions for contingent liabilities and for commitments Value re-adjustments in respect of loans and advances and provisions for contingent liabilities and for commitments. 1. These items shall include, on the one hand, charges for value adjustments in respect of loans and advances to be shown under Assets items 3 and 4 and provisions for contingent liabilities and for commitments to be shown under Off-balance sheet items 1 and 2, on the other hand, credits from the recovery of written-off loans and advances and amounts written back following earlier value adjustments and provisions. 2. In those Member States which exercise the option provided for in Article 37, this item shall also include the net profit or loss on transactions in securities included in Assets items 5 and 6 which are neither held as financial fixed Assets as defined in Article 35 (2) nor included in a trading portfolio, together with value adjustments and value re-adjustments on such securities taking into account, where Article 36 (2) has been applied, the difference resulting from application of that article. The nomenclature of this item shall be adapted accordingly. 3. The Member States may permit the charges and income covered by these items to be set off against each other, so that only a net item (income or charge) is shown. 4. Value adjustments in respect of loans and advances to credit institutions, to customers, to undertakings with which a credit institution is linked by virtue of participating interests and to affiliated undertakings shall be shown separately in the notes on the accounts where they are material. This provision need not be applied if a Member State permits setting-off pursuant to paragraph 3. Article 34 Article 27, items 13 and 14 (vertical layout) Article 28, items A 8 and B 5 (horizontal layout) Value adjustments in respect of transferable securities held as financial fixed assets, participating interests and shares in affiliated undertakings Value re-adjustments in respect of transferable securities held as financial fixed assets, participating interests and shares in affiliated undertakings. 1. These items shall include, on the one hand, charges for value adjustments in respect of assets shown in Assets items 5 to 8 and, on the other hand, all the amounts written back following earlier value adjustments, in so far as the charges and income relate to transferable securities held as financial fixed assets as defined in Article 35 (2), participating interests and shares in affiliated undertakings. 2. The Member States may permit the charges and income covered by these items to be set off against each other, so that only a net item (income or charge) is shown. 3. Value adjustments in respect of these transferable securities, participating interests and shares in affiliated undertakings shall be shown separately in the notes on the accounts where they are material. This provision need not be applied if a Member State permits setting off pursuant to paragraph 2. SECTION 7 VALUATION RULES Article 35 1. Assets items 9 and 10 must be valued as fixed assets. The assets included in other balance sheet items shall be valued as fixed assets where they are intended for use on a continuing basis in the normal course of an undertakings's activities. 2. Where reference is made to financial fixed assets in Section 7 of Directive 78/660/EEC, this term shall in the case of credit institutions be taken to mean participating interests, shares in affiliated undertakings and securities intended for use on a continuing basis in the normal course of an undertaking's activities. 3. (a) Debt securities including fixed-income securities held as financial fixed assets shall be shown in the balance sheet at purchase price. The Member States may, however, require or permit such debt securities to be shown in the balance sheet at the amount repayable at maturity. (b) Where the purchase price of such debt securities exceeds the amount repayable at maturity the amount of the difference must be charged to the profit and loss account. The Member States may, however, require or permit the amount of the difference to be written off in instalments so that it is completely written off by the time when the debt securities are repaid. The difference must be shown separately in the balance sheet or in the notes on the accounts. (c) Where the purchase price of such debt securities is less than the amount repayable at maturity, the Member States may require or permit the amount of the difference to be released to income in instalments over the period remaining until repayment. The difference must be shown separately in the balance sheet or in the notes on the accounts. Article 36 1. Where transferable securities which are not held as financial fixed assets are shown in the balance sheet at purchase price, credit institutions shall disclose in the notes on their accounts the difference between the purchase price and the higher market value of the balance sheet date. 2. The Member States may, however, require or permit those transferable securities to be shown in the balance sheet at the higher market value at the balance sheet date. The difference between the purchase price and the higher market value shall be disclosed in the notes on the accounts. Article 37 1. Article 39 of Directive 78/660/EEC shall apply to the valuation of credit institutions' loans and advances, debt securities, shares and other variable-yield securities which are not held as financial fixed assets. 2. Pending subsequent coordination, however, the Member States may permit: (a) loans and advances to credit institutions and customers (Assets items 3 and 4) and debt securities, shares and other variable-yield securities included in Assets items 5 and 6 which are neither held as financial fixed assets as defined in Article 35 (2) not included in a trading portfolio to be shown at a value lower than that which would result from the application of Article 39(1) of Directive 78/660/EEC, where that is required by the prudence dictated by the particular risks associated with banking. Nevertheless, the difference between the two values must not be more than 4% of the total amount of the assets mentioned above after application of the aforementioned Article 39; (b) that the lower value resulting from the application of subparagraph (a) be maintained until the credit institution decides to adjust it; (c) where a Member State exercises the option provided for in subparagraph (a), neither Article 36 (1) of this Directive nor Article 40 (2) of Directive 78/660/EEC shall apply. Article 38 1. Pending subsequent coordination, those Member States which exercise the option provided for in Article 37 must permit and those Member States which do not exercise that option may permit the introduction of a Liabilities item 6 A entitled 'Fund for general banking risks'. That item shall include those amounts which a credit institution decides to put aside to cover such risks where that is required by the particular risks associated with banking. 2. The net balance of the increases and decreases of the 'Fund for general banking risks' must be shown separately in the profit and loss account. Article 39 1. Assets and liabilities denominated in foreign currency shall be translated at the spot rate of exchange ruling on the balance sheet date. The Member States my, however, require or permit assets held as financial fixed assets and tangible and intangible assets, no covered or not specifically covered in either the spot or forward markets, to be translated at the rates ruling on the dates of their acquisition. 2. Uncompleted forward and spot exchange transactions shall be translated at the spot rates of exchange ruling on the balance sheet date. The Member States may, however, require forward transactions to be translated at the forward rate ruling on the balance sheet date. 3. Without prejudice to Article 29(3), the differences between the book values of the assets, liabilities and forward transactions and the amounts produced by translation in accordance with paragraphs 1 and 2 shall be shown in the profit and loss account. The Member States may, however, require or permit differences produced by translation in accordance with paragraphs 1 and 2 to be included, in whole or in part, in reserves not available for distribution, where they arise on assets held as financial fixed assets, on tangible and intangible assets and on any transactions undertaken to cover those assets. 4. The Member States may provide that positive translation differences arising out of forward transactions, assets or liabilities not covered or not specifically covered by other forward transactions, or by assets or liabilities shall not be shown in the profit and loss account. 5. If a method specified in Article 59 of Directive 78/660/EEC is used, the Member States may provide that any translation differences shall be transferred, in whole or in part, directly to reserves. Positive and negative translation differences transferred to reserves shall be shown separately in the balance sheet or in the notes on the accounts. 6. The Member States may require or permit translation differences arising on consolidation out of the retranslation of an affiliated undertaking's capital and reserves or the share of a participating interest's capital and reserves at the beginning of the accounting period to be included, in whole or in part, in consolidated reserves, together with the translation differences arising on the translation of any transactions undertaken to cover that capital and those reserves. 7. The Member States may require or permit the income and expenditure of affiliated undertakings and participating interests to be translated on consolidation at the average rates of exchange ruling during the accounting period. SECTION 8 CONTENTS OF THE NOTES ON THE ACCOUNTS Article 40 1. Article 43 (1) of Directive 78/660/EEC shall apply, subject to Article 37 of this Directive and to the following provisions. 2. In addition to the information required under Article 43 (1) (5) of Directive 78/660/EEC, credit institutions shall disclose the following information relating to Liabilities item 8 (Subordinated liabilities): (a) in respect of each borrowing which exceeds 10% of the total amount of the subordinated liabilities: (i) the amount of the borrowing, the currency in which it is denominated, the rate of interest and the maturity date or the fact that it is a perpetual issue; (ii) whether there are any circumstances in which early repayment is required; (iii) the terms of the subordination, the existence of any provisions to convert the subordinated liability into capital or some other form of liability and the terms of any such provisions. (b) an overall indication of the rules governing other borrowings. 3. (a) In place of the information required under Article 43 (1) (6) of Directive 78/660/EEC, credit institutions shall in the notes on their accounts state separately for each of the Assets items 3 (b) and 4 and the Liabilities items 1 (b), 2 (a), 2 (b) (bb) and 3 (b) the amounts of those loans and advances and liabilities on the basis of their remaining maturity as follows: - not more than three months, - more than three months but not more than one year, - more than one year but not more than five years, - more than five years. For Assets item 4, loans and advances on call and at short notice must also be shown. If loans and advances or liabilities involve payment by instalments, the remaining maturity shall be the period between the balance sheet date and the date on which each instalment falls due. However, for five years after the date referred to in Article 47 (2) the Member States may require or permit the listing by maturity of the assets and liabilities referred to in this Article to be based on the originally agreed maturity or period of notice. In that event, where a credit institution has acquired an existing loan not evidenced by a certificate, the Member States shall require classification of that loan to be based on the remaining maturity as at the date on which it was acquired. For the purposes of this subparagraph, the originally agreed maturity for loans shall be the period between the date of first drawing and the date of repayment; the period of notice shall be deemed to be the period between the date on which notice is given and the date on which repayment is to be made; if loans and advances or liabilities are redeemable by instalments, the agreed maturity shall be the period between the date on which such loans and advances or liabilities arose and the date on which the last instalment falls due. Credit institutions shall also indicate for the balance sheet items referred to in this subparagraph what proportion of those assets and liabilities will become due within one year of the balance sheet date. (b) Credit institutions shall, in respect of Assets item 5 (Debt securities including fixed-income securities) and Liabilities item 3 (a) (Debt securities in issue), indicate what proportion of assets and liabilities will become due within one year of the balance sheet date. (c) The Member States may require the information referred to in subparagraphs (a) and (b) to be given in the balance sheet. (d) Credit institutions shall give particulars of the assets which they have pledged as security for their own liabilities or for those of third parties (including contingent liabilities); the particulars should be in sufficient detail to indicate for each Liabilities item and for each Off-balance sheet item the total amount of the assets pledged as security. 4. Where credit institutions have to provide the information referred to in Article 43 (1) (7) of Directive 78/660/EEC in Off-balance sheet items, such information need not be repeated in the notes on the accounts. 5. In place of the information required under Article 43 (1) (8) of Directive 78/660/EEC, a credit institution shall indicate in the notes on its accounts the proportion of its income relating to items 1, 3, 4, 6 and 7 of Article 27 or to items B 1, B 2, B 3, B 4 and B 7 of Article 28 by geographical markets, in so far as, taking account of the manner in which the credit institution is organized, those markets differ substantially from one another. Article 45 (1) (b) of Directive 78/660/EEC shall apply. 6. The reference in Article 43 (1) (9) of Directive 78/660/EEC to Article 23 (6) of that Directive shall be deemed to be a reference to Article 27 (8) or Article 28 (A 4) of this Directive. 7. By way of derogation from Article 43 (1) (13) of Directive 78/660/EEC, credit institutions need disclose only the amounts of advances and credits granted to the members of their administrative, managerial and supervisory bodies, and the commitments entered into on their behalf by way of guarantees of any kind. That information must be given in the form of a total for each category. Article 41 1. The information prescribed in Article 15 (3) of Directive 78/660/EEC must be given in respect of assets held as fixed assets as defined in Article 35 of this Directive. The obligation to show value adjustments separately shall not, however, apply where a Member State has permitted set-offs between value adjustments pursuant to Article 34 (2) of this Directive. In that event value adjustments may be combined with other items. 2. The Member States shall require credit institutions to give the following information as well in the notes on their accounts: (a) a breakdown of the transferable securities shown under Assets items 5 to 8 into listed and unlisted securities; (b) a breakdown of the transferable securities shown under Assets items 5 and 6 into securities which, pursuant to Article 35, are or are not held as financial fixed assets and the criterion used to distinguish between the two categories of transferable securities; (c) the value of leasing transactions, apportioned between the relevant balance sheet items; (d) a breakdown of Assets item 13, Liabilities item 4, items 10 and 18 in the vertical layout or A 6 and A 11 in the horizontal layout and items 7 and 17 in the vertical layout or B 7 and B 9 in the horizontal layout in the profit and loss account into their main component amounts, where such amounts are important for the purpose of assessing the annual accounts, as well as explanations of their nature and amount; (e) the charges paid on account of subordinated liabilities by a credit institution in the year under review; (f) the fact that an institution provides management and agency services to third parties where the scale of business of that kind is material in relation to the institution's activities as a whole; (g) the aggregate amounts of assets and of liabilities denominated in foreign currencies, translated into the currency in which the annual accounts are drawn up; (h) a statement of the types of unmatured forward transactions outstanding at the balance sheet date indicating, in particular, for each type of transaction, whether they are made to a material extent for the purpose of hedging the effects of fluctuations in interest rates, exchange rates and market prices, and whether they are made to a material extent for dealing purposes. These types of transaction shall include all those in connection with which the income or expenditure is to be included in Article 27, item 6, Article 28, items A 3 or B 4 or Article 29 (3), for example, foreign currencies, precious metals, transferable securities, certificates of deposit and other assets. SECTION 9 PROVISIONS RELATING TO CONSOLIDATED ACCOUNTS Article 42 1. Credit institutions shall draw up consolidated accounts and consolidated annual reports in accordance with Directive 83/349/EEC, in so far as this section does not provide otherwise. 2. Insofar as a Member State does not have recourse to Article 5 of Directive 83/349/EEC, paragraph 1 of this Article shall also apply to parent undertakings the sole object of which is to acquire holdings in subsidiary undertakings and to manage such holdings and turn them to profit, where those subsidiary undertakings are either exclusively or mainly credit institutions. Article 43 1. Directive 83/349/EEC shall apply, subject to Article 1 of this Directive and paragraph 2 of this Article. 2. (a) Articles 4, 6, 15 and 40 of Directive 83/349/EEC shall not apply. (b) The Member States may make application of Article 7 of Directive 83/349/EEC subject to the following additional conditions: - the parent undertaking must have declared that it guarantees the commitments entered into by the exempted undertaking; the existence of that declaration shall be disclosed in the accounts of the exempted undertaking; - the parent undertaking must be a credit institution within meaning of Article 2 (1) (a) of this Directive. (c) The information referred to in the first two indents of Article 9 (2) of Directive 83/349/EEC, namely: - the amount of the fixed assets and - the net turnover shall be replaced by: - the sum of items 1, 3, 4, 6 and 7 in Article 27 or B 1, B 2, B 3, B 4 and B 7 in Article 28 of this Directive. (d) Where, as a result of applying Article 13 (3) (c) of Directive 83/349/EEC, a subsidiary undertaking which is a credit institution is not included in consolidated accounts but where the shares of that undertaking are temporarily held as a result of a financial assistance operation with a view to the reorganization or rescue of the undertaking in question, the annual accounts of that undertaking shall be attached to the consolidated accounts and additional information shall be given in the notes on the accounts concerning the nature and terms of the financial assistance operation. (e) A Member State may also apply Article 12 of Directive 83/349/EEC to two or more credit institutions which are not connected as described in Article 1 (1) or (2) of that Directive but are managed on a unified basis other than pursuant to a contract or provisions in the memorandum or articles of association. (f) Article 14 of Directive 83/349/EEC, with the exception of paragraph 2, shall apply subject to the following provision. Where a parent undertaking is a credit institution and where one or more subsidiary undertakings to be consolidated do not have that status, those subsidiary undertakings shall be included in the consolidation if their activities are a direct extension of banking or concern services ancillary to banking, such as leasing, factoring, the management of unit trusts, the management of dataprocessing services or any other similar activity. (g) For the purposes of the layout of consolidated accounts: - Articles 3, 5 to 26 and 29 to 34 of this Directive shall apply; - the reference in Article 17 of Directive 83/349/EEC to Article 15 (3) of Directive 78/660/EEC shall apply to the assets deemed to be fixed assets pursuant to Article 35 of this Directive. (h) Article 34 of Directive 83/349/EEC shall apply in respect of the contents of the notes on consolidated accounts, subject to Articles 40 and 41 of this Directive. SECTION 10 PUBLICATON Article 44 1. The duly approved annual accounts of credit institutions together with the annual reports and the reports by the persons responsible for auditing the accounts shall be published as laid down by national law in accordance with Article 3 of Directive 68/151/EEC (1). (1) OJ No L 65, 14.3.1968, p. 8. National law may, however, permit the annual report not to be published as stipulated above. In that case, it shall be made available to the public at the company's registered office in the Member State concerned. It must be possible to obtain a copy of all or part of any such report on request. The price of such a copy must not exceed its administrative cost. 2. Paragraph 1 shall also apply to the duly approved consolidated accounts, the consolidated annual reports and the reports by the persons responsible for auditing the accounts. 3. However, where a credit institution which has drawn up annual accounts or consolidated accounts is not established as one of the types of company listed in Article 1 (1) of Directive 78/660/EEC and is not required by its national law to publish the documents referred to in paragraphs 1 and 2 of this Article as prescribed in Article 3 of Directive 68/151/EEC, it must at least make them available to the public at its registered office or, in the absence of a registered office, at its principal place of business. It must be possible to obtain copies of such documents on request. The prices of such copies must not exceed their administrative cost. 4. The annual accounts and consolidated accounts of a credit institution must be published in every Member State in which that credit institution has branches within the meaning of the third indent of Article 1 of Directive 77/780/EEC. Such Member States may require that those documents be published in their official languages. 5. The Member States shall provide for appropriate sanctions for failure to comply with the publication rules referred to in this Article. SECTION 11 AUDITING Article 45 A Member State need not apply Article 2 (1) (b) (iii) of Directive 84/253/EEC (2) to public savings banks where the statutory auditing of the documents of those undertakings referred to in Article 1 (1) of that Directive is reserved to an existing supervisory body for those savings banks at the time of the entry into force of this Directive and where the person responsible complies at least with the conditions laid down in Article 3 to 9 of Directive 84/253/EEC. (2) OJ No L 126, 12.5.1984, p. 20. SECTION 12 FINAL PROVISIONS Article 46 The Contact Committee established in accordance with Article 52 of Directive 78/660/EEC shall, when meeting as constituted appropriately, also have the following functions: (a) to facilitate, without prejudice to Articles 169 and 170 of the Treaty, harmonized application of this Directive through regular meetings dealing in particular with practical problems arising in connection with its application; (b) to advise the Commission, if necessary, on additions or amendments to this Directive. Article 47 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive by 31 December 1990. They shall forthwith inform the Commission thereof. 2. A Member State may provide that the provisions referred to in paragraph 1 shall first apply to annual accounts and consolidated accounts for financial years beginning on 1 January 1993 or during the calendar year 1993. 3. 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 48 Five years the date referred to in Article 47 (2), the Council, acting on a proposal from the Commission, shall examine and if need be revise all those provisions of this Directive which provide for Member State options, together with Articles 2 (1), 27, 28 and 41, in the light of the experience acquired in applying this Directive and in particular of the aims of greater transparency and harmonization of the provisions referred to by this Directive. Article 49 This Directive is addressed to the Member States.

