Datasets:

eu_regulatory_ir

like 2

31994L0065

1994

Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the Opinion of the European Parliament (2), Having regard to the Opinion of the Economic and Social Committee (3), Whereas minced meat and meat preparations are included in the list of products in Annex II to the Treaty; whereas the production of and trade in minced meat and meat preparations constitute an important source of income for part of the farming population; Whereas in order to ensure the rational development of the industry producing such meat and to increase productivity, public health rules for the production and placing on the market of such meat must be laid down at Community level; Whereas the laying down of such rules improves the protection of public health and consequently facilitates the completion of the internal market; Whereas, to achieve this purpose, it is necessary to repeal Council Directive 88/657/EEC of 14 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (4), and to replace it by this Directive; Whereas meat which has not undergone any treatment - other than cold treatment - is subject to the requirements of Directives 64/433/EEC (5) and 71/118/EEC (6); whereas products which have undergone treatment modifying the characteristics of fresh meat are regulated by Directive 77/99/EEC (7); whereas the production of other products, whether they are presented in the form of minced meat or meat preparations, should as a result be subject to the requirements of this Directive; Whereas to take account of consumption habits in some Member States, and of the risk presented by some of those products if they are eaten lightly cooked, very strict requirements should be maintained for minced meat and preparations which may be traded; Whereas the fundamental criterion which the Community must adopt as regards the functioning of the internal market is that of a high standard of consumer protection; Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (8) and Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (9) are applicable; Whereas a system of approval should be introduced for the establishments which meet the health requirements laid down by this Directive, together with a Community inspection procedure to ensure that the conditions for such approval are observed; Whereas that system should be based on the principle of self-monitoring by the establishments; Whereas health marking of meat products is the best way of satisfying the competent authority of the place of destination that a consignment complies with the provisions of this Directive; whereas the health certificate should be maintained for the purposes of verifying the destination of certain products; Whereas the rules, principles and safeguard measures established by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (10) should apply here; Whereas, in the context of intra-Community trade, the rules laid down in Directive 89/662/EEC (11) should also be applied; Whereas the rules applicable to imports from third countries should be defined; Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, CHAPTER I Article 1 1. This Directive lays down rules for the production, placing on the market in the Union and importing of meat preparations and minced meat. 2. This Directive shall not apply to meat preparations and minced meat which are produced in retail shops or in premises adjacent to sales points, with a view to sale there directly to the final consumer, such operations remaining subject to the health checks required by national rules governing supervision of the retail trade. 3. This Directive shall not apply to mechanically recovered meat for industrial use which undergoes heat treatment in establishments approved in accordance with Directive 77/99/EEC. 4. National rules applicable to the production and placing on the market of minced meat intended for use as raw material for the manufacture of the products referred to in Article 21 (a) shall be unaffected by this Directive. Article 2 For the purposes of this Directive: 1. the definitions contained in Article 2 of Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (12) shall apply as necessary; 2. the following definitions shall apply; (a) minced meat: meat which has been minced into fragments or passed through a spiral-screw mincer; (b) meat preparations: meat within the meaning of Article 2 of Directives 64/433/EEC, 71/118/EEC and 92/45/EEC (13), and meat satisfying the requirements of Articles 3, 6 and 8 of Directive 91/495/EEC (14) which has had foodstuffs, seasonings or additives added to it or which has undergone a treatment insufficient to modify the internal cellular structure of the meat and thus to cause the characteristics of the fresh meat to disappear; (c) seasonings: salt intended for human consumption, mustard, spices and aromatic spice extracts, aromatic herbs and aromatic extracts thereof; (d) production plant: any plant in which minced meat or meat preparations are produced: - which is located in a cutting plant and satisfies the requirements of Chapter I of Annex I to this Directive, - which in the case of the production of meat preparations, is located in an establishment fulfilling the requirements of Chapter III of Annex I to this Directive, - which, if it is not located on the premises of, or in an annex to, an establishment approved under Directives 64/433/EEC, 71/118/EEC or 77/99/EEC, fulfils the requirements of point 2 of Chapter I or point 2 of Chapter III of Annex I to this Directive; (e) trade: trade between Member States within the meaning of Article 9 (2) of the Treaty; (f) competent authority: the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that power. CHAPTER II Placing on the market of minced meat Article 3 1. Each Member State shall ensure that only fresh meat obtained from bovine animals, pigs, sheep or goats and presented in the form of minced meat, which meets the following requirements is traded: (a) it must have been prepared from striated muscle (15)() - except heart muscle - which meets the requirements of: (i) Article 3 of Directive 64/433/EEC; or (ii) Directive 72/462/EEC; and has been inspected in accordance with Directive 90/675/EEC. In the case of fresh pigmeat, it must furthermore have been examined for trichinae in accordance with Article 2 of Directive 77/96/EEC (16) or have undergone cold treatment as referred to in Annex IV to that Directive; (b) it must have been prepared, in accordance with the requirements of Chapter II of Annex I in a plant which: (i) meets the requirements of points 1, 2 and 3 of Chapter I of Annex I, and (ii) has been approved and is included on the list(s) drawn up in accordance with Article 8 (1); (c) it must have been inspected in accordance with Chapter V of Annex I and with Article 8; d) it must be marked and labelled in accordance with Chapter VI of Annex I; (e) it must have been wrapped, packaged and stored in accordance with the respective provisions of Chapters VII and VIII of Annex I; (f) it must be transported in accordance with Chapter IX of Annex I; (g) it must, during transport, be accompanied by: (i) an accompanying commercial document which must: - be drawn up by the dispatching establishment, - bear the veterinary approval number of the approved production plant and in the case of frozen minced meat, the month and year of freezing in clear, - for minced meat intended for Finland and Sweden, bear one of the indications provided for in the third indent of Part IV of Annex IV, - be kept by the consignee so that it can be produced at the request of the competent authority. Computer data must be printed out at the request of the aforesaid authority. However, at the request of the competent authority in the Member State of destination, veterinary certification must be provided when meat is intended for export to a third country after mincing. The cost of such certification shall be borne by the operators: (ii) a health certificate in accordance with Chapter III of Annex I, in the case of minced meat from a production plant situated in a restricted region or area or minced meat to be sent to another Member State, after transit through a third country in a sealed lorry. 2. Minced meat must meet the following requirements in addition to those listed in paragraph 1: (a) the fresh meat from which it is obtained must: (i) where it has been frozen or deep-frozen, be obtained from fresh boned meat which has been stored for no longer than 18 months for beef and veal, 12 months for sheepmeat and six months for pigmeat, after freezing or deep-freezing, in a cold store approved in accordance with Article 10 of Directive 64/433/EEC. However, the competent authority may authorize the boning of pigmeat and sheepmeat on the spot immediately before mincing where this operation is carried out in satisfactory conditions of hygiene and quality; (ii) where it has been chilled, be used: - within no more than six days after slaughter of the animals, or - within no more than 15 days after slaughter of the animals in the case of boned, vacuum-packed beef and veal; (b) the minced meat must have undergone cold treatment within a period of not more than one hour after portioning and wrapping, except where processes requiring the lowering of the internal temperature of the meat during production are used; (c) the minced meat must be packaged and presented in one of the following forms: (i) chilled and in this case obtained from meat as described in (a) (ii) and cooled to an internal temperature below + 2°C in the shortest time possible. However, the addition of a limited quantity of frozen meat satisfying the conditions laid down in (a) (i) shall be authorized to accelerate the refrigeration process provided that this addition is mentioned on the label. In such cases, the period referred to above must not exceed one hour; (ii) deep-frozen, and in this case obtained from meat as described in (a) and cooled to an internal temperature below - 18°C as quickly as possible, in accordance with Article 1 (2) of Directive 89/108/EEC (17)(); (d) the minced meat must not have been subjected to ionizing radiation or ultraviolet treatment; (e) the designations in Section 1 of Annex II, possibly combined with the name of the species of animal from which the meat was obtained, may be used on packages only if the requirements set out in Section 1 of Annex II are met for those designations. 3. Minced meat to which not more than 1 % salt has been added shall be subject to the requirements of paragraphs 1 and 2. Article 4 1. In order to take account of particular habits of consumption and while ensuring that the health requirements of this Directive are observed, Member States may authorize the production and placing on the market of minced meat to be sold in their territory only obtained: a) from meat referred to in Article 2 (b); b) from production plants which are approved or registered and have the premises referred to in Annex I; c) by derogation from i) point 4 of Chapter VI of Annex I; ii) Article 3 (1) (f) and (g) and Article 3 (2), except for the first, second and third indents of Annex II, point 1; 2. Minced meat obtained in accordance with this Article must not bear the health mark provided for in Chapter VI of Annex I. 3. A Member State which wishes to make use of the provisions of paragraph 1 shall notify the Commission of the nature of the derogations it intends to grant. Should the Commission, after consulting the Member State concerned, consider that the derogations fail to guarantee the health standard provided for by the Directive, appropriate steps shall be taken in accordance with the procedure laid down in Article 20. Otherwise, the Commission shall inform the other Member States of the measures notified to it. CHAPTER III Placing on the market of meat preparations Article 5 1. Meat preparations within the meaning of Article 2 (2) (b) may be traded only if: (a) they have been prepared from fresh meat, other than meat from solipeds, which: (i) complies with Article 3 of the Directives referred to in Article 2 (2) (b); (ii) in the case of imported meat, complies with Directive 72/462/EEC or Chapter III of Directives 71/118/EEC and 92/45/EEC and the requirements laid down in Articles 3, 6 and 8 of Directive 91/495/EEC, or Chapter 11 of Annex I to Directive 92/118/EEC (18) and be inspected in accordance with Directive 90/675/EEC. In the case of fresh meat from pigs, it must have been examined for trichinae in accordance with Article 2 of Directive 77/96/EEC or have undergone cold treatment in accordance with Annex IV to that Directive; (b) they have been prepared in one of the establishments referred to in Article 2 (2) (d) which: (i) meets the requirements of Chapter III of Annex I; and (ii) has been approved and is included on the list(s) drawn up in accordance with Article 8 (1). (c) they have been obtained from meat which, if it has been deep-frozen, must be used within a maximum period after slaughter of 18 months for beef and veal, 12 months for sheepmeat and goatmeat, poultrymeat, rabbit meat and farmed game meat and six months for meat from other species; However, the competent authority may authorize boning of pigmeat and sheepmeat on the spot immediately before preparation, provided this operation is carried out in satisfactory conditions of hygiene and quality. (d) they have been packaged and where they are to be placed on the market: (i) chilled, they must be cooled as quickly as possible to an internal temperature below + 2°C for meat preparations obtained from minced meat, + 7°C for preparations obtained from fresh meat, + 4°C for preparations of poultry meat and + 3°C for preparations containing offal; (iii) deep-frozen, they must be cooled to an internal temperature below - 18°C as quickly as possible, in accordance with Article 1 (2) of Directive 89/108/EEC. 2. Meat preparations must fulfil the following requirements in addition to those laid down in paragraph 1: (a) they must have been prepared in accordance with Chapter IV of Annex I; (b) they must have been inspected in accordance with Article 8 and Chapter V of Annex I; (c) they must be marked and labelled in accordance with Chapter VI of Annex I; (d) they must be wrapped and packaged in accordance with the requirements of Chapter VII of Annex I and stored in accordance with Chapter VIII of Annex I; (e) they must be transported in accordance with Chapter IX of Annex I; (f) they must during transport be accompanied by a health certificate in accordance with Annex V, which must be kept by the consignee for a period of not less than one year for presentation on request to the competent authority. 3. With the exception of fresh sausages and sausage meat, meat preparations obtained from minced meat of slaughter animals may be traded only if they fulfil the requirements of Article 3. 4. Pending the possible introduction of Community rules on ionization, meat preparations must not have been subjected to ionizing radiation. This provision shall not affect national rules applicable to ionization for medical purposes. 5. Member States may, for the purpose of their approval, grant manufacturing plants manufacturing meat preparations without an industrial structure or production capacity derogations from the requirements of Chapter I of Annex I to this Directive and from those of Chapter I of Annex B to Directive 77/99/EEC and of Chapter I (2) (a) (as regards taps) and point 11 (as regards lockers) of Annex A to Directive 64/433/EEC. Moreover, derogations may be granted from point 7 of Chapter I of Annex B to Directive 77/99/EEC as regards rooms where raw materials and finished products are stored. However, in this case, the establishment must have at least: (i) a room or secure place for the storage of raw materials, if such storage takes place; (ii) a refrigerated room or secure place for the storage of finished products, if such storage takes place. Article 6 1. In order to take account of particular habits of consumption and while ensuring that the health requirements of this Directive are observed, Member States may authorize the production and placing on the market of minced meat to be sold in their territory only obtained: (a) from meat referred to in Article 2 (b); (b) from production plants which are approved or registered and have the premises referred to in Annex III; (c) by derogation from: - points (b) and (d) of Chapter IV of Annex I, - Article 5 (1) (c) and (d), - point 4 of Chapter VI of Annex I, - Article 5 (2) (e) and (f) and Article 5 (3). 2. Meat preparations obtained in accordance with paragraph 1 must not bear the health mark provided for in Chapter VI of Annex I. 3. A Member State which wishes to make use of the provisions of paragraph 1 shall notify the Commission of the nature of the derogations it intends to grant. Should the Commission, after consulting the Member State concerned, consider that the derogations fail to guarantee the health standard provided for by the Directive, appropriate steps shall be taken in accordance with the procedure laid down in Article 20. Otherwise, the Commission shall inform the other Member States of the measures notified to it. CHAPTER IV Common provisions Article 7 1. Member States shall ensure that the operator or manager of the production plant takes all necessary measure to ensure that, at all stages of production, the provisions of this Directive are complied with. To that end, the said persons must comply with the requirements of Articles 3 and 6 of Directive 93/43/EEC (19) and, in addition, constantly carry out their own checks in compliance with the following principles: - checking raw materials entering the establishment to ensure compliance with the criteria in Annexes II and IV in respect of the final product, - checking cleaning and disinfection methods, - taking samples for analysis in a laboratory recognized by the competent authority, - keeping written or recorded track of the information required in accordance with the preceding indent with a view to submitting it to the competent authority. The results of the different checks and tests shall in particular be kept for a period of at least two years, save in the case of chilled products for which this period may be reduced to six months after the use-by date of the product, - providing guarantees for the competent authority as regards the administration of the health marking, particularly the labels bearing the health mark, - when the laboratory examination or any other information at their disposal reveals that there is a health risk, informing the competent authority thereof, - in the event of an immediate human health risk, withdrawing from the market the quantity of products obtained in technologically similar conditions and likely to present the same risk. This withdrawn quantity must stay under the supervision and control of the competent authority until it is destroyed, used for purposes other than human consumption or, after authorization by the competent authority, reprocessed in an appropriate manner to ensure its safety. 2. For inspection purposes, the operator or manager of the establishment must ensure that the packaging of the products bears a clear and legible indication of the temperature at which the products must be transported and stored, as well as the use-by date for deep-frozen products or the minimum conservation date for chilled products. The operator or manager of the establishment must arrange or establish a staff training programme enabling workers to comply with conditions of hygienic production adapted to the production structure, unless such staff already have adequate qualifications attested by diplomas. The competent authority responsible for the establishment must be involved in the planning and implementation of the programme. 3. Microbiological tests must be carried out on minced meat as referred to in Article 3 and minced-meat preparations as referred to in Article 5 on a daily basis and at least weekly on other minced meat and meat preparations. These tests must be carried out either in the production plant, if it is recognized by the competent authority, or in an approved laboratory. The sample taken for analysis must comprise five units and be representative of daily production. Samples of meat preparations must be taken from deep in the muscle after the skin has been cauterized. The microbiological checks 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. The results of the microbiological checks must be assessed using the criteria for interpretation laid down in Annex II in the case of minced meat and meat preparations obtained from minced meat of slaughter animals, except for fresh sausages and sausage meat, in accordance with the criteria in Annex IV in the case of other meat preparations. In the event of disputes arising in trade, Member States shall recognize the EN methods as reference methods. 4. The requirements as regards self-monitoring must have been drawn up in conjunction with the competent authority, which must regularly monitor compliance therewith. 5. The arrangements for implementing this Article, in particular in cases where paragraph 1 applies, shall be detailed in accordance with the procedure laid down in Article 20. Article 8 1. Each Member State shall draw up a list of establishments producing minced meat or meat preparations, making a distinction between those approved under Articles 3 and 5 and those registered under Articles 4 and 6. It shall send a list of the production plants approved under Articles 3 and 5 to the other Member States and to the Commission. It shall assign to each production plant the approval number of the establishment approved in accordance with Directives 64/433/EEC, 71/118/EEC, 77/99/EEC, 91/495/EEC or 92/45/EEC with an indication that it has been approved for the production of minced meat or meat preparations, and to each independent production unit an individual approval number. A single approval number ma be given to: (i) an establishment making preparations obtained from or with raw materials covered by more than one of the Directives referred to in the following subparagraph: (ii) an establishment located on the same site as an establishment approved in accordance with Article 2 of one of the above Directives. Production plants thus approved shall be entered either for the production of minced meat or for that of meat preparations in a separate column in the list of establishments referred to in Article 10 of Directive 64/433/EEC, Article 6 of Directive 71/118/EEC, Article 8 of Directive 77/99/EEC or that referred to in Article 7 of Directive 92/45/EEC and, in the case of an independent production unit, on a separate list drawn up according to the same criteria. The competent authority shall not approve an establishment unless it is satisfied that it complies with this Directive with respect to the nature of its activities. However, if an establishment seeking approval pursuant to this Directive forms an integral part of an establishment approved under Directives 64/433/EEC, 71/118/EEC, 79/99/EEC or 92/45/EEC, the premises, equipment and installations for staff and, generally, all premises where there is no risk of contamination of raw materials or unwrapped products may be common to both establishments. 2. Production plants must remain under the control of the competent authority, which shall inspect and monitor them with the following frequency: - for production plants attached to cutting plants: same frequency as for the said cutting plants, - for approved production plants producing the products referred to in Article 3: at least once a day during the production of minced meat, - for other production plants: the need for permanent or periodic presence of the competent authority in a given establishment will depend on the size of the establishment, the type of product manufactured, risk assessment and the guarantees offered in accordance with the second subparagraph of Article 7 (1). The competent authority must at all times have free access to all parts of establishments in order to ensure that this Directive is being complied with and, where there is doubt as to the origin of meat, to accounting documents which enable the slaughterhouse or establishment of origin of the raw material to be traced and, as regards compliance with the criteria laid down in Annexed II and IV, to the results of the self-monitoring provided for in Article 7, including the result of checks on raw materials. In the case of computer data, they must be printed out at the request of the competent authority. The competent authority must regularly analyse the results of the checks provided for in Article 7. It may, on the basis of these analyses, conduct further examinations at all stages of production or on the products. The nature of these checks, their frequency and the methods of sampling and of carrying out microbiological examinations shall be established under the procedure laid down in Article 20. The results of these analyses shall be set out in a report, the conclusions or recommendations of which shall be notified to the operator or manager of the establishment, who shall be obliged to rectify the shortcomings noted with a view to improving hygiene. The competent authority may, when carrying out the said checks, be helped by assistants who hold the professional qualifications specified in Annex III to Directive 64/433/EEC or in Annex III to Directive 71/118/EEC. 3. Where the competent authority finds, in the course of checks carried out in accordance with Chapter V of Annex I, that there is repeated non-compliance during self-monitoring with the criteria laid down in Annexes II and IV, it shall intensify the measures for monitoring the production of the establishment in question, and may seize the labels and other items bearing the health mark referred to in Chapter VI of Annex I. If, after the expiry of 15 days, the output from production plants still fails to meet the above standards, the competent authority shall take all appropriate measures to make good the shortcomings noted and shall if necessary require products from the establishment in question to undergo heat treatment. If these measures are not adequate, the establishment's approval shall be suspended. 4. Where the competent authority finds an obvious failure to comply with the hygiene rules laid down by this Directive or obstacles to an adequate health inspection: (i) it shall be empowered to act in respect of the use of equipment or premises and to take any requisite measures which may go as far as reducing the rate of production or temporarily suspending the production process; (ii) where these measures or the measures provided for in the final indent of Article 7 (1) have proved insufficient to remedy the situation, it shall temporarily suspend approval, if appropriate, for the type of production in question. If the operator or manager of the establishment does not make good the shortcomings noted within the period fixed by the competent authority, the latter shall withdraw approval. The competent authority in question shall in particular be obliged to comply with the conclusions of any check carried out in accordance with Article 9. The other Member States and the Commission shall be informed of the suspension or withdrawal of approval. 5. In the event of repeated shortcomings, checks shall be increased and, where appropriate, labels, seals or other items bearing the health mark shall be removed. 6. The arrangements for implementing this Article, in particular details of help by assistants, shall be adopted in accordance with the procedure laid down in Article 20. Article 9 Experts from the Commission may, in so far as is necessary for the uniform application of this Directive and in cooperation with the competent authorities, make on-site checks. To do this, they may verify, by checking a representative percentage of production plants, whether the competent authorities are, in a uniform manner, ensuring that such plants are complying with the provisions of this Directive, and in particular with Article 7 (self-monitoring). These checks may be carried out when other checks are being made by Commission experts pursuant to Community legislation. The Commission shall inform the Member States of the results of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. The general provisions for applying this Article - in particular those aimed at regulating procedures for cooperation with national authorities - shall be adopted in accordance with the procedure laid down in Article 20. Article 10 The provisions of Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market shall apply, in particular with respect to the organization of and the action to be taken on the checks carried out by the Member State of destination and the safeguard measures to be applied. Article 11 Any addition of additives to the minced meat or meat preparations covered by this Directive shall take place in compliance with Directive 94/36/EEC (20). Article 12 1. Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that the provisions of this Directive have not been complied with or there is doubt as to whether the products referred to in Article 1 are fit for consumption, carry out any checks it deems appropriate. 2. Each Member State shall determine the penalties to be applied in the event of infringement of the provisions of this Directive. CHAPTER V Provisions applicable to imports into the Community of meat preparations and minced meat Article 13 I. Member States shall ensure that imports of minced meat satisfying the requirements of Article 3 which has been deep-frozen at the production plant of origin and preparations satisfying the requirements of Article 5 which have been deep-frozen at the production plant of origin are not authorized unless they meet the requirements of this chapter. A. The guarantees provided by the production plant of origin and confirmed by the competent authority of the third country regarding compliance with the requirements laid down for the placing on the market of products of Community origin obtained in accordance with Articles 3 and 5 must be approved in accordance with the procedure laid down in Article 20. B. For the purposes of uniform application of A, the provisions of the following paragraphs shall apply. 1. In order to be imported into the Community, deep-frozen minced meat as referred to in Article 3 and deep-frozen meat preparations as referred to in Article 5 must: (a) come from third countries or parts of third countries from which imports are not prohibited on animal health grounds in accordance with Directive 91/494/EEC (21), 92/118/EEC, 72/462/EEC and 92/45/EEC; (b) come from a third country on the lists drawn up in accordance with the Directives governing health and animal health aspects to be complied with for imports of meat used in meat preparations and offering the guarantees provided for in this Directive; (c) be accompanied by the animal and public health certificate which is to be drawn up in accordance with the procedure laid down in Article 20 supplemented by a declaration signed by the official veterinarian to the effect that this minced meat and these preparations fulfil respectively the requirements laid down in Articles 3 and 5, come from establishments offering the guarantees provided for in Annex I, and have been deep-frozen at the production plant of origin. 2. The following shall be established in accordance with the procedure laid down in Article 20: (a) a Community list of establishments which satisfy the requirements in (b). Pending the compilation of that list, Member States are authorized to maintain the controls provided for in Article 11 (2) of Directive 90/675/EEC and the national health certificate required for establishments which have been the subject of national approval; (b) the specific conditions relating to the requirements of this Directive, other than those enabling meat to be excluded from human consumption in accordance with Directive 64/433/EEC and 71/118/EEC. Such conditions and guarantees may not be less stringent than those laid down in Articles 3 and 5. Pending the decisions referred to in (a) and (b), imports from establishments approved under Directive 72/462/EEC with respect to which the competent authorities are able to guarantee that the requirements of this Directive are complied with, may be authorized as from the date laid down in Article 22. 3. Experts from the Commission shall, in cooperation with the competent authorities of the Member States, carry out on-the-spot inspections to check: (a) the guarantees given by the third country regarding the conditions of production and placing on the market; (b) whether the conditions of paragraphs 1 and 2 are fulfilled. The experts from the Member States responsible for these inspections shall be appointed by the Commission, acting on a proposal from the Member States. These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection. The frequency of and procedure for these inspections shall be determined in accordance with the procedure laid down in Article 20. 4. Pending the organization of the inspections referred to in paragraph 3, national rules applicable to inspection in third countries shall continue to apply, subject to notification through the Standing Veterinary Committee of any failure to comply with hygiene rules found during these inspections. II. Under the procedure laid down in Article 19, derogations may be made from the requirements of this Article. Article 14 The lists provided for in Article 13 (I) (B) (2) may include only third countries or parts of third countries: (a) from which imports are not prohibited pursuant to Articles 9 to 12 of Directive 91/494/EEC and Articles 14, 17 and 20 of Directive 72/462/EEC; (b) which, in view of their legislation and the organization of their veterinary services and of their inspection services, the powers of such services and the supervision to which they are subject, have been recognized, in accordance with Article 3 (2) of Directive 72/462(EEC) of Article 9 (2) of Directive 91/494/EEC, as capable of guaranteeing and supervising the implementation of their legislation in force, or the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Articles 3 and 5 are being complied with. Article 15 1. Member States shall ensure that deep-frozen minced meat as referred to in Article 3 and deep-frozen meat preparations as referred to in Article 5 are imported into the Community only if they: - are accompanied by the certificate provided for in Article 13 (1) (B) (1) (c), - have satisfied the checks required by Directive 90/675/EEC. 2. Pending the establishment of detailed rules for implementing this chapter: - the import of minced meat remains prohibited, - the national rules applicable to imports of meat preparations from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided that they are not more favourable than those laid down in Article 5, - imports must take place under the conditions laid down in Article 11 of Directive 90/675/EEC. Article 16 The principles and rules laid down in Directive 90/675/EEC shall apply, with particular reference to the organization of and follow-up to the inspections to be carried out by the Member States and the safeguard measures to be implemented. Pending implementation of the decisions provided for in Article 8 (3) of Directive 90/675/EEC, imports must take place in accordance with Article 11 (2) that Directive. CHAPTER VI Final provisions Article 17 1. The following paragraph 3 shall be added to Article 5 of Directive 71/118/EEC: '3. Member States shall ensure that mechanically recovered meat may be traded only if it has previously undergone heat treatment in accordance with Directive 77/99/EEC in the establishment of origin or any other establishment designated by the competent authority.' 2. The following paragraph 4 shall be added to Article 6 of Directive 91/495/EEC: '4. Member States shall ensure that mechanically recovered meat may be traded only if it has previously undergone heat treatment in accordance with Directive 77/99/EEC in the establishment of origin or any other establishment designated by the competent authority.' Article 18 1. The provisions of the Annexes shall not apply to production plants situated on certain islands of the Hellenic Republic or in certain French Overseas Departments and territories where the production of such establishments remains exclusively reserved for local consumption. 2. The arrangements for applying paragraph 1 shall be adopted in accordance with the procedure provided for in Article 20. Under the same procedure it may be decided to amend paragraph 1 with a view to the progressive extension of Community standards to all production plants situated in the abovementioned islands and parts of territories. Article 19 The Annexes shall be amended by the Council acting by a qualified majority on a proposal from the Commission, in particular to adapt them to technological and scientific progress. Article 20 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Standing Veterinary Committee (hereinafter referred to as 'the Committee') set up by Decision 68/361/EEC (22) by its chairman, either on his own initiative or at the request of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within the time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, within three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures save where the Council has rejected the said measures by a simple majority. Article 21 The Council, acting by a qualified majority on a proposal from the Commission, shall before 1 January 1996 lay down the health rules applicable to: (a) the production and placing on the market of sausage meat intended for the subsequent production of a meat-based product; (b) the production and use of mechanically recovered meat. Article 22 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. The Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 23 Directive 88/657/EEC shall be repealed with effect from 1 January 1996. Article 24 This Directive is addressed to the Member States.