31987L0094

1986

Commission Directive 87/94/EEC of 8 December 1986 on the approximation of the laws of the Member States relating to procedures for the control of characteristics of, limits for and resistance to detonation of straight ammonium nitrate fertilizers of high nitrogen content Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 80/876/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to straight ammonium nitrate fertilizers of high nitrogen content (1), and in particular Article 8 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 (2), and in particular Article 9 (2) thereof, Whereas Directive 80/876/EEC provides for characteristics of, limits for and a test of resistance to detonation for the fertilizers in question; whereas Article 8 thereof provides that the methods of checking, analysis and test be established in accordance with the procedure laid down in Article 11 of Directive 76/116/EEC; Whereas Directive 76/116/EEC provides for official control for Community fertilizers for the purpose of checking compliance with requirements arising under the Community provisions concerning the quality and composition of fertilizers; Whereas it seemed necessary, having regard to the particular nature of straight ammonium nitrate fertilizers of high nitrogen content and to the requirements it entails regarding public safety, health, and protection of workers, to lay down additional Community rules for these fertilizers; Whereas for straight ammonium nitrate fertilizers, sampling and analysis for official controls of Community fertilizers are carried out in accordance with the methods described in Commission Directive 77/535/EEC Whereas in accordance with the same procedure the number of the thermal cycles to which the sample is to be submitted before being tested for resistance to detonation is established as provided in Annex II to Directive 80/876/EEC, and the limit value for heavy metals is established as provided in Annex I to the same Directive; Whereas the method of the closed thermal cycles as described is regarded as stimulating sufficiently the conditions to be taken into account within the scope of application of Directive 80/876/EEC; whereas, however, this method may not necessarily simulate all conditions arising during bulk transport by water; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Removal of Technical Barriers to Trade in Fertilizers, Article 1 1. Member States shall take the necessary measures to ensure that the methods of checking, analysis and test for official controls of straight ammonium nitrate fertilizers of high nitrogen content provided for by Directive 80/876/EEC are carried out in accordance with the methods described in Annexes II and III to this Directive. 2. Annex I fixes: - the permissible heavy metals content, - the required number of thermal cycles applicable to samples submitted to the detonation test. Article 2 1. Member States shall take the measures necessary to comply with this Directive not later than 31 December 1987. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31986L0613

1986

Council Directive 86/613/EEC of 11 December 1986 on the application of the principle of equal treatment between men and women engaged in an activity, including agriculture, in a self-employed capacity, and on the protection of self-employed women during pregnancy and motherhood Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission (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 its resolution of 12 July 1982 on the promotion of equal opportunities for women (4), the Council approved the general objectives of the Commission communication concerning a new Community action programme on the promotion of equal opportunities for women (1982 to 1985) and expressed the will to implement appropriate measures to achieve them; Whereas action 5 of the programme referred to above concerns the application of the principle of equal treatment to self-employed women and to women in agriculture; Whereas the implementation of the principle of equal pay for men and women workers, as laid down in Article 119 of the Treaty, forms an integral part of the establishment and functioning of the common market; Whereas on 10 February 1975 the Council adopted Directive 75/117/EEC on the approximation of the laws of the Member States relating to the application of the principle of equal pay for men and women (5); Whereas, as regards other aspects of equality of treatment between men and women, on 9 February 1976 the Council adopted Directive 76/207/EEC on the implementation of the principle of equal treament for men and women as regards access to employment, vocational training and promotion, and working conditions (6) and on 19 December 1978 Directive 79/7/EEC on the progressive implementation of the principle of equal treatment for men and women in matters of social security (7); Whereas, as regards persons engaged in a self-employed capacity, in an activity in which their spouses are also engaged, the implementation of the principle of equal treatment should be pursued through the adoption of detailed provisions designed to cover the specific situation of these persons; Whereas differences persist between the Member States in this field, whereas, therefore it is necessary to approximate national provisions with regard to the application of the principle of equal treatment; Whereas in certain respects the Treaty does not confer the powers necessary for the specific actions required; Whereas the implementation of the principle of equal treatment is without prejudice to measures concerning the protection of women during pregnancy and motherhood, SECTION I Aims and scope Article 1 The purpose of this Directive is to ensure, in accordance with the following provisions, application in the Member States of the principle of equal treatment as between men and women engaged in an activity in a self-employed capacity, or contributing to the pursuit of such an activity, as regards those aspects not covered by Directives 76/207/EEC and 79/7/EEC. Article 2 This Directive covers: (a) self-employed workers, i.e. all persons pursuing a gainful activity for their own account, under the conditions laid down by national law, including farmers and members of the liberal professions; (b) their spouses, not being employees or partners, where they habitually, under the conditions laid down by national law, participate in the activities of the self-employed worker and perform the same tasks or ancillary tasks. Article 3 For the purposes of this Directive the principle of equal treatment implies the absence of all discrimination on grounds of sex, either directly or indirectly, by reference in particular to marital or family status. SECTION II Equal treatment between self-employed male and female workers - position of the spouses without professional status of self-employed workers - protection of self-employed workers or wives of self-employed workers during pregnancy and motherhood Article 4 As regards self-employed persons, Member States shall take the measures necessary to ensure the elimination of all provisions which are contrary to the principle of equal treatment as defined in Directive 76/207/EEC, especially in respect of the establishment, equipment or extension of a business or the launching or extension of any other form of self-employed activity including financial facilities. Article 5 Without prejudice to the specific conditions for access to certain activities which apply equally to both sexes, Member States shall take the measures necessary to ensure that the conditions for the formation of a company between spouses are not more restrictive than the conditions for the formation of a company between unmarried persons. Article 6 Where a contributory social security system for selfemployed workers exists in a Member State, that Member State shall take the necessary measures to enable the spouses referred to in Article 2 (b) who are not protected under the self-employed worker's social security scheme to join a contributory social security scheme voluntarily. Article 7 Member States shall undertake to examine under what conditions recognition of the work of the spouses referred to in Article 2 (b) may be encouraged and, in the light of such examination, consider any appropriate steps for encouraging such recognition. Article 8 Member States shall undertake to examine whether, and under what conditions, female self-employed workers and the wives of self-employed workers may, during interruptions in their occupaional activity owing to pregnancy or motherhood, - have access to services supplying temporary replacements or existing national social services, or - be entitled to cash benefits under a social security scheme or under any other public social protection system. SECTION III General and final provisions Article 9 Member States shall introduce into their national legal systems such measures as are necessary to enable all persons who consider themselves wronged by failure to apply the principle of equal treatment in self-employed activities to pursue their claims by judicial process, possibly after recourse to other competent authorities. Article 10 Member States shall ensure that the measures adopted pursuant to this Directive, together with the relevant provisions already in force, are brought to the attention of bodies representing self-employed workers and vocational training centres. Article 11 The Council shall review this Directive, on a proposal from the Commission, before 1 July 1993. Article 12 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1989. However, if a Member State which, in order to comply with Article 5 of this Directive, has to amend its legislation on matrimonial rights and obligations, the date on which such Member State must comply with Article 5 shall be 30 June 1991. 2. Member States shall immediately inform the Commission of the measures taken to comply with this Directive. Article 13 Member States shall forward to the Commission, not later than 30 June 1991, all the information necessary to enable it to draw up a report on the application of this Directive for submission to the Council. Article 14 This Directive is addressed to the Member States.

31987L0054

1986

COUNCIL DIRECTIVE of 16 December 1986 on the legal protection of topographies of semiconductor products (87/54/EEC) Having regard to the Treaty establishing the European Economic Community and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas semiconductor products are playing an increasingly important role in a broad range of industries and semiconductor technology can accordingly be considered as being of fundamental importance for the Community's industrial development; Whereas the functions of semiconductor products depend in large part on the topographies of such products and whereas the development of such topographies requires the investment of considerable resources, human, technical and financial, while topographies of such products can be copied at a fraction of the cost needed to develop them independently; Whereas topographies of semiconductor products are at present not clearly protected in all Member States by existing legislation and such protection, where it exists, has different attributes; Whereas certain existing differences in the legal protection of semiconductor products offered by the laws of the Member States have direct and negative effects on the functioning of the common market as regards semiconductor products and such differences could well become greater as Member States introduce new legislation on this subject; Whereas existing differences having such effects need to be removed and new ones having a negative effect on the common market prevented from arising; Whereas, in relation to extension of protection to persons outside the Community, Member States should be free to act on their own behalf in so far as Community decisions have not been taken within a limited period of time; Whereas the Community's legal framework on the protection of topographies of semiconductor products can, in the first instance, be limited to certain basic principles by provisions specifying whom and what should be protected, the exclusive rights on which protected persons should be able to rely to authorize or prohibit certain acts, exceptions to these rights and for how long the protection should last; Whereas other matters can for the time being be decided in accordance with national law, in particular, whether registration or deposit is required as a condition for protection and, subject to an exclusion of licences granted for the sole reason that a certain period of time has elapsed, whether and on what conditions non-voluntary licences may be granted in respect of protected topographies; Whereas protection of topographies of semiconductor products in accordance with this Directive should be without prejudice to the application of some other forms of protection; Whereas further measures concerning the legal protection of topographies of semiconductor products in the Community can be considered at a later stage, if necessary, while the application of common basic principles by all Member States in accordance with the provisions of this Directive is an urgent necessity, CHAPTER 1 Definitions Article 1 1. For the purposes of this Directive: (a) a ‘semiconductor product’ shall mean the final or an intermediate form of any product: (i) consisting of a body of material which includes a layer of semiconducting material; and (ii) having one or more other layers composed of conducting, insulating or semiconducting material, the layers being arranged in accordance with a predetermined three-dimensional pattern; and (iii) intended to perform, exclusively or together with other functions, an electronic function; (b) the ‘topography’ of a semiconductor product shall mean a series of related images, however fixed or encoded; (i) representing the three-dimensional pattern of the layers of which a semiconductor product is composed; and (ii) in which series, each image has the pattern or part of the pattern of a surface of the semiconductor product at any stage of its manufacture; (c) ‘commercial exploitation’ means the sale, rental, leasing or any other method of commercial distribution, or an offer for these purposes. However, for the purposes of Articles 3 (4), 4 (1), 7 (1), (3) and (4) ‘commercial exploitation’ shall not include exploitation under conditions of confidentiality to the extent that no further distribution to third parties occurs, except where exploitation of a topography takes place under conditions of confidentiality required by a measure taken in conformity with Article 223 (1) (b) of the Treaty. 2. The Council acting by qualified majority on a proposal from the Commission, may amend paragraph 1 (a) (i) and (ii) in order to adapt these provisions in the light of technical progress. CHAPTER 2 Protection of topographies of semiconductor products Article 2 1. Member States shall protect the topographies of semiconductor products by adopting legislative provisions conferring exclusive rights in accordance with the provisions of the Directive. 2. The topography of a semiconductor product shall be protected in so far as it satisfies the conditions that it is the result of its creator's own intellectual effort and is not commonplace in the semiconductor industry. Where the topography of a semiconductor product consists of elements that are commonplace in the semiconductor industry, it shall be protected only to the extent that the combination of such elements, taken as a whole, fulfils the abovementioned conditions. Article 3 1. Subject to paragraphs 2 to 5, the right to protection shall apply in favour of persons who are the creators of the topographies of semiconductor products. 2. Member States may provide that, (a) where a topography is created in the course of the creator's employment, the right to protection shall apply in favour of the creator's employer unless the terms of employment provide to the contrary; (b) where a topography is created under a contract other than a contract of employment, the right to protection shall apply in favour of a party to the contract by whom the topography has been commissioned, unless the contract provides to the contrary. 3. (a) As regards the persons referred to in paragraph 1, the right to protection shall apply in favour of natural persons who are nationals of a Member State or who have their habitual residence on the territory of a Member State. (b) Where Member States make provision in accordance with paragraph 2, the right to protection shall apply in favour of: (i) natural persons who are nationals of a Member State or who have their habitual residence on the territory of a Member State; (ii) companies or other legal persons which have a real and effective industrial or commercial establishment on the territory of a Member State. 4. Where no right to protection exists in accordance with other provisions of this Article, the right to protection shall also apply in favour of the persons referred to in paragraph 3 (b) (i) and (ii) who: (a) first commercially exploit within a Member State a topography which has not yet been exploited commercially anywhere in the world; and (b) have been exclusively authorized to exploit commercially the topography throughout the Community by the person entitled to dispose of it. 5. The right to protection shall also apply in favour of the successors in title of the persons mentioned in paragraphs 1 to 4. 6. Subject to paragraph 7, Member States may negotiate and conclude agreements or understandings with third States and multilateral Conventions concerning the legal protection of topographies of semiconductor products whilst respecting Community law and in particular the rules laid down in this Directive. 7. Member States may enter into negotiations which third States with a view to extending the right to protection to persons who do not benefit from the right to protection according to the provisions of this Directive. Member States who enter into such negotiations shall inform the Commission thereof. When a Member State wishes to extend protection to persons who otherwise do not benefit from the right to protection according to the provisions of this Directive or to conclude an agreement or understanding on the extension of protection with a non-Member State it shall notify the Commission. The Commission shall inform the other Member States thereof. The Member State shall hold the extension of protection or the conclusion of the agreement or understanding in abeyance for one month from the date on which it notifies the Commission. However, if within that period the Commission notifies the Member State concerned of its intention to submit a proposal to the Council for all Member States to extend protection in respect of the persons or non-Member State concerned, the Member State shall hold the extension of protection or the conclusion of the agreement or undestanding in abeyance for a period of two months from the date of the notification by the Member State. Where, before the end of this two-month period, the Commission submits such a proposal to the Council, the Member State shall hold the extension of protection or the conclusion of the agreement or understanding in abeyance for a further period of four months from the date on which the proposal was submitted. In the absence of a Commission notification or proposal or a Council decision within the time limits prescribed above, the Member State may extend protection or conclude the agreement or understanding. A proposal by the Commission to extend protection, whether or not it is made following a notification by a Member State in accordance with the preceding paragraphs shall be adopted by the Council acting by qualified majority. A Decision of the Council on the basis of a Commission proposal shall not prevent a Member State from extending protection to persons, in addition to those to benefit from protection in all Member States, who were included in the envisaged extension, agreement or understanding as notified, unless the Council acting by qualified majority has decided otherwise. 8. Commission proposals and Council decisions pursuant to paragraph 7 shall be published for information in the Official Journal of the European Communities. Article 4 1. Member States may provide that the exclusive rights conferred in conformity with Article 2 shall not come into existence or shall no longer apply to the topography of a semiconductor product unless an application for registration in due form has been filed with a public authority within two years of its first commercial exploitation. Member States may require in addition to such registration that material identifying or exemplifying the topography or any combination thereof has been deposited with a public authority, as well as a statement as to the date of first commercial exploitation of the topography where it precedes the date of the applciation for registration. 2. Member States shall ensure that material deposited in conformity with paragraph 1 is not made available to the public where it is a trade secret. This provision shall be without prejudice to the disclosure of such material pursuant to an order of a court or other competent authority to persons involved in litigation concerning the validity or infringement of the excusive rights referred to in Article 2. 3. Member States may require that transfers of rights in protected topographies be registered. 4. Member States may subject registration and deposit in accordance with paragraphs 1 and 3 to the payment of fees not exceeding their administrative costs. 5. Conditions prescribing the fulfilment of additional formalities for obtaining or maintaining protection shall not be admitted. 6. Member States which require registration shall provide for legal remedies in favour of a person having the right to protection in accordance with the provisions of this Directive who can prove that another person has applied for or obtained the registration of a topography without his authorization. Article 5 1. The exclusive rights referred to in Article 2 shall include the rights to authorize or prohibit any of the following acts: (a) reproduction of a topography in so far as it is protected under Article 2 (2); (b) commercial exploitation or the importation for that purpose of a topography or of a semiconductor product manufactured by using the topography. 2. Notwithstanding paragraph 1, a Member State pay permit the reproduction of a topography privately for non commercial aims. 3. The exclusive rights referred to in paragraph 1 (a) shall not apply to reproduction for the purpose of analyzing, evaluating or teaching the concepts, processes, systems or techniques embodied in the topography or the topography itself. 4. The exclusive rights referred to in paragraph 1 shall not extend to any such act in relation to a topography meeting the requirements of Article 2 (2) and created on the basis of an analysis and evaluation of another topography, carried out in conformity with paragraph 3. 5. The exclusive rights to authorize or prohibit the acts specified in paragraph 1 (b) shall not apply to any such act committed after the topography or the semiconductor product has been put on the market in a Member State by the person entitled to authorize its marketing or with his consent. 6. A person who, when he acquires a semiconductor product, does not know, or has no reasonable grounds to believe, that the product is protected by an exclusive right conferred by a Member State in conformity with this Directive shall not be prevented from commercially exploiting that product. However, for acts committed after that person knows, or has reasonable grounds to believe, that the semiconductor product is so protected, Member States shall ensure that on the demand of the rightholder a tribunal may require, in accordance with the provisions of the national law applicable, the payment of adequate remuneration. 7. The provisions of paragraph 6 shall apply to the successors in title of the person referred to in the first sentence of that paragraph. Article 6 Member States shall not subject the exclusive rights referred to in Article 2 to licences granted, for the sole reason that a certain period of time has elapsed, automatically, and by operation of law. Article 7 1. Member States shall provide that the exclusive rights referred to in Article 2 shall come into existence: (a) where registration is the condition for the coming into existence of the exclusive rights in accordance with Article 4, on the earlier of the following dates: (i) the date when the topography is first commercially exploited anywhere in the world; (ii) the date when an application or registration has been filed in due form; or (b) when the topography is first commercially exploited anywhere in the world; or (c) when the topography is first fixed or encoded. 2. Where the exclusive rights come into existence in accordance with paragraph 1 (a) or (b), the Member States shall provide, for the period prior to those rights coming into existence, legal remedies in favour of a person having the right to protection in accordance with the provisions of this Directive who can prove that another person has fraudulently reproduced or commercially exploited or imported for that purpose a topography. This paragraph shall be without prejudice to legal remedies made available to enforce the exclusive rights conferred in conformity with Article 2. 3. The exclusive rights shall come to an end 10 years from the end of the calendar year in which the topography is first commercially exploited anywhere in the world or, where registration is a condition for the coming into existence or continuing application of the exclusive rights, 10 years from the earlier of the following dates: (a) the end of the calendar year in which the topography is first commercially exploited anywhere in the world; (b) the end of the calendar year in which the application for registration has been filed in due form. 4. Where a topography has not been commercially exploited anywhere in the world within a period of 15 years from its first fixation or encoding, any exclusive rights in existence pursuant to paragraph 1 shall come to an end and no new exclusive rights shall come into existence unless an application for registration in due form has been filed within that period in those Member States where registration is a condition for the coming into existence or continuing application of the exclusive rights. Article 8 The protection granted to the topographies of semiconductor products in accordance with Article 2 shall not extend to any concept, process, system, technique or encoded information embodied in the topography other than the topography itself. Article 9 Where the legislation of Member States provides that semiconductor products manufactured using protected topographies may carry an indication, the indication to be used shall be a capital T as follows: T, ‘T’ [T], , T* or . CHAPTER 3 Continued application of other legal provisions Article 10 1. The provisions of this Directive shall be without prejudice to legal provisions concerning patent and utility model rights. 2. The provisions of this Directive shall be without prejudice: (a) to rights conferred by the Member States in fulfilment of their obligations under international agreements, including provisions extending such rights to nationals of, or residents in, the territory of the Member State concerned; (b) to the law of copyright in Member States, restricting the reproduction of drawing or other artistic representations of topographies by copying them in two dimensions. 3. Protection granted by national law to topographies of semiconductor products fixed or encoded before the entry into force of the national provisions enacting the Directive, but no later than the date set out in Article 11 (1), shall not be affected by the provisions of this Directive. CHAPTER 4 Final provisions Article 11 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 7 November 1987. 2. Member States shall ensure that they communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 12 This Directive is addressed to the Member States.

31987L0018

1986

Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas 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 (3), as last amended by Directive 84/449/EEC (4), requires tests to be carried out on chemical substances in order to enable their potential risk to man and the environment to be determined; Whereas Directive 75/318/EEC (5) as amended by Directive 87/19/EEC (6), and Directive 81/852/EEC (7) as amended by Directive 87/20/EEC (8) lay down that non-clinical tests on pharmaceutical products shall be carried out in accordance with the principles of good laboratory practice in force in the Community for chemical substances; Whereas when the active substances in pesticides undergo tests they shall do so in accordance with the protocols provided for by Directive 67/548/EEC, and hence in accordance with good laboratory practice for chemical substances; Whereas the methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC; Whereas it is necessary to comply with the principles of good laboratory practice in carrying out the tests laid down by Directive 67/548/EEC so as to ensure that the results are comparable and of high quality; Whereas the Commission intends shortly to submit a proposal to the Council for a Directive aiming at verifying compliance with the principles of good laboratory practice; Whereas the resources devoted to the tests must not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another; Whereas the Council of the Organization for Economic Cooperation and Development (OECD) took a Decision on 12 May 1981 on the mutual acceptance of data for the evaluation of chemical products; whereas it issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with good laboratory practice; Whereas animal protection requires that the number of experiments conducted on animals be restricted; whereas mutual recognition of the results of tests obtained using standard and recognized methods is an essential condition for reducing the number of experiments in this area; Whereas it is necessary to set up a procedure allowing rapid adaptation of the principles of good laboratory practice, Article 1 1. Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice specified in Annex 2 to the Decision of 12 May 1981 of the Council of the OECD on the mutual acceptance of data for the evaluation of chemical products. 2. Paragraph 1 shall apply also where other Community provisions provide for the application of the principles of good laboratory practice in respect of tests on chemical products to evaluate their safety for man and/or the environment. Article 2 When submitting results, the laboratories referred to in Article 1 must certify that the tests have been carried out in conformity with the principles of good laboratory practice referred to in that Article. Article 3 1. Member States shall adopt the measures necessary for verification of compliance with the principles of good laboratory practice. These measures shall include, in particular, inspections and study checks in accordance with the recommendations of the OECD in this area. 2. Member States shall notify to the Commission the name or names of the authority or authorities responsible for verifying compliance with the principles of good laboratory practice, as referred to in paragraph 1. The Commission shall inform the other Member States thereof. Article 4 Adaptations to the principles of good laboratory practice mentioned in Article 1 may be adopted in accordance with the procedure laid down in Article 21 of Directive 67/548/EEC. Article 5 1. Where Community provisions require application of the principles of good laboratory practice following the entry into force of this Directive for tests on chemical products, Member States may not, on grounds relating to the principles of good laboratory practice, prohibit, restrict or impede the placing on the market of chemical products if the principles applied by the laboratories concerned are in conformity with those mentioned in Article 1. 2. Should a Member State establish on the basis of detailed evidence that the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man and the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that substance on its territory. It shall immediately inform the Commission and the other Member States thereof and give the grounds for its decision. The Commission shall, within six weeks, consult the Member States concerned and then give its opinion and take suitable measures without delay. Should the Commission consider that technical adaptations to this Directive are necessary, those adaptations shall be adopted either by the Commission or by the Council in accordance with the procedure laid down in Article 4. In that case, the Member State which adopted the safeguard measures may maintain them until entry into force of those adaptations. Article 6 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1988. They shall forthwith inform the Commission thereof. Article 7 This Directive is addressed to the Member States.