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Council Directive 94/67/EC of 16 December 1994 on the incineration of hazardous waste Having regard to the Treaty establishing the European Community, and in particular Article 103s (1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), Whereas the objectives and principles of the Community's environment policy as set out in Article 130r of the Treaty, aim in particular at preventing pollution, rectifying pollution by acting as a priority at source, and applying the principle that the polluter should pay; Whereas Council resolution of 7 May 1990 on waste policy (4) invited the Commission to complete its proposals on incinerators for industrial waste, as a matter of urgency; Whereas the incineration of hazardous waste gives rise to emissions which may cause pollution and thereby, unless properly controlled, harm human health and the environment; whereas in some cases there might be transboundary pollution; Whereas preventive action is therefore required to protect the environment against dangerous emissions from the incineration of hazardous waste; Whereas the current differences in national provisions applicable to the incineration of hazardous waste, and in some cases the absence of such provisions, justify action at Community level; Whereas, in accordance with Article 130t of the Treaty, the adoption of this Directive will not prevent any Member State from maintaining or introducing more stringent measures for the protection of the environment compatible with the Treaty; Whereas Article 4 of Council Directive 75/442/EEC of 15 July 1975 on waste (5), requires Member States to take the necessary measures to ensure that waste is recovered or disposed of without endangering human health and without harming the environment; whereas, to this end, Article 9 of that Directive stipulates that any installation or undertaking treating waste must obtain a permit from the competent authorities relating, inter alia, to the precautions to be taken; Whereas Articles 3 and 4 of Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants (6), provide that prior authorization shall be required for the operation of industrial plants belonging to listed categories among which are waste incineration plants; Whereas the purpose of the incineration plants established and operated under this Directive is to reduce the pollution-related risks of hazardous waste through a process of oxidation, to reduce the quantity and volume of the waste and to produce residues that can be re-used or diposed of safely; Whereas a high level of environmental protection requires the setting and maintaining of appropriate operating conditions and emission limit values for hazardous waste incineration plants within the Community; whereas special provisions are necessary in the case of emissions of dioxins and furans which it is essential to reduce by using the most progressive technology; Whereas high-standard measurement techniques are required to monitor emissions to ensure compliance with the emission limit and guide values for the pollutants; Whereas integrated protection of the environment against emissions resulting from the incineration of hazardous waste is required; whereas, therefore, aqueous waste resulting from the cleaning of exhaust gases may be discharged after separate treatment only, in order to limit a transfer of pollution from one environmental medium to another; whereas specific emission limit values for pollutants in such aqueous waste should be established within two years of the date of entry into force of this Directive; Whereas provisions should be laid down for cases where the emission limit values are exceeded as well as for technically unavoidable stoppages, disturbances or failures of the purification devices; Whereas the coincineration of hazardous waste in plants not primarily intended to incinerate hazardous waste should not be allowed to cause higher emissions of polluting substances in that part of the exhaust gas volume resulting from such coincineration and should therefore be subject to appropriate limitations; Whereas, for better protection of human health and the environment, rapid adaptation of existing incineration plants to the emission limit values laid down in this Directive is required so as to avoid an increased transfer of hazardous wastes to such plants; Whereas a committee should be set up to assist the Commission in implementing this Directive and adapting it to scientific and technical progress; Whereas the reports on the implementation of this Directive are an important element for informing the Commission and Member States on the progress achieved in emission control techniques; Whereas proposals for the revision of the emission limit values and related provisions of this Directive should be submitted to the Council before 31 December 2000 in the light of the expected development of the state of technology, of experience in the operation of incineration plants and of environmental requirements, Article 1 1. The aim of this Directive is to provide for measures and procedures to prevent or, where that is not practicable, to reduce as fas as possible negative effects on the environment, in particular the pollution of air, soil, surface and groundwater, and the resulting risks to human health, from the incineration of hazardous waste and, to that end, to set up and maintain appropriate operating conditions and emission limit values for hazardous waste incineration plants within the Community. 2. This Directive applies without prejudice to other relevant Community legislation, in particular relating to waste and the protection of the health and safety of workers at incineration plants. Article 2 For the purposes of this Directive: 1. 'hazardous waste` means any solid or liquid waste as defined in Article 1 (4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (1). The following hazardous wastes shall however be excluded from the scope of this Directive: - combustible liquid wastes including waste oils as defined in Article 1 of Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils (2) provided that they meet the following three criteria: (i) the mass content of polychlorinated aromatic hydrocarbons, e.g. polychlorinated biphenyls (PCB) or pentachlorinated phenol (PCP), amounts to concentrations not higher than those set out in the relevant Community legislation; (ii) these wastes are not rendered hazardous by virtue of containing other constituents listed in Annex II to Directive 91/689/EEC in quantities or in concentrations which are inconsistent with the achievement of the objectives set out in Article 4 of Directive 75/442/EEC; and (iii) the net calorific value amounts to at least 30 MJ per kilogramme, - any combustible liquid wastes which cannot cause, in the flue gas directly resulting from their combustion, emissions other than those from gasoil as defined in Article 1 (1) of Directive 75/716/EEC (3) or a higher concentration of emissions than those resulting from the combustion of gasoil as so defined, - hazardous waste resulting from the exploration for and the exploitation of oil and gas resources from off-shore installations and incinerated on board, - municipal waste covered by Directives 89/369/EEC (1) and 89/429/EEC (2), - sewage sludges from the treatment of municipal waste waters which are not rendered hazardous by virtue of containing constituents listed in Annex II to Directive 91/689/EEC in quantities or in concentrations, as defined by the Member States until the list of hazardous wastes referred to in Article 1 (4) of that Directive is established, which are inconsistent with the achievement of the objectives set out in Article 4 of Directive 75/442/EEC. This exlusion is without prejudice to Directive 86/278/EEC (3); 2. 'incineration plant` means any technical equipment used for the incineration by oxidation of hazardous wastes with or without recovery of the combustion heat generated, including pretreatment as well as pyrolysis or other thermal treatment processes, e. g. plasma process, insofar as their products are subsequently incinerated. This includes plants burning such wastes as a regular or additional fuel for any industrial process. This definition covers the site and the entire installation comprising the waste reception, storage and pretreatment facilities, the incinerator, its wastes, fuel and air-supply systems, exhaust gas and waste water treatment facilities, and devices and systems for controlling incineration operations and continuously recording and monitoring incineration conditions. The following plants are not covered by this definition: - incinerators for animal carcases or remains, - incinerators for infectious clinical waste provided that such waste is not rendered hazardous as a result of the presence of other constituents listed in Annex II to Directive 91/689/EEC, or - municipal waste incinerators also burning infectious clinical waste which is not mixed with other wastes which are rendered hazardous as a result of one of the other properties listed in Annex III to Directive 91/689/EEC; 3. 'new incineration plant` means a plant for which the permit to operate is granted on or after the date specified in Article 18 (1); 4. 'existing incineration plant` means a plant for which the original permit to operate is granted before the date specified in Article 18 (1); 5. 'emission limit value` means the mass concentration of polluting substances which is not to be exceeded in emissions from plants during a specified period; 6. 'operator` means any natural or legal person who operates the incineration plant, or who has or has been delegated decisive economic power over it. Article 3 1. The permit referred to in Articles 9 and 10 of Directive 75/442/EEC, in Article 11 of the said Directive, as complemented by Article 3 of Directive 91/689/EEC, and in Article 3 of Directive 84/360/EEC shall be granted only if the application shows that the incineration plant is designed, equipped and will be operated in such a manner that the appropriate preventive measures against environmental pollution will be taken and the requirements provided for in Articles 5 to 12 of this Directive will be met. 2. The permit granted by the competent authorities must explicitly list the types and quantities of those hazardous wastes which may be treated in the incineration plant as well as the total capacity of the incinerator. 3. Where a plant not intended primarily to incinerate hazardous wastes is being fed with hazardous wastes (coincineration), the resulting heat release from which is no higher than 40 % inclusive of the total heat released in the plant at each moment of the operation, at least the following Articles shall apply: - Articles 1 to 5, - Article 6 (1) and (5), - Article 7, including the provisions relating to the measurements referred to in Articles 10 and 11, - Article 9, - Articles 12, 13 and 14. 4. The permit for coincineration as described in paragraph 3 shall be granted only if it is demonstrated in the application: - that the hazardous waste burners are located and the waste fed in such a way as to achieve a level of incineration as complete as possible, and - with calculations as laid down in Annex II that the provisions of Article 7 will be met. That permit shall explicitly list the types and quantities of those hazardous wastes which may be coincinerated in the plant. It shall, moreover, specify the minimum and maximum mass flows of those hazardous wastes, their lowest and maximum calorific values and their maximum contents of pollutants, e.g. PCB, PCP, chlorine, fluorine, sulphur, heavy metals. The results of measurements carried out within six months after the start of operation, under the most unfavourable conditions anticipated, shall show that the provisions of Article 7 are complied with. For this period the competent authorities may grant exemptions from the percentage requirement stipulated in paragraph 3. Article 4 Applications for permits and decisions of the competent authorities thereon, and the results of the monitoring provided for in Article 11 of this Directive, shall be made available to the public in accordance with Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (1). Article 5 1. The operator shall take all necessary measures concerning the delivery and reception of waste in order to prevent or, where that is not practicable, to reduce as far as possible negative effects on the environment, in particular the pollution of air, soil, surface and groundwater, and the risks to human health. These measures shall cover at least the requirements set out in paragraphs 2 and 3. 2. Prior to accepting the waste at the incineration plant, the operator shall have available a description of the waste covering: - the physical, and as far as practicable, the chemical composition of the waste and all information necessary to evaluate its suitability for the intended incineration process, - the hazard characteristics of the waste, the substances with which it cannot be mixed, and the precautions to be taken in handling the waste. 3. Prior to accepting the waste at the incineration plant, at least the following reception procedures shall be carried out by the operator: - determination of the mass of the waste, - the checking of those documents required by Directive 91/689/EEC and, where applicable, those required by Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community (2) and by dangerous goods transport regulations, - the taking of representative samples, unless inappropriate, as far as possible before unloading, to verify conformity with the description provided for in paragraph 2 by carrying out controls and to enable the competent authorities to identify the nature of the wastes treated. These samples shall be kept for at least one month after the incineration. 4. The competent authorities may grant exemptions from paragraphs 2 and 3 for industrial plants and undertakings incinerating only their own waste at the place of production of the waste provided that the same level of protection is met. Article 6 1. Plants for the incineration of hazardous wastes shall be operated in order to achieve a level of incineration as complete as possible. This may require the use of appropriate techniques of waste pretreatment. 2. All incineration plants shall be designed, equipped and operated in such a way that the gas resulting from the incineration of the hazardous waste is raised, after the last injection of combustion air, in a controlled and homogeneous fashion and even under the most unfavourable conditions anticipated, to a temperature of at least 850 °C, as achieved at or near the inner wall of the combustion chamber, for at least two seconds in the presence of at least 6 % oxygen; if hazardous wastes with a content of more than 1 % of halogenated organic substances, expressed as chlorine, are incinerated, the temperature has to be raised to at least 1 100 °C. When the furnace is fuelled with liquid hazardous waste only or with a mixture of gaseous substances and powdered solids from a thermal pretreatment of hazardous waste under oxygen deficiency, and when the gaseous part accounts for more than 50 % of the entire heat released, the oxygen content after the last injection of combustion air shall amout to at least 3 %. 3. All incineration plants shall be equipped with burners which switch on automatically when the temperature of the combustion gases, after the last injection of combustion air, falls below the relevant minimum temperature stated in paragraph 2. Such burners shall also be used during plant start-up or shut-down operations in order to ensure that the relevant minimum temperature is maintained while unburnt waste is in the combustion chamber. During start-up and shut-down or when the temperature of the combustion gases falls below the relevant minimum temperature stated in paragraph 2, the burners must not be fed with fuels which can cause higher emissions than those resulting from the burning of gasoil as defined in Article 1 (1) of Directive 75/716/EEC, liquefied gas or natural gas. It is mandatory to have and to operate a system to prevent hazardous waste feed: - at start-up, until the required minimum incineration temperature has been reached, - whenever the required minimum incineration temperature is not maintained, - whenever the continuous measurements required by Article 11 (1) (a) show that any emission limit value is exceeded owing to disturbances or failures of the purification devices. 4. Requirements different from those laid down in paragraph 2 and specified in the permit for certain hazardous wastes may be authorized by the competent authorities. Such authorization shall be conditional upon at least the provisions of Article 7 being complied with and the levels of dioxins and furans emitted being lower or equivalent to those obtained by applying the requirements laid down in paragraph 2 of the present Article. All operating conditions determined under the provisions of this paragraph and the results of verifications made shall be communicated to the Commission as part of the information provided in accordance with Article 17. 5. During the operation of the incineration plant the following limit values for carbon monoxide (CO) concentrations shall not be exceeded in the combustion gases: (a) 50 mg/m³ of combustion gas determined as daily average value; (b) 150 mg/m³ of combustion gas of at least 95 % of all measurements determined as 10-minute average values or 100 mg/m³ of combustion gas of all measurements determined as half-hourly average values taken in any 24-hour period. 6. All incineration plants shall be designed, equipped and operated in such a way as to prevent emissions into the air giving rise to significant ground-level air pollution; in particular, exhaust gases shall be discharged in a controlled fashion by means of a stack. The stack height shall be calculated in such a way as to safeguard human health and the environment. Article 7 1. Incineration plants shall be designed, equipped and operated in such a way that at least the following emission limit values are not exceeded in the exhaust gases: (a) Daily average values: >TABLE> (b) Half-hourly average values: >TABLE> (c) All average values over the sample period of a minimum of 30 minutes and a maximum of eight hours; >TABLE> These average values also cover the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds. 2. The emission of dioxins and furans shall be reduced by the most progressive techniques. At the latest from 1 January 1997, all average values measured over the sample period of a minimum of six hours and a maximum of eight hours shall not exceed a limit value of 0,1 ng/m³ unless, at least six months before that date, the availability of harmonized measurement methods has not been established at Community level by the Commission acting in accordance with the procedure laid down in Article 16. This limit value is defined as the sum of the concentrations of the individual dioxins and furans evaluated in accordance with Annex I. Until the date of application of this limit value, Member States shall use this value at least as a guide value. 3. The results of the measurements made to verify compliance with the limit and guide values set out in Article 6 and in this Article shall be standardized at the conditions laid down in Article 11 (2). 4. Where hazardous wastes are co-incinerated in accordance with Article 3 (3), the provisions of Article 6 (5) and paragraphs 1, 2 and 3 of this Article shall only apply, according to the criteria laid down in Annex II, to that part of the volume of exhaust gas resulting from the incineration of the hazardous wastes. Appropriate emission limit and guide values for the relevant pollutants emitted in the exhaust gas of the plants referred to in Article 3 (3) shall be determined in accordance with Annex II. Article 8 1. Any waste water discharged from an incineration plant shall be subject to a permit granted by the competent authorities. 2. Discharges to the aquatic environment of aqueous waste resulting from the cleaning of exhaust gases shall be limited as far as possible. Subject to a specific provision in the permit, the aqueous wastes may be discharged after separate treatment on condition that: - the requirements of relevant Community, national and local provisions are complied with in the form of emission limit values, and - the mass of heavy metals, dioxins and furans contained in those aqueous wastes in relation to the quantity of hazardous waste processed is reduced in such a way that the mass allowed to be discharged to water is less than that allowed to be discharged into the air. 3. Without prejudice to paragraph 2, the Council, acting on a proposal from the Commission, shall establish within two years of the entry into force of this Directive a set of specific limit values for the pollutants contained in the effluents from the cleaning of exhaust gases to be discharged. 4. Incineration plant sites including associated storage areas for hazardous wastes shall be designed and operated in such a way as to prevent the release of any polluting substance into soil and groundwater following the provisions of Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (1). Moreover, storage capacity shall be provided for rainwater runoff from the incineration plant site or for contaminated water arising from spillages or firefighting operations. This storage capacity shall be adequate to ensure that such waters can be tested and treated before discharge where necessary. Article 9 1. Residues resulting from the operation of the incineration plant shall be recovered or disposed of in accordance with Directives 75/442/EEC and 91/689/EEC. This may require a pretreatment of the residues. Such residues should be kept separate from each other pending assessment of their recovery or disposal; in order to further facilitate these, the appropriate technologies should be applied. 2. Transport and intermediate storage of dry residues in the form of dust, e.g. boiler dust and dry residues from the treatment of exhaust gases, shall take place in closed containers. 3. Any heat generated by the incineration processes should be used as far as possible. 4. Prior to determining the routes for the disposal or recovery of the residues from incineration, appropriate tests shall be carried out to establish the physical and chemical characteristics and the polluting potential of the different incineration residues. The analysis shall concern in particular the soluble fraction and heavy metals. Article 10 1. Measurement requirements in order to monitor in accordance with Article 11 the parameters, conditions and mass concentrations of the pollutants relevant to the incineration process shall be laid down in the permit or in the conditions attached to the permit issued by the competent authorities or in the relevant general binding rules on measurement requirements. 2. The permit shall only be granted if the application shows that the proposed measurement techniques comply with Annex III. The values of the confidence interval (95 %) at the emission limit values given in Article 6 (5) (a) and Article 7 (1) (a), Nos 1, 2, 3 and 5, shall not exceed the values given in Annex III, point 4. The appropriate installation and the functioning of the automated monitoring equipment shall be subject to control and to an annual surveillance test. 3. The sampling and measurement procedures used to satisfy the obligations imposed for periodical measurements of each air pollutant and the location of the sampling or measurement points shall be specified in the permit granted by the competent authorities, or in the conditions attached to the permit or in the relevant general binding rules on sampling and measurement procedures. The requirements for periodical measurements shall be fixed by the competent authorities in accordance with Annex III. Article 11 1. The following measurements shall be carried out in accordance with Annex III at the incineration plant: (a) continuous measurements of the substances referred to in Article 6 (5) and Article 7 (1) (a) and (b); (b) continuous measurements of the following process operation parameters: - temperature as referred to in Article 6 (2) and (4), - concentration of oxygen, pressure, temperature and water vapour content of the exhaust gas; (c) at least two measurements per year of the substances referred to in Article 7 (1) (c) and (2); one measurement every two months shall however be carried out for the first 12 months of operation; (d) the residence time, the relevant minimum temperature and the oxygen content of the exhaust gases as specified in Article 6 (2) and (4) shall be subject to appropriate verification, at least once when the incineration plant is brought into service and under the most unfavourable operating conditions anticipated. The continuous measurement of HF may be omitted if treatment stages for HCl are used which make sure that the emission limit value under Article 7 (1) (a) (3) and (1) (b) (3) is not being exceeded. In this case the emissions of HF shall be subject to periodical measurements. The continuous measurement of the water vapour content shall not be necessary, provided that the sampled exhaust gas is dried before the emissions are analysed. Measurements of the pollutants listed in Article 7 (1) shall not be necessary, provided that the permit allows the incineration of only those hazardous wastes which cannot cause average values of those pollutants higher than 10 % of the emission limit values set out in Article 7 (1). The Commission, acting in accordance with the procedure laid down in Article 16, shall decide, as soon as appropriate measurement techniques are available within the Community, the date from which continuous measurements of the substances referred to in Article 7 (1) (c) and (2) are to be carried out in accordance with Annex III. 2. The results of the measurements made to verify compliance with the emission limit and guide values set out in Articles 6 and 7 shall be standardized at the following conditions: - Temperature 273 K, pressure 101,3 kPa, 11 % oxygen, dry gas, - Temperature 273 K, pressure 101,3 kPa, 3 % oxygen, dry gas, in case of incineration of waste oil only as defined in Directive 75/439/EEC. When the hazardous wastes are incinerated in an oxygen-enriched atmosphere, the results of the measurements can be standardized at an oxygen content laid down by the competent authorities reflecting the special circumstances of the individual case. In a case covered by Article 3 (3), the results of the measurements shall be standardized at a total oxygen content as calculated in Annex II. When the emissions of pollutants are reduced by exhaust gas treatment, the standardization with respect to the oxygen contents provided for in the first subparagraph shall be done only if the oxygen content measured over the same period as for the pollutant concerned exceeds the relevant standard oxygen content. 3. The emission limit values are complied with if: - all the daily average values do not exceed the emission limit values set out in Article 6 (5) (a) and Article 7 (1) (a), and either all the half-hourly average values over the year do not exceed the emission limit values set out in column A of Article 7 (1) (b), or 97 % of the half-hourly average values over the year do not exceed the emission limit values set out in column B of Article 7 (1) (b), - all average values over the sample period set out in Article 7 (1) (c) do not exceed the emission limit values set out in that subparagraph, - the provisions of Article 6 (5) (b) are complied with. The average values determined within the periods referred to in Article 12 (2) shall be excluded from the judgment on compliance. The half-hourly average values and the 10-minute averages shall be determined within the effective operating time (including the start-up and shut-off periods when hazardous waste is being incinerated) from the measured values after having subtracted the value of the confidence interval specified in point 4 of Annex III. The daily average values shall be determined from those validated average values. The average values over the sample period and, in the case of periodical measurements of HF, the average values for HF shall be determined in accordance with the requirements of Article 10 (3). Article 12 1. Should the measurements taken show that the emission limit values laid down in this Directive have been exceeded, the competent authorities shall be informed without delay. The plant concerned shall not continue to feed hazardous waste while failing to comply with emission limit values, until such time as the competent authorities allow the resumption of the feeding of such waste. 2. The competent authorities shall lay down the maximum permissible period of any technically unavoidable stoppages, disturbances, or failures of the purification devices or the measurement devices, during which the concentrations in the discharges into the air of the regulated substances may exceed the emission limit values laid down. Under no circumstances shall the plant continue to incinerate hazardous waste for a time period of more than four hours uninterrupted; moreover, the cumulative duration of operation in such conditions over one year shall be less than 60 hours. In case of a breakdown, the operator shall reduce or close down operations as soon as practicable until normal operations can be restored. In plants covered by Article 3 (3) feeding of hazardous wastes shall be stopped. The total dust content of the discharges shall under no circumstances exceed 150 mg/m³ expressed as a half-hourly average; morever, the emission limit value laid down in Article 7 (1) (a) (2) and (1) (b) (2) must not be exceeded. All other conditions referred to in Article 6 shall be complied with. Article 13 1. The provisions of this Directive shall apply to existing incineration plants within three years and six months after the date specified in Article 18 (1). 2. However, the operator may notify the competent authorities within six months after the date specified in Article 18 (1) that the existing plant will not be operated for more than 20 000 hours within a period of five years at maximum, starting from the operator's notification, before being definitely shut down. In this case the provisions of paragraph 1 shall not apply. Article 14 Before 31 December 2000, and notably in the light of the expected development of the state of technology, of experience in the operation of the plants, and of environmental requirements, the Commission shall submit to the Council a report, based on experience of the application of the Directive and on the progress achieved in emission control techniques, accompanied by proposals for revision of the emission limit values and related provisions referred to in this Directive. Any emission limit value established following such revision shall not apply to existing incineration plants before 31 December 2006. Article 15 The Commission, acting in accordance with the procedure laid down in Article 16, shall adopt the amendments required to adapt to technical progress the provisions of Articles 10 to 12 and Annexes I to III. Article 16 1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. (b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 17 The reports on the implementation of this Directive shall be established in accordance with the procedure laid down in Article 5 of Directive 91/692/EEC. The first report shall cover the first full three-year period after the entry into force of this Directive. Article 18 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 December 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of domestic law which they adopt in the field covered by this Directive. Article 19 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 20 This Directive is addressed to the Member States.

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1994

Commission Directive 94/68/EC of 16 December 1994 adapting to technical progress Council Directive 78/318/EEC on the approximation of the laws of the Member States relating to the windscreen wiper and washer systems of motor vehicles Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), at last amended by Commission Directive 93/81/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 78/318/EEC of 21 December 1977 on the approximation of the laws of the Member States relating to the wiper and washer systems of motor vehicles (3), and in particular Article 5 thereof, Whereas Directive 78/318/EEC is one of the separate directives of EEC type-approval procedure established under Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require that each separate directive shall have attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas Council Directive 77/649/EEC of 27 September 1977 on the approximation of the laws of the Member States relating to the field of vision of motor vehicle drivers (4), as last amended by Commission Directive 90/630/EEC (5) established the procedure for determining different characteristics of vehicles which are to be maintained; Whereas in the light of technical progress it is possible to adapt Directive 78/318/EEC in order to bring the test specifications and procedures closer to the actual operating conditions for these systems; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 78/318/EEC shall be amended as follows: 1. In Article 1, the term between brackets 'as defined in Annex I to Directive 70/156/EEC' shall be replaced by the term 'as defined in Annex II A to Directive 70/156/EEC'. 2. Article 2 is amended as follows: (a) in the first indent the words 'Annexes I to V' are replaced by 'the relevant Annexes'; (b) in the second and third indents the words 'within the meaning of Article 9a of Directive 70/156/EEC' are replaced by 'within the meaning of Article 2 of Directive 70/156/EEC'. 3. Article 3 is amended as follows: (a) paragraph 1 is amended as follows: (i) in the first indent the words 'Annexes I to V' are replaced by 'the relevant Annexes'; (ii) in the second indent the words 'within the meaning of Article 9a of Directive 70/156/EEC' are replaced by 'within the meaning of Article 2 of Directive 70/156/EEC'; (b) in paragraph 2 the words 'within the meaning of Article 9a of Directive 70/156/EEC' are replaced by 'within the meaning of Article 2 of Directive 70/156/EEC'. 4. In Article 4, '2.2' is replaced by '2.1'. 5. In Article 5, the words 'Annexes I to VII' are replaced by 'the Annexes'. 6. The list of Annexes and Annexes I, II, VI and VII are amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 July 1995 Member States may not, on grounds relating to windscreen wiper and washer systems: - refuse, in respect of a type of motor vehicle or a type of windscreen wiper and washer system, to grant EEC type-approval or national type-approval; or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of windscreen wiper and washer systems, if the windscreen wiper and washer systems comply with the requirements of Directive 78/318/EEC as amended by this Directive. 2. With effect from 1 January 1996 Member States: - shall no longer grant EEC type-approval, and - may refuse to grant national type-approval for a type of vehicle on grounds relating to windscreen wiper and washer systems and for a type of windscreen wiper and washer system if the requirements of Directive 78/318/EEC, as amended by this Directive, are not fulfilled. 3. Notwithstanding paragraph 2 above, for the purposes of replacement parts, Member States shall continue to grant EEC type-approval of windscreen wiper and washer systems in accordance with the original version of Directive 78/318/EEC, provided that such windscreen washer systems: - are intended to be fitted to vehicles already in use, and - comply with the requirements of that Directive as they were applicable when the vehicles were first registered. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1995 and shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the legal provisions subsequently adopted in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

31994L0069

1994

Commission Directive 94/69/EC of 19 December 1994 adapting to technical progress for the twenty-first time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substancesSVolume I and Volume IIS(Annex I: Nos 006-001-00-2 to 650-015-00-7 and Annex II: Nos 006- 076-00-1 to 649-550-00-9) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 93/101/EC (2), and in particular Article 28 thereof, Whereas Annex I of Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance; Whereas present scientific and technical knowledge has shown that the list of dangerous substances in Annex I should be adapted and augmented, particularly to include a number of complex coal- and oil-derived substances, and whereas in consequence it is necessary to amend the Foreword to Annex I to include notas and particulars relating to the identification and labelling of complex coal- and oil-derived substances and corresponding preparations; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Annex I of Directive 67/548/EEC is hereby amended as follows: 1. the foreword in Annex I to this Directive replaces the foreword to Annex I; 2. the entries in Annex I to this Directive replace the corresponding entries in Annex I of Directive 67/548/EEC; 3. the entries in Annex II to this Directive are included for the first time in Annex I of Directive 67/548/EEC. Article 2 Not later than 1 September 1996, the Member States shall implement the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31994L0060

1994

European Parliament and Council Directive 94/60/EC of 20 December 1994 amending for the 14th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Comittee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas measures should be adopted for the achievement of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is guaranteed; Whereas work on the internal market should also gradually improve the quality of life, health protection and consumer safety; whereas the measures proposed by this Directive are in line with the Council resolution of 9 November 1989 on future priorities for relaunching consumer protection policy (4); Whereas the Council and the Representatives of the Governments of the Member States, meeting within the Council, adopted Decision 90/238/Euratom, ECSC, EEC (5) concerning a 1990 to 1994 action plan in the context of the 'Europe against Cancer` programme; Whereas the substances which appear in Annex I to Council Directive 67/548/EEC (6) and are classified as carcinogens category 1 or 2 may cause cancer; whereas to improve health protection such substances and preparations containing them should not be placed on the market for use by the general public; Whereas the substances which appear in Annex I to Directive 67/548/EEC and are classified as mutagens category 1 or 2 may cause heritable genetic damage; whereas to improve health protection such substances and preparations containing them should not be placed on the market for use by the general public; Whereas the substances which appear in Annex I to Directive 67/548/EEC and are classified as toxic for reproductive purposes category 1 or 2 may cause birth defects; whereas to improve health protection such substances and preparations containing them should not be placed on the market for use by the general public; Whereas, for reasons of transparency and clarity, such substances should be referred to using a recognized nomenclature, preferably that of the Iupac (International Union of Pure and Applied Chemistry); whereas Annex I to Directive 67/548/EEC ('List of dangerous substances`) is regularly updated by way of adaptation to technical progress; whereas the Commission will submit to the European Parliament and the Council, no later than six months after publication of such adaptation to technical progress in the Official Journal of the European Communities, a proposal for a Directive governing the substances newly classified as carcinogenic in categories 1 and 2, mutagenic in categories 1 and 2, and toxic for reproductive purposes in categories 1 and 2, so as to update this Directive; Whereas the said proposal from the Commission will take account of the risks and advantages of the substances newly classified as well as of the Community legislative provisions on risk analysis; Whereas Annex I to Directive 67/548/EEC lays down individual concentration limits for such substances and, in the absence of such limits, Table VI of Annex I to Council Directive 88/379/EEC (1), lays down general concentration limits which apply to such substances contained in preparations; Whereas creosote, as defined in the Annex to this Directive, may be damaging to health because of its content of known carcinogens; whereas for these reasons the use of creosote in wood treatment and the marketing and use of creosote-treated wood should be limited; Whereas some of the components of creosote are poorly degradable and deleterious to certain organisms in the environment; whereas these components may enter the environment as a result of the use of treated wood; Whereas some chlorinated solvents present a danger to health and should not be marketed to the general public in substances and preparations; Whereas the restrictions on the use of creosote in wood treatment, on the marketing and use of creosote-treated wood and on the marketing and use of chlorinated solvents laid down by this Directive take into account the current state of knowledge and techniques regarding safer alternatives; Whereas restrictions already adopted by certain Member States on the marketing and use of the substances mentioned above or the preparations containing them directly affect the establishment and functioning of the internal market; whereas it is therefore necessary to approximate the laws of the Member States in this field and consequently amend Annex I to Council Directive 76/769/EEC (2); Whereas this Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC (3) and in individual directives based thereon, in particular Directive 90/394/EEC (4), Article 1 Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex hereto. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than one year after the date of its adoption and shall forthwith inform the Commission thereof. They shall apply these provisions as from 20 June 1995. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive is addressed to the Member States.