31986L0653

1986

COUNCIL DIRECTIVE of 18 December 1986 on the coordination of the laws of the Member States relating to self-employed commercial agents (86/653/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57 (2) and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the restrictions on the freedom of establishment and the freedom to provide services in respect of activities of intermediaries in commerce, industry and small craft industries were abolished by Directive 64/224/EEC (4); Whereas the differences in national laws concerning commercial representation substantially affect the conditions of competition and the carrying-on of that activity within the Community and are detrimental both to the protection available to commercial agents vis-à-vis their principals and to the security of commercial transactions; whereas moreover those differences are such as to inhibit substantially the conclusion and operation of commercial representation contracts where principal and commercial agent are established in different Member States; Whereas trade in goods between Member States should be carried on under conditions which are similar to those of a single market, and this necessitates approximation of the legal systems of the Member States to the extent required for the proper functioning of the common market; whereas in this regard the rules concerning conflict of laws do not, in the matter of commercial representation, remove the inconsistencies referred to above, nor would they even if they were made uniform, and accordingly the proposed harmonization is necessary notwithstanding the existence of those rules; Whereas in this regard the legal relationship between commercial agent and principal must be given priority; Whereas it is appropriate to be guided by the principles of Article 117 of the Treaty and to maintain improvements already made, when harmonizing the laws of the Member States relating to commercial agents; Whereas additional transitional periods should be allowed for certain Member States which have to make a particular effort to adapt their regulations, especially those concerning indemnity for termination of contract between the principal and the commercial agent, to the requirements of this Directive, CHAPTER I Scope Article 1 1. The harmonization measures prescribed by this Directive shall apply to the laws, regulations and administrative provisions of the Member States governing the relations between commercial agents and their principals. 2. For the purposes of this Directive, ‘commercial agent’ shall mean a self-employed intermediary who has continuing authority to negotiate the sale or the purchase of goods on behalf of another person, hereinafter called the ‘principal’, or to negotiate and conclude such transactions on behalf of and in the name of that principal. 3. A commercial agent shall be understood within the meaning of this Directive as not including in particular: — a person who, in his capacity as an officer, is empowered to enter into commitments binding on a company or association, — a partner who is lawfully authorized to enter into commitments binding on his partners, — a receiver, a receiver and manager, a liquidator or a trustee in bankruptcy. Article 2 1. This Directive shall not apply to: — commercial agents whose activities are unpaid, — commercial agents when they operate on commodity exchanges or in the commodity market, or — the body known as the Crown Agents for Overseas Governments and Administrations, as set up under the Crown Agents Act 1979 in the United Kingdom, or its subsidiaries. 2. Each of the Member States shall have the right to provide that the Directive shall not apply to those persons whose activities as commercial agents are considered secondary by the law of that Member State. CHAPTER II Rights and obligations Article 3 1. In performing has activities a commercial agent must look after his principal's interests and act dutifully and in good faith. 2. In particular, a commercial agent must: (a) make proper efforts to negotiate and, where appropriate, conclude the transactions he is instructed to take care of; (b) communicate to his principal all the necessary information available to him; (c) comply with reasonable instructions given by his principal. Article 4 1. In his relations with his commercial agent a principal must act dutifully and in good faith. 2. A principal must in particular: (a) provide his commercial agent with the necessary documentation relating to the goods concerned; (b) obtain for his commercial agent the information necessary for the performance of the agency contract, and in particular notify the commercial agent within a reasonable period once he anticipates that the volume of commercial transactions will be significantly lower than that which the commercial agent could normally have expected. 3. A principal must, in addition, inform the commercial agent within a reasonable period of his acceptance, refusal, and of any non-execution of a commercial transaction which the commercial agent has procured for the principal. Article 5 The parties may not derogate from the provisions of Articles 3 and 4. CHAPTER III Remuneration Article 6 1. In the absence of any agreement on this matter between the parties, and without prejudice to the application of the compulsory provisions of the Member States concerning the level of remuneration, a commercial agent shall be entitled to the remuneration that commercial agents appointed for the goods forming the subject of his agency contract are customarily allowed in the place where he carries on his activities. If there is no such customary practice a commercial agent shall be entitled to reasonable remuneration taking into account all the aspects of the transaction. 2. Any part of the remuneration which varies with the number or value of business transactions shall be deemed to be commission within the meaning of this Directive. 3. Articles 7 to 12 shall not apply if the commercial agent is not remunerated wholly or in part by commission. Article 7 1. A commercial agent shall be entitled to commission on commercial transactions concluded during the period covered by the agency contract: (a) where the transaction has been concluded as a result of his action; or (b) where the transaction is concluded with a third party whom he has previously acquired as a customer for transactions of the same kind. 2. A commercial agent shall also be entitled to commission on transactions concluded during the period covered by the agency contract: — either where he is entrusted with a specific geographical area or group of customers, — or where he has an exclusive right to a specific geographical area or group of customers, and where the transaction has been entered into with a customer belonging to that area or group. Member States shall include in their legislation one of the possibilities referred to in the above two indents. Article 8 A commercial agent shall be entitled to commission on commercial transactions concluded after the agency contract has terminated: (a) if the transaction is mainly attributable to the commercial agent's efforts during the period covered by the agency contract and if the transaction was entered into within a reasonable period after that contract terminated; or (b) if, in accordance with the conditions mentioned in Article 7, the order of the third party reached the principal or the commercial agent before the agency contract terminated. Article 9 A commercial agent shall not be entitled to the commission referred to in Article 7, if that commission is payable, pursuant to Article 8, to the previous commercial agent, unless it is equitable because of the circumstances for the commission to be shared between the commercial agents. Article 10 1. The commission shall become due as soon as and to the extent that one of the following circumstances obtains: (a) the principal has executed the transaction; or (b) the principal should, according to his agreement with the third party, have executed the transaction; or (c) the third party has executed the transaction. 2. The commission shall become due at the latest when the third party has executed his part of the transaction or should have done so if the principal had executed his part of the transaction, as he should have. 3. The commission shall be paid not later than on the last day of the month following the quarter in which it became due. 4. Agreements to derogate from paragraphs 2 and 3 to the detriment of the commercial agent shall not be permitted. Article 11 1. The right to commission can be extinguished only if and to the extent that: — it is established that the contract between the third party and the principal will not be executed, and — that face is due to a reason for which the principal is not to blame. 2. Any commission which the commercial agent has already received shall be refunded if the right to it is extinguished. 3. Agreements to derogate from paragraph 1 to the detriment of the commercial agent shall not be permitted. Article 12 1. The principal shall supply his commercial agent with a statement of the commission due, not later than the last day of the month following the quarter in which the commission has become due. This statement shall set out the main components used in calculating the amount of commission. 2. A commercial agent shall be entitled to demand that he be provided with all the information, and in particular an extract from the books, which is available to his principal and which he needs in order to check the amount of the commission due to him. 3. Agreements to derogate from paragraphs 1 and 2 to the detriment of the commercial agent shall not be permitted. 4. This Directive shall not conflict with the internal provisions of Member States which recognize the right of a commercial agent to inspect a principal's books. CHAPTER IV Conclusion and termination of the agency contract Article 13 1. Each party shall be entitled to receive from the other on request a signed written document setting out the terms of the agency contract including any terms subsequently agreed. Waiver of this right shall not be permitted. 2. Notwithstanding paragraph 1 a Member State may provide that an agency contract shall not be valid unless evidenced in writing. Article 14 An agency contract for a fixed period which continues to be performed by both parties after that period has expired shall be deemed to be converted into an agency contract for an indefinite period. Article 15 1. Where an agency contract is concluded for an indefinite period either party may terminate it by notice. 2. The period of notice shall be one month for the first year of the contract, two months for the second year commenced, and three months for the third year commenced and subsequent years. The parties may not agree on shorter periods of notice. 3. Member States may fix the period of notice at four months for the fourth year of the contract, five months for the fifth year and six months for the sixth and subsequent years. They may decide that the parties may not agree to shorter periods. 4. If the parties agree on longer periods than those laid down in paragraphs 2 and 3, the period of notice to be observed by the principal must not be shorter than that to be observed by the commercial agent. 5. Unless otherwise agreed by the parties, the end of the period of notice must coincide with the end of a calendar month. 6. The provisions of this Article shall apply to an agency contract for a fixed period where it is converted under Article 14 into an agency contract for an indefinite period, subject to the proviso that the earlier fixed period must be taken into account in the calculation of the period of notice. Article 16 Nothing in this Directive shall affect the application of the law of the Member States where the latter provides for the immediate termination of the agency contract: (a) because of the failure of one party to carry out all or part of his obligations; (b) where exceptional circumstances arise. Article 17 1. Member States shall take the measures necessary to ensure that the commercial agent is, after termination of the agency contract, indemnified in accordance with paragraph 2 or compensated for damage in accordance with paragraph 3. 2. (a) The commercial agent shall be entitled to an indemnity if and to the extent that: — he has brought the principal new customers or has significantly increased the volume of business with existing customers and the principal continues to derive substantial benefits from the business with such customers, and — the payment of this indemnity is equitable having regard to all the circumstances and, in particular, the commission lost by the commercial agent on the business transacted with such customers. Member States may provide for such circumstances also to include the application or otherwise of a restraint of trade clause, within the meaning of Article 20; (b) The amount of the indemnity may not exceed a figure equivalent to an indemnity for one year calculated from the commercial agent's average annual remuneration over the preceding five years and if the contract goes back less than five years the indemnity shall be calculated on the average for the period in question; (c) The grant of such an indemnity shall not prevent the commercial agent from seeking damages. 3. The commercial agent shall be entitled to compensation for the damage he suffers as a result of the termination of his relations with the principal. Such damage shall be deemed to occur particularly when the termination takes place in circumstances: — depriving the commercial agent of the commission which proper performance of the agency contract would have procured him whilst providing the principal with substantial benefits linked to the commercial agent's activities, — and/or which have not enabled the commercial agent to amortize the costs and expenses that he had incurred for the performance of the agency contract on the principal's advice. 4. Entitlement to the indemnity as provided for in paragraph 2 or to compensation for damage as provided for under paragraph 3, shall also arise where the agency contract is terminated as a result of the commercial agent's death. 5. The commercial agent shall lose his entitlement to the indemnity in the instances provided for in paragraph 2 or to compensation for damage in the instances provided for in paragraph 3, if within one year following termination of the contract he has not notified the principal that he intends pursuing his entitlement. 6. The Commission shall submit to the Council, within eight years following the date of notification of this Directive, a report on the implementation of this Article, and shall if necessary submit to it proposals for amendments. Article 18 The indemnity or compensation referred to in Article 17 shall not be payable: (a) where the principal has terminated the agency contract because of default attributable to the commercial agent which would justify immediate termination of the agency contract under national law; (b) where the commercial agent has terminated the agency contract, unless such termination is justified by circumstances attributable to the principal or on grounds of age, infirmity or illness of the commercial agent in consequence of which he cannot reasonably be required to continue his activities; (c) where, with the agreement of the principal, the commercial agent assigns his rights and duties under the agency contract to another person. Article 19 The parties may not derogate from Articles 17 and 18 to the detriment of the commercial agent before the agency contract expires. Article 20 1. For the purposes of this Directive, an agreement restricting the business activities of a commercial agent following termination of the agency contract is hereinafter referred to as a restraint of trade clause. 2. A restraint of trade clause shall be valid only if and to the extent that: (a) it is concluded in writing; and (b) it relates to the geographical area or the group of customers and the geographical area entrusted to the commercial agent and to the kind of goods covered by his agency under the contract. 3. A restraint of trade clause shall be valid for not more than two years after termination of the agency contract. 4. This Article shall not affect provisions of national law which impose other restrictions on the validity or enforceability of restraint of trade clauses or which enable the courts to reduce the obligations on the parties resulting from such an agreement. CHAPTER V General and final provisions Article 21 Nothing in this Directive shall require a Member State to provide for the disclosure of information where such disclosure would be contrary to public policy. Article 22 1. Member States shall bring into force the provisions necessary to comply with this Directive before 1 January 1990. They shall forthwith inform the Commission thereof. Such provisions shall apply at least to contracts concluded after their entry into force. They shall apply to contracts in operation by 1 January 1994 at the latest. 2. As from the notification of this Directive, Member States shall communicate to the Commission the main laws, regulations and administrative provisions which they adopt in the field governed by this Directive. 3. However, with regard to Ireland and the United Kingdom, 1 January 1990 referred to in paragraph 1 shall be replaced by 1 January 1994. With regard to Italy, 1 January 1990 shall be replaced by 1 January 1993 in the case of the obligations deriving from Article 17. Article 23 This Directive is addressed to the Member States.

31987L0056

1986

Council Directive 87/56/EEC of 18 December 1986 amending Directive 78/1015/EEC on the approximation of the laws of the Member States relating to the permissible sound level and exhaust system of motorcycles Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Annex I to Directive 78/1015/EEC (1) defines limits for the sound level of motorcycles; whereas Article 8 of that Directive states that the Council shall, on a proposal from the Commission, decide on a reduction in the maximum permissible sound levels provided for in the said Annex I; Whereas, when Directive 78/1015/EEC was adopted, emphasis was given to the fact that it costituted a step towards the improvement of the environment, that the technical development of less noisy motorcycles should be further encouraged that the limit values prescribed at the time should be reduced to approximately 80 dB (A) before 1985, particularly in the case of more powerful motorcycles, and that the levels to be fixed should take account of the technical resources which would be available at that date; Whereas the protection of the population in urban environments against acoustic nuisance calls for suitable measures to reduce the sound level of motorcycles; whereas such a reduction should be made possible by the technical progress achieved or to be promoted in the manufacture of these types of vehicle; Whereas, to this end, Directive 78/1015/EEC should be amended in order to make the prescribed method of measurement more representative of the conditions of actual use of motorcycles in urban traffic, to reduce the number of categories of motorcycle in view of the different methodology and to reduce the differences in the treatment of these categores; whereas the definition of sound level limit values for each of these new categories of motorcycle will lead to an effective reduction in the level of sound at present emitted by these types of vehicle; whereas this reduction should be put into effect in two stages in order to give manufacturers sufficient time to improve their products; Whereas these reductions constitute an important step towards the improvement of the environment, Article 1 Annex I to Directive 78/1015/EEC shall be amended in accordance with the Annex hereto. Article 2 1. From 1 October 1988: - in those Member States where motorcycles or certain categories of motorcycles are subject to national type-approval, that approval shall be based on the harmonized technical requirements of Directive 78/1015/EEC, instead of the corresponding national requirements, if the manufacturer or his authorized representative so requests, - no Member State where motorcycles or certain categories of motorcycles are not subject to national type-approval may refuse the registeration, or prohibit the sale, entry into service or use of such motorcycles on the grounds that the harmonized technical provisions of Directive 78/1015/EEC have been complied with instead of the corresponding national requirements. 2. As from the dates laid down in the table contained in section 2.1.1 of Annex I for obtaining national type-approval of the three categories of motorcycle: - Member States may no longer issue the certificate referred to in the second subparagraph of Article 3 (1) of Directive 78/1015/EEC in respect of a type of motorcycle the sound level and exhaust system of which do not comply with Directive 78/1015/EEC, - Member States may refuse to grant national type-approval for a type of motorcycle the sound level and exhaust system of which do not comply with Directive 78/1015/EEC. 3. Two years after the dates referred to in paragraph 2, Member States may prohibit the initial entry into service of motorcycles the sound level and exhaust system of which do not comply with the said Directive. This time limit shall, however, be reduced to one year for each new motorcycle of category 2 as regards compliance with the limit value laid down for the first stage. Article 3 By 1 October 1988, Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply such provisions with effect from 1 October 1988. Article 4 This Directive is addressed to the Member States.