31994L0062

1994

European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas the differing national measures concerning the management of packaging and packaging waste should be harmonized in order, on the one hand, to prevent any impact thereof on the environment or to reduce such impact, thus providing a high level of environmental protection, and, on the other hand, to ensure the functioning of the internal market and to avoid obstacles to trade and distortion and restriction of competition within the Community; Whereas the best means of preventing the creation of packaging waste is to reduce the overall volume of packaging; Whereas it is important, in relation of the objectives of this Directive, to respect the general principle that measures taken in one Member State to protect the environment should not adversely affect the ability of other Member States to achieve the objectives of the Directive; Whereas the reduction of waste is essential for the sustainable growth specifically called for by the Treaty on European Union; Whereas this Directive should cover all types of packaging placed on the market and all packaging waste; whereas; therefore, Council Directive 85/339/EEC of 27 June 1985 on containers of liquids for human consumption (4) should be repealed; Whereas packaging has a vital social and economic function and therefore measures provided for in this Directive should apply without prejudice to other relevant legislative requirements affecting quality and transport of packaging or packaged goods; Whereas, in line with the Community strategy for waste management set out in Council resolution of 7 May 1990 on waste policy (5) and Council Directive 75/442/EEC of 15 July 1975 on waste (6), the management of packaging and packaging waste should include as a first priority, prevention of packaging waste and, as additional fundamental principles, reuse of packaging, recycling and other forms of recovering packaging waste and, hence, reduction of the final disposal of such waste; Whereas, until scientific and technological progress is made with regard to recovery processes, reuse and recycling should be considered preferable in terms of environmental impact; whereas this requires the setting up in the Member States of systems guaranteeing the return of used packaging and/or packaging waste; whereas life-cycle assessments should be completed as soon as possible to justify a clear hierarchy between reusable, recyclable and recoverable packaging; Whereas prevention of packaging waste shall be carried out through appropriate measures, including initiatives taken within the Member States in accordance with the objectives of this Directive; Whereas Member States may encourage, in accordance with the Treaty, reuse systems of packaging which can be reused in an environmentally sound manner, in order to take advantage of the contribution of such systems to environmental protection; Whereas from an environmental point of view recycling should be regarded as an important part of recovery with a particular view to reducing the consumption of energy and of primary raw materials and the final disposal of waste; Whereas energy recovery is one effective means of packaging waste recovery; Whereas targets set in Member States for the recovery and recycling of packaging waste should be confined within certain ranges so as to take account of the different situations in Member States and to avoid creating barriers to trade and distortion of competition; Whereas, in order to achieve results in the medium term and to give economic operators, consumers and public authorities the necessary perspective for the longer term, a medium-term deadline should be set for attaining the aforementioned targets and a long-term deadline set for targets to be determined at a later stage with a view to substantially increasing those targets; Whereas the European Parliament and the Council should, on the basis of reports by the Commission, examine the practical experience gained in Member States in working towards the aforementioned targets and the findings of scientific research and evaluation techniques such as eco-balances; Whereas Member States which have, or will set, programmes going beyond such target ranges should be permitted to pursue those targets in the interest of a high level of environmental protection on condition shat such measures avoid disturbances on the internal market and do not prevent other Member States from complying with this Directive; whereas the Commission should confirm such measures after appropriate verification; Whereas, on the other hand, certain Member States may be allowed to adopt lower targets because of the specific circumstances in those Member States, on condition that they achieve a minimum target for recovery within the standard deadline, and the standard targets by a later deadline; Whereas the management of packaging and packaging waste requires the Member States to set up return, collection and recovery systems; whereas such systems should be open to the participation of all interested parties and be designed to avoid discrimination against imported products and barriers to trade or distortions of competition and to guarantee the maximum possible return of packaging and packaging waste, in accordance with the Treaty; Whereas the issue of Community marking of packaging requires further study, but should be decided by the Community in the near future; Whereas, in order to minimize the impact of packaging and packaging waste on the environment and to avoid barriers to trade and distortion of competition, it is also necessary to define the essential requirements governing the composition and the reusable and recoverable (including recyclable) nature of packaging; Whereas the presence of noxious metals and other substances in packaging should be limited in view of their environmental impact (in particular in the light of their likely presence in emissions or ash when packaging is incinerated, or in leachate when packaging is landfilled); whereas it is essential, as a first step towards reducing the toxicity of packaging waste, to prevent the addition of noxious heavy metals to packaging and ensure that such substances are not released into the environment, with appropriate exemptions which should be determined by the Commission in specific cases under a Committee procedure; Whereas, if a high level of recycling is to be attained and health and safety problems are to be avoided by those employed to collect and process packaging waste, it is essential for such waste to be sorted at source; Whereas the requirements for the manufacturing of packaging should not apply to packaging used for a given product before the date of entry into force of this Directive; whereas a transition period for the marketing of packaging is also required; Whereas the timing of the provision on the placing on the market of packaging which meets all essential requirements should take account of the fact that European standards are being prepared by the competent standardization body; whereas, however, the provisions on means of proof of conformity of national standards should apply without delay; Whereas the preparation of European standards for essential requirements and other related issues should be promoted; Whereas the measures provided for in this Directive imply the development of recovery and recycling capacities and market outlets for recycled packaging materials; Whereas the inclusion of recycled material in packaging should not contradict relevant provisions on hygiene, health and consumer safety; Whereas Community-wide data on packaging and packaging waste are needed in order to monitor the implementation of the objectives of this Directive; Whereas it is essential that all those involved in the production, use, import and distribution of packaging and packaged products become more aware of the extent to which packaging becomes waste, and that in accordance with the polluter-pays principle they accept responsibility for such waste; whereas the development and implementation of the measures provided for in this Directive should involve and require the close cooperation of all the partners, where appropriate, within a spirit of shared responsibility; Whereas consumers play a key role in the management of packaging and packaging waste and thus have to be adequately informed in order to adapt their behaviour and attitudes; Whereas the inclusion of a specific chapter on the management of packaging and packaging waste in the waste management plans required pursuant to Directive 75/442/EEC will contribute to the effective implementation of this Directive; Whereas, in order to facilitate the achievement of the objectives of this Directive, it may be appropriate for the Community and the Member States to use economic instruments in accordance with the provisions of the Treaty, so as to avoid new forms of protectionism; Whereas Member States should, without prejudice to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (1), notify the Commission of drafts of any measures they intend to adopt before adopting them, so that it can be established whether or not they comply with the Directive; Whereas the adaptation to scientific and technical progress of the packaging identification system and the formats relating to a database system should be ensured by the Commission under a committee procedure; Whereas it is necessary to provide for specific measures to be taken to deal with any difficulties encountered in the implementation of this Directive in accordance, where appropriate, with the same committee procedure, Article 1 Objectives 1. This Directive aims to harmonize national measures concerning the management of packaging and packaging waste in order, on the one hand, to prevent any impact thereof on the environment of all Member States as well as of third countries or to reduce such impact, thus providing a high level of environmental protection, and, on the other hand, to ensure the functioning of the internal market and to avoid obstacles to trade and distortion and restriction of competition within the Community. 2. To this end this Directive lays down measures aimed, as a first priority, at preventing the production of packaging waste and, as additional fundamental principles, at reusing packaging, at recycling and other forms of recovering packaging waste and, hence, at reducing the final disposal of such waste. Article 2 Scope 1. This Directive covers all packaging placed on the market in the Community and all packaging waste, whether it is used or released at industrial, commercial, office, shop, service, household or any other level, regardless of the material used. 2. This Directive shall apply without prejudice to existing quality requirements for packaging such as those regarding safety, the protection of health and the hygiene of the packed products or to existing transport requirements or to the provisions of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (2). Article 3 Definitions For the purposes of this Directive: 1. 'packaging` shall mean all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer. 'Non-returnable` items used for the same purposes shall also be considered to constitute packaging. 'Packaging` consists only of: (a) sales packaging or primary packaging, i. e. packaging conceived so as to constitute a sales unit to the final user or consumer at the point of purchase; (b) grouped packaging or secondary packaging, i. e. packaging conceived so as to constitute at the point of purchase a grouping of a certain number of sales units whether the latter is sold as such to the final user or consumer or whether it serves only as a means to replenish the shelves at the point of sale; it can be removed from the product without affecting its characteristics; (c) transport packaging or tertiary packaging, i. e. packaging conceived so as to facilitate handling and transport of a number of sales units or grouped packagings in order to prevent physical handling and transport damage. Transport packaging does not include road, rail, ship and air containers; 2. 'packaging waste` shall mean any packaging or packaging material covered by the definition of waste in Directive 75/442/EEC, excluding production residues; 3. 'packaging waste management` shall mean the management of waste as defined in Directive 75/442/EEC; 4. 'prevention` shall mean the reduction of the quantity and of the harmfulness for the environment of: - materials and substances contained in packaging and packaging waste, - packaging and packaging waste at production process level and at the marketing, distribution, utilization and elimination stages, in particular by developing 'clean` products and technology; 5. 'reuse` shall mean any operation by which packaging, which has been conceived and designed to accomplish within its life cycle a minimum number of trips or rotations, is refilled or used for the same purpose for which it was conceived, with or without the support of auxiliary products present on the market enabling the packaging to be refilled; such reused packaging will become packaging waste when no longer subject to reuse; 6. 'recovery` shall mean any of the applicable operations provided for in Annex II.B to Directive 75/442/EEC; 7. 'recycling` shall mean the reprocessing in a production process of the waste materials for the original purpose or for other purposes including organic recycling but excluding energy recovery; 8. 'energy recovery` shall mean the use of combustible packaging waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat; 9. 'organic recycling` shall mean the aerobic (composting) or anaerobic (biomethanization) treatment, under controlled conditions and using micro-organisms, of the biodegradable parts of packaging waste, which produces stabilized organic residues or methane. Landfill shall not be considered a form of organic recycling; 10. 'disposal` shall mean any of the applicable operations provided for in Annex II.A to Directive 75/442/EEC; 11. 'economic operators` in relation to packaging shall mean suppliers of packaging materials, packaging producers and converters, fillers and users, importers, traders and distributors, authorities and statutory organizations; 12. 'voluntary agreement` shall mean the formal agreement concluded between the competent public authorities of the Member State and the economic sectors concerned, which has to be open to all partners who wish to meet the conditions of the agreement with a view to working towards the objectives of this Directive. Article 4 Prevention 1. Member States shall ensure that, in addition to the measures to prevent the formation of packaging waste taken in accordance with Article 9, other preventive measures are implemented. Such other measures may consist of national programmes or similar actions adopted, if appropriate in consultation with economic operators, and designed to collect and take advantage of the many initiatives taken within Member States as regards prevention. They shall comply with the objectives of this Directive as defined in Article 1 (1). 2. The Commission shall help to promote prevention by encouraging the development of suitable European standards, in accordance with Article 10. Article 5 Member States may encourage reuse systems of packaging, which can be reused in an environmentally sound manner, in conformity with the Treaty. Article 6 Recovery and recycling 1. In order to comply with the objectives of this Directive, Member States shall take the necessary measures to attain the following targets covering the whole of their territory; (a) no later than five years from the date by which this Directive must be implemented in national law, between 50 % as a minimum and 65 % as a maximum by weight of the packaging waste will be recovered; (b) within this general target, and with the same time limit, between 25 % as a minimum and 45 % as a maximum by weight of the totality of packaging materials contained in packaging waste will be recycled with a minimum of 15 % by weight for each packaging material; (c) no later than 10 years from the date by which this Directive must be implemented in national law, a percentage of packaging waste will be recovered and recycled, which will have to be determined by the Council in accordance with paragraph 3 (b) with a view to substantially increasing the targets mentioned in paragraphs (a) and (b). 2. Member States shall, where appropriate, encourage the use of materials obtained from recycled packaging waste for the manufacturing of packaging and other products. 3. (a) The European Parliament and the Council shall, on the basis of an interim report by the Commission, and four years from the date referred to in paragraph 1 (a) on the basis of a final report, examine the practical experience gained in the Member States in the pursuance of the targets and objective laid down in paragraphs 1 (a) and (b) and 2 and the findings of scientific research and evaluation techniques such as eco-balances. (b) No later than six months before the end of the first five-year phase referred to in paragraph 1 (a) the Council shall, acting by qualified majority and on a proposal from the Commission, fix targets for the second five-year phase referred to in paragraph 1 (c). This process shall be repeated every five years thereafter. 4. The measures and targets referred to in paragraph 1 (a) and (b) shall be published by the Member States and shall be the subject of an information campaign for the general public and economic operators. 5. Greece, Ireland and Portugal may, because of their specific situation, i. e. respectively the large number of small islands, the presence of rural and mountain areas and the current low level of packaging consumption, decide to: (a) attain, no later than five years from the date of implementation of this Directive, lower targets than those fixed in paragraph 1 (a) and (b), but shall at least attain 25 % for recovery; (b) postpone at the same time the attainment of the targets in paragraph 1 (a) and (b) to a later deadline which, however, shall not exceed 31 December 2005. 6. Member States which have, or will, set programmes going beyond the targets of paragraph 1 (a) and (b) and which provide to this effect appropriate capacities for recycling and recovery, are permitted to pursue those targets in the interest of a high level of environmental protection, on condition that these measures avoid distortions of the internal market and do not hinder compliance by other Member States with the Directive. Member States shall inform the Commission thereof. The Commission shall confirm these measures, after having verified, in cooperation with the Member States, that they are consistent with the considerations above and do not constitute an arbitrary means of discrimination or a disguised restriction on trade between Member States. Article 7 Return, collection and recovery systems 1. Member States shall take the necessary measures to ensure that systems are set up to provide for: (a) the return and/or collection of used packaging and/or packaging waste from the consumer, other final user, or from the waste stream in order to channel it to the most appropriate waste management alternatives; (b) the reuse or recovery including recycling of the packaging and/or packaging waste collected, in order to meet the objectives laid down in this Directive. These systems shall be open to the participation of the economic operators of the sectors concerned and to the participation of the competent public authorities. They shall also apply to imported products under non-discriminatory conditions, including the detailed arrangements and any tariffs imposed for access to the systems, and shall be designed so as to avoid barriers to trade or distortions of competition in conformity with the Treaty. 2. The measures referred to in paragraph 1 shall form part of a policy covering all packaging and packaging waste and shall take into account, in particular, requirements regarding the protection of environmental and consumer health, safety and hygiene; the protection of the quality,the authenticity and the technical characteristics of the packed goods and materials used; and the protection of industrial and commercial property rights. Article 8 Marking and identification system 1. The Council shall, in accordance with the conditions laid down in the Treaty, decide no later than two years after the entry into force of this Directive on the marking of packaging. 2. To facilitate collection, reuse and recovery including recycling, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. To that end, the Commission shall, not later than 12 months after the entry into force of this Directive determine, on the basis of Annex I and in accordance with the procedure laid down in Article 21, the numbering and abbreviations on which the identification system is based and shall specify which materials shall be subject to the identification system in accordance with the same procedure. 3. Packaging shall bear the appropriate marking either on the packaging itself or on the label. It shall be clearly visible and easily legible. The marking shall be appropriately durable and lasting, including when the packaging is opened. Article 9 Essential requirements 1. Member States shall ensure that three years from the date of the entry into force of this Directive, packaging may be placed on the market only if it complies with all essential requirements defined by this Directive including Annex II. 2. Member States shall, from the date set out in Article 22 (1), presume compliance with all essential requirements set out in this Directive including Annex II in the case of packaging which complies: (a) with the relevant harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities. Member States shall publish the reference numbers of national standards transposing these harmonized standards; (b) with the relevant national standards referred to in paragraph 3 in so far as, in the areas covered by such standards, no harmonized standards exist. 3. Member States shall communicate to the Commission the text of their national standards, as referred to in paragraph 2 (b), which they deem to comply with the requirements referred to in this Article. The Commission shall forward such texts forthwith to the other Member States. Member States shall publish the references of these standards. The Commission shall ensure that they are published in the Official Journal of the European Communities. 4. Where a Member State or the Commission considers that the standards referred to in paragraph 2 do not entirely meet the essential requirements referred to in paragraph 1, the Commission or the Member State concerned shall bring the matter before the Committee set up by Directive 83/189/EEC giving the reasons therefor. This Committee shall deliver an opinion without delay. In the light of the Committee's opinion, the Commission shall inform Member States whether or not it is necessary to withdraw those standards from the publications referred to in paragraphs 2 and 3. Article 10 Standardization The Commission shall promote, as appropriate, the preparation of European standards relating to the essential requirements referred to in Annex II. The Commission shall promote, in particular, the preparation of European standards relating to: - criteria and methodologies for life-cycle analysis of packaging, - the methods for measuring and verifying the presence of heavy metals and other dangerous substances in the packaging and their release into the environment from packaging and packaging waste, - criteria for a minimum content of recycled material in packaging for appropriate types of packaging, - criteria for recycling methods, - criteria for composting methods and produced compost, - criteria for the marking of packaging. Article 11 Concentration levels of heavy metals present in packaging 1. Member States shall ensure that the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components shall not exceed the following: - 600 ppm by weight two years after the date referred to in Article 22 (i); - 250 ppm by weight three years after the date referred to in Article 22 (i); - 100 ppm by weight five years after the date referred to in Article 22 (i). 2. The concentration levels referred to in paragraph 1 shall not apply to packaging entirely made of lead crystal glass as defined in Directive 69/493/EEC (1). 3. The Commission shall, in accordance with the procedure laid down in Article 21, determine: - the conditions under which the above concentration levels will not apply to recycled materials and to product loops which are in a closed and controlled chain, - the types of packaging which are exempted from the requirement referred to in paragraph 1, third indent. Article 12 Information systems 1. Member States shall take the necessary measures to ensure that databases on packaging and packaging waste are established, where not already in place, on a harmonized basis in order to contribute to enabling Member States and the Commission to monitor the implementation of the objectives set out in this Directive. 2. To this effect, the databases shall provide in particular information on the magnitude, characteristics and evolution of the packaging and packaging waste flows (including information on the toxicity or danger of packaging materials and components used for their manufacture) at the level of individual Member States. 3. In order to harmonize the characteristics and presentation of the data produced and to make the data of the Member States compatible, Member States shall provide the Commission with their available data by means of formats which shall be adopted by the Commission one year from the date of entry into force of this Directive on the basis of Annex III, in accordance with the procedure laid down in Article 21. 4. Member States shall take into account the particular problems of small and medium-sized enterprises in providing detailed data. 5. The data obtained shall be made available with the national reports referred to in Article 17 and shall be updated in subsequent reports. 6. Member States shall require all economic operators involved to provide competent authorities with reliable data on their sector as required in this Article. Article 13 Information for users of packaging Member States shall take measures, within two years of the date referred to in Article 22 (1), to ensure that users of packaging, including in particular consumers, obtain the necessary information about: - the return, collection and recovery systems available to them, - their role in contributing to reuse, recovery and recycling of packaging and packaging waste, - the meaning of markings on packaging existing on the market, - the appropriate elements of the management plans for packaging and packaging waste as referred to in Article 14. Article 14 Management Plans In pursuance of the objectives and measures referred to in this Directive, Member States shall include in the waste management plans required pursuant to Article 17 of Directive 75/442/EEC, a specific chapter on the management of packaging and packaging waste, including measures taken pursuant to Articles 4 and 5. Article 15 Economic instruments Acting on the basis of the relevant provisions of the Treaty, the Council adopts economic instruments to promote the implementation of the objectives set by this Directive. In the absence of such measures, the Member States may, in accordance with the principles governing Community environmental policy, inter alia, the polluter-pays principle, and the obligations arising out of the Treaty, adopt measures to implement those objectives. Article 16 Notification 1. Without prejudice to Directive 83/189/EEC, before adopting such measures, Member States shall notify the drafts of measures which they intend to adopt within the framework of this Directive to the Commission, excluding measures of a fiscal nature, but including technical specifications linked to fiscal measures which encourage compliance with such technical specifications, in order to permit the latter to examine them in the light of existing provisions following in each case the procedure under the above Directive. 2. If the proposed measure is also a technical matter within the meaning of Directive 83/189/EEC, the Member State concerned may indicate, when following the notification procedures referred to in this Directive, that the notification is equally valid for Directive 83/189/EEC. Article 17 Obligation to report Member States shall report to the Commission on the application of this Directive in accordance with Article 5 of Council Directive 91/692/EEC of 23 December 1991 standardizing and rationalizing reports on the implementation of certain Directives relating to the environment (1). The first report shall cover the period 1995 to 1997. Article 18 Freedom to place on the market Member States shall not impede the placing on the market of their territory of packaging which satisfies the provisions of this Directive. Article 19 Adaptation to scientific and technical progress The amendments necessary for adapting to scientific and technical progress the identification system - as referred to in Article 8 (2), Annex I and Article 10, last indent - and the formats relating to the database system - as referred to in Article 12 (3) and Annex III - shall be adopted in accordance with the procedure laid down in Article 21. Article 20 Specific measures 1. The Commission, in accordance with the procedure laid down in Article 21, shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive in particular to primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging. 2. The Commission shall also present a report to the European Parliament and the Council on any other measure to be taken, if appropriate accompanied by a proposal. Article 21 Committee procedure 1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. (b) >If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period which may in no case exceed three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 22 Implementation in national law 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 30 June 1996. They shall immediately inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. the methods for making such reference shall be laid down by the Member States. 3. In addition, Member States shall communicate to the Commission all existing laws, regulations and administrative provisions adopted within the scope of this Directive. 4. The requirements for the manufacturing of packaging shall in no case apply to packaging used for a given product before the date of entry into force of this Directive. 5. Member States shall, for a period not exceeding five years from the date of the entry into force of the present Directive, allow the placing on the market of packaging manufactured before this date and which is in conformity with their existing national law. Article 23 Directive 85/339/EEC is hereby repealed with effect from the date referred to in Article 22 (1). Article 24 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 25 This Directive is addressed to the Member States.

31994L0063

1994

European Parliament and Council Directive 94/63/EC of 20 December 1994 on the control of volatile organic compound (VOC) emissions resulting from the storage of petrol and its distribution from terminals to service stations Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas successive programmes of action of the European Communities on the protection of the environment (4) have stressed the importance of preventing and reducing air pollution; Whereas emissions of volatile organic compounds (VOCs) from petrol and solvents in the Community would be in the order of 10 million tonnes per year if no control measures were taken; whereas VOC emissions contribute to the formation of photochemical oxidants such as ozone, which in high concentrations can impair human health and damage vegetation and materials; whereas some of the VOC emissions from petrol are classified as toxic, carcinogenic or teratogenic; Whereas on 2 April 1992 the Community signed the Protocol to the 1979 Convention on long range transboundary air pollution concerning the control of emissions of volatile organic compounds (VOCs) or their transboundary fluxes, which provides for a considerable reduction of the VOC emissions; Whereas a significant step in a strategy for an overall reduction of VOC emissions in the Community was taken by Council Directive 91/441/EEC of 26 June 1991 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (5) which aims at reducing by some 80 to 90 %, over 10 to 15 years, VOC emissions from tail-pipe exhaust gases and evaporative emissions from motor vehicles, representing some 40 % of the present emissions of man-made VOCs to the atmosphere; whereas, at the time of adoption of that Directive, the Commission was requested to submit a proposal for a Directive on the measures to reduce evaporation losses at every stage in the process of storage and distribution of motor fuels; Whereas the VOC emissions from the system for storage and distribution of petrol represent some 500 000 tonnes per year or some 5 % of the total emissions of man-made VOCs in the Community; whereas these emissions, represent a significant contribution to air pollution especially in urban areas; Whereas available technologies can ensure a considerable reduction of the evaporative losses in the distribution system for petrol, not least through the recovery of vapours which are displaced; Whereas, on grounds of international standardization and of safety during the loading of ships, standards must be drawn up at International Maritime Organization level for vapour control and recovery systems to apply to both loading installations and ships; whereas the Community must therefore endeavour to ensure that the necessary provisions are introduced into the Marpol Convention during the current revision of Marpol due to be completed in 1996; whereas in the event that the Marpol Convention is not so revised, the Community, after discussion with its major trading partners, should propose appropriate measures to apply to ships and port installations servicing ships; Whereas further action will be needed to reduce the vapour emissions during refuelling operations at service stations, which at present amount so some 200 000 tonnes per year, thereby controlling all vapour emissions during the distribution of petrol; Whereas, in order to avoid distortion of competition and in order to ensure the operation of the internal market, it is necessary to harmonize certain measures concerning the distribution of petrol on the basis of a high level of environmental protection; Whereas account should nevertheless be taken of the advantages and burdens which may result from action or the absence of action; whereas it is therefore appropriate to provide for the possibility of derogations and sometimes of exclusions in certain cases; whereas certain Member States should also be given the option of longer periods in which to adapt in order to take account of any major environmental measures of differing kinds which they may already have adopted in this area or of the particular burden imposed by the measures in this Directive owing to the structure of their networks; Whereas Community action must take account of environmental conditions in the various regions of the Community; whereas in this connection Member States must be able to uphold or impose more stringent measures relating to the evaporative losses from fixed installations throughout their territory or in geographical areas where it is established that such measures are necessary for the protection of human health or the environment because of special conditions; Whereas the provisions of paragraph 1 of Articles 3, 4 and 6 of this Directive apply without prejudice to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations; Whereas it is necessary to introduce harmonized specifications for the equipment for bottom loading of road tankers in order to ensure the possibility of free trade in petrol and equipment within the Community and to ensure a high level of safety; whereas provision should be made for standardizing such specifications and adapting them to technical progress; Whereas a committee should be set up to assist the Commission in adapting the Annexes to this Directive to technical progress, Article 1 Scope This Directive shall apply to the operations, installations, vehicles and vessels used for storage, loading and transport of petrol from one terminal to another or from a terminal to a service station. Article 2 Definitions For the purpose of this Directive: (a) 'petrol` shall mean any petroleum derivative, with or without additives, having a reid vapour pressure of 27,6 kilopascals or more, which is intended for use as a fuel for motor vehicles, except liquefied petroleum gas (LPG); (b) 'vapours` shall mean any gaseous compound which evaporates from petrol; (c) 'storage installation` shall mean any stationary tank at a terminal used for the storage of petrol; (d) 'terminal` shall mean any facility which is used for the storage and loading of petrol onto road tankers, rail tankers, or vessels, including all storage installations on the site of the facility; (e) 'mobile container` shall mean any tank, transported by road, rail or waterways used for the transfer of petrol from one terminal to another or from a terminal to a service station; (f) 'service station` shall mean any installation where petrol is dispensed to motor vehicle fuel tanks from stationary storage tanks; (g) 'existing` petrol storage installations, loading installations, service stations and mobile containers shall mean such installations, service stations and mobile containers which were in operation before the date referred to in Article 10 or for which an individual construction licence or operating licence, where required under national legislation, was granted before the date referred to in Article 10; (h) 'new` in relation to petrol storage installations, loading installations, service stations and mobile containers shall mean such installations, service stations and mobile containers which are not covered by paragraph (g); (i) 'throughput` shall mean the largest total annual quantity of petrol loaded from a storage installation at a terminal or from a service station into mobile containers during the three preceding years; (j) 'vapour-recovery unit` shall mean equipment for the recovery of petrol from vapours including any buffer reservoir systems at a terminal; (k) 'vessel` shall mean an inland waterway vessel as defined in Chapter 1 of Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels (1); (l) 'target reference value` shall mean the guideline given for the overall assessment of the adequacy of technical measures in the Annexes and is not a limit value against which the performance of individual installations, terminals and service stations will be measured; (m) 'intermediate storage of vapours` shall mean the intermediate storage of vapours in a fixed roof tank at a terminal for later transfer to and recovery at another terminal. The transfer of vapours from one storage installation to another at a terminal shall not be considered as intermediate storage of vapour within the meaning of this Directive; (n) 'loading installation` shall mean any facility at a terminal at which petrol can be loaded onto mobile containers. Loading installations for road tankers comprise one or more 'gantries`; (o) 'gantry` shall mean any structure at a terminal at which petrol can be loaded on to a single road tanker at any one time. Article 3 Storage installations at terminals 1. Storage installations shall be designed and operated in accordance with the technical provisions of Annex I. These provisions are designed to reduce the total annual loss of petrol resulting from loading and storage at each storage installation at terminals to below the target reference value of 0,01 weight by weight (w/w) % of the throughput. Member States may maintain or require more stringent measures throughout their territory or in geographical areas where it is established that such measures are necessary for the protection of human health or the environment owing to specific conditions. Member States may adopt technical measures for the reduction of losses of petrol other than those set down in Annex I if such alternative measures are demonstrated to have at least the same efficiency. Member States shall inform the other Member States and the Commission of any existing measures or of any special measures referred to in this paragraph which they contemplate taking and of their grounds for taking them. 2. The provisions of paragraph 1 shall apply: (a) from the date referred to in Article 10 for new installations; (b) three years from the date referred to in Article 10 for existing installations if the throughput loaded at a terminal is greater than 50 000 tonnes/year; (c) six years from the date referred to in Article 10 for existing installations if the throughput loaded at a terminal is greater than 25 000 tonnes/year; (d) nine years from the date referred to in Article 10 for all other existing storage installations at terminals. Article 4 Loading and unloading of mobile containers at terminals 1. Loading and unloading equipment shall be designed and operated in accordance with the technical provisions of Annex II. These provisions are designed to reduce the total annual loss of petrol resulting from loading and unloading of mobile containers at terminals to below the target reference value of 0,005 w/w % of the throughput. Member States may maintain or require more stringent measures throughout their territory or in geographical areas where it is established that such measures are necessary for the protection of human health or the environment owing to specific conditions. Member States may adopt technical measures for the reduction of losses of petrol other than those set down in Annex II if such alternative measures are demonstrated to have at least the same efficiency. Member States shall inform the other Member States and the Commission of any existing measures or of any special measures referred to in this paragraph which they contemplate taking and of their grounds for taking them. The Commission shall verify the compatibility of these measures with the provisions of the Treaty and those of this paragraph. All terminals with loading facilities for road tankers shall be equipped with at least one gantry which meets the specifications for bottom-loading equipment laid down in Annex IV. These specifications shall be re-examined at regular intervals and, if appropriate, shall be revised in accordance with the procedure laid down in Article 8. 2. The provisions of paragraph 1 shall apply: (a) from the date referred to in Article 10 for new terminals for loading onto road tankers, rail tankers and/or vessels; (b) three years from the date referred to in Article 10 for existing terminals for loading onto road tankers, rail tankers and/or vessels if the throughput is greater than 150 000 tonnes/year; (c) six years from the date referred to in Article 10 for existing terminals for loading onto road tankers and rail tankers if the throughput is greater than 25 000 tonnes/year; (d) nine years from the date referred to in Article 10 for all other existing loading installations at terminals for loading onto road tankers and rail tankers. 3. Nine years after the date referred to in Article 10 the requirements for bottom-loading equipment set in Annex IV shall apply to all road tanker loading gantries at all terminals unless exempted under the terms of paragraph 4. 4. By way of derogation, paragraphs 1 and 3 shall not apply: (a) to existing terminals with a throughput of less than 10 000 tonnes/year and; (b) to new terminals with a throughput of less than 5 000 tonnes/year located in small remote islands. Member States shall inform the Commission of terminals concerned by such a derogation through the reporting arrangements referred to in Article 9. 5. The Kingdom of Spain may grant a derogation of one year from the time limit set down in paragraph 2 (b). Article 5 Mobile containers 1. Mobile containers shall be designed and operated in accordance with the following requirements: (a) mobile containers shall be designed and operated so that residual vapours are retained in the container after unloading of petrol; (b) mobile containers which supply petrol to service stations and terminals shall be designed and operated so as to accept and retain return vapours from the storage installations at the service stations or terminals. For rail tankers this is only required if they supply petrol to service stations or to terminals where intermediate storage of vapours is used; (c) except for release through the pressure relief valves, the vapours mentioned in subparagraphs (a) and (b) shall be retained in the mobile container until reloading takes place at a terminal. If after the unloading of petrol the mobile container is subsequently used for products other than petrol, in so far as vapour recovery or intermediate storage of vapours is not possible, ventilation may be permitted in a geographical area where emissions are unlikely to contribute significantly to environmental or health problems; (d) the Member States' competent authorities must ensure that road tankers are regularly tested for vapour tightness and that vacuum/pressure valves on all mobile containers are periodically inspected for correct functioning. 2. The provisions of paragraph 1 shall apply: (a) from the date referred to in Article 10 for new road tankers, rail tankers and vessels; (b) three years from the date referred to in Article 10 for existing rail tankers and vessels if loaded at a terminal to which the requirement of Article 4 (1) applies; (c) for existing road tankers when retrofitted for bottom loading in accordance with the specifications laid down in Annex IV. 3. By way of derogation, the provisions of paragraph 1, subparagraphs (a), (b) and (c) shall not apply to losses of vapours resulting from measuring operations using dipsticks in relation to: (a) existing mobile containers; and (b) new mobile containers which come into operation during the four years following the date referred to in Article 10. Article 6 Loading into storage installations at service stations 1. Loding and storage equipment shall be designed and operated in accordance with the technical provisions of Annex III. These provisions are designed to reduce the total annual loss of petrol resulting from loading into storage installations at service stations to below the target reference value of 0,01 w/w % of the throughput. Member States may maintain or require more stringent measures throughout their territory or in geographical areas where it is established that such measures are necessary for the protection of human health or the environment owing to specific conditions. Member States may adopt technical measures for the reduction of losses of petrol other than those set down in Annex III if such alternative measures are demonstrated to have at least the same efficiency. Member States shall inform the other Member States and the Commission of any existing measures or of any special measures referred to in this paragraph which they contemplate taking and of their grounds for taking them. 2. The provisions of paragraph 1 shall apply: (a) from the date referred to in Article 10 for new service stations; (b) three years from the date referred to in Article 10: - for existing service stations with a throughput greater than 1 000 m3/year, - for existing service stations, regardless of their throughput, which are located under permanent living quarters or working areas; (c) six years from the date referred to in Article 10 for existing service stations with a throughput greater than 500 m3/year; (d) nine years from the date referred to in Article 10 for all other existing service stations. 3. By way of derogation, paragraphs 1 and 2 shall not apply to service stations with a throughput of less than 100 m3/year. 4. For service stations with an annual throughput of less than 500 m3/year, Member States may grant a derogation from the requirements of paragraph 1 where the service station is located in a geographical area or on a site where vapour emissions are unlikely to contribute significantly to environmental or health problems. Member States shall inform the Commission of the details of the areas within which they intend to grant such derogation in the framework of the reporting arrangements referred to in Article 9 and subsequently of any changes to such areas. 5. The Kingdom of the Netherlands may grant a derogation from the timetable set down in paragraph 2, subject to the following conditions: - the measures required by this Article are implemented as part of a broader, existing national programme for service stations which simultaneously addresses various environmental problems, such as water pollution, air pollution, ground pollution and waste pollution and the implementation of which is tightly scheduled, - the timetable may only be varied by a maximum of two years, all programmes being completed within the time limit set out in paragraph 2 (d), - the Commission shall be notified of the decision to diverge from the timetable set down in paragraph 2, including full information on the scope and deadline of the derogation. 6. The Kingdom of Spain and the Portuguese Republic may grant a derogation of one year from the time limit set down in paragraph 2 (b). Article 7 Amendments to the Annexes Except for the limit values refered to in Annex II, point 2, the amendments necessary for adapting the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure specified in Article 8. Article 8 The committee 1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. 4. If on the expiry of three months from the date of referral to it the Council has not acted, the proposed measures shall be adopted by the Commission. Article 9 Monitoring and reporting The reports on the implementation of this Directive shall be established according to the procedure laid down in Article 5 of Council Directive 91/692/EEC of 23 December 1991 standardizing and rationalizing reports on the implementation of certain Directives relating to the environment (1). The Commission is invited to accompany its first report where appropriate with proposals for the amendment of this Directive, including in particular the extension of the scope to include vapour control and recovery systems for loading installations and ships. Article 10 Transposition into national legislation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1995. They shall forthwith inform the Commission thereof. When these measures are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 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 11 Final provision This Directive is addressed to the Member States.

31994L0079

1994

Commission Directive 94/79/EC of 21 December 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Directive 94/43/EC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary to indicate, in Annexes II and III, to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files; Whereas it is now possible to introduce more precision with regard to the data requirements concerning toxicological and metabolism studies on the active substance provided for in Section 5 of Part A of Annex II; Whereas it is also now possible to introduce more precision with regard to the data requirements concerning toxicological studies on the plant protection product provided for in Section 7 of Part A of Annex II; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 91/414/EEC is amended as follows: 1. in Part A of Annex II the section headed '5. Toxicological and metabolism studies on the active substance' is replaced by Annex I hereto; 2. in Part A of Annex III the section headed '7. Toxicological studies' is replaced by Annex II hereto; 3. Point 1.2 of the introduction to Annexes II and III is replaced by the following: '1.2 where relevant, be generated using test guidelines, according to the latest adopted version, referred to or described in this Annex; in the case of studies initiated before the entry into force of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;' 4. in point 1.3 of the introduction to Annexes II and III, the following words are added at the end: 'in particular, when reference is made in this Annex to an EEC Method which consists in the transposal of a method developed by an international organization (e.g. OECD), Member States may accept that the required information is generated according to the latest version of that method if at the initiation of the studies the EEC Method has not yet been updated;'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 January 1996. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States Article 3 This Directive shall enter into force on 1 February 1995. Article 4 This Directive is addressed to the Member States.