31986L0651

1986

Council Directive 86/651/EEC of 18 December 1986 amending, consequent on the accession of Spain and Portugal, Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products Having regard to the Act of Accession of Spain and Portugal, and in particular Article 396 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Whereas by means of Directive 77/93/EEC (2), as last amended by Regulation (EEC) N° 3768/85 (3), the Council has established a system for the protection against the introduction into the Member States of organisms harmful to plants or plant products; Whereas, in accordance with the conclusion of the Conference on the accession of Spain and Portugal to the European Communities, it is necessary to take account of the ecological conditions and of the plant health situation which characterize the territories of those States and the territories of the other Member States; Whereas protection should therefore be extended to include Spain and Portugal or particular regions of those Statesagainst certain harmful organisms affecting the Community as a whole and certain parts thereof; Whereas protection against certain other harmful organisms affecting Spain and Portugal or particular regions thereof or affecting other Member States or regions with similar ecological conditions should be extended to include the Member States or regions concerned; Whereas protection should be extended against certain plants known to bear a particular risk of carrying harmful organisms by permitting the Kingdom of Spain and the Portuguese Republic to prohibit or restrict the importation of those plants; Whereas provision should be made for a transitional period to enable those two States to take all the measures required to comply with Directive 77/93/EEC. Article 1 Directive 77/93/EEC in hereby amended as follows: 1. Article 1 (2) shall be replaced by the following: 2. This Directive shall not apply to the French overseas departments, nor to the Canary Islands, Ceuta or Melilla.' 2. The following paragraph shall be added to Article 20: 2. The Kingdom of Spain and the Portuguese Republic shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 1987 at the latest. The other Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive in respect of Spain and Portugal on the same date at the latest.' 3. Annex I is hereby amended as follows: (a) The following items in part A (a) shall be deleted: 9. Rhagoletis cingulata (Loew) (1) OJ N° C 68, 24. 3. 1986, p. 166. (2) OJ N° L 26, 31. 1. 1977, p. 20. (3) OJ N° L 362, 31. 12. 1985, p. 8. 10. Rhagoletis fausta (Osten Sacken) 11. Rhagoletis pomonella (Walsh); (b) The following item shall be added to part A (a): 17. Trypetidae (non-European): (a) Rhagoletis cingulata (Loew), (b) Rhagoletis completa Cress, (c) Rhagoletis fausta (Osten Sacken), (d) Rhagoletis pomonella (Walsh), (e) Anastrepha fraterculus (Wied.), (f) Anastrepha ludens (Loew), (g) Anastrepha mombinpraeoptans, (h) Ceratitis rosa Karsch, (i) Dacus cucurbitae Coq, (j) Dacus dorsalis Hendel, (k) Other harmful Trypetidae in so far as they do not exist in Europe.'; (c) The following items in part B (a) shall be deleted: 2. Anastrepha fraterculus (Wied) 3. Anastrepha ludens (Loew) 5. Dacus dorsalis Hendel; (d) In part B (a), 1, 6, 7, 8, 11, 12, 14 and 15, 'Spain, Portugal' shall be added in the right hand column; (e) In part B (a), 10, 'Spain (Minorca and Ibiza) and Portugal (Azores and Madeira)' shall be added in the right hand column; (f) In part (B (a), 10a, 'Portugal' shall be added in the right hand column; (g) In part B (b), 'Spain, Portugal' shall be added in the right hand column; (h) In part B (c), 1 to 5a, 'Spain, Portugal' shall be added in the right hand column; (i) In part B (d), 'Spain, Portugal' shall be added in the right hand column. 4. Annex II is hereby amended as follows: (a) In part A (a), 10, 'Viteus vitifolii (Fitch)' shall be replaced by 'Dactulosphaira vitifoliae (Fitch)'; (b) In part B (a) the following item shall be added: 11 a. Thaumetopoea pityocampa Schiff.Plants of Pinus L., other than fruit and seedsSpain, (Ibiza)' (c) In part B (a), 2, 10a and 12, 'Spain' shall be added in the right hand column; (d) In part B (a), 1, 6, 7, 8, 10, 10a and 12, 'Portugal' shall be added in the right hand column; (e) In part B (b), 1, 'Spain, Portugal' shall be added in the right hand column; (f) In part B (b), 2, 'Spain, France, Italy, Portugal' shall be added in the right hand column; (g) In part B (c), 1, 2, 4, 4a, 5 and 6, 'Spain' shall be added in the right hand column; (h) In part B (c), 1, 2, 4, 5 and 6, 'Portugal' shall be added in the right hand column; (i) In part B (c) the following item shall be added: '6. (a) Phytophthora cinnamomi RandsAvocado (Persea Mill.), other than fruitGreece (Crete), Spain, Italy (Sicily and Calabria), Portugal (Algarve)' 5. Annex III is hereby amended as follows: (a) In part B, 1, 2, 9 and 10, 'Spain, Portugal' shall be added to the right hand column; (b) In part B the following item shall be added: 6 a Isolated Eucalayptus barkGreece, Spain, France, Italy, Portugal' 6. Annex IV is hereby amended as follows: (a) In part B, 7a: - 'Spain' shall be added in the second column in part A, 1 and in the third column after 'Greece', - 'Portugal' shall be added in the second column in part A, 1 after 'Italy' and in the third column after 'Luxembourg'; (b) In part B, 8, 'Fortunella and Poncirus' shall be inserted after 'citrus' in the left hand column and 'Spain, Portugal' shall be added in the right hand column; (c) In part B, 9 and 14, 'Spain, (Minorca and Ibiza), Portugal (Azores and Madeira)' shall be added in the third column; (d) In part B, 17, 'Spain, France, Italy, Portugal' shall be added in the right hand column; (e) In part B, 18, 'Spain' shall be added in the third column; (f) In part B the following items shall be added: 3 a. Wood of EucalyptusThe wood shall be treated by the appropriate procedure prior to shipment or shall be stripped of its bark and originate in a region free from Phoracantha spp.Greece, Spain, France, Italy, Portugal 5 a. Plants of Pinus, other than fruit and seedOfficial statement that plants originate in regions free from Thaumetopoea pityocampaSpain (Ibiza)' Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 1 March 1987 at the latest. Article 3 This Directive is addressed to the Member States.

31987L0101

1986

Council Directive 87/101/EEC of 22 December 1986 amending Directive 75/439/EEC on the disposal of waste oils Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 75/439/EEC (4) provides that Member States shall take the necessary measures to ensure the safe collection and disposal of waste oils and to ensure that, as far as possible, the disposal of waste oils is carried out by recycling (regeneration and/or combustion other than for destruction); Whereas regeneration is generally the most rational way of re-using waste oils in view of the energy savings which can be achieved; whereas therefore, priority should be given to the processing of waste oils by regeneration, where technical, economic and organizational constraints allow it; Whereas, in the present state of Community law, Member States may, under certain conditions, ban the combustion of waste oils on their territory; whereas this Directive is not intended to change this state of law; Whereas the burning of waste oil generates waste gases containing substances which are harmful to the environment when emitted above certain concentration; whereas measures laying down arrangements for burning waste oils should, therefore, be taken; Whereas it is desirable to improve the efficiency of waste oil collection and to tighten up monitoring in this area; Whereas, in view of the particularly dangerous character of PCB/PCTs, it is necessary to strengthen Community law concerning the combustion or the regeneration of waste oils contaminated by these substances; Whereas Member States should have the possibility, whilst respecting the conditions of the Treaty, to take more stringent measures for the purpose of environmental protection, Article 1 Directive 75/439/EEC is hereby amended as follows: 1. Articles 1 to 6 shall be replaced by the following: 'Article 1 For the purposes of this Directive: - "waste oils" means: any mineral-based lubrication or industrial oils which have become unfit for the use for which they were originally intended, and in particular used combustion engine oils and gearbox oils, and also mineral lubricating oils, oils for turbines and hydraulic oils; - "disposal" means: the processing or destruction of waste oils as well as their storage and tipping above or under ground; - "processing" means: operations designed to permit the re-use of waste oils, that is to say, regeneration and combustion; - "regeneration" means: any process whereby base oils can be produced by refining waste oils, in particular by removing the contaminants, oxidation products and additives contained in such oils; - "combustion" means: the use of waste oils as fuel with the heat produced being adequately recovered; - "collection" means: all operations whereby waste oils can be transferred from the holders to undertakings which dispose of such oils.'. Article 2 Without prejudice to the provisions of Directive 78/319/EEC (1), Member States shall take the necessary measures to ensure that waste oils are collected and disposed of without causing any avoidable damage to man and the environment. (1) OJ No L 84, 31. 3. 1973, p. 43. Article 3 1. Where technical, economic and organizational constraints so allow, Member States shall take the measures necessary to give priority to the processing of waste oils by regeneration. 2. Where waste oils are not regenerated, on account of the constraints mentioned in paragraph 1 above, Member States shall take the measures necessary to ensure that any combustion of waste oils is carried out under environmentally acceptable conditions, in accordance with the provisions of this Directive, provided that such combustion is technically, economically and organizationally feasible. 3. Where waste oils are neither regenerated nor burned, on account of the constraints mentioned in paragraphs 1 and 2, Member States shall take the measures necessary to ensure their safe destruction or their controlled storage or tipping. Article 4 Member States shall take the necessary measures to ensure the prohibition of: (a) any discharge of waste oils into inland surface water, ground water, territorial sea water and drainage systems; (b) any deposit and/or discharge of waste oils harmful to the soil and any uncontrolled discharge of residues resulting from the processing of waste oils; (c) any processing of waste oils causing air pollution which exceeds the level prescribed by existing provisions. Article 5 1. Where necessary in order to achieve the objectives of this Directive and without prejudice to the provisions of Article 2, Member States shall carry out public information and promotional campaigns to ensure that waste oils are stored appropriately and collected as far as possible. 2. Where the objectives defined in Articles 2, 3 and 4 cannot otherwise be achieved, Member States shall take the necessary measures to ensure that one or more undertakings carry out the collection and/or disposal of waste oils offered to them by holders, where appropriate in the area assigned to them by the competent authorities. 3. To achieve the objectives defined in Articles 2 and 4, Member States may decide to allocate the waste oils to any of the types of processing set out in Article 3. To this end, they may institute appropriate checks. 4. To ensure compliance with the measures taken pursuant to Article 4, any undertaking which collects waste oils must be subject to registration and adequate supervision by the competent national authorities, possibly inclusing a system of permits. Article 6 1. In order to comply with the measures taken pursuant to Article 4, any undertaking which disposes of waste oils must obtain a permit. Where necessary, this permit shall be granted after examination of the installations. 2. Without prejudice to the requirements laid down by national and Community provisions with a purpose other than that of this Directive, a permit may be granted to undertakings which regenerate waste oils or use waste oils as fuel only where the competent authority has satisfied itself that all appropriate environmental and health protection measures have been taken, including use of the best technology available, where the cost is not excessive. Article 7 Where waste oils are regenerated, Member States shall take the measures necessary to ensure that: (a) the operation of the regeneration plant will not cause avoidable damage to the environment. To this end, the Member States shall ensure that the risks associated with the quantity of residues of regeneration and with the toxic and dangerous character of such residues are reduced to a minimum and that the residues are disposed of in accordance with Article 9 of Directive 78/319/EEC; (b) the base oils derived from regeneration do not constitute a toxic and dangerous waste as defined in Article 1 (b) of Directive 78/319/EEC and do not contain polychlorinated biphenyls and polychlorinated tophenyls (PCB/PCT) in concentrations beyond the limits laid down in Article 10. Member States shall inform the Commission of these measures. On the basis of this information, the Commission shall, within five years of the date of notification of this Directive, submit a report to the Council, accompanied if necessary by appropriate proposals. Article 8 1. Without prejudice to the provisions of Directive 84/360/EEC (1) and Article 3 (1) of this Directive, where waste oils are used as fuel, Member States shall take the measures necessary to ensure that operation of the plant will not cause any significant level of air pollution, in particular by the emission of substances listed in the Annex. To this end: (a) Member States shall satisfy themselves that in the case of the combustion of oils in plants with a thermal input of 3 MW or more based on the lower heating value (LHV), the emission limit values set in that Annex are being observed. Member States may at any time set limit values more stringent than those given in the Annex. They may also set limit values for substances and parameters other than those listed in the Annex; (b) Member States shall take such measures as they consider necessary to ensure that combustion of waste oils in plants with a thermal input of less than 3 MW based on the lower heating value (LHV) is subject to adequate control. They shall inform the Commission of these measures. On the basis of this information the Commission shall, within five years of the date of notification of this Directive, submit a report to the Council, accompanied if necessary by appropriate proposals. 2. The Member States shall further ensure that: (a) the residues from the combustion of waste oils are disposed of in accordance with Article 9 of Directive 78/319/EEC; (b) the waste oils used as fuel do not constitute a toxic and dangerous waste as defined in Article 1 (b) of Directive 78/319/EEC and do not contain PCB/PCT in concentrations beyond 50 ppm; 3. Observance of the limit values set out in the Annex may alternatively be ensured by means of an appropriate system of control of concentrations of pollutants in waste oils, or mixtures of waste oils and other fuels, intended for combustion taking account of the technical characteristics of the plant. In the case of plants where emissions of substances listed in the Annex may arise additionally from heating products, Member States shall ensure, through an established control system, that the proportion of these substances arising from the combustion of waste oils does not exceed the limit values fixed in the Annex. (1) OJ No L 188, 16. 7. 1984, p. 10' 2. Article 7 becomes Article 9. 3. Articles 8 and 9 are deleted. 4. A new Article 10 is inserted to read as follows: 'Article 10 1. During storage and collection, holders and collectors must not mix waste oils with PCBs and PCTs within the meaning of Directive 76/403/EEC (1) nor with toxic and dangerous waste within the meaning of Directive 78/319/EEC. 2. Except as provided for in paragraph 3, the provisions of Directive 76/403/EEC shall apply to waste oils containing more than 50 ppm of PCB/PCT. Member States shall further take such special technical measures as are necessary to ensure that any waste oils containing PCB/PCT's are disposed of without any avoidable damage to man and the environment. 3. The regeneration of waste oils containing PCBs or PCTs may be permitted if the regeneration processes make it possible either to destroy the PCBs and PCTs or to reduce them so that the regenerated oils do not contain PCB/PCT beyond a maximum limit which in no case may exceed 50 ppm. 4. The reference method of measurement to determine the PCB/PCT content of waste oils shall be fixed by the Commission after consultation of the Committee for adaptation to technical progress established under Article 18 of Directive 78/319/EEC. 5. Waste oils contaminated by substances which fall within the definition of toxic and dangerous waste as laid down in Article 1 (b) of Directive 78/319/EEC shall be disposed of in accordance with the provisions of that Directive. (1) OJ No L 108, 26. 4. 1976, p. 41.' 5. Article 10 becomes Article 11. 6. Article 11 becomes Article 12, and is amended to read as follows: 'Article 12 Any undertaking which collects, holds and/or disposes of waste oils must convey to the competent authorities, at their request, any information concerning the collection and/or disposal of waste oils or their residues.'. 7. Article 12 becomes Article 13 and is amended to read as follows: 'Article 13 1. The undertakings referred to in Article 6 shall be inspected periodically by the Member States, particularly as regards their compliance with the conditions of their permits. 2. The competent authorities shall examine trends in the state of technical development and/or of the environment with a view to revising, where necessary, permits granted to undertakings in accordance with this Directive.'. 8. Articles 13 and 14 become Articles 14 and 15 respectively. 9. A new Article 16 is added to read as follows: 'Article 16 Member States may, whilst respecting the provisions of the Treaty, take measures for the purpose of environmental protection which are more stringent than those provided for in this Directive. Such measures may, under the same provisions, include inter alia the prohibition of the combustion of waste oils.'. 10. Articles 15 and 16 become Articles 17 and 18 respectively. 11. The Annex to this Directive shall be added. Article 2 Member States shall take the measures necessary to comply with this Directive with effect from 1 January 1990 and shall forthwith inform the Commission thereof. Article 3 The measures adopted by Member States pursuant to this Directive may be progressively applied to the undertakings referred to in Article 6 of Directive 75/439/EEC existing at the time of notification of this Directive, within seven years of the said notification (1). Article 4 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 5 This Directive is addressed to the Member States.

31986L0662

1986

Council Directive 86/662/EEC of 22 December 1986 on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator- loaders Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas the 1973(4) and 1977(5) action programmes of the European Communities on the environment highlight the importance of the problem of noise nuisance and, in particular, the need for action to regulate the worst noise sources; Whereas, during the Council meeting of 18 and 19 December 1978, the Ministers for the Environment declared that the technical requirements relating to the measurement of noise at the operator's position would have to be included in the Annexes to the special Directives on each type of equipment under consideration; Whereas the disparity between the provisions applicable in the various Member States concerning the limitation of the sound emission level of hydraulic and rope-operated excavators and of dozers and excavator-loaders directly affects the functioning of the common market; whereas it is therefore appropriate to carry out in this field the approximation of laws for which Article 100 of the Treaty provides; Whereas Council Directive 84/532/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to common provisions for construction plant and equipment(6) laid down, inter alia, the procedures for EEC type-approval verification; whereas it is necessary, pursuant to that Directive, to prescribe the harmonized requirements which each category of equipment must satisfy; Whereas Council Directive 79/113/EEC of 19 December 1978 on the approximation of the laws of the Member States relating to the determination of the noise emission of construction plant and equipment(7), as amended by Directive 81/1051/EEC(8), laid down the method which should be used for establishing the acoustic criteria for hydraulic and rope-operated excavators and for dozers, loaders and excavator-loaders; Whereas, owing to the effect of the noise emitted by hydraulic and rope-operated excavators and by dozers, loaders and excavator-loaders on the environment and, more particularly, on human well-being and health, it is necessary to bring about a progressive and appreciable reduction in the permissible sound emission level of hydraulic and rope-operated excavators and of dozers, loaders and excavator loaders; Whereas it is appropriate to set a sound emission level applicable when this Directive comes into force and to make these provisions more stringent on a gradual basis; Whereas it is appropriate to publish, for information purposes, the sound-power level and the sound-pressure level at the operator's position; Whereas the technical provisions must be supplemented and rapidly adapted to technical progress; whereas, to this end, provision should be made for application of the procedure defined in Article 5 of Directive 79/113/EEC, Article 1 1. This Directive shall apply to the sound-power level of airborne noise emitted in the environment and the sound-pressure level of airborne noise emitted at the operator's position of hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders, hereinafter referred to as 'earth-moving machines', used to perform work on civil-engineering and building sites. 2. This is a separate Directive within the meaning of Article 3 (2) of Council Directive 84/532/EEC, hereinafter referred to as the 'framework Directive'. Article 2 For the purposes of this Directive: 2.1.Hydraulic or rope-operated excavators means machines combining a self-propelled undercarriage with an upper structure which can swivel through more than 360°. The machine excavates, lifts, carries and dumps material by moving either a boom, an arm and bucket (as is the case with a face shovel or a backhoe) or a bucket controlled by the winding-gear (as is the case with a drag-line or a clamshell). 2.2.Dozers means self-propelled wheeled or crawler machines fitted in front with a blade which serves primarily to displace or spread materials. 2.3.Loaders means self-propelled wheeled or crawler machines fitted in front with a bucket. The machine loads, raises, transports and dumps material by combining its own movements and those of the bucket. 2.4.Excavator-loaders means self-propelled wheeled or crawler machines, designed to be fitted with a loading bucket at the front and an excavating arm at the rear as original equipment. The loading bucket loads, raises, transports and dumps material by combining its own movements with those of the machine. The excavating arm excavates, raises and dumps material by movements of the boom, arm and bucket. Article 3 1. The approved bodies shall issue an EEC type- examination certificate for every type of earth-moving machine referred to in Article 1 (1): (a)during a six-year period from the date on which the Directive enters into force, where the sound-power level of airborne noise emitted in the environment measured under the conditions of stationary operation set out in Annex I to Directive 79/113/EEC, as supplemented by Annex I to this Directive, does not exceed the permissible level specified with reference to the net installed power in the following table: >TABLE> (b)after expiry of the abovementioned six-year period, where the sound-power level of airborne noise emitted into the environment measured under the conditions of real dynamic operation laid down in Annex I to Directive 79/113/EEC, as supplemented by Annex II to this Directive, does not exceed the permissible level determined pursuant to Article 7. 2. All applications for an EEC type-examination certificate in respect of the permissible sound-power levels of a type of earth-moving machine shall be accompanied by an information document conforming to the model shown in Annex IV. 3. For each type of earth-moving machine it certifies, the approved body shall complete all the sections of the type-examination certificate conforming to the model given in Annex III to the framework Directive. 4. The period of validity of EEC type-examination certificates shall be limited to six years. However, the certificate granted in accordance with the provisions of paragraph 1 (a) shall cease to be valid after a period of seven years has elapsed from the date the Directive entered into force. The conditions for renewing certificates granted shall be determined pursuant to Article 7. 6. For every earth-moving machine built in conformity with the type certified by EEC type-examination, the manufacturer shall complete a certificate of conformity conforming to the model given in Annex IV to the framework Directive and shall indicate thereon the net installed power and the corresponding swivel system. 7. Each earth-moving machine built in accordance with the type certified by EEC type-examination shall bear a clear and permanent mark indicating the -sound-power level in dB(A) in relation to 1 pW, -sound-pressure level in dB(A) in relation to 20 ìPa at the operator's position, guaranteed by the manufacturer and determined as laid down in Annex I to Directive 79/113/EEC, as amended by Directive 81/1051/EEC and supplemented by Annex I or II and III to this Directive, together with the symbol 'aa' (epsilon). The model for these marks is given in Annex V to this Directive. Article 4 The provisions of this Directive shall not affect the Member States' entitlement to limit, with due observance of the Treaty and, in particular, Articles 30 to 36 thereof, the noise level observed at the operator's position in earth-moving machines provided that this does not entail any obligation to adjust earth-moving machines which meet the requirements of this Directive to different emission specifications within the meaning of Annex I to the Directive. Article 5 Member States may take measures to regulate the use of earth-moving machines in areas which they consider sensitive. Article 6 Checking of the conformity of production models with the type examined, as provided for in Article 12 of the framework Directive, shall be carried out using the technical procedure laid down in Annex VI. Article 7 At the earliest opportunity and at the latest 18 months after the entry into force of the Directive, the Commission will submit to the Council a proposal aimed at determining, on the basis of the measurement method to be adopted in accordance with the first indent of Article 8, the permissible sound levels referred to in Article 3 (1) (b) and also the conditions for possible extension of EEC type-examination certificates and their period of validity referred to in Article 3 (4). The permissible sound levels shall be so determined that their effect on the environment is reduced by approximately 3 dB according to the category of power and the type of machine, measured according to the stationary operation method. The Council will take a decision on the proposal, in accordance with the provisions of the Treaty, within 24 months of the date on which it was forwarded to the Council. Article 8 The following shall be adopted in accordance with the procedure laid down in Article 5 of Directive 79/113/EEC as amended by Directive 81/1051/EEC: -the real, dynamic method of measurement referred to in Annex II, -the amendments necessary to adapt the requirements of the Annexes to this Directive to technical progress. Article 9 The Council shall, in accordance with the provisions of the Treaty and within a period of 18 months, take a decision on the proposal for the reduction of permissible noise-levels which the Commission will put forward five years after the period referred to in Article 3 (1) (b) has entered into force. Article 10 Member States shall take all necessary measures to ensure that earth-moving machines as defined in Article 2 cannot be placed on the market unless they satisfy the provisions of this Directive and of the framework Directive. Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on the day following expiry of a period of 24 months from its notification(1) and shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 12 This Directive is addressed to the Member States.

31986L0663

1986

Council Directive 86/663/EEC of 22 December 1986 on the approximation of the laws of the Member States relating to self-propelled industrial trucks Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas in each Member State the design and construction of self-propelled industrial trucks are subject to safety provisions which differ from one Member State to another and consequently hinder trade in these appliances; whereas it is therefore necessary to approximate these provisions; Whereas Council Directive 84/528/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to common provisions for lifting and mechanical handling appliances(4) laid down a series of common procedures, such as EEC type-approval, EEC type-examination and EEC self-certification, for the placing on the market of these lifting and mechanical handling appliances; whereas, in the case of self-propelled industrial trucks, EEC self-certification should be provided for, as is the usual practice in the Member States; Whereas this Directive is a separate Directive within the meaning of Article 2 (2) of Directive 84/528/EEC; Whereas the technical provisions contained in Annex I do not preclude Community or national measures concerning other safety aspects of these industrial trucks such as the operator restraint system, electrical safety, traffic safety, safety when working in areas subject to explosion, exhaust emissions and noise; Whereas, in the interests of greater safety, it would appear advisable to introduce provisions relating to the controls and the fuel tank; whereas a transition period is justified in order to enable manufacturers to adapt their products to these new provisions; Whereas technical progress necessitates rapid adaptation of the technical requirements; whereas the procedure laid down in Article 22 of Directive 84/528/EEC should therefore be adopted for such adaptations of this Directive; Whereas certain provisions in Annex I should be excluded from the application of the derogating clause provided for in Article 23 of Directive 84/528/EEC; Whereas the institution of examination and testing methods is an implementing measure of a technical nature and should therefore be adopted by the Commission in accordance with the procedure referred to above, Article 1 1. This Directive shall apply to self-propelled industrial trucks, the capacity of which does not exceed 10 000 kilograms, and to tractors with a draw-bar pull of less than 20 000 newtons. 2. For the purpose of this Directive, 'self-propelled industrial truck' means any wheeled vehicle, other than those running on rails, that is designed to carry, tow, push, lift, stack or tier in racks any kind of load and is controlled by an operator who either walks with the truck or rides on a specially arranged driving platform which is either fixed to the chassis or can be raised. Article 2 1. This Directive does not cover: (a)tipper vehicles (known as dumpers) or motor-driven barrows operating on building and construction sites; (b)tractors other than those referred to in Annex I, section 1.2, lorries with or without trailer, forestry and agricultural tractors, construction plant and trucks used in underground mining operations; (c)milk floats and similar delivery vehicles; (d)stacking appliances which move only inside guides and are known as stacker cranes; (e)trucks with elevating operator position and rated load capacity exceeding 5 000 kilograms; (f)trucks specifically designed to travel with elevated loads exceeding 5 000 kilograms; (g)straddle carriers; (h)remote-controlled tractors and trucks not carrying an operator; (i)equipment used for elevated maintenance; (j)trucks powered by external forms of electrical energy; (k)mobile cranes; (l)mobile lifting platforms; (m)trucks with telescopic arms. 2. This Directive shall not preclude Community or national measures concerning the environment and other safety aspects of industrial trucks not covered by this Directive, such as: -electrical equipment for use within specific voltage limits, -road traffic, -exhaust emissions, -risks of operating in explosive atmospheres, -noise at place of work and in the environment, -operator restraint. Article 3 Member States shall take all the necessary measures to ensure that self-propelled industrial trucks covered by this Directive cannot be placed on the market or put into service unless they satisfy the provisions of this Directive. Article 4 The manufacturer or his authorized representative established in the Community shall certify on his own responsibility the conformity of each industrial truck with this Directive by means of a certificate of conformity, a specimen of which is reproduced in Annex II, and by affixing the conformity mark to the truck under the conditions laid down in Annex III. Article 5 1. The manufacturer or his authorized representative established in the Community shall issue the certificate of conformity and affix the mark of conformity as laid down in Article 4 provided he is able to show that: -he possesses the necessary means to carry out the tests referred to in Annex I, and where appropriate, -he has arranged for such tests as are referred to in Annex I which are not performed by him to be carried out by one or more of the bodies approved for that purpose by the Member State. 2. The manufacturer or his authorized representative established in the Community shall hold at the disposal of the competent bodies of the Member State all documents showing that the tests laid down in Annex I have been performed and that the technical requirements have been complied with. 3. Each Member State shall forward to the other Member States and to the Commission: -the list of approved bodies authorized to carry out the tests referred to in this Article; -any subsequent amendments to that list. Article 6 The Member State shall take all the necessary measures to ensure that the provisions of Article 5 are complied with. Article 7 The Member State may carry out spot checks to verify whether the equipment referred to in Article 1 complies with the requirements of this Directive. However, such checks must not impose tests and requirements more stringent than those laid down in this Directive. Article 8 Where the checks referred to in Article 7 show that a self-propelled industrial truck does not comply with the requirements of this Directive, the Member State shall take all the necessary steps to: -prohibit its being placed on the market, -prohibit its use, -order its withdrawal from the market. Where non-compliance is the result of a design fault or series production defect in the trucks which affect safety, the Member State shall inform the other Member States and the Commission of the faults and/or defects noted and the measures taken. The measures taken shall be revoked where it is proved that the truck complies with the requirements of the Directive. Article 9 N° Member State may, on grounds relating to the requirements referred to by this Directive, refuse, prohibit or restrict the placing on the market, entry into service or use for their intended purpose of industrial trucks which comply with the requirements of this Directive. Article 10 Any amendments necessary to adapt Annex I to technical progress, with the exception of sections 9.12.1.1 and 9.12.1.2, shall be adopted in accordance with the procedure laid down in Article 22 of Directive 84/528/EEC. Test and examination methods shall also be adopted and adapted to technical progress in accordance with that procedure. The procedure laid down in Article 23 of Directive 84/528/EEC shall apply to Annex I. Article 11 The provisions of this Directive shall not affect the Member States' entitlement to lay down, with due observance of the Treaty, the requirements they deem necessary to ensure that workers are protected when using the equipment in question, provided that this does not mean that the equipment is modified in a way not specified in the Directive. Article 12 1. Member States shall adopt, publish and bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 January 1989. They shall forthwith inform the Commission thereof. 2. Member States shall ensure that the texts of the provisions of national law which they adopt in the field governed by this Directive are communicated to the Commission. Article 13 This Directive is addressed to the Member States.