31994L0078

1994

Commission Directive 94/78/EC of 21 December 1994 adapting to technical progress Council Directive 78/549/EEC, as regards the wheel guards of motor vehicles Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1) as last amended by Commission Directive 93/81/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 78/549/EEC of 12 June 1978 on the approximation of the laws of the Member States relating to the wheel guards of motor vehicles (3), and in particular Article 4 thereof, Whereas Directive 78/549/EEC is one of the separate directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas the number of four-wheel-drive passenger cars is increasing, whether the four-wheel-drive is engaged permanently, automatically or under the control of the driver; whereas it is necessary, in the case of such passenger cars, and in the light of technical progress, to review certain design and operating parameters and to amend certain provisions of Directive 78/549/EEC in a manner which reflects the current and future market situation and which is consistent with proper design, construction and safe operating practice; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 78/549/EEC is amended as follows: 1. In Article 1, the words '(as defined in Annex I to Directive 70/156/EEC)' are replaced by the words '(as defined in Annex II A to Directive 70/156/EEC)'. 2. Annexes I and II are amended in accordance with points 1, 2 and 3 of the Annex hereto. 3. Annex III set out in point 4 of the Annex hereto is added. Article 2 1. With effect from 1 July 1995 Member States may not, on grounds relating to wheel guards: - refuse, in respect of a type of motor vehicle, to grant EEC type-approval or to grant national type-approval, or - prohibit the registration, sale or entry into service of vehicles if the wheel guards comply with the requirements of Directive 78/549/EEC, as amended by this Directive. 2. With effect from 1 January 1996 the Member States: - shall no longer grant EEC type-approval, and - may refuse to grant national type-approval for a type of vehicle on grounds relating to the wheel guards if the requirements of Directive 78/549/EEC, as amended by this Directive, are not fulfilled. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1995. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

31994L0076

1994

Council Directive 94/76/EC of 22 December 1994 amending Directive 77/388/EEC by the introduction of transitional measures applicable, in the context of the enlargement of the European Union on 1 January 1995, as regards value added tax Having regard to the 1994 Accession Treaty, and in particular Articles 2 and 3 thereof, and the 1994 act of Accession, and in particular Article 169 thereof, Having regard to the proposal from the Commission, Whereas, subject to the special provisions set out in Chapter IX of Annex XV to the Act of Accession, the common system of value added tax is to apply to the new Member States as from the date on which the Accession Treaty enters into force; Whereas, as a result of the abolition on that date of the imposition of tax on importation and remission of tax on exportation in trade between the Community as constituted at present and the new Member States, and between the new Member States themselves, transitional measures are necessary to safeguard the neutrality of the common system of value added tax and prevent situations of double taxation or non-taxation; Whereas such measures must, in this respect, meet concerns akin to those that led to the measures adopted on completion of the internal market on 1 January 1993, and in particular the provisions of Article 28n of Council Directive 77/388/EEC of 17 May 1977 on the harmonization of the laws of the Member States relating to turn-over taxes - Common system of value added tax: uniform basis of assessment (1); Whereas, in the customs sphere, goods will be deemed to be in free circulation in the enlarged Community where it is shown that they were in free circulation in the current Community or in one of the new Member States at the time of accession; whereas conclusions should be drawn from this, particularly for Article 7 (1) and (3) and Article 10 (3) of Directive 77/388/EEC; Whereas it is necessary in particular to cover situations in which goods have been placed, prior to accession, under one of the arrangements referred to in Article 16 (1) (B) (a) to (d), under a temporary admission procedure with full exemption from import duties or under a similar procedure in the new Member States; Whereas it is also necessary to lay down specific arrangements for cases where a special procedure (export or transit), initiated prior to the entry into force of the Accession Treaty in the framework of trade between the current Community and the new Member States and between those Member States for the purposes of a supply effected prior to that date by a taxable person acting as such, is not terminated until after the date of accession, Article 1 In Directive 77/388/EEC, the following Title and Article shall be inserted: 'TITLE XVIc Transitional measures applicable in the context of the accession to the European Union of Austria, Finland and Sweden Article 28p 1. For the purpose of applying this Article: - 'Community` shall mean the territory of the Community as defined in Article 3 before accession, - 'new Member States` shall mean the territory of the Member States acceding to the European Union by the Treaty signed on 24 June 1994, as defined for each of those Member States in Article 3 of this Directive, - 'enlarged Community` shall mean the territory of the Community as defined in Article 3, after accession. 2. When goods: - entered the territory of the Community or of one of the new Member States before the date of accession, and - were placed, on entry into the territory of the Community or of one of the new Member States, under a temporary admission procedure with full exemption from import duties, under one of the regimes referred to in Article 16 (1) (B) (a) to (d) or under a similar regime in one of the new Member States, and - have not left that regime before the date of accession, the provisions in force at the moment the goods were placed under that regime shall continue to apply until the goods leave this regime, after the date of accession. 3. When goods: - were placed, before the date of accession, under the common transit procedure or under another customs transit procedure, and - have not left that procedure before the date of accession, the provisions in force at the moment the goods were placed under that procedure shall continue to apply until the goods leave this procedure, after the date of accession. For the purposes of the first indent, 'common transit procedure` shall mean the measures for the transport of goods in transit between the Community and the countries of the European Free Trade Association (EFTA) and between the EFTA countries themselves, as provided for in the Convention of 20 May 1987 on a common transit procedure (1). 4. The following shall be deemed to be an importation of goods within the meaning of Article 7 (1) where it is shown that the goods were in free circulation in one of the new Member States or in the Community: (a) the removal, including irregular removal, of goods from a temporary admission procedure under which they were placed before the date of accession under the conditions set out in paragraph 2; (b) the removal, including irregular removal, of goods either from one of the regimes referred to in Article 16 (1) (B) (a) to (d) or from a similar regime under which they were placed before the date of accession under the conditions set out in paragraph 2; (c) the termination of one of the procedures referred to in paragraph 3 which was started before the date of accession in one of new Member States for the purposes of a supply of goods for consideration effected before that date in that Member State by a taxable person acting as such; (d) any irregularity or offence committed during one of the procedures referred to in paragraph 3 under the conditions set out at (c). 5. The use after the date of accession within a Member State, by a taxable or non-taxable person, of goods supplied to him before the date of accession within the Community or one of the new Member States shall also be deemed to be an importation of goods within the meaning of Article 7 (1) where the following conditions are met: - the supply of those goods has been exempted, or was likely to be exempted, either under Article 15 (1) and (2) or under a similar provision in the new Member States, - the goods were not imported into one of the new Member States or into the Community before the date of accession. 6. In the cases referred to in paragraph 4, the place of import within the meaning of Article 7 (3) shall be the Member State within whose territory the goods cease to be covered by the regime under which they were placed before the date of accession. 7. By way of derogation from Article 10 (3), the importation of goods within the meaning of paragraphs 4 and 5 of this Article shall terminate without the occurrence of a chargeable event when: (a) the imported goods are dispatched or transported outside the enlarged Community; or (b) the imported goods within the meaning of paragraph 4 (a) are other than means of transport and are redispatched or transported to the Member State from which they were exported and to the person who exported them; or (c) the imported goods within the meaning of paragraph 4 (a) are means of transport which were acquired or imported before the date of accession in accordance with the general conditions of taxation in force on the domestic market of one of the new Member States or of one of the Member States of the Community and/or have not been subject, by reason of their exportation, to any exemption from, or refund of, value added tax. This condition shall be deemed to be fulfilled when the date of the first use of the means of transport was before 1 January 1987 or when the amount of tax due by reason of the importation is insignificant. (1) OJ No L 226, 13. 8. 1987, p. 2.` Article 2 1. Subject to the entry into force of the 1994 Accession Treaty, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on the date of entry into force of this Directive. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the provisions of domestic law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the same date as the 1994 Accession Treaty. Article 4 This Directive is addressed to the Member States.

31995L0001

1995

Directive 95/1/EC of the European Parliament and of the Council of 2 February 1995 on the maximum design speed, maximum torque and maximum net engine power of two or three-wheel motor vehicles Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles (), Having regard to the proposal from the Commission (), Having regard to the opinion of the Economic and Social Committee (), Acting in accordance with the procedure referred to in Article 189b of the Treaty (), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas the measures required for that purpose need to be adopted; Whereas the methods of measuring the maximum design speed, maximum torque and net engine power of two or three-wheel motor vehicles differ from one Member State to another; whereas as a result of their differences, such methods constitute barriers to trade within the Community; Whereas the barriers to the operation of the internal market may be removed if the same requirements are adopted by all Member States in place of their national rules; Whereas it is necessary to draw up harmonized requirements for methods of measuring the maximum design speed, maximum torque and maximum net engine power of two or three-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle, Article 1 This Directive applies to the methods of measuring the maximum design speed, maximum engine torque and the net maximum engine power of all the types of vehicle defined in Article 1 of Council Directive 92/61/EEC. Article 2 The procedure for the granting of component type-approval in respect of the maximum design speed, maximum engine torque and the maximum net engine power (measuring methods) of a type of two or three-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Directive 92/61/EEC. Article 3 Within two years of the adoption of this Directive the Commission shall carry out a comprehensive new study to establish whether there is a link between accidents and maximum engine power above 74 kW. The study shall collate and evaluate the latest scientific research findings and carry out appropriate new research with a view to establishing definitive policy recommendations on this subject. On the basis of the study's conclusions, the Commission shall, if necessary, propose new legislative measures. Article 4 Any amendments necessary to adapt the requirements of Annexes I and II to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC (). Article 5 1. Member States shall adopt and publish the provisions necessary to comply with this Directive not later than 2 August 1996. They shall forthwith inform the Commission thereof. When the Member States adopt such provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply these provisions as from 2 February 1997. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 6 National legislation may permit Member States to refuse the initial registration and any subsequent registration within their territory of vehicles with a maximum net power of more than 74 kW. Article 7 This Directive is addressed to the Member States.

31995L0003

1995

Commission Directive 95/3/EC of 14 February 1995 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, After consulting the Scientific Committee for Food, Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas those objectives cannot be achieved by Member States individually; whereas, furthermore, their attainment at Community level is already provided for by Directive 89/109/EEC; Whereas Commission Directive 90/128/EEC (2), as last amended by Directive 93/9/EEC (3), and in particular Article 3 (4) thereof, provides for the revision of Annex II and particularly Section B; Whereas, on the basis of the information available, certain substances provisionally admitted at national level may be included in the Community list; Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period, since the data requested by the Scientific Committee for Food are not yet available although the requisite studies are in progress or are planned; Whereas other substances have been requested for use following the adoption of Directive 90/128/EEC, and the technical data supplied permit their inclusion in the Community list; Whereas, for certain substances, the restrictions already set out should be amended according to the information available; Whereas it is necessary to extend this list to additives in order to obtain a more complete harmonization of this sector; Whereas the number of substances to be included in a complete list of additives is so large that it is necessary to proceed step by step, although the final step will be a complete list of additives (positive list); Whereas the list which appears in this Directive is an initial, incomplete list which, therefore, does not contain all the substances which are currently accepted in one or more Member States and then these substances can continue to be regulated by national laws pending a decision on inclusion in the Community list; Whereas certain substances may require specific rules concerning purity criteria which are not yet included in this Directive, and therefore this aspect continues to be governed by national laws pending a decision at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 90/128/EEC is amended as follows: 1. The following Article 3a is inserted: 'Article 3a An incomplete list of additives which may be used for the manufacture of plastics materials and articles is set out in Annex III.' 2. Annex II is amended as shown in Annex I to this Directive. 3. Annex II to this Directive is added as Annex III. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 April 1996. They shall immediately inform the Commission thereof. Member States shall: - permit, as from 1 April 1996, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs complying with this Directive; - prohibit, as from 1 April 1998, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.

31995L0002

1995

European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Having regard to the Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (4), and in particular Article 3 (2) thereof, Whereas differences between national laws relating to preservatives, antioxidants and other additives and their conditions of use hinder the free movement of foodstuffs; whereas this may create conditions of unfair competition; Whereas the prime consideration for any rules on these food additives and their conditions of use should be the need to protect the consumer; Whereas it is generally recognized that unprocessed foodstuffs and certain other foodstuffs should be free from food additives; Whereas, having regard to the most recent scientific and toxicological information on these substances, some of them are to be permitted only for certain foodstuffs and under certain conditions of use; Whereas it is necessary to lay down strict rules for the use of food additives in infant formulae, follow-on formulae and weaning foods, as referred to in Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (5), and in particular Article 4 (1) (e) thereof; Whereas this Directive is not intended to affect rules relating to sweeteners and colours; Whereas, pending specific provisions pursuant to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (6), and pursuant to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (7), certain substances belonging to this category are provisionally covered by this Directive; Whereas the Commission is to adapt Community provisions to accord with the rules laid down in this Directive; Whereas the Scientific Committee for Food has been consulted for those substances which are not yet the subject of a Community provision; Whereas it is necessary to include in this Directive specific provisions concerning additives referred to in other Community provisions; Whereas it is desirable that when a decision is taken on whether a particular foodstuff belongs to a certain category of foods, the consultation of the Standing Committee for Foodstuffs procedure is followed; Whereas modifications of existing purity criteria for food additives other than colours and sweeteners and new specifications for those where no purity criteria exist will be adopted in accordance with the procedure laid down in Article 11 of Directive 89/107/EEC; Whereas the Scientific Committee for Food has not yet given an opinion on flour treatment agents; whereas those agents will be the subject of a separate Directive; Whereas this Directive replaces Directives 64/54/EEC (8), 70/357/EEC (9), 74/329/EEC (10) and 83/463/EEC (11); whereas those Directives are hereby repealed, Article 1 1. This Directive is a specific Directive forming a part of the comprehensive Directive, within the meaning of Article 3 of Directive 89/107/EEC, and applies to additives other than colours, sweeteners and flour treatment agents. 2. Only additives which satisfy the requirements laid down by the Scientific Committee for Food may be used in foodstuffs. 3. For the purpose of this Directive: (a) 'preservatives` are substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by micro-organisms; (b) 'antioxidants` are substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes; (c) 'carriers`, including carrier solvents, are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive without altering its technological function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use; (d) 'acids` are substances which increase the acidity of a foodstuff and/or impart a sour taste to it; (e) 'acidity regulators` are substances which alter or control the acidity or alkalinity of a foodstuff; (f) 'anti-caking agents` are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another; (g) 'anti-foaming agents` are substances which prevent or reduce foaming; (h) 'bulking agents` are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value; (i) 'emulsifiers` are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff; (j) 'emulsifying salts` are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components; (k) 'firming agents` are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel; (l) 'flavour enhancers` are substances which enhance the existing taste and/or odour of a foodstuff; (m) 'foaming agents` are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff; (n) 'gelling agents` are substances which give a foodstuff texture through formation of a gel; (o) 'glazing agents` (including lubricants) are substances which, when applied to the external surface of a foodstuff, impart a shiny appearance or provide a protective coating; (p) 'humectants` are substances which prevent foodstuffs from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium; (q) 'modified starches` are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached; (r) 'packaging gases` are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container; (s) 'propellants` are gases other than air which expel a foodstuff from a container; (t) 'raising agents` are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter; (u) 'sequestrants` are substances which form chemical complexes with metallic ions; (v) 'stabilizers` are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilizers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff and include also substances which stabilize, retain or intensify an existing colour of a foodstuff; (w) 'thickeners` are substances which increase the viscosity of a foodstuff. 4. Flour treatment agents other than emulsifiers are substances which are added to flour or dough to improve its baking quality. 5. For the purposes of this Directive the following are not considered as food additives: (a) substances used for treatment of drinking water as provided for in Directive 80/778/EEC (12); (b) products containing pectin and derived from dried apple pomace or peel of citrus fruits, or from a mixture of both, by the action of dilute acid followed by partial neutralization with sodium or potassium salts ('liquid pectin`); (c) chewing gum bases; (d) white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes; (e) ammonium chloride; (f) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten; (g) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts and having no additive function; (h) caseinates and casein; (i) inulin. Article 2 1. Only substances listed in Annexes I, III, IV and V may be used in foodstuffs for the purposes mentioned in Article 1 (3). 2. Food additives listed in Annex I are permitted in foodstuffs, for the purposes mentioned in Article 1 (3), with the exception of those foodstuffs listed in Annex II, following the 'quantum satis` principle. 3. Except where specifically provided for, paragraph 2 does not apply to: (a) - unprocessed foodstuffs, - honey as defined in Directive 74/409/EEC (13) - non-emulsified oils and fats of animal or vegetable origin, - butter, - pasteurized and sterilized (including UHT sterilization) milk and cream (including skimmed, plain and semi-skimmed), - unflavoured, live fermented milk products, - natural mineral water as defined in Directive 80/777/EEC (14) and spring water, - coffee (excluding flavoured instant coffee) and coffee extracts, - unflavoured leaf tea, - sugars as defined in Directive 73/437/EEC (15), - dry pasta, - natural unflavoured buttermilk (excluding sterilized buttermilk). Within the meaning of this Directive, the term 'unprocessed` means not having undergone any treatment resulting in a substantial change in the original state of the foodstuffs; however, the foodstuffs may have been, for example, divided, parted, severed, boned, minced, skinned, pared, peeled, ground, cut, cleaned, trimmed, deep-frozen or frozen, chilled, milled or husked, packed or unpacked; (b) foods for infants and young children as referred to in Directive 89/398/EEC, including foods for infants and young children not in good health; these foodstuffs are subject to the provisions of Annex VI; (c) the foodstuffs listed in Annex II, which may contain only those additives referred to in that Annex and those additives referred to in Annexes III and IV under the conditions specified therein. 4. Additives listed in Annexes III and IV may only be used in the foodstuffs referred to in those Annexes and under the conditions specified therein. 5. Only those additives listed in Annex V may be used as carriers or carrier solvents for food additives and must be used under the conditions specified therein. 6. The provisions of this Directive shall also apply to the corresponding foodstuffs intended for particular nutritional uses in accordance with Directive 89/398/EEC. 7. Maximum levels indicated in the Annexes refer to foodstuffs as marketed, unless otherwise stated. 8. In the Annexes to this Directive, 'quantum satis` means that no maximum level is specified. However, additives shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer. Article 3 1. The presence of a food additive in a foodstuff is permissible: - in a compound foodstuff other than one mentioned in Article 2 (3) to the extent that the food additive is permitted in one of the ingredients of the compound foodstuff, or - if the foodstuff is destined to be used solely in the preparation of a compound foodstuff and to an extent such that the compound foodstuff conforms to the provisions of this Directive. 2. Paragraph 1 does not apply to infant formulae, follow-on formulae and weaning foods, as referred to in Directive 89/398/EEC, except where specially provided for. Article 4 This Directive shall apply without prejudice to specific Directives permitting additives listed in the Annexes to be used as sweeteners or colours. Article 5 Where necessary, it may be decided by the procedure laid down in Article 6 of this Directive: - whether a particular foodstuff not categorized at the moment this Directive was adopted belongs to a category of foodstuffs referred to in Article 2 or in one of the Annexes, or - whether a food additive listed in the Annexes and authorized at 'quantum satis` is used in accordance with the criteria referred to in Article 2, or - whether a substance is a food additive within the meaning of Article 1. Article 6 1. Where the procedure laid down in this Article is to be followed, the Commission shall be assisted by the Standing Committee for Foodstuffs, set up under Decision 69/414/EEC (16), hereinafter referred to as 'the Committee`. 2. The Chairman shall refer the matter to the Committee either on his own initiative or at the request of the representative of a Member State. 3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 7 Member States shall, within three years of the entry into force of this Directive, establish systems to monitor the consumption and use of food additives and report their findings to the Commission. The Commission shall report to the European Parliament and the Council within five years of the entry into force of this Directive on the changes which have taken place in the food additives market, the levels of use and consumption. In accordance with the general criteria in point 4 of Annex II to Directive 89/107/EEC, within five years of the entry into force of this Directive, the Commission shall review the conditions of use referred to in this Directive, and propose amendments where necessary. Article 8 1. Directives 64/54/EEC, 70/357/EEC, 74/329/EEC and 83/463/EEC are hereby repealed. 2. References to these repealed Directives and to the purity criteria for certain food additives referred to in them shall henceforth be construed as references to this Directive. Article 9 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 25 September 1996 in order to: - allow, by 25 September 1996 at the latest, trade in and use of products conforming to this Directive, - prohibit by 25 March 1997 at the latest, trade in and use of products not conforming to this Directive; products put on the market or labelled before that date which do not comply with this Directive may, however, be marketed until stocks are exhausted. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 10 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States.

31995L0004

1995

Commission Directive 95/4/EC of 21 February 1995 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular the second indent, third and fourth subindents of Article 13, Whereas the harmful organism Thrips palmi Karny has not hitherto been known to occur in the Community; Whereas Thrips Palmi Karny has been found to be present on plants of Ficus L. during checks carried out in the Community following the introduction of these plants; Whereas Pseudomonas solanacearum (Smith) Smith has been found to be present in a larger area of the Community than was originally recognized; Whereas Pseudomonas solanacearum (Smith) Smith has been found on potato tubers imported from Egypt and Turkey; Whereas, therefore, the provisions on the protective measures against Pseudomonas solanacearum (Smith) Smith should be improved and in particular the list of host plants should be extended; Whereas by virtue of Council Directive 66/400/EEC of 14 June 1966 on the marketing of beet seed (2), as last amended by Directive 90/654/EEC (3), certain conditions govern basic and certified seed of sugar and fodder beet of the species Beta vulgaris L. in order to ensure that such seed is free from beet necrotic yellow vein virus (rhizomania); Whereas it is desirable that seed of sugar and fodder beet of the species Beta vulgaris L. which has not yet been finally certified and which is intended for official certification in another Member State should also be subject to controls to ensure that there is no risk of beet necrotic yellow vein virus spreading during transport, processing or the disposal of waste arising out of such processing; Whereas there are at present no conditions to prevent the spread of beet necrotic yellow vein virus in the course of the marketing of vegetable seed of the species Beta vulgaris L.; Whereas therefore it is desirable to introduce protective measures against Beet necrotic yellow vein virus in relation to seed of sugar, fodder and vegetable beet of the species Beta vulgaris L.; Whereas some provisions for protective measures against tubers of Solanum tuberosum L., other than those intended for planting, should be modified because it is no longer appropriate to maintain the current prohibitions set out in Directive 77/93/EEC in respect of potato tubers originating in Syria; Whereas therefore the relevant Annexes to the said Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes I to IV to Directive 77/93/EEC are hereby amended in accordance with 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 1 April 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. The Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.

31995L0005

1995

Council Directive 95/5/EEC of 27 February 1995 amending Directive 92/120/EEC on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of certain products of animal origin Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas, under Directive 92/120/EEC (4), the maximum output for slaughterhouses benefiting from the derogation was increased to 20 livestock units per week and 1 000 livestock units per year respectively, until 28 February 1995; Whereas the Council has received a proposal from the Commission aimed at reviewing the provisions applicable to small establishments benefiting from the derogation and whereas the Council has been unable to act on that proposal before 28 February 1995; Whereas it is possible that, by reason of certain particular situations, establishments may not be able, by 1 March 1995, to observe all the specific rules laid down; whereas, pending a decision by the Council and in order to take into account local conditions and to avoid abrupt closures of establishments, provision should be made for a system of granting temporary and limited derogations, Article 1 The date '28 February 1995' in Article 2 (2) of Directive 92/120/EEC shall be replaced by '30 June 1995'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 March 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 3 This Directive is addressed to the Member States.

31995L0006

1995

Commission Directive 95/6/EC of 20 March 1995 amending Annexes I and II to Council Directive 66/402/EEC on the marketing of cereal seed Having regard to the Treaty establishing the European Community, Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), as last amended by Commission Directive 93/2/EEC (2), and in particular Article 21a thereof, Whereas hybrids of rye are included in the scope of Directive 66/402/EEC, but the Directive does not establish the conditions to be satisfied by the crop and the seed of hybrids of rye; Whereas in order to establish such conditions Commission Decision 89/374/EEC of 2 June 1989 on the organization of a temporary experiment under Council Directive 66/402/EEC on the marketing of cereal seed, in order to establish the conditions to be satisfied by the crop and the seed of hybrids of rye (3), as amended by Decision 92/520/EEC (4), was adopted; Whereas that experiment ended on 30 June 1994; Whereas on the basis of the results of that experiment the conditions to be satisfied by the crop and the seed of hybrids of rye may now be established and Annexes I and II to Directive 66/402/EEC should be amended 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 Annexes I and II to Directive 66/402/EEC are amended as set out in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1995. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0010

1995

Commission Directive 95/10/EC of 7 April 1995 fixing the method of calculating the energy value of dog and cat food intended for particular nutritional purposes Having regard to the Treaty establishing the European Community, Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (1), as last amended by Directive 93/74/EEC (2), and in particular Article 10 (d) thereof, Whereas Article 5 (1) (d) of Council Directive 93/74/EEC on feedingstuffs intended for particular nutritional purposes provided for specific labelling declarations concerning animal feedingstuffs intended for particular nutritional purposes; Whereas, when Commission Directive 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (3), amended by Directive 95/9/EC (4), was adopted, certain nutritional purposes, for which the energy value is an essential nutritional characteristic, could not be included because of the absence of a Community method for checking the energy value in pet foods; Whereas the methods for calculating energy value that are currently available are not entirely satisfactory, either at the control level or with regard to the accuracy of the data; Whereas, however, pending the availability of a satisfactory method, a provisional method should be adopted for a defined period to make possible the declaration of the energy value of feedingstuffs intended for certain particular nutritional purposes, to allow the use of those feedingstuffs for feeding animals in certain situations which necessitate the use of a diet specific to their condition; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Where the energy value of dog and cat food intended for particular nutritional purposes must be declared pursuant to Article 5 (1) (d) of Directive 93/74/EEC, Member States shall lay down that such value is to be calculated using the method described in the Annex to this Directive. Article 2 Member States shall provide that the method of calculating the energy value of dog and cat food intended for particular nutritional purposes set forth in the Annex shall be valid until 30 June 1998. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the text of the essential provisions under national law that they adopt in the sphere governed by this Directive. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31995L0009

1995

Commission Directive 95/9/EC of 7 April 1995 amending Directive 94/39/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (1), and in particular Article 6 (c) thereof, Whereas Article 6 (c) of Directive 93/74/EEC provides that the measures adopted according to Article 6 (a) may be adjusted to developments in scientific and technical knowledge; whereas those measures have been adopted by Commission Directive 94/39/EC (2); Whereas certain nutritional purposes could not at first be included in the list of intended uses of animal feedingstuffs for particular nutritional purposes owing to the absence at the time of Community methods for calculating the energy value of pet foods; Whereas a method for calculating that energy value has now been adopted at Community level and the said nutritional purposes can therefore be included in the list; Whereas, furthermore, the list of particular nutritional purposes adopted for equines should be adapted and supplemented on the basis of available data; 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 94/39/EC is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1995. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the essential provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0008

1995

Commission Directive 95/8/EC of 10 April 1995 amending Directive 77/535/EEC on the approximation of the laws of Member States relating to methods of sampling and analysis for fertilizers (Methods of analysis for trace elements at a concentration greater than 10 %) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (1), as last amended by Council Directive 89/530/EEC (2), and in particular Article 9 (2) thereof, Whereas Article 8a of the Treaty establishes an area without internal frontiers in which the free movement of goods, persons, services and capital in ensured; Whereas Directive 89/530/EEC supplement and amends Directive 76/116/EEC in respect of the trace elements boron, cobalt, copper, iron, manganese, molybdendum and zinc in fertilizers; Whereas Commission Directive 77/535/EEC (3), as last amended by Directive 93/1/EEC (4), provides for official controls for Community fertilizers for the purpose of checking compliance with the requirements imposed by the Community provisions concerning the quality and composition of fertilizers; whereas Directive 77/535/EEC should be supplemented so that fertilizers to which Council Directive 89/530/EEC should be supplemented so that fertilizers to which Council Directive 89/530/EEC relates, can also be checked; Whereas, in view of the scope and effects of the proposed action, the Community measures provided for by this Directive are not only necessary but also indispensable for the attainment of the stated objectives, whereas these objectives cannot be achieved by Member States individually and whereas their attainment at Community level is, in fact, already provided for by Directive 76/116/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Removal of Technical Barriers to Trade in Fertilizers, Article 1 The text set out in the Annex of this Directive is hereby added to Annex II of Directive 77/535/EEC. The methods are applicable to Community fertilizers for the determination of each trace element, the declared contant of which is more than 10 %. Article 2 1. Member States shall bring into force the provisions necessary to comply with this Directive by 31 December 1995. They shall immediately inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by the Directive. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

31995L0012

1995

Commission Directive 95/12/EC of 23 May 1995 implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources of household appliances (1), and in particular Articles 9 and 12 thereof, Whereas under Directive 92/75/EEC the Commission is to adopt an implementing directive in respect of household appliances including washing machines; Whereas electricity use by washing machines accounts for a significant part of total Community energy demand; whereas the scope for reduced energy use by these appliances is substantial; Whereas a better washing performance often requires a higher consumption of water and energy; whereas information on the washing performance of an appliance is helpful in evaluating the information on its energy and water consumption; whereas this will help consumers make a choice of appliance which is consistent with the rational use of energy; Whereas the Community, confirming its interest in an international standardization system capable of producing standards that are actually used by all partners in international trade and of meeting the requirements of Community policy, invites the European standards organizations to continue their cooperation with international standards organizations; Whereas the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are the bodies recognized as competent to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and these two bodies signed on 13 November 1984, whereas, within the meaning of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by Cenelec, on the basis of a remit (mandate) from the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (2), as last amended by Directive 94/10/EC of the European Parliament and the Council (3), and on the basis of those general guidelines; Whereas the measures set out in this Directive are in accordance with the opinion of the committee set up under Article 10 of Directive 92/75/EEC, Article 1 1. This Directive shall apply to electric mains operated household washing machines, excluding: - machines with no spin capability, - machines with separate washing and spin drying vessels (such as twin tubs), and - combined washer-driers. Appliances that can also use other energy sources are excluded. 2. The information required by this Directive shall be measured in accordance with harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities and for which Member States have published the reference numbers of the national standards transposing those harmonized standards. Throughout this Directive any provisions requiring the giving of information relating to noise shall apply where that information is required under Article 3 of Council Directive 86/594/EEC (1). This information, where required, shall be measured in accordance with Directive 83/189/EEC. 4. 'Dealer', 'supplier', 'information sheet', 'other essential resources' and 'supplementary information' shall have the meanings set out in Article 1 (4) of Directive 92/75/EEC. Article 2 1. The technical documentation referred to in Article 2 (3) of Directive 92/75/EEC shall include: - the name and address of the supplier, - a general description of the appliance, sufficient for it to be uniquely identified, - information, including drawings as relevant, on the main design features of the model and in particular items which appreciably affect its energy consumption, - reports of relevant measurement tests carried out under test procedures of the harmonized standards referred to in Article 1 (2), - operating instructions, if any. 2. The label referred to in Article 2 (1) of Directive 92/75/EEC shall be as specified in Annex I to this Directive. The label shall be placed on the outside of the front or top of the appliance, in such a way as to be clearly visible, and not obscured. 3. The content and format of the fiche referred to in Article 2 (1) of Directive 92/75/EEC shall be as specified in Annex II to this Directive. 4. In the circumstances covered by Article 5 of Directive 92/75/EEC, and where the offer for sale, hire, or hire purchase, is provided by means of a printed communication, such as a mail order catalogue, then that printed communication shall include all the information specified in Annex III to this Directive. 5. The energy efficiency class of an appliance, its washing performance class, and its drying efficiency class, as specified in the label and the fiche, shall be as specified in Annex IV. Article 3 Member States shall take all necessary measures to ensure that all suppliers and dealers established in their territory fulfil their obligations under this Directive. Article 4 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 1996. They shall immediately inform the Commission thereof. They shall apply those provisions from 1 April 1996. However, Member States shall allow, until 30 September 1996: - the placing on the market, the commercialization and/or the display of products, - the distribution of the printed communications referred to in Article 2 (4) which do not conform to this Directive. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31995L0019