31987L0102

1986

Council Directive 87/102/EEC of 22 December 1986 for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas wide differences exist in the laws of the Member States in the field of consumer credit; Whereas these differences of law can lead to distortions of competition between grantors of credit in the common market; Whereas these differences limit the opportunities the consumer has to obtain credit in other Member States; whereas they affect the volume and the nature of the credit sought, and also the purchase of goods and services; Whereas, as a result, these differences have an influence on the free movement of goods and services obtainable by consumers on credit and thus directly affect the functioning of the common market; Whereas, given the increasing volume of credit granted in the Community to consumers, the establishment of a common market in consumer credit would benefit alike consumers, grantors of credit, manufacturers, wholesalers and retailers of goods and providers of services; Whereas the programmes of the European Economic Community for a consumer protection and information policy (4) provide, inter alia, that the consumer should be protected against unfair credit terms and that a harmonization of the general conditions governing consumer credit should be undertaken as a priority; Whereas differences of law and practice result in unequal consumer protection in the field of consumer credit from one Member State to another; Whereas there has been much change in recent years in the types of credit available to and used by consumers; whereas new forms of consumer credit have emerged and continue to develop; Whereas the consumer should receive adequate information on the conditions and cost of credit and on his obligations; whereas this information should include, inter alia, the annual percentage rate of charge for credit, or, failing that, the total amount that the consumer must pay for credit; whereas, pending a decision on a Community method or methods of calculating the annual percentage rate of charge, Member States should be able to retain existing methods or practices for calculating this rate, or failing that, should establish provisions for indicating the total cost of the credit to the consumer; Whereas the terms of credit may be disadvantageous to the consumer; whereas better protection of consumers can be achieved by adopting certain requirements which are to apply to all forms of credit; Whereas, having regard to the character of certain credit agreements or types of transaction, these agreements or transactions should be partially or entirely excluded from the field of application of this Directive; Whereas it should be possible for Member States, in consultation with the Commission, to exempt from the Directive certain forms of credit of a non-commercial character granted under particular conditions; Whereas the practices existing in some Member States in respect of authentic acts drawn up before a notary or judge are such as to render the application of certain provisions of this Directive unnecessary in the case of such acts; whereas it should therefore be possible for Member States to exempt such acts from those provisions; Whereas credit agreements for very large financial amounts tend to differ from the usual consumer credit agreements; whereas the application of the provisions of this Directive to agreements for very small amounts could create unnecessary administrative burdens both for consumers and grantors of credit; whereas therefore, agreements above or below specified financial limits should be excluded from the Directive; Whereas the provision of information on the cost of credit in advertising and at the business premises of the creditor or credit broker can make it easier for the consumer to compare different offers; Whereas consumer protection is further improved if credit agreements are made in writing and contain certain minimum particulars concerning the contractual terms; Whereas, in the case of credit granted for the acquisition of goods, Member States should lay down the conditions in which goods may be repossessed, particularly if the consumer has not given his consent; whereas the account between the parties should upon repossession be made up in such manner as to ensure that the repossession does not entail any unjustified enrichment; Whereas the consumer should be allowed to discharge his obligations before the due date; whereas the consumer should then be entitled to an equitable reduction in the total cost of the credit; Whereas the assignment of the creditor's rights arising under a credit agreement should not be allowed to weaken the position of the consumer; Whereas those Member States which permit consumers to use bills of exchange, promissory notes or cheques in connection with credit agreements should ensure that the consumer is suitably protected when so using such instruments; Whereas, as regards goods or services which the consumer has contracted to acquire on credit, the consumer should, at least in the circumstances defined below, have rights vis-à-vis the grantor of credit which are in addition to his normal contractual rights against him and against the supplier of the goods or services; whereas the circumstances referred to above are those where the grantor of credit and the supplier of goods or services have a pre-existing agreement whereunder credit is made available exclusively by that grantor of credit to customers of that supplier for the purpose of enabling the consumer to acquire goods or services from the latter; Whereas the ECU is as defined in Council Regulation (EEC) No 3180/78 (1), as last amended by Regulation (EEC) No 2626/84 (2); whereas Member States should to a limited extent be at liberty to round off the amounts in national currency resulting from the conversion of amounts of this Directive expressed in ECU; whereas the amounts in this Directive should be periodically re-examined in the light of economic and monetary trends in the Community, and, if need be, revised; Whereas suitable measures should be adopted by Member States for authorizing persons offering credit or offering to arrange credit agreements or for inspecting or monitoring the activities of persons granting credit or arranging for credit to be granted or for enabling consumers to complain about credit agreements or credit conditions; Whereas credit agreements should not derogate, to the detriment of the consumer, from the provisions adopted in implementation of this Directive or corresponding to its provisions; whereas those provisions should not be circumvented as a result of the way in which agreements are formulated; Whereas, since this Directive provides for a certain degree of approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit and for a certain level of consumer protection, Member States should not be prevented from retaining or adopting more stringent measures to protect the consumer, with due regard for their obligations under the Treaty; Whereas, not later than 1 January 1995, the Commission should present to the Council a report concerning the operation of this Directive, Article 1 1. This Directive applies to credit agreements. 2. For the purpose of this Directive: (a) 'consumer' means a natural person who, in transactions covered by this Directive, is acting for purposes which can be regarded as outside his trade or profession; (b) 'creditor' means a natural or legal person who grants credit in the course of his trade, business or profession, or a group of such persons; (c) 'credit agreement' means an agreement whereby a creditor grants or promises to grant to a consumer a credit in the form of a deferred payment, a loan or other similar financial accommodation. Agreements for the provision on a continuing basis of a service or a utility, where the consumer has the right to pay for them, for the duration of their provision, by means of instalments, are not deemed to be credit agreements for the purpose of this Directive; (d) 'total cost of the credit to the consumer' means all the costs of the credit including interest and other charges directly connected with the credit agreement, determined in accordance with the provisions or practices existing in, or to be established by, the Member States. (e) 'annual percentage rate of charge' means the total cost of the credit to the consumer expressed as an annual percentage of the amount of the credit granted and calculated according to existing methods of the Member States. Article 2 1. This Directive shall not apply to: (a) credit agreements or agreements promising to grant credit: - intended primarily for the purpose of acquiring or retaining property rights in land or in an existing or projected building, - intended for the purpose of renovating or improving a building as such; (b) hiring agreements except where these provide that the title will pass ultimately to the hirer; (c) credit granted or made available without payment of interest or any other charge; (d) credit agreements under which no interest is charged provided the consumer agrees to repay the credit in a single payment; (e) credit in the form of advances on a current account granted by a credit institution or financial institution other than on credit card accounts. Nevertheless, the provisions of Article 6 shall apply to such credits; (f) credit agreements involving amounts less than 200 ECU or more than 20 000 ECU; (g) credit agreements under which the consumer is required to repay the credit: - either, within a period not exceeding three months, - or, by a maximum number of four payments within a period not exceeding 12 months. 2. A Member State may, in consultation with the Commission, exempt from the application of this Directive certain types of credit which fulfil the following conditions: - they are granted at rates of charge below those prevailing in the market, and - they are not offered to the public generally. 3. The provisions of Article 4 and of Articles 6 to 12 shall not apply to credit agreements or agreements promising to grant credit, secured by mortgage on immovable property, in so far as these are not already excluded from the Directive under paragraph 1 (a) of this Article. 4. Member States may exempt from the provisions of Articles 6 to 12 credit agreements in the form of an authentic act signed before a notary or judge. Article 3 Without prejudice to Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising (1), and to the rules and principles applicable to unfair advertising, any advertisement, or any offer which is displayed at business premises, in which a person offers credit or offers to arrange a credit agreement and in which a rate of interest or any figures relating to the cost of the credit are indicated, shall also include a statement of the annual percentage rate of charge, by means of a representative example if no other means is practicable. Article 4 1. Credit agreements shall be made in writing. The consumer shall receive a copy of the written agreement. 2. The written agreement shall include: (a) a statement of the annual percentage rate of charge; (b) a statement of the conditions under which the annual percentage rate of charge may be amended. In cases where it is not possible to state the annual percentage rate of charge, the consumer shall be provided with adequate information in the written agreement. This information shall at least include the information provided for in the second indent of Article 6 (1). 3. The written agreement shall further include the other essential terms of the contract. By way of illustration, the Annex to this Directive contains a list of terms which Member States may require to be included in the written agreement as being essential. Article 5 By way of derogation from Articles 3 and 4 (2), and pending a decision on the introduction of a Community method or methods of calculating the annual percentage rate of charge, those Member States which, at the time of notification of this Directive, do not require the annual percentage rate of charge to be shown or which do not have an established method for its calculation, shall at least require the total cost of the credit to the consumer to be indicated. Article 6 1. Notwithstanding the exclusion provided for in Article 2 (1) (e), where there is an agreement between a credit institution or financial institution and a consumer for the granting of credit in the form of an advance on a current account, other than on credit card accounts, the consumer shall be informed at the time or before the agreement is concluded: - of the credit limit, if any, - of the annual rate of interest and the charges applicable from the time the agreement is concluded and the conditions under which these may be amended, - of the procedure for terminating the agreement. This information shall be confirmed in writing. 2. Furthermore, during the period of the agreement, the consumer shall be informed of any change in the annual rate of interest or in the relevant charges at the time it occurs. Such information may be given in a statement of account or in any other manner acceptable to Member States. 3. In Member States where tacitly accepted overdrafts are permissible, the Member States concerned shall ensure that the consumer is informed of the annual rate of interest and the charges applicable, and of any amendment thereof, where the overdraft extends beyond a period of three months. Article 7 In the case of credit granted for the acquisition of goods, Member States shall lay down the conditions under which goods may be repossessed, in particular if the consumer has not given his consent. They shall further ensure that where the creditor recovers possession of the goods the account between the parties shall be made up so as to ensure that the repossession does not entail any unjustified enrichment. Article 8 The consumer shall be entitled to discharge his obligations under a credit agreement before the time fixed by the agreement. In this event, in accordance with the rules laid down by the Member States, the consumer shall be entitled to an equitable reduction in the total cost of the credit. Article 9 Where the creditor's rights under a credit agreement are assigned to a third person, the consumer shall be entitled to plead against that third person any defence which was available to him against the original creditor, including set-off where the latter is permitted in the Member State concerned. Article 10 The Member States which, in connection with credit agreements, permit the consumer: (a) to make payment by means of bills of exchange including promissory notes; (b) to give security by means of bills of exchange including promissory notes and cheques, shall ensure that the consumer is suitably protected when using these instruments in those ways. Article 11 1. Member States shall ensure that the existence of a credit agreement shall not in any way affect the rights of the consumer against the supplier of goods or services purchased by means of such an agreement in cases where the goods or services are not supplied or are otherwise not in conformity with the contract for their supply. 2. Where: (a) in order to buy goods or obtain services the consumer enters into a credit agreement with a person other than the supplier of them; and (b) the grantor of the credit and the supplier of the goods or services have a pre-existing agreement whereunder credit is made available exclusively by that grantor of credit to customers of that supplier for the acquisition of goods or services from that supplier; and (c) the consumer referred to in subparagraph (a) obtains his credit pursuant to that pre-existing agreement; and (d) the goods or services covered by the credit agreement are not supplied, or are supplied only in part, or are not in conformity with the contract for supply of them; and (e) the consumer has pursued his remedies against the supplier but has failed to obtain the satisfaction to which he is entitled, the consumer shall have the right to pursue remedies against the grantor of credit. Member States shall determine to what extent and under what conditions these remedies shall be exercisable. 3. Paragraph 2 shall not apply where the individual transaction in question is for an amount less than the equivalent of 200 ECU. Article 12 1. Member States shall: (a) ensure that persons offering credit or offering to arrange credit agreements shall obtain official authorization to do so, either specifically or as suppliers of goods and services; or (b) ensure that persons granting credit or arranging for credit to be granted shall be subject to inspection or monitoring of their activities by an institution or official body; or (c) promote the establishment of appropriate bodies to receive complaints concerning credit agreements or credit conditions and to provide relevant information or advice to consumers regarding them. 2. Member States may provide that the authorization referred to in paragraph 1 (a) shall not be required where persons offering to conclude or arrange credit agreements satisfy the definition in Article 1 of the first Council Directive of 12 December 1977 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions (1) and are authorized in accordance with the provisions of that Directive. Where persons granting credit or arranging for credit to be granted have been authorized both specifically, under the provisions of paragraph 1 (a) and also under the provisions of the aforementioned Directive, but the latter authorization is subsequently withdrawn, the competent authority responsible for issuing the specific authorization to grant credit under paragraph 1 (a) shall be informed and shall decide whether the persons concerned may continue to grant credit, or arrange for credit to be granted, or whether the specific authorization granted under paragraph 1 (a) should be withdrawn. Article 13 1. For the purposes of this Directive, the ECU shall be that defined by Regulation (EEC) No 3180/78, as amended by Regulation (EEC) No 2626/84. The equivalent in national currency shall initially be calculated at the rate obtaining on the date of adoption of this Directive. Member States may round off the amounts in national currency resulting from the conversion of the amounts in ECU provided such rounding off does not exceed 10 ECU. 2. Every five years, and for the first time in 1995, the Council, acting on a proposal from the Commission, shall examine and, if need be, revise the amounts in this Directive, in the light of economic and monetary trends in the Community. Article 14 1. Member States shall ensure that credit agreements shall not derogate, to the detriment of the consumer, from the provisions of national law implementing or corresponding to this Directive. 2. Member States shall further ensure that the provisions which they adopt in implementation of this directive are not circumvented as a result of the way in which agreements are formulated, in particular by the device of distributing the amount of credit over several agreements. Article 15 This Directive shall not preclude Member States from retaining or adopting more stringent provisions to protect consumers consistent with their obligations under the Treaty. Article 16 1. Member States shall bring into force the measures necessary to comply with this Directive not later than 1 January 1990 and shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 17 Not later than 1 January 1995 the Commission shall present a report to the Council concerning the operation of this Directive. Article 18 This Directive is addressed to the Member States.