1995

Council Directive 95/19/EC of 19 June 1995 on the allocation of railway infrastructure capacity and the charging of infrastructure fees Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), Whereas greater integration of the Community transport sector is an essential element of the internal market and whereas the railways are a vital part of the Community transport sector; Whereas the principle of the freedom to provide services needs to be applied in the railway sector, taking account of the specific characteristics of that sector; Whereas Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways (4) provides for certain access rights in international rail transport for railway undertakings and international groupings of railway undertakings; Whereas it is important to ensure that, where railway undertakings and the international groupings which they constitute provide the services referred to in Article 10 of Directive 91/440/EEC, they benefit fully from the new access rights and whereas, to this end, it is appropriate to establish a system for the allocation of railway infrastructure and the charging of infrastructure fees which is non-discriminatory and uniform throughout the Community; Whereas the scope of Directive 91/440/EEC should be maintained, including the exceptions laid down therein for regional, urban and suburban services, and whereas it should be specified that transport operations in the form of shuttle services through the Channel Tunnel are also excluded from the scope of that Directive; Where, pursuant to the principle of subsidiarity, it is appropriate that the Community lay down the broad principles of such a system, leaving it to the Member States to put in place the detailed rules for the relevant practical implementation; Whereas the Member States should ensure sufficient flexibility as regards the allocation of infrastructure capacity to allow efficient and optional use of the infrastructure; Whereas, however, it is necessary to grant certain priority rights with regard to the allocation of infrastructure capacity, notably for public services and services provided on a specific railway infrastructure; Whereas it is also necessary to provide for the possibility of granting special rights in allocating infrastructure capacity if those rights are essential to ensure adequate transport services or to allow the financing of new infrastructure; Whereas the accounts of the infrastructure manager should be in balance so that infrastructure expenditure can be covered; Whereas, furthermore, it is necessary to define non-discriminatory rules as regards the charging of infrastructure fees in the same market; Whereas efficient use of infrastructure capacity requires that fees be fixed according to a common set of general criteria; Whereas, out of a general concern for transparency and non-discrimination, common rules should be adopted concerning the procedures for the allocation of infrastructure capacity and the charging of infrastructure fees; Whereas, in the interests of traffic safety, railway undertakings must, in order to have access to a particular infrastructure, hold a certificate of safety based on certain common criteria and on national provisions, issued by the body competent for the infrastructure used; whereas they must also conclude with the infrastructure manager the requisite technical, administrative and financial agreements; Whereas it is necessary to guarantee possibilities for making an appeal before an independent body against decisions taken by the authorities and bodies competent as regards the allocation of infrastructure capacity and the charging of infrastructure fees; whereas this possibility for making an appeal is required in particular to resolve any conflicts of interest in cases where an infrastructure manager is at the same time a transport services operator and is responsible for allocating train paths and/or collecting infrastructure fees, SECTION I Objective and scope Article 1 1. The purpose of this Directive is to define the principles and procedures to be applied with regard to the allocation of railway infrastructure capacity and the charging of infrastructure fees for railway undertakings which are or will be established in the Community and the international groupings which they form, where such undertakings and groupings carry out services referred to in Article 10 of Directive 91/440/EEC under the conditions laid down in that Article. 2. Railway undertakings the activities of which are limited to the operation of urban, suburban and regional services shall be excluded from the scope of this Directive. Railway undertakings and international groupings the business of which is limited to providing shuttle services for road vehicles through the Channel Tunnel are also excluded from the scope of this Directive. 3. Railway infrastructure capacity shall be granted in the form of the allocation of train paths in accordance with Community and national law. Article 2 For the purpose of this Directive: (a) 'railway undertaking` means any public or private undertaking the main business of which is to provide rail transport services for goods and/or passengers, with a requirement that the undertaking must ensure traction; (b) 'international grouping` means any association of at least two railway undertakings established in different Member States for the purpose of providing international transport services between Member States; (c) 'infrastructure manager` means any public body or undertaking responsible in particular for establishing and maintaining railway infrastructure, as well as for operating the control and safety systems; (d) 'train path` means the infrastructure capacity needed to run a train between two places at a given time; (e) 'allocation` means the allocation of railway infrastructure capacity by an allocation body; (f) 'allocation body` means the authority and/or infrastructure manager designated by the Member States for the allocation of infrastructure capacity. SECTION II Allocation of railway infrastructure capacity Article 3 Each Member State shall designate the allocation body in accordance with the requirements of this Directive. In particular, the allocation body, which shall be informed of all train paths available, shall ensure that: - railway infrastructure capacity is allocated on a fair and non-discriminatory basis and that, - subject to Articles 4 and 5, the allocation procedure allows optimum effective use the infrastructure. Article 4 1. Member States may take the necessary measures to ensure that priority is given to the following rail services in the allocation of railway infrastructure capacity: (a) services provided in the interest of the public, as defined in Council Regulation (EEC) No 1191/69 of 26 June 1969 on action by Member States concerning the obligations inherent in the concept of a public service in transport by rail, road and inland waterway (5); (b) services wholly or partly operated on infrastructure constructed or developed for certain specific services (specialized high-speed or freight lines), without prejudice to Articles 85, 86 and 90 of the Treaty. This provision shall apply without discrimination to all services within the scope of Article 1 having comparable characteristics and providing similar services. 2. With regard to services provided under paragraph 1 (a), Member States may compensate the infrastructure manager for any financial losses incurred due to the imposition of a certain infrastructure capacity allocation in the interests of public service. Article 5 Member States may grant special rights as regards infrastructure capacity allocation on a non-discriminatory basis to railway undertakings operating certain types of services or in certain areas if such rights are indispensable to ensure adequate public services or efficient use of infrastructure capacity or to allow the financing of new infrastructures, without prejudice to Articles 85, 86 and 90 of the Treaty. SECTION III Charging of infrastructure fees Article 6 1. The accounts of an infrastructure manager shall, under normal business conditions over a reasonable time period, at least balance income from infrastructure fees plus State contributions on the one hand and infrastructure expenditure on the other. 2. The infrastructure manager may finance infrastructure development including provision or renewal of capital assets, and may make a return on capital employed. Article 7 There shall be no discrimination in the charging for services of an equivalent nature in the same market. After consulting the infrastructure manager, Member States shall lay down the rules for determining the infrastructure fees. These rules shall provide the infrastructure manager with the facility to market the available infrastructure capacity efficiently. Article 8 1. The fees charged by the infrastructure manager shall be fixed according to the nature of the service, the time of the service, the market situation and the type and degree of wear and tear of the infrastructure. 2. As regards the procedures for the payment of fees, Member States may provide for the possibility that a global agreement be concluded with the infrastructure manager as regards public services, in accordance with Regulation (EEC) No 1191/69. Article 9 1. The fees shall be paid to the infrastructure manager(s). 2. Member States may require the infrastructure manager to provide all the information on the fees necessary to satisfy them that they are charged on a non-discriminatory basis. 3. The infrastructure manager shall inform railway undertakings using its infrastructure to provide services referred to in Article 10 of Directive 91/440/EEC in good time of any major changes in the quality or capacity of the infrastructure concerned. SECTION IV General provisions Article 10 1. Member States shall lay down the procedures for the allocation of railway infrastructure capacity referred to in Article 1 (3). They shall publish their procedural rules and inform the Commission thereof. 2. An application for infrastructure capacity shall be submitted to the allocation body of the Member State on the territory of which the departure point of the service concerned is situated. 3. The allocation body to which an application has been submitted shall immediately inform the other allocation bodies concerned of this request. The latter shall take a decision as soon as possible but no later than one month after all relevant information has been submitted; each allocation body shall have the right to refuse an application. They shall immediately inform the allocation body to which the request has been submitted. The allocation body to which an application has been submitted shall, together with the other allocation bodies concerned, take a decision on the application as soon as possible, but no later than two months after all relevant information has been submitted. An application which has been refused on the grounds of insufficient capacity shall be reconsidered at the next time-table adjustment for the routes concerned if the applicant undertaking so requests. The dates for such adjustments and other administrative arrangements shall be available to interested parties. The decision shall be communicated to the applicant undertaking. A refusal shall indicate the reason therefore. 4. An applicant undertaking may directly contact the other allocation bodies concerned with this request on condition that the allocation body to which the application has been submitted is informed. 5. The railway undertakings to which railway infrastructure capacity is allocated shall conclude the necessary administrative, technical and financial agreements with the infrastructure managers. Article 11 1. The Member States shall provide that in addition a safety certificate in which the railway undertakings' safety requirements are set out be submitted in order to ensure safe service on the routes concerned. 2. In order to obtain the safety certificate, the railway undertaking must comply with the regulations under national law, compatible with Community law and applied in a non-discriminatory manner, laying down the technical and operational requirements specific to rail services and the safety requirements applying to staff, rolling stock and the undertaking's internal organization. In particular, it must provide proof that the staff whom it employs to operate and accompany the trains providing services referred to in Article 10 of Directive 91/440/EEC has the necessary training to comply with the traffic rules applied by the infrastructure manager and to meet the safety requirements imposed on it in the interests of train movement. The railway undertaking must also prove that the rolling stock comprising these trains has been approved by the public authority or by the infrastructure manager and checked in accordance with the operating rules applicable to the infrastructure used. The safety certificate shall be issued by the authority designated for the purpose by the Member State in which the infrastructure used is situated. Article 12 Member States may provide for the possibility that applications for infrastructure access are accompanied by a deposit or similar security. If an applicant does not make use of an allocated train path, an amount may be deducted from the deposit which represents the cost incurred in processing the application and any subsequent loss of earnings due to the non-use of the infrastructure capacity concerned. In the other cases, the deposit/security shall be returned in its entirety. SECTION V Final provisions Article 13 1. Member States shall take the measures necessary to ensure that decisions on the allocation of infrastructure capacity or the charging of fees shall be open to appeal before an independent body when so requested in writing by a railway undertaking. This body shall take its decision within two months of the submission of all relevant information. 2. Member States shall take the measures necessary to ensure that decisions taken in accordance with paragraph 1 are subject to judicial review. Article 14 1. The Commission shall, two years after the application of this Directive, submit to the Council a report, accompanied - if necessary - by proposals regarding continued Community action, with particular regard to the possibility of enlarging the scope of the Directive. 2. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than two years following the date of the entry into force of this Directive. They shall forthwith inform the Commission thereof. 3. When Member States adopt the provisions referred to in paragraph 2, they shall contain a reference to this Directive or be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by the Member States. Article 15 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States.

31995L0018

1995

Council Directive 95/18/EC of 19 June 1995 on the licensing of railway undertakings Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), Whereas the single market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the principle of the freedom to provide services should be applied to the railway sector, taking into account that sector's specific characteristics; Whereas Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways (4) provides for certain access rights in international rail transport for railway undertakings and international groupings of railway undertakings; Whereas, in order to ensure that access rights to railway infrastructure are applied throughout the Community on a uniform and non-discriminatory basis, it is appropriate to introduce a licence for railway undertakings providing the services referred to in Article 10 of Directive 91/440/EEC; Whereas it is appropriate to maintain the scope of Directive 91/440/EEC, including the exceptions made in it for regional, urban and suburban services and whereas it should be specified that transport activities in the form of shuttle services through the Channel Tunnel are also excluded from the scope of that Directive; Whereas a licence issued by a Member State should accordingly be recognized as valid throughout the Community; Whereas Community conditions for access to or transit via railway infrastructure will be regulated by other provisions of Community law; Whereas, having regard to the principle of subsidiarity and in order to ensure the requisite uniformity and transparency, it is appropriate that the Community lay down the broad principles of such a licensing system, leaving to Member States the responsibility for the granting and the administration of licences; Whereas, in order to ensure dependable and adequate services, it is necessary to ensure that railway undertakings meet at any time certain requirements in relation to good repute, financial fitness and professional competence; Whereas for the protection of customers and third parties concerned it is important to ensure that railway undertakings are sufficiently insured or have made equivalent arrangements in respect of liability risks; Whereas the suspension and revocation of licences and the granting of temporary licences should also be dealt with in this context; Whereas a railway undertaking will also be required to comply with national and Community rules on the provision of railway services, applied in a non-discriminatory manner, which are intended to ensure that it can carry on its activity in complete safety on specific stretches of track; Whereas, in order to ensure the efficient operation of international rail transport, it is necessary that railway undertakings respect the agreements in force in this field; Whereas, finally, the procedures for the granting, maintenance and amendment of operating licences to railway undertakings should reflect a general desire for transparency and non-discrimination, SECTION I Objective and Scope Article 1 1. This Directive concerns the criteria applicable to the issue, renewal or amendment of licences by a Member State intended for railway undertakings which are or will be established in the Community when they provide the services referred to in Article 10 of Directive 91/440/EEC under the conditions laid down in that Article. 2. Railway undertakings the activities of which are limited to the operation of urban, suburban or regional services shall be excluded from the scope of this Directive. Railway undertakings and international groupings the activity of which is limited to the provision of shuttle services transporting road vehicles through the Channel Tunnel shall also be excluded from the scope of this Directive. 3. A licence shall be valid throughout the territory of the Community. Article 2 For the purposes of this Directive: (a) 'railway undertaking` shall mean any private or public undertaking the main business of which is to provide rail transport services for goods and/or passengers, with a requirement that the undertaking must ensure traction; (b) 'licence` shall mean an authorization issued by a Member State to an undertaking, by which its capacity as a railway undertaking is recognized. That capacity may be limited to the provision of specific types of services; (c) 'licensing authority` shall mean the body charged by a Member State with the issue of licences. (d) - 'urban and suburban services` shall mean transport services operated to meet the transport needs of an urban centre or conurbation, as well as the transport needs between such centre or conurbation and surrounding areas; - 'regional services` shall mean transport services operated to meet the transport needs of a region. Article 3 Each Member State shall designate the body responsible for issuing licences and for carrying out the obligations imposed by this Directive. SECTION II Licences Article 4 1. A railway undertaking shall be entitled to apply for a licence in the Member State in which it is established. 2. Member States shall not issue licences or extend their validity where the requirements of this Directive are not complied with. 3. A railway undertaking which fulfils the requirements imposed in this Directive shall be authorized to receive a licence. 4. No railway undertaking shall be permitted to provide the rail transport services covered by this Directive unless it has been granted the appropriate licence for the services to be provided. However, such a licence shall not itself entitle the holder to access to the railway infrastructure. Article 5 1. A railway undertaking must be able to demonstrate to the licensing authorities of the Member State concerned before the start of its activities that it will at any time be able to meet the requirements relating to good repute, financial fitness, professional competence and cover for its civil liability listed in Articles 6 to 9. 2. For the purposes of paragraph 1, each applicant shall provide all relevant information. Article 6 Member States shall define the conditions under which the requirement of good repute is met to ensure that an applicant railway undertaking or the persons in charge of its management: - has/have not been convicted of serious criminal offences, including offences of a commercial nature, - has/have not been declared bankrupt, - has/have not been convicted of serious offences against specific legislation applicable to transport, - has/have not been convicted of serious or repeated failure to fulfil social- or labour-law obligations, including obligations under occupational safety and health legislation. Article 7 1. The requirements relating to financial fitness shall be met when an applicant railway undertaking can demonstrate that it will be able to meet its actual and potential obligations, established under realistic assumptions, for a period of twelve months. 2. For the purposes of paragraph 1, each applicant shall give at least the particulars listed in section I of the Annex. Article 8 1. The requirements relating to professional competence shall be met when: (a) an applicant railway undertaking has or will have a management organization which possesses the knowledge and/or experience necessary to exercise safe and reliable operational control and supervision of the type of operations specified in the licence, (b) its personnel responsible for safety, in particular drivers, are fully qualified for their field of activity and (c) its personnel, rolling stock and organization can ensure a high level of safety for the services to be provided. 2. For the purposes of paragraph 1, each applicant shall give at least the particulars listed in section II of the Annex. 3. Appropriate written proof of compliance with qualification requirements shall be produced. Article 9 A railway undertaking shall be adequately insured or make equivalent arrangements for cover, in accordance with national and international law, of its liabilities in the event of accidents, in particular in respect of passengers, luggage, freight, mail and third parties. SECTION III Validity of the licence Article 10 1. A licence shall be valid as long as the railway undertaking fulfils the obligations laid down in this Directive. A licensing authority may, however, make provision for a regular review at least every five years. 2. Specific provisions governing the suspension or revocation of a licence may be incorporated in the licence itself. Article 11 1. If there is serious doubt that a railway undertaking which it has licensed complies with the requirements of this Directive, and in particular Article 5 thereof, the licensing authority may, at any time, check whether that railway undertaking does in fact comply with those requirements. Where a licensing authority is satisfied that a railway undertaking can no longer meet the requirements of the Directive, and in particular Article 5 thereof, it shall suspend or revoke the licence. 2. Where the licensing authority of a Member State is satisfied that there is serious doubt regarding compliance with the requirements laid down in this Directive on the part of a railway undertaking to which a licence has been issued by the licensing authority of another Member State, it shall inform the latter authority without delay. 3. Notwithstanding paragraph 1, where a licence is suspended or revoked on grounds of non-compliance with the requirement for financial fitness, the licensing authority may grant a temporary licence pending the re-organization of the railway undertaking, provided that safety is not jeopardized. A temporary licence shall not, however, be valid for more than six months after its date of issue. 4. When a railway undertaking has ceased operations for six months or has not started operations six months after the grant of a licence, the licensing authority may decide that the licence shall be submitted for approval or be suspended. As regards the start of activities, the railway undertaking may ask for a longer period to be fixed, taking account of the specific nature of the services to be provided. 5. In the event of a change affecting the legal situation of an undertaking and, in particular, in the event of a merger or takeover, the licensing authority may decide that the licence shall be resubmitted for approval. The railway undertaking in question may continue operations, unless the licensing authority decides that safety is jeopardized; in that event, the grounds for such a decision shall be given. 6. Where a railway undertaking intends significantly to change or extend its activities, its licence shall be resubmitted to the licensing authority for review. 7. A licensing authority shall not permit a railway undertaking against which bankruptcy or similar proceedings are commenced to retain its licence if that authority is convinced that there is no realistic prospect of satisfactory financial restructuring within a reasonable period of time. 8. When a licensing authority suspends, revokes or amends a licence, the Member State concerned shall immediately inform the Commission accordingly. The Commission shall inform the other Member States forthwith. Article 12 In addition to the requirements of this Directive, a railway undertaking shall also comply with those provisions of national law which are compatible with Community law and are applied in a non-discriminatory manner, in particular: - specific technical and operational requirements for rail services, - safety requirements applying to staff, rolling stock and the internal organization of the undertaking, - provisions on health, safety, social conditions and the rights of workers and consumers. Article 13 Railway undertakings shall respect the agreements applicable to international rail transport in force in the Member States in which they operate. SECTION IV Transitional provision Article 14 Railway undertakings operating rail services shall be granted a transitional period of twelve months as at the final date of transposition referred to in Article 16 (2) in order to comply with the provisions of this Directive. That transitional period shall not cover any provision which might affect the safety of railway operations. SECTION V Final provisions Article 15 1. The procedures for the granting of licences shall be made public by the Member State concerned, which shall inform the Commission thereof. 2. The licensing authority shall take a decision on an application as soon as possible, but not more than three months after all relevant information, notably the particulars referred to in the Annex, has been submitted, taking into account all the available information. The decision shall be communicated to the applicant railway undertaking. A refusal shall state the grounds therefore. 3. Member States shall take the measures necessary to ensure that the licensing authority's decisions are subject to judicial review. Article 16 1. The Commission shall, two years after the application of this Directive, submit to the Council a report on such application accompanied, if necessary, by proposals concerning continued Community action, with particular regard to the possibility of enlarging the scope of the Directive. 2. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive within two years of the date of its entry into force. They shall forthwith inform the Commission thereof. 3. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 17 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 18 This Directive is addressed to the Member States.

31995L0017

1995

Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 94/32/EC (2), and in particular Article 6 (1) (g) thereof, Whereas there is a need to specify the criteria and conditions under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the minimum list of ingredients which must be included on the packaging of cosmetic products, or, where this is impossible for practical reasons, on an enclosed leaflet, label, tape or card; Whereas approval of confidentiality should not, however, impinge on the other obligations pursuant to Directive 76/768/EEC and the responsibilities arising from the Articles concerning the cosmetic product's safety, from the Annexes, and from the provisions as to the information necessary for appropriate medical treatment and the case-file to which the national monitoring authorities must have access; Whereas approval of confidentiality should not be prejudicial to consumer safety; Whereas the request for confidentiality must be submitted in the Member State of manufacture or initial importation into the Community market, which must also have access to the information referred to in Article 7a of Directive 76/768/EEC, as amended by Directive 93/35/EEC (3), for control purposes; Whereas to be adequately assessed and monitored the request must include all the particulars necessary for identifying the applicants, for the identification and human health assessment of the ingredient as used in the cosmetic product(s) and for determining the intended use of the ingredient concerned, as well as the grounds for confidentiality and the name(s) of the product containing the ingredient; Whereas for economic reasons and in deference to his rights the competent authority should inform the applicant, within a brief period of not more than four months, other than in exceptional cases, of the ruling in this case; whereas any refusal to grant confidentiality should be duly reasoned and the means of appeal and time limits clearly indicated; Whereas in the interests of transparency and monitoring, the competent authority should allocate a registration number to each request it approves; whereas this number should replace the ingredient in the list of ingredients referred to in Article 6 (1) (g) of Directive 76/768/EEC; Whereas all amendments to the particulars contained in the initial request must be communicated by the applicant to the competent authority, which may then withdraw its approval of confidentiality in view of those modifications, or if new information makes such a measure necessary for compelling public health reasons; Whereas the duration of the right to confidentiality should not exceed five years, subject to the option, in exceptional circumstances, of an extension for a further three years at the most; Whereas, in the interests of monitoring product safety and proper enforcement of the Directive, the Commission and the other Member States should be adequately informed of the decisions taken by the competent authority; whereas, on the other hand, such decisions should be recognized throughout the Community territory, except for exceptional reasons; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetics Products Sector, Article 1 This Directive shall apply without prejudice to the other obligations arising from Directive 76/768/EEC and the responsibilities arising therefrom, in particular from Articles 2, 4, 5, 7 (3) and 7a thereof. Article 2 Any manufacturer or his agent or person on whose account a cosmetic product is manufactured, or any person responsible for placing an imported cosmetic product on the Community market, who, for reasons of trade secrecy, wishes not to include one or more ingredients of a cosmetic product on the list referred to in Article 6 (1) (g) of Directive 76/768/EEC, shall submit a request to that effect to the competent authority referred to in Article 10 of this Directive of the Member State of the place of manufacture or initial importation, prior to placing the product on the Community market. Article 3 The request referred to in Article 2 must include the following particulars: (a) name or style and address or head office of the applicant; (b) precise identification of the ingredient for which confidentiality is requested, namely: - the CAS, Einecs and colour index numbers, the chemical name, the Iupac name, the INCI (1) name, the European Pharmacopoeia name, the international non-proprietary name recommended by the World Health Organization, and the common nomenclature name referred to in Article 7 (2) of Directive 76/768/EEC, where they exist, - the Elincs name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC (2) and indication of approval or refusal to approve a request for confidentiality pursuant to Article 19 of that Directive, - where the names or numbers referred to in the first and second indents do not exist, as in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used, and the names of the ingredient's components, such as solvents; (c) the evaluation of the safety for human health of the ingredient as used in the finished product(s), taking into account the ingredient's toxicological profile, chemical structure and the level of exposure, as specified in Article 7a (1) (d) and (e) and Article 7a (2) of Directive 76/768/EEC; (d) the envisaged use of the ingredient and in particular the different categories of products in which it will be used; (e) a detailed justification of why, by way of exception, confidentiality is sought; for example: - the fact that the identity of the ingredient or its function in the cosmetic product to be marketed has not been described in the literature and is unknown to others in the trade, - the fact that the information is not yet in the public domain, even though a patent application has been lodged for the ingredient or its use, - the fact that if the information were known it would be easily reproducible, to the detriment of the applicant; (f) if known, the name of each product which is to contain the ingredient(s), and if different names are to be used in the Community market, precise details on each one of them. If the name of a product is not yet known, it may be communicated at a later date, but at least 15 days before placing the product on the market. If the ingredient is used in several products, one request shall suffice, provided that the products are clearly indicated to the competent authority; (g) a statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the ingredient for which confidentiality is sought, and particulars on the outcome of any such request. Article 4 1. After receipt of the request for confidentiality in accordance with Article 3 the competent authority shall, within a period not exceeding four months, examine the request and inform the applicant in writing of its decision. In the event of approval, the authority shall also communicate the registration number it has allocated to the product in accordance with the procedure laid down in the Annex. However, if there are exceptional reasons, the competent authority may inform the applicant in writing that an additional period of two months will be required for the examination of the request. 2. Any refusal to grant a request for confidentiality must include a statement of reasons; appeal procedures, together with their time limits, must be clearly explained to the applicant. Article 5 The registration number referred to in Article 4 (1) shall replace the ingredient in question in the list referred to in Article 6 (1) (g) of Directive 76/768/EEC. Article 6 1. All amendments to the information provided pursuant to Article 3 must be communicated as rapidly as possible to the competent authority that has granted the request for confidentiality. All changes to the names of cosmetic products containing the ingredient must be communicated to the competent authority at least 15 days before those products are placed on the market under their new name. 2. Taking into consideration the amendments referred to in paragraph 1, or if new information makes it imperative to do so, particularly for compelling reasons of public health, the competent authority may withdraw its approval. In this event it shall inform the applicant of its new decision within the time limits and in accordance with the procedure referred to in Article 4. Article 7 The decision granting the right to confidentiality shall be valid for a period of five years. If the beneficiary of this decision considers that there are exceptional reasons justifying an extension of this period, he may submit a reasoned request to the competent authority which initially granted the request for confidentiality. The competent authority shall decide on this new request within the time limits and under the conditions referred to in Article 4. The confidentiality period shall not be extended by more than three years. Article 8 1. Member States shall inform the Commission and the other Member States of their decisions to grant requests for confidentiality or to extend such approval, indicating the name or style and address or head office of the applicants, the names of the cosmetic products containing the ingredient in respect of which the request for confidentiality has been granted, and the registration number referred to in Article 4 (1). The Commission and the other Member States may obtain, on request, a copy of the case file containing the request for confidentiality together with the decision of the competent authority. Particularly in this framework the competent authorities of the Member States and the Commission shall make arrangements to ensure proper cooperation. 2. Member States shall inform the Commission and the other Member States of their reasoned decisions to refuse or to withdraw approval of confidentiality or to refuse to extend the confidentiality period. 3. Member States and the Commission shall take the necessary measures to ensure that confidential data made known to them is not improperly disclosed. Article 9 Member States shall recognize the decisions taken by a competent authority as to the approval of confidentiality or extension of the confidentiality period. However, if, after having been informed or after having received a copy of the case file in accordance with the procedure under Article 8 (1), a Member State challenges a decision taken by the competent authority of another Member State, it may ask the Commission to take a decision pursuant to the procedure referred to in Article 10 of Directive 76/768/EEC. Article 10 Member States shall designate the competent authorities referred to in this Directive and shall inform the Commission thereof, which shall publish them in the Official Journal of the European Communities. A Member State may also designate the competent authority of another Member State, willing to accept for the purposes of examination in exceptional cases the requests referred to in Article 2. Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 November 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Direcitve. Article 12 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities. Article 13 This Directive is addressed to the Member States.

31995L0025

1995

Council Directive 95/25/EC of 22 June 1995 amending Directive 64/432/EEC on health problems affecting intra- Community trade in bovine animals and swine Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 3 (3) of Directive 64/432/EEC (4) lays down the conditions to be fulfilled by bovine animals intended for trade; Whereas with a view to these rules being extended to cover the placing on the market of the said animals, account should be taken of the improvement in the situation in Member States with regard to brucellosis and tuberculosis, Article 1 The following paragraph (g) shall be added to Article 3 (3) of Directive 64/432/EEC: '(g) by way of derogation from (a) and (b) above, not be subject to the test requirements laid down in the said (a) and (b) in the case of bovine animals aged less than 30 months intended for meat production which: - come from a herd officially tuberculosis-free and officially brucellosis-free, - are identified by a special mark at the time of their dispatch and remain under supervision until their slaughter, - have not come into contact during transport with bovine animals not coming from herds officially free from those diseases, and provided that: - these arrangements are restricted to trade between Member States with the same health status with regard to tuberculosis and brucellosis, - the Member State of destination takes all necessary measures to avoid any contamination of indigenous herds;'. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions comprising possible sanctions necessary to comply with this Directive not later than 31 December 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0023

1995

Council Directive 95/23/EC of 22 June 1995 amending Directive 64/433/EEC on conditions for the production and marketing of fresh meat Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 64/433/EEC (4) regulates the production and marketing of fresh meat of bovine animals, swine, sheep and goats and domestic solipeds; Whereas the regulations for low-capacity establishments eligible for approval under simplified structure and infrastructure criteria should be simplified, to take account of particular circumstances and of the principle of subsidiarity; Whereas hygiene requirements should be defined for the production and marketing of sliced offal; Whereas the regulations on accompanying documents can be simplified; Whereas meat from low-capacity establishments should comply only with general hygiene requirements for meat production and marketing and for this reason may be not marked with the Community stamp and be the subject of trade; Whereas the maximum handling limits for low-capacity slaughterhouses and cutting plants should be aligned on those laid down in Council Directive 92/120/EEC of 17 December 1992 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of certain products of animal origin (5); Whereas, however, account should be taken of certain specific situations in applying these limits; Whereas experience has shown the need to amend the Directive 64/433/EEC on a number of technical points which have caused problems of practical application, Article 1 Directive 64/433/EEC is hereby amended as follows: (1) The following point shall be added to Article 2: '(o) "repackaging centre" means a workshop or depot where wrapped meet intended for placing on the market is reassembled and/or repackaged.' (2) Article 3 (1) shall be amended as follows: (a) Section A (a) shall be replaced by the following: '(a) have been obtained in a slaughterhouse meeting the conditions laid down in Chapters I and II of Annex I and approved and supervised in accordance with Article 10;' (b) in Section A (f): (ba) subdivision (ii) shall be replaced by the following: '(ii) an accompanying commercial document which must: - be drawn up by the dispatching establishment, - in addition to the particulars provided for in point 50 of Chapter X of Annex I, bear the veterinary approval number of the approved establishment and in the case of frozen meat, the month and year of freezing in clear, - for meat intended for Finland and Sweden, bear one of the indications provided for in the third indent of Part IV of Annex IV, - be kept by the consignee so that it can be produced at the request of the competent authority. Computer data must be printed at the request of the aforesaid authority'; (bb) the last subparagraph shall be replaced by the following: 'At the request of the competent authority in the Member State of destination, a health attestation must be supplied where meat is intended for export to a third country after processing. The costs incurred in such attestation shall be borne by operators;' (c) in Section B: - the introductory phrase shall be replaced by the following: 'B. cuts or pieces smaller than those referred to in Section A, or boned meat whether or not wrapped:'; - in points (a) and (b), the words 'or wrapped' shall be inserted each time after 'cut'; (d) in Section C: - in the first subparagraph the second sentence shall be replaced by the following: 'Uncut offal must comply with the requirements of Sections A and B.', - in the last sentence of the first subparagraph 'sliced' shall be deleted, - the second subparagraph shall be deleted; (e) the following sentence shall be added to Section D (b): 'In this case the veterinary approval number of the cold store must be given on the accompanying commercial document.'; (f) the following section shall be added: 'F. fresh meat from which the packaging has been removed and which is to be re-packaged in an establishment other than that in which it was first wrapped: (a) must meat the requirements of Sections A, B, C and D; (b) must be removed from its packaging and repackaged in a repackaging centre which satisfies the requirements of Chapter I of Annex I and is approved and supervised in accordance with Article 10.' (3) Article 4 shall be replaced by the following: 'Article 4 A. As from 1 January 1995, Member States may, by way of derogation from Article 3, allow meat from slaughterhouses which do not satisfy the requirements of Chapters I and II of Annex I to be placed on the market for marketing in their national territory, provided the following conditions are met: (a) the slaughterhouses in question must: (i) handle not more than 20 livestock units per week with a maximum of 1 000 livestock units per year; (ii) satisfy the requirements of Annex I, Chapters V and VII, point 66 first, second and fourth paragraphs and point 67 of Chapter XIV and point 69 of Chapter XV, with the exception of the requirements relating to imported fresh meat, and points 71, 72 and 73; (iii) fulfil the requirements of Annex II; (iv) notify the veterinary service in advance of the time of slaughter and the number and the origin of the animals to allow it to carry out the ante mortem inspection in accordance with Chapter VI of Annex I, either on the farm or at the slaughterhouse. (b) the operator of the slaughterhouse, the owner or his agent must keep a register of: - animals entering the establishment and slaughter products leaving it, - the checks carried out, - the results of those checks. This information shall be communicated to the competent authority at its request; (c) the official veterinarian or an auxiliary must carry out the post-mortem inspection of the meat in accordance with Annex I, Chapter VIII, in compliance with the requirements of Annex I, Chapter VII, point 32. Where the meat has lesions or appears to have deteriorated, the post-mortem inspection must be carried out by the official veterinarian. The official veterinarian or the auxiliary under his responsibility must regularly monitor compliance with the hygiene rules laid down in Chapters V and VII of Annex I. When applying this Article, Member States shall use the following conversion rates: (i) beef and veal - adult bovine animals within the meaning of Regulation (EEC) No 805/68 and solipeds: 1 livestock unit - other bovines: 0,50 livestock unit (ii) pigmeat - pigs with a live weight of over 100 kg: 0,20 livestock unit - other pigs (a): 0,15 livestock unit (iii) other meat - sheep and goats: 0,10 livestock unit - lambs, kids and piglets of less than 15 kg live weight: 0,05 livestock unit. B. Within the limit of 1 000 livestock units referred to in Section A, first subparagraph, subdivision (a) (i), Member States may derogate from the weekly limit laid down therein to take account of the need to slaughter lambs and kids in the period leading up to religious festivals, provided that the official veterinarian is present at the time of slaughter, that the hygiene requirements are complied with and that the meat has not been frozen before being placed on the market. C. The maximum amounts provided for in Section A, first subparagraph, subdivision (a) (i) may be applied to individual operators slaughtering on their own account at quite separate times in the week in an establishment which satisfies the following requirements: (a) the owner of the establishment or any other person using this establishment has received specific training, recognized by the competent authority, in production hygiene; (b) the animals to be slaughtered are the property of the owner of the establishment, or of a self-employed butcher or have been purchased by them to meet the requirements referred to in point (d); (c) the meat is produced in premises which meet the requirements of Annex II; (d) production must be confined to supplying establishments belonging to the butchers referred to in (b) and to sale on the spot to the consumer or to local bodies. Where several individual slaughter quantities are added up, the maximum amounts provided for in Section A, first subparagraph, subdivision (a) (i) may be raised to 30 livestock units per week and 1 500 livestock units per year for the slaughterhouse meeting the conditions set out in the first subparagraph. Member States availing themselves of this possibility shall forward the list of establishments benefiting from these provisions to the Commission. D. Under the procedures provided for in Article 16, Member States may, at their request, be authorized to apply the requirements of Section A to slaughterhouses situated in regions suffering from special geographical constraints or affected by supply difficulties which handle not more than 2 000 livestock units per year. E. Derogations may be granted by the competent authority in accordance with Annex II in the case of cutting plants which are not situated in an approved establishment and which produce not more than five tonnes of boned meat per week or the equivalent of bone-in meat. The provisions of Annex I, Chapter V, Chapter VII, point 38, Chapter IX - with the exception of the requirement for the temperature of the cutting room laid down in the second sentence of point 46 (c) - and point 48 of Chapter X shall apply to cutting and storage operations in the establishments referred to in the first subparagraph. F. Meat that comes from the establishments referred to in this Article and that has been judged fit for human consumption, bearing in mind the hygiene and health requirements laid down by this Directive, must be marked with a national stamp which cannot be confused with the Community stamp and may in particular not be oval. However, this stamp shall not be necessary for cuts which have not been packaged. G. Member States may also allow derogations from the minimum requirements of Chapter I of Annex I for low-capacity cold stores in which only packaged meat and other foodstuffs are stored. Sweden may, until 20 June 1997, authorize packaged meat and non-packaged meat to be stored in one and the same cold store by means of an appropriate separation. H. Slaughterhouses benefiting from the derogations provided for in this Article shall be subject to the Community inspection required for approved establishments. (a) Game animals being treated in the same way as the respective species for the purposes of applying the conversion rates.'; (4) The following Article shall be inserted: 'Article 4a 1. Member States shall communicate, by 31 December 1995, the list of the establishments referred to in Article 1 of Directive 91/498/EEC (*) and the list of the establishments for which the time limits are set pursuant to this Article. 2. The competent authorities may allow a slaughterhouse which qualifies for a derogation in accordance with Article 2 of Directive 91/498/EEC (*) and which can show, to the satisfaction of the competent authority, that it has begun to bring itself into compliance with the requirements of this Directive but which cannot, for reasons not attributable to it, meet the time limits originally laid down, the additional time essential in order for it to comply with them. 3. Where an establishment registered in accordance with Article 4 is undergoing alterations on the basis of a restructuring plan approved by the competent authority with the aim of obtaining authorization in accordance with Article 10, that authority may determine the quantities marketed by the establishment in question in line with the progress of the work. 4. In transposing the provisions of this Directive into their national legislation, Member States shall specify the manner in which the penalties provided for in Article 10 and in Article 2 (2) of Directive 91/498/EEC are to apply in the event of failure by an establishment referred to in this Article to honour the commitments entered into upon being granted a temporary derogation, so that those penalties can be applied by 31 December 1995 and, as regards Sweden, by 31 December 1996 and, as regards Austria and Finland, by 31 December 1997. (*) Council Directive 91/498/EEC of 29 July 1991 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of fresh meat (OJ No L 268, 24. 9. 1991, p. 105). Directive as last amended by the 1994 Act of Accession.' (5) In Article 5 in 1 (a) (iii), 'macroscopically visible' shall be added before 'sarcocystosis'. (6) Article 6 shall be amended as follows: - in the fifth indent of subparagraph (e) of paragraph 1, the words 'the correct conduct of bleeding' shall be deleted; - in paragraph 1, subparagraph (h) shall be replaced by the following: '(h) meat must be marked with a national stamp which cannot be confused with the Community samp and in particular is not oval.' (7) In (iii) of the first subparagraph of Article 9, the words 'and in an approved packaging centre' shall be inserted after 'cold-store'. (8) The following shall be added at the end of the fourth and fifth subparagraphs of Article 10 (1): 'with regard to part of the activity in question or the whole establishment'. (9) In Article 12: (a) paragraph 1 shall be replaced by the following: '1. Veterinary experts from the Commission may, in so far as is necessary to ensure uniform application of this Directive and in cooperation with the competent authorities in the Member States, make on-site checks. By checking a representative number of establishments, they may also verify whether the competent authorities are checking on compliance with this Directive by establishments. The Member State on whose territory the checks are being carried out shall provide the experts with all necessary assistance to fulfil their mission. The Commission shall inform the Member State concerned of the results of the checks carried out.' (b) the following paragraph shall be added: '3. Provisions for the implementation of this Article, in particular those to cover the arrangements for cooperating with the national authorities, shall be adopted in accordance with the procedure laid down in Article 16'. (10) Article 13 (1) shall be deleted. (11) Annex I shall be amended as follows: (a) the following shall be added to point 14 (c) (i) of Chapter II: '. . . if such operations are carried out in the slaughterhouse. In addition, where swine are concerned, this provision shall apply to the extent necessary to prevent contamination of fresh meat and offal'; (b) in point 17 (a) of Chapter IV, the reference to 'the fourth paragraph of point 66 of Chapter XIV' shall be replaced by 'the eighth paragraph of point 66 of Chapter XIV'; (c) the first paragraph of point 25 of Chapter VI shall be replaced by the following: 'Animals must undergo ante-mortem inspection within a period which is less than 24 hours after their arrival in the slaughterhouse and less than 24 hours before slaughter. In addition, the official veterinarian may require inspection at any other time'; (d) in point 33 of Chapter VII, the following sentence shall be added: 'Mechanical insufflation for the flaying of lambs and kids of a live weight of less than 15 kg may be approved by the competent authorities in compliance with the hygiene requirements.'; (e) in point 43 of Chapter IX, the word 'slicing' shall be replaced by 'cutting' and the words 'of animals of the bovine species' shall be deleted; (f) in Chapter XI: - point 49 shall be replaced by the following: 'Health marking must be carried out under the responsibility of the official veterinarian. For this purpose, he shall supervise (a) the health mark; (b) the marks and wrapping material when marked as provided for in this Chapter.'; - in point 50 (b), the following subparagraph shall be added: 'The dimensions and characters of the mark may be reduced for health marking of lamb, kids and piglets.'; - in point 51: (i) the following shall be inserted as second indent: '- lamb, kid and piglet carcases must bear at least two stamps, one on each side of the carcase, on the shoulder or on the external surface of the thighs,'; (ii) the following shall be inserted as second subparagraph: 'However, in the case of lamb, kid and piglet carcases, health marking may take the form of a label or tag but it must be possible to use them only once.'; - points 52 to 56 shall be replaced by the following: '52. The livers of bovine animals, swine and solipeds must be hot-branded in accordance with point 50 if they are intended for another Member State or for an EEA country. 53. All other subproducts of slaughtering fit for human consumption must be marked immediately in accordance with point 50, either directly on the product or on the wrapping or packaging. The mark in accordance with point 50 must be applied to a label fixed to the wrapping or packaging or printed on the packaging. If wrapping or packaging takes place in a slaughterhouse, the mark must include the approval number of the establishment. 54. Packaging must always be marked in accordance with point 55. 55. Packaged cut meat and packaged offal referred to in point 52 and point 53 must bear a health mark in accordance with point 50. The mark must include the veterinary approval number of the cutting plant instead of that of the slaughterhouse. The mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. Non-destruction of the mark must be tolerated only when the packaging is destroyed by being opered. However, when cut meat or offal is wrapped in accordance with point 62 of Chapter XII, the label referred to above may be affixed to the wrapping. In the case of offal packaged in a slaughterhouse, the number included in the mark must be the veterinary approval number of the slaughterhouse concerned. This requirement also applies where stackable meat transport containers (Euro-boxes) satisfying the requirements of point 59 (b) are used. 56. Where fresh meat is wrapped in commercial portions intended for direct sale to the consumer, points 53 and 55 shall apply. The dimension requirements of point 50 need not apply to the mark required under this point. If meat is re-packaged in a plant other than that in which it was first wrapped, the wrapping must bear the health mark of the cutting plant where it was first wrapped, and the packaging must bear the health mark of the packaging centre.'; - point 58 shall be replaced by the following: '58. The colours used for health marking must be those listed in Article 2 (8) of Directive 94/36/EC (OJ No L 237, 10. 9. 1994, p. 13).' (g) in Chapter XII, - the following subparagraph shall be added to point 59 (a): 'Wood may not be used except in the case of lamb and kid carcases, provided that all precautions are taken to prevent contact between the meat and the packaging in the event of a tear in the wrapping.', - the fourth subparagraph of point 60 shall be replaced by the following: 'Where livers, kidneys or hearts are the subject of trade or are imported, each wrapping may contain only a complete organ.', - point 62 shall be replaced by the following: 'However, when wrapping fulfils all the protective conditions of packaging, it need not be transparent and colourless. Euro-boxes may also be used as a second container, provided that the other conditions of point 59 are fulfilled.', - the following subparagraph shall be added to point 63: 'Fresh meat may also be packed in a cutting room, provided that Euro-boxes, which must meet the requirements of point 59 (b) have been cleaned and disinfected prior to being brought into the cutting room.', - the following phrase shall be added to point 64: 'except in the case of commercial portions intended for direct sale to the consumer', (h) in point 66 of Chapter XIV, the second paragraph shall be replaced by the following: 'Derogations from this requirement may, for technical reasons relating to maturation of the meat, be granted by the competent authority on a case-by-case basis for the transportation of meat to cutting plants or butcher shops in the immediate vicinity of the slaughterhouse, provided that such transportation takes not more than two hours.' (12) In Annex II, Chapter II: (i) in point 10: - in point (c), the words 'distinctly separated areas' shall be replaced by the words 'a distinctly separated area', - point (f) shall be replaced by the following: '(f) a refrigerating room of sufficient capacity in relation to the size and type of animals slaughtered, with a separate area intended for storing confiscated carcases, except in cases where confiscated carcases are immediately dispatched, under official control, to a specialist establishment for additional examinations.'; (ii) in point 11: - the words 'or clean' shall be deleted, - the following sentence shall be added: 'In the slaughter room, stomachs and intestines may be cleaned at times when no slaughtering is taking place.'; (ii) the following point shall be added: '(15) Slaughterhouses must have a room with a lockable cupboard at the disposal of the inspection service through its work.' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions including any penalties, necessary to comply with this Directive by 1 July 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. 3. Pending the application of this Directive, the relevant national rules shall apply, in compliance with the general rules of the Treaty. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. It shall apply from 1 July 1995. Article 4 This Directive is addressed to the Member States.

31995L0029

1995

Council Directive 95/29/EC of 29 June 1995 amending Directive 90/628/EEC concerning the protection of animals during transport Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 13 (1) of Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport (4) requires the Commission to submit a report, possibly accompanied by proposals, on maximum journey times, feeding and watering intervals, resting periods, space allowances and standards to be met by means of transport as regards the transport of certain types of animal; Whereas the report from the Commission, based on an opinion from the Scientific Veterinary Committee, shows that standards can be established on the abovementioned matters in respect of certain types of animal, based on scientific knowledge and well established experience; Whereas some Member States have rules on journey times, feeding and watering intervals, resting periods and space allowances; whereas these rules are, in some cases, extremely detailed and are used by some Member States to restrict intra-Community trade in live animals; whereas persons involved in the transport of animals need clearly defined criteria to enable them to operate on a Community-wide basis without coming into conflict with differing national provisions; Whereas, in order to eliminate technical barriers to trade in live animals and to allow the market organizations in question to operate smoothly, while ensuring a satisfactory level of protection for the animals concerned, it is necessary in the context of the internal market to modify the rules of Directive 91/628/EEC with a view to harmonizing travelling times and resting periods, feeding and watering intervals, and space allowances, for certain types of animal; Whereas Member States should further be authorized to lay down stricter conditions for journey times for animals destined for slaughter where the animals are to be transported between a place of departure and a place of destination situated in their territory whilst complying with the general provisions of the Treaty, Article 1 Directive 91/628/EEC is hereby amended as follows: 1. Article 1 (2) (a) shall be replaced by the following text: '(a) - to transport which is not of a commercial nature or to any individual animal accompanied by a natural person who has responsibility for the animal during transport, - to the transport of pet animals accompanying their owner on a private journey.` 2. In Article 2 (2): (a) in point (e), the words 'and accommodated for at least 10 hours` shall be replaced by the words 'and accommodated for 24 hours`; (b) the following subparagraphs shall be added: '(h) "rest period", a continuous period in the course of a journey during which animals are not being moved by a means of transport; (i) "transporter", any natural or legal person transporting animals - on his own account, or - for the account of a third party, or - by providing a third party with a means of transport of animals, where such transport is of a commercial nature and carried out for the purpose of gain;` 3. In Article 3 (1), the following subparagraph shall be inserted: '(aa) - space allowances (loading densities) for animals at least comply with the figures laid down in Chapter VI of the Annex, in respect of the animals and the means of transport referred to in that Chapter, - travelling times and rest periods and feeding and watering intervals for certain types of animals comply with those laid down in Chapter VII of the Annex, in respect of the animals referred to in that Chapter, without prejudice to the provisions of Regulation (EEC) No 3820/85 (*); (*) OJ No L 370, 31. 12. 1985, p. 1.` 4. Article 5 shall be replaced by the following: 'Article 5 A. Member States shall ensure that: 1. any transporter: (a) is: (i) registered in a manner enabling the competent authority to identify the person rapidly in the event of failure to comply with the requirements of this Directive; (ii) covered by an authorization valid for all transport of vertebrate animals carried out in one of the territories referred to in Annex I to Directive 90/675/EEC, granted by the competent authority of the Member State of establishment or, if an undertaking established in a third country is concerned, by a competent authority of a Member State of the Union, subject to a written undertaking by the person in charge of the transport undertaking to comply with the requirements of the Community veterinary legislation in force. This written undertaking shall in particular state that: - the transporter referred to in point 2 has taken all the measures necessary to comply with the requirements of this Directive as far as the place of destination and, more particularly where export to third countries is concerned, as far as the place of destination as defined by Community legislation, - without prejudice to the provisions of Chapter 1A (6) (b) of the Annex, the staff referred to in subparagraph (a) of point 2 have received specific training, either within the undertaking or from a training body, or have equivalent practical experience qualifying them to handle and transport vertebrate animals and to administer, if necessary, appropriate care to the animals transported; (b) does not transport any animal, or cause any animal to be transported, in a way which is likely to cause injury or undue suffering to that animal; (c) uses, for the transport of animals referred to in this Directive, means of transport that will ensure compliance with Community requirements concerning welfare during transport, and in particular the requirements laid down in the Annex and those to be laid down in accordance with Article 13 (1); 2. the transporter: (a) entrusts the transport of the live animals to staff who possess the necessary ability, professional competence and knowledge laid down in subparagraph (a) of point 1; (b) for the animals referred to in Article 1 (1) (a) which are to be traded between Member States or exported to third countries, and in cases where the journey time exceeds eight hours, draws up a route plan in accordance with the specimen in Chapter VIII of the Annex, which will be attached to the health certificate during the journey, and also indicates any staging and transfer points. A single route plan will have to be drawn up in accordance with point (c) to cover the whole period of the journey; (c) submits the route plan referred to in (b) to the competent authority so that it can draw up the health certificate, after which, the number or numbers of such certificates must be marked on the route plan and it must be stamped by the veterinarian of the place of departure, who will also give notice of the existence of the route plan through the Animo system; (d) ensures: (i) that the original copy of the route plan referred to in (b) - is duly drawn up and completed by the appropriate persons at the appropriate time, - is attached to the health certificate accompanying the consignment throughout the journey; (ii) that the staff in charge of the transport - state in the route plan the times and places at which the animals transported have been fed and watered during the journey, - where animals are being exported to third countries and the travelling time within Community territory, exceeds eight hours, have the route plan certified, after checking, by the competent authority of the authorized crossing point or of the point of exit designated by a Member State (stamps and signature), after the animals have been checked and judged by the official veterinarian to be fit to continue their journey. Member Sates may specify that expenses incurred by the abovementioned veterinary check shall be borne by the operator exporting the animals, - on their return, send back the route plan to the competent authority of the place of origin. However, where animals are being exported to third countries by sea and the travelling time exceeds eight hours, the same provisions shall apply; (e) keeps, for a period fixed by the competent authority, a second copy of the route plan referred to in (b) which may, if required, be submitted on request to the competent authority for verification; (f) demonstrates, according to the species transported and where the length of the journey entails compliance with Chapter VII (4), that steps have been taken to meet the animals' needs for food and water during the journey, even where the route plan is changed or where the journey is interrupted for reasons beyond his control; (g) ensures that the animals are transported without delay to their place of destination; (h) without prejudice to compliance with the provisions in Chapter III of the Annex, ensures that animals of species not referred to in Chapter VII of the Annex are suitably fed and watered at appropriate internals during transport; 3. that the staging points, agreed upon in advance by the person in charge referred to in point 2, are regularly checked by the competent authority which must also satisfy itself that the animals are fit to continue their journey; 4. that the costs of meeting animals' feeding, watering and rest requirements are borne by the operators referred to in point 1. B. Any procedures for application which result from this Article shall be adopted in accordance with the procedure provided for in Article 17.` 5. Article 8 shall read as follows: 'Article 8 Member States shall ensure that, in accordance with the principles and rules of control laid down in Directive 90/425/EEC, the competent authorities check that the requirements of this Directive have been complied with, by carrying out non-discriminatory inspections of: (a) means of transport and animals during transport by road; (b) means of transport and animals arriving at their place of destination; (c) means of transport and animals at markets, at places of departure, at staging points and at transfer points; (d) the particulars on the accompanying documents. Such inspections must be carried out on an adequate sample of the animals transported each year within each Member State, and may be carried out at the same time as checks for other purposes. The competent authority in each Member State shall submit to the Commission an annual report stating the number of inspections carried out in the preceding calendar year in respect of each of the points (a), (b), (c) and (d) and including details of any reported infringements and the action taken as a result by the competent authority. Furthermore, where the competent authority of a Member State has information leading it to suspect an infringement, checks may also be carried out during the transport of animals on its territory. This Article shall not affect checks carried out as part of tasks conducted in a non-discriminatory manner by authorities responsible for the general application of laws in a Member State.` 6. The following shall be added as third subparagraph to Article 9 (1): 'Any measure taken pursuant to the second subparagraph shall be notified by the competent authority by the Animo network according to the procedures, including financial procedures, to be established according to the procedure provided for in Article 17.` 7. Article 10 shall be replaced by the following: 'Article 10 1. Commission experts may, to the extent necessary to ensure uniform application of this Directive, carry out on-the-spot checks. In so doing, they may carry out random, non-discriminatory checks to ensure that the competent authority is monitoring compliance with the requirements of this Directive. The Commission shall inform the Member States of the results of these checks. 2. The checks referred to in paragraph 1 shall be carried out in collaboration with the competent authority. 3. The Member State in the territory of which the inspections are carried out shall provide the experts with any assistance they require to accomplish their task. 4. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 17.` 8. Article 11 shall be replaced by the following: `Article 11 1. The rules laid down by Directive 91/496/EEC shall apply, in particular with regard to the organization of and follow-up to checks. 2. The importation, transit and transport into and through Community territory of live animals covered by this Directive coming from third countries shall be authorized only if the transporter: - gives a written undertaking to comply with the requirements of this Directive, in particular those referred to in Article 5, and has made arrangements to comply with them, - submits a route plan drawn up in accordance with Article 5. 3. In addition, when checking that the requirements of paragraph 2 have been complied with, the official veterinarian of the border inspection post shall verify compliance with animal welfare requirements. If he establishes that requirements for the feeding and watering of animals have not been complied with, he shall take, at the operator's expense, the measures provided for in Article 9. 4. The certificate or documents provided for in the third indent of Article 4 (1) of Directive 91/496/EEC shall be supplemented in accordance with the procedure laid down in Article 17, in order to take account of the requirements of this Directive. Pending adoption of these measures, the relevant national rules shall apply, subject to the general rules laid down by the Treaty.` 9. Article 13 shall be replaced by the following: 'Article 13 1. Before 31 December 1995, the Commission shall submit proposals to the Council for the fixing of standards with which means of transport must comply. The Council shall act on those proposals by a qualified majority. 2. The Council, acting by a qualified majority on a proposal from the Commission, shall, before 30 June 1996, lay down the Community criteria to be met by staging points with regard to the reception structure, feeding, watering, loading, unloading and where necessary housing of certain types of animal as well as the health requirements applicable to such staging points. 3. Before 31 December 1999, the Commission shall submit a report to the Council on the experience acquired by the Member States since the implementation of this Directive, possibly accompanied by proposals on which the Council shall act by a qualified majority. 4. Pending implementation of the provisions referred to in paragraphs 1 and 2, the relevant national rules shall apply subject to the general rules laid down by the Treaty.` 10. Article 16 shall be replaced by the following: 'Article 16 1. Member States may exempt from the provisions of this Directive movements of animals in certain parts of the territories referred to in Annex I to Directive 90/675/EEC, to take account of their remoteness from the mainland part of the Community territory. 2. Member States which make use of this option shall inform the other Member States and the Commission in the Standing Veterinary Committee of the measures they have taken.` 11. Article 18 (2) shall be replaced by the following: '2. In the case of repeated infringements of this Directive or an infringement which involves serious suffering for the animals, a Member State shall, without prejudice to any other penalties provided for, take the measures necessary to remedy the shortcomings noted, up to and including suspension or even withdrawal of the authorization referred to in Article 5A (1) (a) (ii). Member States shall, when they transpose provisions into their national legislation, provide for the measures which they will take to remedy the shortcomings noted.` 12. The following paragraphs shall be added to Article 18: '3. Where it is established in the Member State of transit or destination by the competent authority of one of those Member States that a transport undertaking is not observing the provisions of this Directive, they shall contact the competent authority of the Member State which granted the authorization without delay. The latter shall take all the necessary measures, in particular those laid down in paragraph 2. It shall communicate the decision taken and the reasons therefor to the competent authority of the Member State in which the infringement was established and to the Commission. The Commission shall regularly inform the other Member States thereof. 4. The Member States shall, acting in accordance with the provisions laid down in Directive 89/608/EEC (*), provide each other with mutual assistance in applying this Directive in order, in particular, to ensure compliance with the provisions of this Article. Where it has been established that serious or repeated infringements have taken place, provided that all the possibilities afforded by mutual assistance have been exhausted and after contacts between the parties and the Commission, the Member State in which the infringements have been established may temporarily prohibit the transporter who is implicated from transporting animals on its territory. 5. This Article shall not affect national rules applicable to penal sanctions. (*) OJ No L 351, 2. 12. 1989, p. 34.` 13. The following shall be added to Chapter I, Section A. 2 (b) of the Annex: 'Sufficient space should be provided inside the animals' compartment and at each of its levels to ensure that there is adequate ventilation above the animals when they are in a naturally standing position without on any account hindering their natural movement.` 14. Chapter I, Section A. 2 (d) of the Annex shall be replaced by the following: '(d) During transport the animals must receive water and appropriate food at the intervals laid down for this purpose in Chapter VII.` 15. The Chapters which appear in the Annex to this Directive shall be added to the Annex. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1996 at the latest. They shall forthwith inform the Commission thereof. However, Member States shall have an additional period running until 31 December 1997 within which to apply the requirements laid down in Chapter VII (3) to the means of transport referred to in points (3), (6) and (7) of that Chapter. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0016

1995

European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the Opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3) in the light of the joint text approved by the Conciliation Committee on 17 May 1995, Whereas Member States are responsible within their territory for the health and safety of people; Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, approved by the European Council in June 1985, provide for a new approach to the approximation of laws; Whereas Council Directive 84/529/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electrically, hydraulically or oil-electrically operated lifts (4) does not ensure freedom of movement for all types of lift; whereas disparities between the binding provisions of the various national systems for types of lift not covered by Directive 84/529/EEC constitute barriers to trade within the Community; whereas the national rules on lifts should therefore be harmonized; 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 (5) serves as a framework Directive for two specific Directives, namely Directive 84/529/EEC and 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 (6), repealed by Council Directive 91/368/EEC of 20 June 1991 amending Directive 89/392/EEC on the approximation of the laws of the Member States relating to machinery (7); Whereas on 8 June 1995 the Commission adopted recommendation No 95/216/EC (8) to the Member States concerning improvement of safety of existing lifts; Whereas the essential requirements of this Directive will guarantee the intended level of safety only if appropriate conformity assessment procedures, chosen from among the provisions of Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives (9), ensure compliance therewith; Whereas the CE marking must be visibly affixed to lifts or to certain safety components of lifts which meet the essential health and safety requirements of this Directive to enable them to be placed on the market; Whereas this Directive defines only general essential health and safety requirements; whereas, in order to help manufacturers prove conformity with these essential requirements, it is desirable to have standards harmonized at European level concerning the prevention of risks arising from the design and installation of lifts, and also in order to enable conformity with the essential requirements to be verified; whereas such standards are drawn up at European level by private-law bodies and must retain their non-binding status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for adopting harmonized standards in accordance with the general guidelines for cooperation between the Commission and CEN and Cenelec signed on 13 November 1984; whereas a harmonized standard within the meaning of this Directive is a technical specification adopted by CEN and/or Cenelec on the basis of a mandate 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 (1) and pursuant to the abovementioned general guidelines; Whereas provision should be made for transitional arrangements to enable installers to place on the market lifts manufactured before the date of implementation of this Directive; Whereas this Directive is designed to cover all risks caused by lifts and run by their users and by the occupants of the construction; whereas this Directive should therefore be regarded as a Directive within the meaning of Article 2 (3) of Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (2); Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994, CHAPTER I Scope, placing on the market and free movement Article 1 1. This Directive shall apply to lifts permanently serving buildings and constructions. It shall also apply to the safety components for use in such lifts listed in Annex IV. 2. For the purposes of this Directive, 'lift' shall mean an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of: - persons, - persons and goods, - goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. Lifts moving along a fixed course even where they do not move along guides which are rigid shall fall within the scope of this Directive (for example, scissor lifts). 3. The Directive shall not apply to: - cableways, including funicular railways, for the public or private transportation of persons, - lifts specially designed and constructed for military or police purposes, - mine winding gear, - theatre elevators, - lifts fitted in means of transport, - lifts connected to machinery and intended exclusively for access to the workplace, - rack and pinion trains, - construction-site hoists intended for lifting persons or persons and goods. 4. For the purposes of this Directive: - the 'installer of a lift' shall mean the natural or legal person who takes responsibility for the design, manufacture, installation and placing on the market of the lift and who affixes the CE marking and draws up the EC declaration of conformity, - 'placing on the market of the lift' shall occur when the installer first makes the lift available to the user, - 'safety component' shall mean a component as listed in Annex IV, - the 'manufacturer of the safety components' shall mean the natural or legal person who takes responsibility for the design and manufacture of the safety components and who affixes the CE marking and draws up the EC declaration of conformity, - a 'model lift' shall mean a representative lift whose technical dossier shows the way in which the essential safety requirements will be met for lifts which conform to the model lift defined by objective parameters and which uses identical safety components. All permitted variations between the model lift and the lifts forming part of the lifts derived from the model lift must be clearly specified (with maximum and minimum values) in the technical dossier. By calculation and/or on the basis of design plans it is permitted to demonstrate the similarity of a range of equipment to satisfy the essential safety requirements. 5. Where, for lifts, the risks referred to in this Directive are wholly or partly covered by specific Directives, this Directive shall not apply or shall cease to apply in the case of such lifts and such risks as from application of those specific Directives. Article 2 1. Member States shall take all appropriate measures to ensure that: - lifts covered by this Directive may be placed on the market and put into service only if they are not liable to endanger the health or safety of persons or, where appropriate, the safety of property, when properly installed and maintained and used for their intended purpose. - safety components covered by this Directive may be placed on the market and put into service only if the lifts in which they are to be installed are not liable to endanger the health or safety of persons or, where appropriate, the safety of property when properly installed and maintained and used for their intended purpose. 2. Member States shall take all appropriate measures to ensure that the person responsible for work on the building or construction and the installer of the lift, on the one hand, keep each other informed of the facts necessary for, and, on the other hand, take the appropriate steps to ensure, the proper operation and safe use of the lift. 3. Member States shall take all necessary measures to ensure that shafts intended for lifts do not contain any piping or wiring or fittings other than that necessary for the operation and safety of the lift. 4. Without prejudice to paragraphs 1, 2 and 3, the provisions of this Directive shall not affect Member States' entitlement to lay down in conformity with the Treaty such requirements as they may deem necessary to ensure that persons are protected when the lifts in question are put into service or used, provided that this does not mean that the lifts are modified in a way not specified in the Directive. 5. At trade fairs, exhibitions or demonstrations in particular, Member States shall not prevent the showing of lifts or safety components which do not conform to the Community provisions in force, provided that a visible sign clearly indicates that such lifts or safety components are not in conformity and are not for sale until they have been brought into conformity by the installer of the lift, the manufacturer of the safety components or the latter's authorized representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons. Article 3 Lifts covered by this Directive must satisfy the essential health and safety requirements set out in Annex I. The safety components covered by this Directive must satisfy the essential health and safety requirements set out in Annex I or enable the lifts in which they are installed to satisfy the said essential requirements. Article 4 1. Member States may not prohibit, restrict or impede the placing on the market or putting into service on their territory of lifts and/or safety components which comply with this Directive. 2. Member States may not prohibit, restrict or impede the placing on the market of components which, on the basis of a declaration by the manufacturer or his authorized representative established in the Community, are intended to be incorporated into a lift covered by this Directive. Article 5 1. Member States shall regard lifts and safety components bearing the CE marking and accompanied by the EC declaration of conformity referred to in Annex II as conforming to all the provisions of this Directive, including the conformity assessment procedures laid down in Chapter II. In the absence of harmonized standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential health and safety requirements in Annex I. 2. Where a national standard transposing a harmonized standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential health and safety requirements: - lifts constructed in accordance with that standard shall be presumed to comply with the relevant essential requirements. or - safety components constructed in accordance with that standard shall be presumed suitable to enable a lift on which they are correctly installed to comply with the relevant essential requirements. Member States shall publish the references of national standards transposing harmonized standards. 3. Member States shall ensure that appropriate measures are taken to enable both sides of industry to have an influence at national level on the process of preparing and monitoring the harmonized standards. Article 6 1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Committee set up under Directive 83/189/EEC, giving the reasons therefor. The Committee shall deliver an opinion without delay. Upon receipt of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5 (2). 2. The Commission may adopt any appropriate measure with a view to ensuring the practical application in a uniform manner of this Directive in accordance with the procedure laid down in paragraph 3. 3. The Commission shall be assisted by a Standing Committee composed of the representatives of the Member States and chaired by the representative of the Commission. The Standing Committee shall draw up its own rules of procedure. The representative of the Commission shall submit to the Standing Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes, in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the Standing Committee. It shall inform that Committee of the manner in which its opinion has been taken into account. 4. The Standing Committee may, furthermore, examine any question concerning the application of this Directive and raised by its chairman either at the latter's initiative or at the request of a Member State. Article 7 1. Where a Member State ascertains that a lift or a safety component bearing the CE marking and used in accordance with its intended purpose is liable to endanger the safety of persons and, where appropriate, of property, it shall take all appropriate measures to withdraw it from the market, to prohibit it from being placed on the market or put into service or to restrict its free movement. The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and in particular whether non-conformity is due to: (a) failure to satisfy the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5 (2); (c) shortcomings in the standards referred to in Article 5 (2) themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that: - the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is based on shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6 (1), if the Member State which has taken the decision intends to maintain it, and shall initiate the procedure referred to in Article 6 (1), - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the installer of the lift, the manufacturer of the safety components or the latter's authorized representative established in the Community. 3. Where a lift or safety component which does not comply bears the CE marking, the competent Member State shall take appropriate action against whomsoever affixed the marking and shall so inform the Commission and the other Member States. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedure. CHAPTER II Conformity assessment procedure Article 8 1. Before placing safety components listed in Annex IV on the market, the manufacturer of a safety component or his authorized representative established in the Community must: (a) (i) either submit the model of the safety component for EC type-examination in accordance with Annex V and for production checks by a notified body in accordance with Annex XI; (ii) or submit the model of the safety component for EC type-examination in accordance with Annex V and operate a quality assurance system in accordance with Annex VIII for checking production; (iii) or operate a full quality assurance system in accordance with Annex IX; (b) affix the CE marking on each safety component and draw up a declaration of conformity containing the information listed in Annex II, taking account of the specifications given in the Annex used (Annex VIII, IX or XI as the case may be); (c) keep a copy of the declaration of conformity for 10 years from the date on which the safety component was last manufactured. 2. Before being placed on the market, a lift must have undergone one of the following procedures: (i) either, if it was designed in accordance with a lift having undergone an EC type-examination as referred to in Annex V, it shall be constructed, installed and tested by implementing: - the final inspection referred to in Annex VI, or - the quality assurance system referred to in Annex XII, or - the quality assurance system referred to in Annex XIV. The procedures for the design and construction stages, on the one hand, and the installation and testing stages, on the other, may be carried out on the same lift; (ii) or, if it was designed in accordance with a model lift having undergone an EC type-examination as referred to in Annex V, it shall be constructed, installed and tested by implementing: - the final inspection referred to in Annex VI, or - the quality assurance system referred to in Annex XII, or - the quality assurance system referred to in Annex XIV; (iii) or, if it was designed in accordance with a lift for which a quality assurance system pursuant to Annex XIII was implemented, supplemented by an examination of the design if the latter is not wholly in accordance with the harmonized standards, it shall be installed and constructed and tested by implementing, in addition: - the final inspection referred to in Annex VI, or - the quality assurance system in accordance with Annex XII, or - the quality assurance system in accordance with Annex XIV; (iv) or, having undergone the unit verification procedure, referred to in Annex X, by a notified body; (v) or, having been subject to the quality assurance system in accordance with Annex XIII, supplemented by an examination of the design if the latter is not wholly in accordance with the harmonized standards. In the cases referred to in (i), (ii) and (iii) above, the person responsible for the design must supply to the person responsible for the construction, installation and testing all necessary documents and information for the latter to be able to operate in absolute security. 3. In all the cases referred to in paragraph 2: - the installer shall affix the CE marking on the lift and draw up a declaration of conformity containing the information listed in Annex II, taking account of the specifications given in the Annex used (Annex VI, X, XII, XIII or XIV, as the case may be), - the installer must keep a copy of the declaration of conformity for 10 years from the date on which the lift was placed on the market, - the Commission, the Member States and the other notified bodies may, on request, obtain from the installer a copy of the declaration of conformity and reports of the tests involved in the final inspection. 4. (a) Where the lifts or safety components are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the lift or safety component is also presumed to conform to the provisions of those other Directives. (b) However, where one or more of these Directives allows the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only to the Directives applied by the installer of the lift or the manufacturer of the safety components. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying the lift or safety component. 5. Where neither the installer of the lift nor the manufacturer of the safety component nor his authorized representative established in the Community has complied with the obligations of the preceding paragraphs, those obligations shall devolve upon whomsoever places the lift or the safety component on the market in the Community. The same obligations shall apply to whomsoever manufactures the lift or safety component for his own use. Article 9 1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 8, together with the specific tasks and examination procedures which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission. The Commission shall publish for information in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date. 2. Member States shall apply the criteria laid down in Annex VII in assessing the notified bodies. Bodies meeting the assessment criteria laid down in the relevant harmonized standards shall be presumed to fulfil the criteria laid down in Annex VII. 3. A Member State which has notified a body must withdraw its notification if it finds that the body no longer meets the criteria laid down in Annex VII. It shall immediately inform the Commission and the other Member States accordingly. CHAPTER III CE marking Article 10 1. The CE marking shall consist of the initials CE. Annex III sets out the model to be used. 2. The CE marking shall be affixed to every lift car distinctly and visibly in accordance with Section 5 of Annex I and shall be affixed on each of the safety components listed in Annex IV or, where that is not possible, on a label inseparably attached to the safety component. 3. The affixing on the lifts or safety components of markings which are likely to mislead third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the lifts or safety components, provided that the visibility and legibility of the CE marking are not thereby reduced. 4. Without prejudice to Article 7: (a) where a Member State establishes that the CE marking has been affixed irregularly, the installer of the lift, the manufacturer of the safety component or the authorized representative of the latter established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State; (b) should non-conformity persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the safety component in question or to ensure that it is withdrawn from the market and prohibit the lift from being used and inform the other Member States in accordance with the procedures laid down in Article 7 (4). CHAPTER IV Final provisions Article 11 Any decision taken pursuant to this Directive which restricts: - the placing on the market and/or putting into service and/or use of a lift, - the placing on the market and/or putting into service of a safety component, shall state the exact grounds on which it is based. Such a decision shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject. Article 12 The Commission shall take the necessary steps to have information on all the relevant decisions relating to the implementation of this Directive made available. Article 13 Directive 84/528/EEC and Directive 84/529/EEC are hereby repealed with effect from 1 July 1999. Article 14 With regard to the aspects concerning the installation of the lift, this Directive is a Directive within the meaning of Article 2 (3) of Directive 89/106/EEC. Article 15 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1997. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Member States shall apply these measures with effect from 1 July 1997. 2. Until 30 June 1999 Member States shall allow: - the placing on the market and putting into service of lifts, - the placing on the market and putting into service of safety components, which conform to the provisions in force in their territories on the date of adoption of this Directive. 3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 16 No later than 30 June 2002, the Commission shall, in consultation with the Committee referred to in Article 6 (3) and on the basis of reports provided by the Member States, re-examine the functioning of the procedures laid down in this Directive and, if necessary, submit any proposals for appropriate amendments. Article 17 This Directive is addressed to the Member States.