31987L0120

1987

Commission Directive 87/120/EEC of 14 January 1987 amending various Council Directives on the marketing of seeds and propagating materials Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 66/400/EEC of 14 June 1966 on the marketing of beet seed (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 21a thereof, Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (3), as last amended by Directive 86/155/EEC (4) and in particular Articles 2 (1a) and 21a thereof, Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (5), as last amended by Commission Directive 86/320/EEC (6), and in particular Articles 2 (1a) and 21a thereof, Having regard to Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (7), as last amended by Directive 86/155/EEC, and in particular Articles 2 (1a) and 20a thereof, Having regard to Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (8), as last amended by Directive 86/155/EEC, and in particular Articles 2 (1a) and 40a thereof, Whereas, in the light of the development of scientific and technical knowledge, Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 69/208/EEC and 70/458/EEC should be amended for the reasons set out hereafter; Whereas some of the botanical names used in Directives 66/401/EEC, 66/402/EEC, 69/208/EEC and 70/458/EEC have been shown to be incorrect or of doubtful authenticity; Whereas those names should be aligned with those normally accepted internationally; Whereas current international methods allow a tolerance of 5 % on the maximum weight of seed lots; Whereas it is desirable that a similar tolerance should be applied under the Community Directives; Whereas the conditions laid down by the Organization for Economic Cooperation and Development for previous cropping and crop isolation for the production of sugar beet seed and fodder beet seed have been shown to be suitable for adoption by the Community; Whereas it is desirable that the rules for the bitter lupin seed content of sweet lupin seed should be improved in the light of the development of the seed quality normally achieved; Whereas it is necessary to control the presence of wild plants and the content of red-grain plants in crops for the production of rice seed; Whereas stricter requirements need to be laid down for the content of red grains in rice seed; Whereas current international rules have recently been revised in respect of maximum weights for seed lots of certain cereal species; whereas that revision was approved by the Community; Whereas the maximum weights in the Community rules for seed lots of those species should therefore be revised accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 Directive 66/400/EEC is hereby amended as follows: 1. The following paragraph is inserted before Annex I (A) (1): '01. The previous cropping of the field shall not have been incompatible with the production of seeds of Beta vulgaris of the variety of the crop, and the field shall be sufficiently free from such plants which are volunteers from previous cropping.' 2. Annex I (A) (5) is replaced by the following paragraph: '5. The minimum distances from neighbouring pollen sources shall be: 1.2 // // // Crop // Minimum distance // // // 1. For the production of basic seed: // // from any pollen sources of the genus Beta // 1 000 m // 2. For the production of certified seed: // // (a) of sugar beet: // // - from any pollen sources of the genus Beta not included below // 1 000 m // - the intended pollinator or one of the intended pollinators being diploid, from tetraploid sugar beet pollen sources // 600 m // - the intended pollinator being exclusively tetraploid, from diploid sugar beet pollen sources // 600 m // - from sugar beet pollen sources, the ploidy of which is unknown // 600 m // - the intended pollinator or one of the intended pollinators being diploid, from diploid sugar beet pollen sources // 300 m // - the intended pollinator being exclusively tetraploid, from tetraploid sugar beet pollen sources // 300 m // - between two sugar beet seed production fields in which male sterility is not used // 300 m // (b) of fodder beet: // // - from any pollen sources of the genus Beta not included below // 1 000 m // - the intended pollinator or one of the pollinators being diploid, from tetraploid fodder beet pollen sources // 600 m // - the intended pollinator being exclusively tetraploid, from diploid fodder beet pollen sources // 600 m // - from fodder beet pollen sources, the ploidy of which is unknown // 600 m // - the intended pollinator or one of the pollinators being diploid, from diploid fodder beet pollen sources // 300 m // - the intended pollinator being exclusively tetraploid, from tetraploid fodder beet pollen sources // 300 m // - between two fodder beet seed production fields in which male sterility is not used // 300 m // // The above distances can be disregarded if there is sufficient protection from any undesirable foreign pollinator. No isolation is necessary between seed crops using the same pollinator. The ploidy of both seed-bearing and pollen-shedding components of seed-producing crops is to be established by reference to the common catalogue of varieties of agricultural plant species compiled under Council Directive 70/457/EEC (1), as last amended by Directive 86/155/EEC (2), or the national catalogues of varieties established under that Directive. If this information is not included for any variety, the ploidy is to be regarded as unknown, and thus a minimum isolation distance of 600 metres is required. (1) OJ No L 225, 12. 10. 1970, p. 1. (2) OJ No L 118, 7. 5. 1985, p. 23.' 3. The following sentence is added to Annex II: 'The maximum lot weight shall not be exceeded by more than 5 %.' Article 2 Directive 66/401/EEC is hereby amended as follows: 1. In Article 2 (1) (A) the words on the left below are replaced by the corresponding words on the right: 1.2 // Agrostis tenuis Sibth. // Agrostis capillaris L. // Arrhenatherum elatius (L.) Beauv. ex J. et K. Presl // Arrhenatherum elatius (L.) P. Beauv. ex J. S. et K. B. Presl // Festuca arundinacea Schreb. // Festuca arundinacea Schreber // Festuca pratensis Huds. // Festuca pratensis Hudson // Lolium x hybridum Hausskn. // Lolium x boucheanum Kunth // Trisetum flavescens (L.) Beauv. // Trisetum flavescens (L.) P. Beauv. // Medicago x varia Martyn // Medicago x varia T. Martyn // Brassica napus L. var. napobrassica (L.) Peterm. // Brassica napus L. var. napobrassica (L.) Rchb. // Brassica oleracea L. convar. acephala (DC) // Brassica oleracea L. convar. acephala (DC.) Alef. var. medullosa Thell. + var. varidis L. // Raphanus sativus L. ssp. oleifera (DC) Metzg. // Raphanus sativus L. var. oleiformis Pers. 2. In Article 3 (1) the words on the left below are replaced by the corresponding words on the right: 1.2 // Brassica napus L. var. napobrassica (L.) Peterm. // Brassica napus L. var. napobrassica (L.) Rchb. // Brassica oleracea L. convar. acephala (DC) // Brassica oleracea L. convar. acephala (DC.) Alef. var. medullosa Thell. + var. viridis L. // Festuca arundinacea Schreb. // Festuca arundinacea Schreber // Festuca pratensis Huds. // Festuca pratensis Hudson // Lolium x hybridum Hausskn. // Lolium x boucheanum Kunth // Medicago x varia Martyn // Medicago x varia T. Martyn // Raphanus sativus L. ssp. oleifera (DC) Metzg. // Raphanus sativus L. var. oleiformis Pers. 3. In column 1 of the table in Annex II (I) (2) (A): - 'Agrostis tenuis' is replaced by 'Agrostis capillaris', - 'Lolium x hybridum' is replaced by 'Lolium x boucheanum', - 'ssp. oleifera' is replaced by 'var. oleiformis'. 4. In Annex II (I) (2) (B) (p) '2,5 %' is inserted after the word 'exceed' and the rest of the item is deleted. 5. In column 1 of the table in Annex II (II) (2) (A): - 'Agrostis tenuis' is replaced by 'Agrostis capillaris', - 'Lolium x hybridum' is replaced by 'Lolium x boucheanum', - 'ssp. oleifera' is replaced by 'var. oleiformis'. 6. Annex II (III) (6) (c) is deleted. 7. In column 1 of the table in Annex III: - 'Agrostis tenuis' is replaced by 'Agrostis capillaris', - 'Lolium x hybridum' is replaced by 'Lolium x boucheanum', - 'ssp. oleifera' is replaced by 'var. oleiformis'. 8. In Annex III the following is added after the table: 'The maximum lot weight shall not be exceeded by more than 5 %'. Article 3 Directive 66/402/EEC is hereby amended as follows: 1. In Article 2 (1) (A), 'except Zea mays convar. microsperma (Koern) and Zea mays convar. saccharata (Koern)' is replaced by '(partim)'. 2. In the introductory wording of the third paragraph of Annex I (3), 'Oryza sativa,' is inserted after 'crops of'. 3. In the third paragraph of Annex I (3) the following is added: 'D. Oryza sativa: the number of plants which are recognizable as obviously being wild plants or red-grain plants shall not exceed: - 0 for the production of basic seed, - 1 per 50 m2 for the production of certified seed.' 4. In column 5 of the table in Annex II (2) (A) '2', '5' and '10' are replaced by '1', '3' and '5' respectively. 5. In column 2 of the table in Annex III '20' is replaced by '25' in both cases where it appears. 6. The following sentence is added to Annex III: 'The maximum lot weight shall not be exceeded by more than 5 %'. Article 4 Directive 69/208/EEC is hereby amended as follows: 1. In Article 2 (1) (A) the words on the left below are replaced by the corresponding words on the right: 1.2 // Brassica juncea (L.) Czern. et Coss. in Czern. // Brassica juncea (L.) Czernj. et Cosson // Brassica napus L. // Brassica napus L. (partim) // Brassica nigra (L.) W. Koch // Brassica nigra (L.) Koch // Brassica rapa L. (partim) // Brassica rapa L. var. silvestris (Lam.) Briggs 2. In Article 3 (1) the words on the left below are replaced by the corresponding words on the right: 1.2 // Brassica napus L. ssp. oleifera (Metzg.) Sinsk. // Brassica napus L. (partim) // Brassica rapa L. (partim) // Brassica rapa L. var. silvestris (Lam.) Briggs 3. In column 1 of the table in Annex I (2) 'ssp. oleifera' is deleted in both cases where they appear. 4. In column 1 of the table in Annex II (I) (1) 'ssp. oleifera' is deleted in both cases where it appears. 5. In column 1 of the table in Annex II (I) (3) (A) 'ssp. oleifera' is deleted. 6. In column 1 of the table in Annex III 'ssp. oleifera' is deleted. 7. The following sentence is added to Annex III: 'The maximum lot weight shall not be exceeded by more than 5 %.' Article 5 Directive 70/458/EEC is hereby amended as follows: 1. In Article 2 (1) (A) the words on the left below are replaced by the corresponding words on the right: 1.2 // Beta vulgaris L. var. cycla (L.) Ulrich // Beta vulgaris L. var. vulgaris // Beta vulgaris L. var. esculenta L. // Beta vulgaris L. var. conditiva Alef. // Brassica oleracea L. var. acephala DC subvar. laciniata L. // Brassica oleracea L. convar. acephala (DC.) Alef. var sabellica L. // Brassica oleracea L. convar. botrytis (L.) Alef. var botrytis // Brassica oleracea L. convar. botrytis (L.) Alef. var. botrytis L. // Brassica oleracea L. convar. botrytis (L.) Alef. var. italica Plenck // Brassica oleracea L. convar. botrytis (L.) Alef. var. cymosa Duch. // Brassica oleracea L. var. bullata subvar. gemmifera DC. // Brassica oleracea L. convar. oleracea var. gemmifera DC. // Brassica oleracea L. var. bullata DC. et var. subauda L. // Brassica oleracea L. convar. capitata (L.) Alef. var. sabauda L. // Brassica oleracea L. var. capitata L. f. alba DC. // Brassica oleracea L. convar. capitata (L.) Alef. var. alba DC. // Brassica oleracea L. var. capitata L. f. rubra (L.) Thell. // Brassica oleracea L. convar. capitata (L.) Alef. var. rubra DC. // Brassica oleracea L. var. gongylodes L. // Brassica oleracea L. convar. acephala (DC.) Alef. var. gongylodes // Brassica rapa L. var. rapa (L.) Thell. // Brassica rapa L. var. rapa // Cichorium intybus L. var. foliosum Bisch. // Cichorium intybus L. (partim) // Foeniculum vulgare P. Mill. // Foeniculum vulgare Miller // Lycopersicon lycopersicum (L.) Karst. ex Farwell // Lycopersicon lycopersicum (L.) Karsten ex Farw. // Petroselinum crispum (Mill.) Nym. ex A. W. Hill // Petroselinum crispum (Miller) Nyman ex A. W. Hill 2. In the first column of the table in Annex II (3) (a) 'var. botrytis' is replaced by '(cauliflower)' and '(other species)' is replaced by '(other subspecies)'. 3. The following sentence is added to Annex III (1): 'The maximum lot weight shall not be exceeded by more than 5 %.' Article 6 Member States shall take the necessary measures to comply with this Directive not later than 1 July 1988. They shall forthwith inform the Commission thereof. Article 7 This Directive is addressed to the Member States.