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European Parliament and Council Directive 95/26/EC of 29 June 1995 amending Directives 77/780/EEC and 89/646/EEC in the field of credit institutions, Directives 73/239/EEC and 92/49/EEC in the field of non- life insurance, Directives 79/267/EEC and 92/96/EEC in the field of life assurance, Directive 93/22/EEC in the field of investment firms and Directive 85/611/EEC in the field of undertakings for collective investment in transferable securities (Ucits), with a view to reinforcing prudential supervision Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 57 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3) in the light of the joint text approved by the Conciliation Committee on 11 May 1995, (1) Whereas certain events have shown that it is appropriate to amend in certain respects certain Council Directives, specifying the general framework within which credit institutions, insurance undertakings, investment firms and undertakings for investment in transferable securities (Ucits) may carry on their business, namely Directives 77/780/EEC (4) and 89/646/EEC, Directives 73/239/EEC (5) and 92/49/EEC, Directives 79/267/EEC (6) and 92/96/EEC, Directive 93/22/EEC (7) and Directive 85/611/EEC (8), with a view to reinforcing prudential supervision; whereas it is desirable to adopt similar measures throughout the financial services sector; (2) Whereas those Directives lay down, inter alia, the conditions which must be fulfilled before the competent authorities may grant authorization for the taking-up of business; (3) Whereas the competent authorities should not authorize or continue the authorization of a financial undertaking where they are liable to be prevented from effectively exercising their supervisory functions by the close links between that undertaking and other natural or legal persons; whereas financial undertakings already authorized must also satisfy the competent authorities in that respect; (4) Whereas the definition of 'close links' in this Directive lays down minimum criteria and that does not prevent Member States from applying it to situations other than those envisaged by the definition; (5) Whereas the sole fact of having acquired a significant proportion of a company's capital does not constitute participation for the purposes of this Directive if that holding has been acquired solely as a temporary investment which does not make it possible to exercise influence over the structure or financial policy of the undertaking; (6) Whereas the reference to the supervisory authorities' effective exercise of their supervisory functions covers supervision on a consolidated basis which must be exercised over a financial undertaking where the provisions of Community law so provide; whereas, in such cases, the authorities applied to for authorization must be able to identify the authorities competent to exercise supervision on a consolidated basis over that financial undertaking; (7) Whereas the principles of mutual recognition and of home Member State supervision require that Member States' competent authorities should not grant or should withdraw authorization where factors such as the content of programmes of operations, the geographical distribution of the activities actually carried on indicate clearly that a financial undertaking has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within whose territory it carries on or intends to carry on the greater part of its activities; whereas a financial undertaking which is a legal person must be authorized in the Member State in which it has its registered office; whereas a financial undertaking which is not a legal person must have its head office in the Member State in which it has been authorized; whereas, in addition, Member States must require that a financial undertaking's head office always be situated in its home Member State and that it actually operates there; (8) Whereas it is appropriate to provide for the possibility of exchanges of information between the competent authorities and authorities or bodies which, by virtue of their function, help to strengthen the stability of the financial system; whereas, in order to preserve the confidential nature of the information forwarded, the list of addressees must remain within strict limits; (9) Whereas certain behaviour, such as fraud and insider offenses, is liable to affect the stability, including integrity, of the financial system, even when involving undertakings other than financial ones; (10) Whereas it is necessary to specify the conditions under which such exchanges of information are authorized; (11) Whereas, where it is stipulated that information may be disclosed only with the express agreement of the competent authorities, these may, where appropriate, make their agreement subject to compliance with strict conditions; (12) Whereas exchanges of information between, on the one hand, the competent authorities and, on the other, central banks and other bodies with a similar function in their capacity as monetary authorities and, where appropriate, other public authorities responsible for supervising payment systems should also be authorized; (13) Whereas the same obligation of professional secrecy on the authorities responsible for authorizing and supervising Ucits and the undertakings that take part in those activities and the same possibilities for exchanging information as those granted to the authorities responsible for authorizing and supervising credit institutions, investment firms and insurance undertakings, should be included in Directive 85/611/EEC; (14) Whereas this Directive coordinates all the provisions governing information exchanges between authorities for the entire financial sector as provided for in Directive 93/22/EEC; (15) Whereas, for the purpose of strengthening the prudential supervision of financial undertakings and protection of clients of financial undertakings, it should be stipulated that an auditor must have a duty to report promptly to the competent authorities, wherever, as provided for by this Directive, he becomes aware, while carrying out his tasks, of certain facts which are liable to have a serious effect on the financial situation or the administrative and accounting organization of a financial undertaking; (16) Whereas, having regard to the aim in view, it is desirable for Member States to provide that such a duty should apply in all circumstances where such facts are discovered by an auditor during the performance of his tasks in an undertaking which has close links with a financial undertaking; (17) Whereas the duty of auditors to communicate, where appropriate, to the competent authorities certain facts and decisions concerning a financial undertaking which they discover during the performance of their tasks in a non-financial undertaking does not in itself change the nature of their tasks in that undertaking nor the manner in which they must perform those tasks in that undertaking; (18) Whereas adopting this Directive is the most appropriate means of achieving the objectives in view, and in particular of reinforcing the powers of the competent authorities; whereas this Directive restricts itself to the minimum required to achieve those objectives and does not go beyond what is necessary for that purpose, Article 1 Wherever the term 'financial undertaking' is used in this Directive, it shall be replaced by: - 'credit institution' where this Directive amends Directives 77/780/EEC and 89/646/EEC; - 'insurance undertaking' where this Directive amends Directives 73/239/EEC and 92/49/EEC, and 'life assurance undertaking' where this Directive amends Directives 79/267/EEC and 92/96/EEC; - 'investment firm' where this Directive amends Directive 93/22/EEC; - 'undertaking for collective investment in transferable securities (Ucits) or an undertaking contributing towards its business activity' where this Directive amends Directive 85/611/EEC. Article 2 1. - In Article 1 of Directive 77/780/EEC, a fifth indent, - in Article 1 of Directive 92/49/EEC, a point (l), - in Article 1 of Directive 92/96/EEC, a point (m), and - in Article 1 of Directive 93/22/EEC, a point 15, shall be added containing the following definition: '"close links" shall mean a situation in which two or more natural or legal persons are linked by: (a) "participation", which shall mean the ownership, direct or by way of control, of 20 % or more of the voting rights or capital of an undertaking or (b) "control", which shall mean the relationship between a parent undertaking and a subsidiary, in all the cases referred to in Article 1 (1) and (2) of Directive 83/349/EEC (*), or a similar relationship between any natural or legal person and an undertaking; any subsidiary undertaking of a subsidiary undertaking shall also be considered a subsidiary of the parent undertaking which is at the head of those undertakings. A situation in which two or more natural or legal persons are permanently linked to one and the same person by a control relationship shall also be regarded as constituting a close link between such persons. (*) OJ No L 193, 18. 7. 1983, p. 1. Directive as last amended by Directive 90/605/EEC (OJ No L 317, 16. 11. 1990, p. 60).' 2. The following subparagraphs shall be added at the end of: - Article 3 (2) of Directive 77/780/EEC, - Article 3 (3) of Directive 93/22/EEC, - Article 8 (1) of Directive 73/239/EEC, - Article 8 (1) of Directive 79/267/EEC: 'Moreover, where close links exist between the financial undertaking and other natural or legal persons, the competent authorities shall grant authorization only if those links do not prevent the effective exercise of their supervisory functions. The competent authorities shall also refuse authorization if the laws, regulations or administrative provisions of a non-member country governing one or more natural or legal persons with which the undertaking has close links, or difficulties involved in their enforcement, prevent the effective exercise of their supervisory functions. The competent authorities shall require financial undertakings to provide them with the information they require to monitor compliance with the conditions referred to in this paragraph on a continuous basis.' Article 3 1. The following paragraph shall be inserted in Article 8 of Directive 73/239/EEC and in Article 8 of Directive 79/267/EEC: '1a. Member States shall require that the head offices of insurance undertakings be situated in the same Member State as their registered offices.' 2. The following paragraph shall be inserted in Article 3 of Directive 77/780/EEC: '2a. Each Member State shall require that: - any credit institution which is a legal person and which, under its national law, has a registered office have its head office in the same Member State as its registered office, - any other credit institution have its head office in the Member State which issued its authorization and in which it actually carries on its business.' Article 4 1. In Article 16 of Directive 92/49/EEC and in Article 15 of Directive 92/96/EEC, the following paragraph shall be inserted: '5a. Notwithstanding paragraphs 1 to 4, Member States may authorize exchanges of information between the competent authorities and: - the authorities responsible for overseeing the bodies involved in the liquidation and bankruptcy of financial undertakings and other similar procedures, or - the authorities responsible for overseeing the persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions, or - independent actuaries of insurance undertakings carrying out legal supervision of those undertakings and the bodies responsible for overseeing such actuaries. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditions are met: - this information shall be for the purpose of carrying out the overseeing or legal supervision referred to in the first subparagraph, - information received in this context will be subject to the conditions of professional secrecy imposed in paragraph 1, - where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Member States shall communicate to the Commission and to the other Member States the names of the authorities, person and bodies which may receive information pursuant to this paragraph.' 2. In Article 12 of Directive 77/780/EEC and in Article 25 of Directive 93/22/EEC, the following paragraph shall be inserted: '5a. Notwithstanding paragraphs 1 to 4, Member States may authorize exchanges of information between, the competent authorities and: - the authorities responsible for overseeing the bodies involved in the liquidation and bankruptcy of financial undertakings and other similar procedures, or - the authorities responsible for overseeing persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditions are met: - the information shall be for the purpose of performing the task of overseeing referred to in the first subparagraph, - information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 1, - where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Member States shall communicate to the Commission and to the other Member States the names of the authorities which may receive information pursuant to this paragraph.' 3. In Article 12 of Directive 77/780/EEC, in Article 16 of Directive 92/49/EEC, in Article 25 of Directive 93/22/EEC and in Article 15 of Directive 92/96/EEC, the following paragraph shall be inserted: '5b. Notwithstanding paragraphs 1 to 4, Member States may, with the aim of strengthening the stability, including integrity, of the financial system, authorize the exchange of information between the competent authorities and the authorities or bodies responsible under the law for the detection and investigation of breaches of company law. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditons are met: - the information shall be for the purpose of performing the task referred to in the first subparagraph, - information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 1, - where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Where, in a Member State, the authorities or bodies referred to in the first subparagraph perform their task of detection or investigation with the aid, in view of their specific competence, of persons appointed for that purpose and not employed in the public sector, the possibility of exchanging information provided for in the first subparagraph may be extended to such persons under the conditions stipulated in the second subparagraph. In order to implement the final indent of the second subparagraph, the authorities or bodies referred to in the first subparagraph shall communicate to the competent authorities which have disclosed the information, the names and precise responsibilities of the persons to whom it is to be sent. Member States shall communicate to the Commission and to the other Member States the names of the authorities or bodies which may receive information pursuant to this paragraph. Before 31 December 2000, the Commission shall draw up a report on the application of the provisions of this paragraph.' 4. In Article 12 of Directive 77/780/EEC and in Article 25 of Directive 93/22/EEC, paragraph 6 shall be replaced by the following: '6. This Article shall not prevent a competent authority from transmitting: - to central banks and other bodies with a similar function in their capacity as monetary authorities, - where appropriate, to other public authorities responsible for overseeing payment systems, information intended for the performance of their task, nor shall it prevent such authorities or bodies from communicating to the competent authorities such information as they may need for the purposes of paragraph 4. Information received in this context shall be subject to the conditions of professional secrecy imposed in this Article.' 5. In Article 16 of Directive 92/49/EEC and in Article 15 of Directive 92/96/EEC, the following shall be inserted: '5c. Member States may authorize the competent authorities to transmit: - to central banks and other bodies with a similar function in their capacity as monetary authorities, - where appropriate, to other public authorities responsible for overseeing payment systems, information intended for the performance of their task and may authorize such authorities or bodies to communicate to the competent authorities such information as they may need for the purposes of paragraph 4. Information received in this context shall be subject to the conditions of professonial secrecy imposed in this Article.' 6. The following paragraph 8 shall be added to Article 12 of Directive 77/780/EEC: '8. This Article shall not prevent the competent authorities from communicating the information referred to in paragraphs 1 to 4 to a clearing house or other similar body recognized under national law for the provision of clearing or settlement services for one of their Member States' markets if they consider that it is necessary to communicate the information in order to ensure the proper functioning of those bodies in relation to defaults or potential defaults by market participants. The information received in this context shall be subject to the conditions of professional secrecy referred to in paragraph 1. The Member States shall, however, ensure that information received under paragraph 2 may not be disclosed in the circumstances referred to in this paragraph without the express consent of the competent authorities which disclosed it.' 7. In Article 50 of Directive 85/611/EEC, paragraphs 2, 3 and 4 shall be replaced by the following: '2. Member States shall provide that all persons who work or who have worked for the competent authorities, as well as auditors and experts instructed by the competent authorities, shall be bound by the obligation of professional secrecy. Such secrecy implies that no confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, save in summary or aggregate form such that Ucits and management companies and depositaries (hereinafter referred to as undertakings contributing towards their business activity) cannot be individually identified, without prejudice to cases covered by criminal law. Nevertheless, when an Ucits or an undertaking contributing towards its business activity has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in rescue attempts may be divulged in civil or commercial proceedings. 3. Paragraph 2 shall not prevent the competent authorities of the various Member States from exchanging information in accordance with this Directive or other Directives applicable to Ucits or to undertakings contributing towards their business activity. That information shall be subject to the conditions of professional secrecy imposed in paragraph 2. 4. Member States may conclude cooperation agreements providing for exchanges of information with the competent authorities of third countries only if the information communicated is covered by guarantees of professional secrecy at least equivalent to those provided for in this Article. 5. Competent authorities receiving confidential information under paragraphs 2 or 3 may use it only in the course of their duties: - to check that the conditions governing the taking-up of the business of Ucits or of undertakings contributing towards their business activity are met and to facilitate the monitoring of the conduct of that business, administrative and accounting procedures and internal-control mechanisms, - to impose sanctions, - in administrative appeals against decisions by the competent authorities, or - in court proceedings initiated under Article 51 (2). 6. Paragraphs 2 and 5 shall not preclude the exchange of information: (a) within a Member State, where there are two or more competent authorities; or (b) within a Member State or between Member States, between competent authorities; and - authorities with public responsibility for the supervision of credit institutions, investment undertakings, insurance undertakings and other financial organizations and the authorities responsible for the supervision of financial markets, - bodies involved in the liquidation or bankruptcy of Ucits and other similar procedures and of undertakings contributing towards their business activity, - persons responsible for carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment undertakings and other financial institutions, in the performance of their supervisory functions, or the disclosure to bodies which administer compensation schemes of information necessary for the performance of their functions. Such information shall be subject to the conditions of professional secrecy imposed in paragraph 2. 7. Notwithstanding paragraphs 2 to 5, Member States may authorize exchanges of information between the competent authorities and: - the authorities responsible for overseeing the bodies involved in the liquidation and bankruptcy of financial undertakings and other similar procedures, or - the authorities responsible for overseeing persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditions are met: - the information shall be for the purpose of performing the task of overseeing referred to in the first subparagraph, - information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 2, - where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Member States shall communicate to the Commission and to the other Member States the names of the authorities which may receive information pursuant to this paragraph. 8. Notwithstanding paragraphs 2 to 5, Member States may, with the aim of strengthening the stability, including integrity, of the financial system, authorize the exchange of information between the competent authorities and the authorities or bodies responsible under the law for the detection and investigation of breaches of company law. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditons are met: - the information shall be for the purpose of performing the task referred to in the first subparagraph, - information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 2, - where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Where, in a Member State, the authorities or bodies referred to in the first subparagraph perform their task of detection or investigation with the aid, in view of their specific competence, of persons appointed for that purpose and not employed in the public sector the possibility of exchanging information provided for in the first subparagraph may be extended to such persons under the conditions stipulated in the second subparagraph. In order to implement the final indent of the second subparagraph, the authorities or bodies referred to in the first subparagraph shall communicate to the competent authorities which have disclosed the information the names and precise responsibilities of the persons to whom it is to be sent. Member States shall communicate to the Commission and to the other Member States the names of the authorities or bodies which may receive information pursuant to this paragraph. Before 31 December 2000, the Commission shall draw up a report on the application of this paragraph. 9. This Article shall not prevent a competent authority from transmitting to central banks and other bodies with a similar function in their capacity as monetary authorities information intended for the performance of their tasks, nor shall it prevent such authorities or bodies from communicating to the competent authorities such information as they may need for the purposes of paragraph 5. Information received in this context shall be subject to the conditions of professional secrecy imposed in this Article. 10. This Article shall not prevent the competent authorities from communicating the information referred to in paragraphs 2 to 5 to a clearing house or other similar body recognized under national law for the provision of clearing or settlement services for one of their Member State's markets if they consider that it is necessary to communicate the information in order to ensure the proper functioning of those bodies in relation to defaults or potential defaults by market participants. The information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 2. Member States shall, however, ensure that information received under paragraph 3 may not be disclosed in the circumstances referred to in this paragraph without the express consent of the competent authorities which disclosed it. 11. In addition, notwithstanding the provisions referred to in paragraphs 2 and 5, Member States may, by virtue of provisions laid down by law, authorize the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of Ucits and of undertakings contributing towards their business activity, credit institutions, financial institutions, investment undertakings and insurance undertakings and to inspectors instructed by those departments. Such disclosures may, however, be made only where necessary for reasons of prudential control. Member States shall, however, provide that information received under paragraphs 3 and 6 may never be disclosed in the circumstances referred to in this paragraph except with the express agreement of the competent authorities which disclosed the information.' Article 5 The following shall be incorporated: - in Directive 77/780/EEC, an Article 12a, - in Directive 92/49/EEC, an Article 16a, - in Directive 92/96/EEC, an Article 15a, - in Directive 93/22/EEC, an Article 25a, - and in Directive 85/611/EEC, an Article 50a, reading as follows: '1. Member States shall provide at least that: (a) any person authorized within the meaning of Directive 84/253/EEC (*), performing in a financial undertaking the task described in Article 51 of Directive 78/660/EEC (**), Article 37 of Directive 83/349/EEC or Article 31 of Directive 85/611/EEC or any other statutory task, shall have a duty to report promptly to the competent authorities any fact or decision concerning that undertaking of which he has become aware while carrying out that task which is liable to: - constitute a material breach of the laws, regulations or administrative provisions which lay down the conditions governing authorization or which specifically govern pursuit of the activities of financial undertakings, or - affect the continuous functioning of the financial undertaking, or - lead to refusal to certify the accounts or to the expression of reservations; (b) that person shall likewise have a duty to report any facts and decisions of which he becomes aware in the course of carrying out a task as described in (a) in an undertaking having close links resulting from a control relationship with the financial undertaking within which he is carrying out the abovementioned task. 2. The disclosure in good faith to the competent authorities, by persons authorized within the meaning of Directive 84/253/EEC, of any fact or decision referred to in paragraph 1 shall not constitute a breach of any restriction on disclosure of information imposed by contract of by any legislative, regulatory or administrative provision and shall not involce such persons in liability of any kind. (*) OJ No L 126, 12. 5. 1984, p. 20. (**) OJ No L 222, 14. 8. 1978, p. 11. Directive as last amended by Directive 90/605/EEC (OJ No L 317, 16. 11. 1990, p. 60).' Article 6 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive by 18 July 1996. They shall forthwith inform the Commission thereof. When the Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 7 This Directive is addressed to the Member States.

31995L0027

1995

European Parliament and Council Directive 95/27/EC of 29 June 1995 amending Council Directive 86/662/EEC on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator- loaders Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal of the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3) in the light of the joint text approved by the Conciliation Committee on 11 May 1995, Whereas within the framework of the internal market, requirements for noise emissions of hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders, hereinafter referred to as 'earth-moving machines' have to be harmonized, while a high level of protection for the environment has to be achieved without creating obstacles to the free movement of earth-moving machines; Whereas Directive 86/662/EEC (4) provides for the EC type-examination of earth-moving machines, used to perform work on civil engineering and building sites, and whereas that Directive also lays down limits for noise levels and a test method; Whereas earth-moving machines above 500 kW are predominantly used in quarries and mines and whereas it is therefore deemed appropriate to exclude these machines from the scope of the Directive; Whereas Directive 86/662/EEC does not provide for permissible sound levels applicable in the period beginning six years after its entry into force, but envisages that after 1994 revised 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 type of machine; Whereas the extension of the validity of Article 3 (1) (a) of Directive 86/662/EEC up to 29 December 1996 and the certificates granted under it up to 29 December 1997 ensure that the industry has sufficient time to prepare itself to the new permissible sound-power levels; Whereas the reduction of the permissible noise levels, to be achieved at stage 1, corresponds to approximately 4 dB compared to existing standards and is aimed at achieving a high level of protection as far as health and environmental protection are concerned; Whereas, as technology is evolving and in order to give the appropriate signals to the industries concerned, further reductions of the admissible noise levels have to be laid down for a second stage, subject, however, to reconsideration, where necessary in the light of the progress made; Whereas the revised test method to be applied after 29 December 1996 has been established according to Directive 86/662/EEC; Whereas an agreement on a 'modus vivendi' between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994; Article 1 Directive 86/662/EEC is hereby amended as follows: 1. In Article 1 (1), the full stop at the end shall be changed to a comma and the following shall be added: '. . . as long as their installed power is below 500 kW.' 2. Article 3 shall be replaced by the following: 'Article 3 1. The approved bodies shall issue an EC type-examination certificate for every type of earth-moving machine referred to in Article 1 (1): (a) up to and including 29 December 1996, 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 amended by Directive 81/1051/EEC and supplemented by Annex I to this Directive, does not exceed the permissible level LWA in dB(A)/1 pW specified with reference to the net installed power P in kW in the following table: >TABLE> (b) as from 30 December 1996 and up to and including 29 December 2001, where the sound-power level of airborne noise emitted in the environment measured under the conditions of real dynamic operation set out in Annex I to Directive 79/113/EEC, as amended by Directive 81/1051/EEC and supplemented by Annex II to this Directive, does not exceed the permissible sound-power level LWA in dB(A)/1 pW specified with reference to the net installed power in kW (*) as follows: (i) tracked machines, (except excavators): LWA = 87 + 11 log P (ii) wheeled dozers, loaders, excavator-loaders: LWA = 85 + 11 log P (iii) excavators: LWA = 83 + 11 log P. These formulae are only valid for values greater than the lowest sound-power levels for the three types of machine shown in the table below. These lowest sound-power levels correspond to the lowest values of net installed power for each type of machine. For net installed powers below these values, the permissible sound-power levels are given by the lowest level shown in the table (see Annex VII). >TABLE> (c) as from 30 December 2001, where the sound-power level of airborne noise emitted in the environment measured under the conditions of real dynamic operation set out in Annex I of Directive 79/113/EEC, as amended by Directive 81/1051/EEC and supplemented by Annex II to this Directive, does not exceed the permissible sound-power level LWA in dB(A)/1 pW specified with reference to the net installed power P in kW (*) as follows: (i) tracked machines (except excavators): LWA = 84 + 11 log P (ii) wheeled dozers, loaders, excavator-loaders: LWA = 82 + 11 log P (iii) excavators: LWA = 80 + 11 log P. These formulae are only valid for values greater than the lowest sound-power levels for the three types of machine shown in the table below. These lowest sound-power levels correspond to the lowest values of net installed power for each type of machine. For net installed powers below these values, the permissible sound power levels are given by the lowest level shown in the table (see Annex VII). >TABLE> 2. Up to 29 December 1996, EC type-examination certificates may also be issued under the conditions laid down in paragraph (1) (b). 3. All applications for an EC 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. 4. 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. 5. EC type-examination certificates granted in accordance with paragraph (1) (a) shall cease to be valid after 29 December 1997. The period of validity of EC type-examination certificates granted in accordance with paragraphs (1) (b) and (1) (c) shall be limited to five years. This may be extended by five years provided that application is made no sooner than 12 months before the expiry of the first five-year period and that the EC type-examination certificates were issued for earth-moving machines which comply with the permissible sound-power levels applicable when the extension enters into force. However, certificates granted in accordance with the provisions on sound-power levels in paragraph (1) (b) shall cease to be valid only after 29 December 2002. 6. For every earth-moving machine built in conformity with the type certified by EC 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 EC 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 µPa 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.' 3. In Article 5 the full stop at the end shall be changed to a comma and the following shall be added: '. . . including the possibility of restricting the working hours of earth-moving machines.' 4. Article 7 shall be deleted. 5. Article 8 shall be replaced by the following: 'Article 8 The amendments necessary to adapt the requirements of the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure laid down in Article 5 of Directive 79/113/EEC, as amended by Directive 81/1051/EEC.' 6. Article 9 shall be replaced by the following: 'Article 9 No later than 1 January 2000, the Commission may submit to the Council a proposal for revision of the limit values and the date laid down in Article 3 (1) (c). Such a proposal must be based on a report on progress made in the technologies taken into consideration when laying down the limit values and date.' 7. The following Annex shall be added: 'ANNEX VII DIAGRAMMATIC SKETCH OF THE PROVISIONS OF ARTICLE (3) (1) (b) AND (c) RELATING TO THE PERMISSIBLE SOUND-POWER LEVEL AS A FUNCTION OF THE NET INSTALLED POWER >REFERENCE TO A GRAPHIC> Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1995. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference when they are officially published. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0031

1995

Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), as amended by Directive 94/34/EC (2), and in particular Article 3 (3) (a) thereof, After consultation of the Scientific Committee on Food, Whereas it is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (3); Whereas it is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius and the Joint FAO/WHO Expert Committee on Food Additives (Jecfa); Whereas food additives, prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or different from those mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food with a view to full evaluation with emphasis on the purity criteria; Whereas the measures provided for in this Directive are in line with the opinion of the Standing Committee on Foodstuffs, Article 1 1. Purity criteria mentioned under Article 3 (3) (a) of Directive 89/107/EEC for sweeteners mentioned in Directive 94/35/EC are set out in the Annex. 2. The purity criteria for E 420 (i), E 420 (ii) and E 421 mentioned in the Annex to this Directive supersede the purity criteria for the said substances mentioned in the Annex to Council Directive 78/663/EEC (4). Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1996. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Products put on the market or labelled before that date which do not comply with this Directive may, however, be marketed until stocks are exhausted. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0032

1995

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 94/32/EC (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 Commission 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 certain methods have already been adopted in Commission Directives 80/1335/EEC (3), as amended by Directive 87/143/EEC (4), 82/434/EEC (5), as amended by Directive 90/207/EEC (6), 83/514/EEC (7), 85/490/EEC (8) and 93/73/EEC (9); Whereas the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products and the identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether in cosmetic products constitute a sixth step; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation of Directive 76/768/EEC to technical progress, Article 1 Member States shall take all the necessary steps to ensure that during official testing of cosmetic products: - identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid, - identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether, shall be carried out in accordance with the methods described in the Annex. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 September 1996. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0034

1995

Eightieth Commission Directive 95/34/EC of 10 July 1995 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 94/32/EC (2), and in particular Article 8 (2) thereof, After consultation of the Scientific Committee on Cosmetology, Whereas furocoumarines are recognized to be photomutagenic and photocarcinogenic; whereas the Scientific Committee on Cosmetology has not been able to conclude from the available scientific, technical and epidemiological data that the association of protective filters with furocoumarines would guarantee the safety of sun protection and bronzing products containing furocoumarines above a minimum level; whereas, in order to protect public health, it is therefore necessary to limit furocoumarines to less than 1 mg/kg in these products; Whereas 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette), is recognized to be a potent photoallergen; whereas, on the basis of recent scientific research, use of this substance in cosmetic products poses a risk to human health; whereas it is therefore necessary to prohibit its use; Whereas toxicological evaluation of Diisobutyl-phenoxy-ethoxy-ethyldimethylbenyl-ammonium chloride (Benzethonium), shows that this ingredient is toxic to a significant degree; whereas the safety margin for human health, when this ingredient is used in cosmetic products, is inadequate; whereas it is therefore necessary to prohibit its use; Whereas cells, tissues or products of human origin are liable to transmit the Creutzfelt-Jakob disease, human spongiform encephalopathy, and certain virus diseases; whereas it is therefore necessary, given the current state of scientific knowledge, to prohibit their use in cosmetic products; Whereas recent toxicological studies of 3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*); show a net clastogenic effect in vitro; whereas the safety margin is low, especially where children are concerned; whereas it is therefore necessary to prohibit its use; Whereas, on the basis of the latest scientific and technical research, 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester may be used as ultraviolet filter in cosmetic products; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, Article 1 Directive 76/768/EEC is hereby amended as shown in the Annex hereto. Article 2 1. Member States shall take all the necessary measures to ensure that as from 1 July 1996 for the substances set out in the Annex, neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances set out in the Annex shall not be sold or otherwise supplied to the final consumer after 30 June 1997. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 1996. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31995L0033

1995

Commission Directive 95/33/EC of 10 July 1995 amending Council Directive 82/471/EEC concerning certain products used in animal nutrition Having regard to the Treaty establishing the European 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 the Act of Accession of Austria, Finland and Sweden, and in particular Article 6 thereof, Whereas Directive 82/471/EEC provides for regular amendment of the content of its Annex to take account of advances in scientific and technical knowledge; Whereas the study of a new product belonging to the group of protein products obtained from micro-organisms, in this case from bacteria, has permitted to show a beneficial effect in pigs, calves and salmon; whereas authorization for the use of this product in animal nutrition should therefore be permitted under certain conditions; Whereas, for technological reasons of production, the minimum concentration of the concentrated liquid L-lysine authorized has to be amended; Whereas the Scientific Committee for Animal Nutrition and the Scientific Committee for Food issued an opinion on the use of the protein product of fermentation from natural gas obtained by culture of Methylococcus capsulatus (Bath), Alcaligenes acidorovans, Bacillus brevis and Bacillus firmus; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Annex to Directive 82/471/EEC is hereby amended as set out in the Annex of this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 30 June 1996 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0035

1995

Commission Directive 95/35/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 94/79/EC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary, in Annexes II and III to Directive 91/414/EEC, to indicate to the applicants as precisely as possible any details on the required information, such as the circumstances, conditions and technical protocols under which certain data has to be generated; whereas those details should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossiers; Whereas the introductions to Annexes II and III to Directive 91/414/EEC currently refer to the application of the principles of good laboratory practice (GLP) where testing is conducted to obtain data on the properties and safety of the substances and preparations; whereas therefore, without prejudice to the provisions of Article 9 (1), third subparagraph thereof, GLP should in principle be applied to residue studies, in particular when they are necessary for the dossiers to be submitted with a view to the inclusion of active substances in Annex I to the said Directive; Whereas, however, it has become evident that in certrain Member States the necessary infrastructure is not yet available for applying GLP requirements to residue studies from supervised trials on crops, food or feedingstuffs; whereas on the other hand Member States already applying GLP requirements should be allowed to continue to do so in trials performed on their territory; whereas this principle should also be clarified for the purpose of the derogations from GLP already contained in the Directive; Whereas it is necessary to provide for a temporary derogation for the application of GLP requirements for active substances already on the market two years after notification of Directive 91/414/EEC whenever a number of precautionary conditions are satisfied; whereas, however, it is not necessary to provide for such a derogation service for active substances not brought onto the market two years after the notification of the said Directive; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes II and III to Directive 91/414/EEC are amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1996. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on 1 July 1995. Article 4 This Directive is addressed to the Member States.

31995L0036

1995

Commission Directive 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 95/35/EC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC provide the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary to indicate, in Annexes II and III to Directive 91/414/EEC, to the applicants as precisely as possible any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files; Whereas it is possible to introduce now more precision with regard to the data requirements concerning fate and behaviour in the environment of the active substance provided for in Annex II, Part A, Section 7; Whereas it is also possible to introduce now more precision with regard to the data requirements concerning fate and behaviour in the environment of the plant protection product provided for in Section 9 of Part A of Annex III, Part A, Section 9; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 91/414/EEC is amended as follows: 1. in Part A of Annex II, the section headed '7. Fate and behaviour in the environment` is replaced by Annex I hereto; 2. in Part A of Annex III, the section headed '9. Fate and behaviour in the environment` is replaced by Annex II hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply, not later than 30 April 1996, with the provisions of this Directive. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive shall enter into force on 1 July 1995. Article 4 This Directive is addressed to the Member States.

31995L0039

1995

Council Directive 95/39/EC of 17 July 1995 amending the Annexes to Directives 86/362/EEC and 86/363/EEC on the fixing of maximum levels for pesticide residues in and on cereals and foodstuffs of animal origin Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 11 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 11 thereof, Having regard to the proposal from the Commission, Whereas the Commission has been instructed, within the framework of Council Directives 86/362/EEC and 86/363/EEC, to prepare a list of pesticide residues and their maximum levels for approval by the Council; Whereas pesticide residues may be found in cereals and foodstuffs of animal origin as a result of agricultural practices; whereas it is necessary to take into account relevant data for both types of authorized pesticide use and, as appropriate, supervised trials and animal feeding studies; Whereas in order better to estimate the maximum potential dietary intake of pesticide residues, it is prudent to establish simultaneously, when it is appropriate, maximum residue levels for individual pesticides in all major components of diet; whereas these levels represent the use of minimum quantities of pesticide necessary to achieve adequate control, applied in such a manner that the amount of residue is the smallest possible or is toxicologically acceptable; Whereas, in the light of technical and scientific progress and the requirements of public health and agriculture, Directives 86/362/EEC and 86/363/EEC should be amended by adding provisions relating to further pesticide residues for cereals and foodstuffs of animal origin, namely methidathion, methomyl thiodicarb, amitraz, pirimiphos-methyl, aldicarb and thiabendazole; Whereas, however, the available data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas in such cases a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas maximum levels should therefore be established on the basis of such data by 1 July 2000 at the latest; whereas failure to provide satisfactory data will result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme referred to in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), Article 1 The following pesticide residues shall be added to Part A of Annex II to Directive 86/362/EEC: >TABLE> Article 2 1. The following pesticide residues shall be added to Part A of Annex II to Directive 86/363/EEC: >TABLE> 2. The following pesticide residues shall be added to Section B of Annex II to Directive 86/363/EEC: >TABLE> Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 22 August 1996. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 4 This Directive is addressed to the Member States.

31995L0038

1995

Council Directive 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (1), and in particular Article 1 thereof, Having regard to the proposal from the Commission, Whereas the Commission has been instructed, within the framework of Directive 90/642/EEC, to prepare a list of pesticide residues and their maximum levels for submission to the Council for approval; Whereas pesticide residues may occur in products of plant origin, including fruit and vegetables, as a result of agricultural practices; whereas it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials; Whereas in order better to estimate the maximum potential dietary intake of pesticide residues, it is prudent to establish simultaneously, where appropriate, maximum residue levels for individual pesticides in all major components of diet; whereas these levels represent the use of minimum quantities of pesticide necessary to achieve adequate control, applied in such a manner that the amount of residue is the smallest possible and is toxicologically acceptable; Whereas it is now appropriate that maximum levels be fixed for certain pesticide residues in products of plant origin, namely methidathion, methomyl thiodicarb, amitraz, pirimiphos-methyl, aldicarb, thiabendazole; whereas, however, it is not possible to do so for all pesticide residue product combinations due to insufficient data; Whereas, in the case of thiabendazole, the available data are insufficient to establish, in accordance with current rules, a maximum residue level for citrus fruit; whereas, however, thiabendazole has been included in the list of substances included in Commission Regulation (EEC) No 3600/92 (2) and is covered by the first stage of the work programme provided for in Article 8 (2) of Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3); whereas an important element of this programme will be the establishment of maximum levels arising from use as plant protection products; Whereas certain pesticide residues may remain, in particular, in spices, which may need to be controlled; whereas it is necessary to amend Annex I to Directive 90/642/EEC to include such spices in the list of groups of product to which maximum residue levels apply; Whereas, it is only considered necessary to establish maximum pesticide residue levels in spices for certain pesticides having regard to the toxicological nature of their residues and their use pattern; Whereas, however, the available data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas in such cases a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas maximum levels should therefore be established on the basis of such data by 1 July 2000 at the latest; whereas failure to provide satisfactory data will result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme referred to in Article 8 (2) of Directive 91/414/EEC, Article 1 Directive 90/642/EEC is hereby amended as follows: 1. Annex I shall be supplemented by the addition of the following: >TABLE> 2. Annex II shall become Annex II, Part A, and shall be supplemented by the following: >TABLE> >TABLE> >TABLE> 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 1996. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive is addressed to the Member States.

31995L0040

1995

Commission Directive 95/40/EC of 19 July 1995 amending Directive 92/76/EEC recognizing protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/4/EC (2), and in particular the first subparagraph of Article 2 (1) (h) thereof, Having regard to Commission Directive 92/76/EEC of 6 October 1992 recognizing protected zones exposed to particular plant health risks in the Community (3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof, Whereas under Commission Directive 92/76/EEC certain zones in the Community were recognized as 'protected zones` in respect of certain harmful organisms for a period expiring on 1 July 1995; Whereas, based on recent new information provided by Greece, Italy and France, it appears that it is no longer appropriate to maintain the 'protected zones` recognized for these countries in respect of, for Greece, Ips sexdentatus Boerner, for Italy, Anthonomus grandis (Boh.) and Glomerella gossypii Edgerton, and for France, Cephalcia lariciphila (Klug.) and Gilpinia hercyniae (Hartig), because these organisms seem to be present locally; Whereas, also from new information provided by France and Portugal, it appears that the extent of the 'protected zones` recognized for these countries should be amended in respect of, for France, Erwinia amylovora (Burr.) Winsl. et al., and for Portugal, Bemisia tabaci Genn. (European populations), because these organisms now seem to be present in parts of the relevant designated 'protected zone`; whereas also the extent of the protected zones recognized for the United Kingdom in respect of Cephalcia lariciphila (Klug.), Dendroctonus micans Kugelan, Gilpinia hercyniae (Hartig), Gremmeniella abietina (Lag.) Morelet, Hypoxylon mammatum (Wahl.) J. Miller and Pissodes spp. (European) and for Portugal in respect of Dendroctonus micans Kugelan, Ips amitinus Eichhof, Ips cembrae Heer, Ips duplicatus Sahlberg and Ips typographus Heer should be modified to take account of the concern in relation to the relevant host plants of these organisms; Whereas from new information supplied by Sweden and Finland the area of protected zone recognized for Sweden in respect of Leptionotarsa decemlineata Say should be extended and a protected zone should be recognized for Finland in respect of Leptinotarsa decemlineata Say; Whereas furthermore the recognition of 'protected zones` was provisional until the results of appropriate surveys monitored by Commission experts confirmed that one or more of the harmful organisms in respect of which the zones were recognized as protected zones were not endemic or established in those zones in accordance with Article 2 (1) (h) of Council Directive 77/93/EEC; Whereas for certain protected zones further developments on the harmful organisms concerned and their respective surveys have occurred; whereas it is, therefore, appropriate to extend the provisional recognition for a further period to enable information on the developments to be evaluated by the said Commission experts; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Article 1 of Directive 92/76/EEC is hereby replaced as follows: 'Article 1 The zones in the Community listed in the Annex are hereby recognized as "protected zones" referred to in the first subparagraph of Article 2 (1) (b) of Directive 77/93/EEC, in respect of harmful organism(s) listed against their names in the Annex; in the case of points (a), 1, 2, 3, 4, 7, 8, 9, 10 11, 14, 15 and 17, (b) 1, 2 and 3, (c) 1, 2, 3, 4 and 5, and (d) 1, 3 and 4 the said zones are recognized for a period expiring on 1 April 1996. In the case of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden, the said zones shall be recognized until 31 December 1996.` Article 2 The Annex to Directive 92/76/EEC is hereby amended as indicated in the Annex to this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 July 1995. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 4 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31995L0041

1995

Commission Directive 95/41/EC of 19 July 1995 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/4/EC (2), and in particular Article 13, second subparagraph, third indent thereof, Whereas certain provisions on protective measures in France against Cephalcia lariciphila (Klug.), Erwinia amylovora (Burr.) Winsl. et al. and Gilpinia hercyniae (Hartig), in Italy against Anthonomus grandis (Boh.) and Glomerella gossypii Edgerton, in Portugal against Bemisia tabaci Genn. (European populations), and in the United Kingdom against Cephalcia lariciphila (Klug.) Gilpinia hercyniae (Hartig), Gremminiella abietina (Lag.) Morelet and Hypoxylon mammatum (Wahl.) J. Miller should be modified because it is no longer appropriate to maintain the current provision set out in the said Directive; Whereas similarly, certain provisions on protective measures in Portugal against certain bark beetles, i.e. Dendroctonus micans Kugelan, Ips amitinus Eichhof, Ips cembrae Heer, Ips duplicatus Sahlberg and Ips typographus Heer, in Greece against the bark beetle Ips sexdentatus Boerner and in the United Kingdom against the bark beetles Dendroctonus micans Kugelan and Pissodes spp. (European), should be modified because it is no longer appropriate to maintain the current provisions set out in the said Directive; Whereas certain provisions on protective measures in Sweden against Leptinotarsa decemlineata Say should be modified because it has been determined that the said organism is not present in a much larger area than originally recognized; whereas furthermore certain provisions on protective measures in some part of Finland against Leptinotarsa decemlineata Say should be improved; Whereas these amendments are in agreement with the requests of the Member States concerned; Whereas therefore the relevant Annexes of the said Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 77/93/EEC is hereby amended as indicated in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 July 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by the Member States. 2. The Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0042

1995

Commission Directive 95/42/EC of 19 July 1995 amending Directive 93/102/EC amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer Having regard to the Treaty establishing the European Community, Having regard to Council Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (1), as last amended by Commission Directive 93/102/EC (2), and in particular Article 6 (5) (b) thereof, first and second indent, Whereas Article 3 of Directive 93/102/EC states that Member States shall, if appropriate, amend their laws, regulations and administrative provisions so that they prohibit trade in products not complying with the Directive with effect from 30 June 1996; Whereas trade in products labelled before that date whose list of ingredients states the name of a category of ingredients not appearing in the Directive 93/102/EC is not permitted after that date; Whereas relabelling of the foodstuffs is difficult to envisage technically and a clause providing for disposal of stocks labelled before the transposition deadline therefore needs to be included; Whereas the measures laid down by this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 The following sentence shall be added to Article 3, second paragraph, second indent, of Directive 93/102/EC: 'However, trade in products placed on the market or labelled before that date and not complying with this Directive shall be permitted for as long as stocks last`. Article 2 The present Directive enters into effect on the 20th day following its publication in the Official Journal of the European Communities. Article 3 This Directive is addressed to the Member States.

31995L0045

1995

Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), as last amended by Directive 94/34/EC (2), and in particular Article 3 (3) (a) thereof, After consulting the Scientific Committee for Food, Whereas it is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (3); Whereas it is necessary to revise the purity criteria for colours mentioned in the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption (4), as last amended by Directive 85/7/EEC (5); Whereas it is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius and the Joint FAO/WHO Expert Committee on Food Additives (JECFA); Whereas food additives, prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or different from those mentioned in this Directive, shall be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 The purity criteria referred to in Article 3 (3) (a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in the Annex hereto. Article 8 and Annex III to the Directive of 23 October 1962 are hereby deleted. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1996. They shall immediately inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Products put on the market or labelled before 1 July 1996 which do not comply with this Directive may, however, be marketed until stocks are exhausted. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0044

1995

Commission Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 77/93/EEC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/4/EC (2), and in particular Articles 3 (7) (e), 4 (5), 5 (5) and 12 (3c), thereof, Whereas under the provisions of Directive 77/93/EEC, harmful organisms listed in its Annexes I and II, whether singly or associated with the relevant plants or plants products listed in Annex II to the said Directive, may not be introduced into and spread by movement within the Community or certain protected zones thereof; Whereas under the same Directive, plants, plant products and other objets listed in its Annex III, may not be introduced into the Community or into certain protected zones thereof; Whereas also plants, plant products and other objects listed in Annex IV to the said Directive, may not be introduced into or moved within the Community or certain protected zones thereof unless the relevant special requirements indicated in the said Annex are met; Whereas plants, plant products and other objects listed in Annex V, Part B to the said Directive coming from third countries may not be introduced into the Community unless they comply with the standards and requirements laid down in the said Directive and are accompanied by an official phytosanitary certificate ensuring such compliance and are, moreover, inspected on an official basis for compliance with these provisions; Whereas, however, Articles 3 (7) (e), 4 (5), 5 (5) and 12 (3c) of the said Directive provide for those rules not to apply to the introduction and movement of such harmful organisms, plants, plant products and other objects, for trial or scientific purposes and for work on varietal selections, to certain conditions which shall be determined at Community level; Whereas therefore, it is necessary to determine the conditions which must be satisfied in the case of such introductions or movements, in order to ensure that there is no risk of harmful organisms spreading; Whereas, however, the conditions for such introductions of potato breeding material have already been determined by Commission Decision 80/862/EEC (3), as last amended by Decision 91/22/EEC (4), and are therefore not affected by this Directive; whereas furthermore, the conditions for such introductions of soil and growing medium originating in third countries have also already been determined by Commission Decision 93/447/EEC (5), as amended by Decision 94/9/EC (6), and are therefore not affected by this Directive; Whereas the conditions laid down for material under Council Regulation (EEC) No 3626/82 of 3 December 1982 on the implementation in the Community of the Convention on international trade in endangered species of wild fauna and flora (7), as last amended by Commission Regulation (EC) No 558/95 (8), and under Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (9), as amended by Commission Directive 94/15/EEC (10), and other more specific Community provisions regarding endangered species of wild fauna/EC and flora and genetically modified organisms, are not affected by this Directive; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 1. Without prejudice to the provisions laid down in Decisions 80/862/EEC and 93/447/EEC for potato breeding material, and for soil and growing medium, respectively, Member States shall ensure that for any activity for trial or scientific purposes and for work on varietal selections, hereinafter referred to as 'the activities`, which would involve the use of harmful organisms, plants, plant products and other objects under Articles 3 (7) (e), 4 (5), 5 (5) or 12 (3c) of Directive 77/93/EEC, hereinafter referred to as 'the material`, an application shall be submitted to the responsible official bodies prior to the introduction into, or movement within, any Member State or relevant protected zones thereof, of any such material. 2. The application referred to in paragraph 1, shall specify at least the following: - the name and address of the person responsible for the activities, - the scientific name or names of the material, including the harmful organism concerned, where appropriate, - the type of material, - the quantity of material, - the place of origin of the material, with appropriate documentary evidence for material to be introduced from a third country, - the duration, nature and objectives of the activities envisaged, including at least, a resumé of the work and a specification for trial for scientific purposes or work on varietal selections, - the address and description of the specific site or sites for quarantine containment and, where appropriate, for testing, - the place of first storage or of first planting, as appropriate, after the material has been officially released, where appropriate, - the proposed method of destruction or treatment of material on completion of the approved activities, where appropriate, - the proposed point in entry into the Community for material to be introduced from a third country. Article 2 1. Member States on receipt of the application referred to in Article 1 shall approve the activities concerned, if it is established that the general conditions laid down in Annex I are satisfied. Member States shall withdraw the said approval at any time if it is established that the conditions laid down in Annex I cease to be met. 2. Following the approval of the activities referred to in paragraph 1, Member States shall approve the introduction into or movement within the Member State or relevant protected zones, of the material referred to in the application, provided that such material is accompanied in all cases by a letter of authority for such introduction or movement of harmful organisms, plants, plant products and other objects of trial for scientific purposes and for work on varietal selections, hereinafter referred to as a 'letter of authority`, conforming to the model set out in Annex II and issued by the responsible official body of the Member State in which the activities are to be undertaken and, (a) the case of material originating in the Community: (i) where the place of origin is in another Member State, the said accompanying letter of authority shall be officially endorsed by the Member State of origin for movement of the material under quarantine containment conditions; and (ii) for those plants, plant products and other objects listed in Annex V, Part A to Directive 77/93/EEC, the material shall also be accompanied by a plant passport issued in accordance with Article 10 of Directive 77/93/EEC, on the basis of the examination carried out pursuant to Article 6 of that Directive for compliance with the provisions laid down therein, other than those relating to any harmful organism in respect of which the activites have been approved under the first subparagraph of paragraph 1. The plant passport shall contain the following statement: 'This material is moved under Directive 95/44/EC`. In cases where the address of the specific site or sites for quarantine containment is located in another Member State, the Member State responsible for issuing the plant passport shall issue a plant passport only on the basis of information regarding the approval referred to in the first subparagraph of paragraph 1 received officially from the Member State responsible for the approval of the activities, and on the assurance that quarantine containment conditions shall be applied during movement of the material; and (b) in the case of material introduced from a third country; (i) Member States shall ensure that the said letter of authority is issued on the basis of appropriate documentary evidence as regards the place of origin the material; and (ii) for plants, plant products and other objects listed in Annex V, Part B to Directive 77/93/EEC the material shall also be accompanied wherever possible by a phytosanitary certificate issued in the country of origin in accordance with Article 7 of Directive 77/93/EEC, on the basis of the examination carried out pursuant to Article 6 of that Directive for compliance with the provisions laid down therein, other than those relating to any harmful organism in respect of which the activities have been approved under the first subparagraph of paragraph 1. The certificate shall, under 'Additional declaration`, contain the following indication: 'This material is imported under Directive 95/44/EC`. The relevant harmful organism or organisms shall also be specified, where appropriate. In all cases Member State shall ensure that the material is held under quarantine containment conditions during the said introduction or movement, and is moved directly and immediately to the site or sites specified in the application. 3. The responsible official body shall monitor the approved activities and shall ensure that: (a) the quarantine containment conditions and other general conditions specified in accordance with Annex I are complied with throughout the duration of the activities, by examination of the premises and activities at appropriate times; (b) the procedures set out below are followed according to the type of approved activities: (i) for plants, plant products or other subjects intended for release from quarantine: - the plants, plant products or other objects shall not be released without approval by the responsible official body, hereinafter referred to as 'official release`. Prior to official release the plants, plant products or other objects shall have been subject to quarantine measures including testing, and must have been found free by such measures from any harmful organism, unless it is identified as one which is known to occur in the Community and is not listed in Directive 77/93/EEC, - the quarantine measures including testing shall be carried out by scientifically trained staff of that body or of any officially approved body, and shall be carried out in accordance with the provisions laid down in Annex III to this Directive for the plants, plant products and other objects specified, - any plants, plant products or other objects which have not been found free, by such measures, from harmful organisms as specified in the first indent, and any other plants, plant products or other objects with which they have been in contact or which may have become contaminated shall be destroyed or subjected to an appropriate treatment or quarantine measure aimed at eradicating the relevant harmful organisms; the provisions of (ii), second indent shall apply accordingly. (ii) for all other material (including harmful organisms), at the end of the duration of the approved activities, and for all material found to be contamined during the activities: - the material (including the harmful organisms and any contamined material) and any other plants, plant products or other objects with which it has been in contact or which may have become contamined shall be destroyed, sterilized or otherwise treated in a manner to be specified by the responsible official body, and - the premises and facilities at which the activities in question have been undertaken shall be sterilized or otherwise cleaned, as necessary, in a manner to be specified by the responsible official body; (c) any contamination of the material by harmful organisms listed in Directive 77/93/EEC and any other harmful organism considered a risk to the Community by the responsible official body and detected during the activity shall be notified immediately to the responsible official body by the person responsible for the activities, along with notification of any event resulting in the escape of the abovementioned organisms into the environment. 4. Member States shall ensure that for activities utilizing plants, plant products and other objects listed in Annex III to Directive 77/93/EEC and not covered by Part A, Sections I to III of Annex III to this Directive, appropriate quarantine measures including testing shall be carried out. These quarantine measures shall be notified to the Commission and to the other Member States. The details of such quarantine measures shall be completed and inserted in Annex III to this Directive once the necessary technical information is available. Article 3 1. Before 1 September each year, Member States shall send to the Commission and to the other Member States a list, with quantities, of the introductions and movements of material approved under this Directive during the preceding period of one year ending on 30 June, and of any contamination by harmful organisms of such material, which has been confirmed under the quarantine measures including testing carried out under Annex III, during the same period. 2. Member States shall cooperate administratively through the authorities established or designated pursuant to Article 1 (6) of Directive 77/93/EEC, with regard to the provision of details of the quarantine containment conditions and measures imposed for activities approved under this Directive. Article 4 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on 1 February 1996. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission all provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 5 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31995L0048

1995

Commission Directive 95/48/EC of 20 September 1995 adapting to technical progress Council Directive 92/21/EEC relating to the masses and dimensions of motor vehicles of category M1 Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 93/81/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 92/21/EEC of 31 March 1992 on the approximation of the laws of the Member States relating to the masses and dimensions of motor vehicles of category M1 (3), and in particular Article 3 thereof, Whereas Directive 92/21/EEC is one of the separate Directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provision laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas reference is made to Council Directive 77/649/EEC (4), as last amended by Commission Directive 90/630/EEC (5), which contains the procedure for determining a reference point for seating positions in motor vehicles and, consequently, it is not necessary to repeat it in this Directive; whereas reference is also made to Council Directive 92/23/EEC (6); Whereas, in the light of experience gained so far with the practical application of Directive 92/21/EEC, it is necessary to specify more precisely certain provisions contained therein in order to ensure uniform interpretation in all Member States; Whereas it will be necessary in the future to lay down special loading conditions for seats which are not designed for, or capable of, accommodating adult passengers; whereas, however, the definition of such seats and the specification of the loading conditions require further consideration; whereas, therefore, the corresponding amendments shall be postponed to a later date; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC; Article 1 1. In Article 1 to Directive 92/21/EEC, 'Annex I to Directive 70/156/EEC` shall be replaced by 'Annex II A to Directive 70/156/EEC`. 2. The Annexes to Directive 92/21/EEC shall be replaced by the Annexes to this Directive and a list of Annexes shall be inserted between the Articles and Annex I. Article 2 1. With effect from 1 January 1996 Member States may not, on grounds relating to the masses and dimensions: - refuse, in respect of a type of motor vehicle of category M1, to grant EEC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of such vehicles, if the vehicles comply with the requirements of Directive 92/21/EEC, as amended by this Directive. 2. With effect from 1 January 1997 Member States: - shall no longer grant EEC type-approval, and - may refuse to grant national type-approval, for a type of vehicle of category M1 on grounds relating to its masses and dimensions, if the requirements of Directive 92/21/EEC, as amended by this Directive, are not fulfilled. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1996 and they shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their offficial publication. The methods of making such a reference shall be laid down by the Member States. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31995L0028

1995

DIRECTIVE 95/28/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 October 1995 relating to the burning behaviour of materials used in the interior construction of certain categories of motor vehicle Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas it is important to adopt measures to that end; Whereas the technical requirements which certain vehicle categories must satisfy pursuant to national law relate, inter alia, to the burning behaviour of materials used in the interior construction of certain categories of motor vehicle; Whereas these requirements differ from one Member State to another; Whereas it is therefore necessary that all Member States adopt the same requirements either in addition to or in place of their existing rules in order, in particular, to allow the EEC type-approval procedure which was the subject of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), to be further implemented; Whereas this Directive will be one of the separate Directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units shall apply for the purposes of this Directive; Whereas it is appropriate to refer to Council Directive 77/649/EEC (5), which contains the procedure for determining the position of the seating reference point (the ‘R-point’); Whereas, with a view to ensuring occupant and road safety, it is important that the materials used in the construction of the inside of bus and coach bodywork satisfy minimum requirements in order to avoid or at least retard development of flames such that it allows occupants to evacuate the vehicle in the event of fire; Whereas it is desirable to introduce alternative routes for the type-approval of vehicles as systems pursuant to this Directive, i. e. either on the basis of tests of the burning behaviour of the interior materials used in motor vehicles or on the basis of an EEC component type-approval for each material and/or equipment such as seats, curtains, etc. to be fitted in the interior construction of these vehicles whereby the correct installation of such approved materials and/or equipment has to be checked, Article 1 For the purposes of this Directive: — ‘vehicle’: means any vehicle as defined in Article 2 of Directive 70/156/EEC, — ‘component’: means a device as defined in Article 2 of Directive 70/156/EEC. Article 2 Member States may not refuse: — EEC type-approval or national type-approval for a vehicle or refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to the burning behaviour of materials used in the interior construction of its bodywork, — EEC type-approval or national type-approval for a component used in the interior construction of the vehicle bodywork or prohibit its sale or use on grounds relating to the burning behaviour of the materials used in its construction, if the relevant requirements set out in Annexes I, IV, V and VI to this Directive are satisfied. Article 3 1. Member States shall adopt and publish the laws, regulations are administrative provisions necessary to comply with this Directive within 18 months of the date of its adoption. They shall forthwith inform the Commission thereof. From the abovementioned date, Member States may no longer prohibit the initial entry into service of vehicles or the sale or use of components complying with this Directive. They shall apply these provisions 48 months following the date of adoption of this Directive. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The method of making such reference shall be laid down by Member States. Article 4 This Directive is addressed to the Member States.

31995L0047

1995

Directive 95/47/EC of the European Parliament and of the Council of 24 October 1995 on the use of standards for the transmission of television signals Having regard to the Treaty establishing the European Community, and in particular Articles 57 (2), 66 and 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas, in Council Decisions 89/337/EEC (4) and 89/630/EEC (5), the Community recognized the strategic importance of advanced television and of High Definition Television (HDTV) services for the European consumer electronics industry and for the European television and film industries and established the strategy framework for the introduction of advanced television and HDTV services in Europe; Whereas the objectives of the strategy for the introduction of HDTV in Europe are an integral part of the Community audiovisual policy, in respect of which the importance of Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities (6) should be reaffirmed, and whereas they must take into account other objectives of this policy within the perspective of the development of Europe's audiovisual capacity, which comprise structural objectives such as the development of production in countries or regions with more limited audiovisual capacity; Whereas Council Directive 92/38/EEC of 11 May 1992 on the adoption of standards for satellite broadcasting of television signals (7) set a regulatory framework of standards for advanced television broadcasting services for television programmes based on the HD-MAC standard (8) for European satellite and cable transmission for non-fully digital HDTV and the D2-MAC (9) standard for other not completely digital satellite and cable transmission in the wide-screen 16:9 aspect ratio format; Whereas Council Decision 93/424/EEC of 22 July 1993 on an action plan for the introduction of advanced television services in Europe (10) aims at promoting the wide-screen 16:9 format (625 or 1250 lines), irrespective of the European television standard used and irrespective of the broadcasting mode (terrestrial, satellite or cable); Whereas Article 7 of Directive 92/38/EEC called on the Commission to report on the effects of the application of that Directive, on the evolution of the market, in particular on market penetration measured by objective criteria, and the use of the Community funding, and to make proposals to the Council to adapt that Directive to these developments if necessary; Whereas, in order to attain the Community's goals as set out in the abovementioned Decisions and to contribute to the proper functioning of the internal market, as provided for in Article 7a of the Treaty, in the broadcasting of television signals, it is necessary to take steps to adopt a common format for wide-screen transmissions; Whereas the wide-screen 16:9 aspect ratio has been adopted at world level by the International Telecommunication Union (ITU) (11) for HDTV and it is desirable and possible to develop the market for advanced television services and products having the same wide-screen 16:9 aspect ratio; Whereas, for the purposes of this Directive, a wide-screen television service must meet the minimum requirements that it uses a transmission system delivering sufficient information to allow a dedicated receiver to display a full frame picture with full vertical resolution and whereas, for the same purposes, a television service using letterbox transmission in 4:3 frame which does not meet the abovementioned minimum criterion should not be considered as a wide-screen television service; Whereas television services are currently delivered to the home by terrestrial systems, by satellite systems and by cable systems and it is essential that advanced wide-screen services should be made available to the largest possible number of viewers; Whereas cable TV networks and their technical capabilities as defined by the Member States are an important feature in the television infrastructure of many Member States and will be crucial to the future of advanced television services; Whereas master antenna systems as defined by Member States are not affected by this Directive; Whereas it is essential to establish common standards for the digital transmission of television signals whether by cable or by satellite or by terrestrial means as an enabling element for effective free-market competition and this is best achieved by mandating a recognized European standardization body taking account, as appropriate, of the outcome of the consensus processes under way among market parties; Whereas such standards should be drawn up in good time, before the introduction to the market of services linked to digital television; Whereas conditional access is an important matter for the consumers and providers of pay television services and for the rights holders of programmes; Whereas a widely based consultation process involving the relevant economic actors in the European market has resulted in agreements on a number of issues concerning conditional access to digital pay-television services; Whereas the operators of conditional access services should be entitled to earn a return on their investments and for the provision of services to broadcasters as an incentive to continue to invest; Whereas it is necessary to make compulsory the inclusion of the common European scrambling algorithm in appropriate consumer equipment in the Community in order to ensure that all pay-television service providers can, in principle, provide all digital pay-television consumers in the European Community with their programmes; Whereas it is appropriate, furthermore, to make provision for transcontrol of conditional access at cable television network head-ends and for the licensing of conditional access technology to manufacturers; Whereas in the European audiovisual digital environment, the scope for piracy will increase, with negative consequences for operators and programme providers, and whereas the introduction and enforcement of efficient anti-piracy legislation at European level will become increasingly necessary; Whereas it is appropriate to repeal Directive 92/38/EEC and to issue a new Directive in the light of these developments in the market and technology; Whereas technologies for advanced television services are developing rapidly and a common approach to their development is necessary; whereas separate and multiple action by the Member States could lead to undesirable fragmentation of the market for products and services and to duplication of effort; whereas consequently such action could be better achieved at Community level; Whereas the Presidency's conclusions at the G7 Conference on the Information Society held in Brussels on 25 to 26 February 1995 highlighted the need for a regulatory framework ensuring open access networks and respect for competition rules, Article 1 Member States shall take appropriate measures to promote the accelerated development of advanced television services including wide-screen television services, high definition television services and television services using fully digital transmission systems. Member States shall see to it that the transfer of wide-screen television services already in operation to digital transmission networks open to the public is made easier, in particular pursuant to Directive 92/38/EEC and Decision 93/424/EEC, in order to protect the interests of operators and television viewers who have invested to produce or receive such services. Article 2 All television services transmitted to viewers in the Community whether by cable, satellite or terrestrial means shall: (a) if they are in wide-screen format and 625 lines, and are not fully digital, use the 16:9 D2-MAC transmission system, or a 16:9 transmission system which is fully compatible with PAL or SECAM. A wide-screen television service consists of programmes produced and edited to be displayed on a wide-screen format. The 16:9 format is the reference format for wide-format television services; (b) if they are in high definition, and are not fully digital, use the HD-MAC transmission system; (c) if they are fully digital, use a transmission system which has been standardized by a recognized European standardization body. In this context, a transmission system comprises the following elements: formation of programme signals (source coding of audio signals, source coding of video signals, multiplexing of signals) and adaptation for transmission media (channel coding, modulation and, if appropriate, energy dispersal). Fully digital transmission networks open to the public for the distribution of television services must be capable of distributing wide-format services. Article 3 Any television set with an integral viewing screen of visible diagonal greater than 42 cm which is put on the market for sale or rent in the Community shall be fitted with at least one open interface socket (as standardized by a recognized European standardization body) permitting simple connection of peripherals, especially additional decoders and digital receivers. Article 4 In relation to conditional access to digital television services broadcast to viewers in the Community, irrespective of the means of transmission, the following conditions shall apply: (a) all consumer equipment, for sale or rent or otherwise made available in the Community, capable of descrambling digital television signals, shall possess the capability: - to allow the descrambling of such signals according to the common European scrambling algorithm as administered by a recognized European standardization body, - to display signals that have been transmitted in clear provided that, in the event that such equipment is rented, the rentee is in compliance with the relevant rental agreement; (b) conditional access systems operated on the market in the Community shall have the necessary technical capability for cost-effective transcontrol at cable head-ends allowing the possibility for full control by cable television operators at local or regional level of the services using such conditional access systems; (c) Member States shall take all the necessary measures to ensure that the operators of conditional access services, irrespective of the means of transmission, who produce and market access services to digital television services: - offer to all broadcasters, on a fair, reasonable and non-discriminatory basis, technical services enabling the broadcasters' digitally-transmitted services to be received by viewers authorized by means of decoders administered by the service operators, and comply with Community competition law, in particular if a dominant position appears, - keep separate financial accounts regarding their activity as conditional access providers. Broadcasters shall publish a list of tariffs for the viewer which takes into account whether associated equipment is supplied or not. A digital television service may take advantage of these provisions only if the services offered comply with the European legislation in force; (d) when granting licences to manufacturers of consumer equipment, holders of industrial property rights to conditional access products and systems shall ensure that this is done on fair, reasonable and non-discriminatory terms. Taking into account technical and commercial factors, holders of rights shall not subject the granting of licences to conditions prohibiting, deterring or discouraging the inclusion in the same product of: - a common interface allowing connection with several other access systems, or - means specific to another access system, provided that the licensee complies with the relevant and reasonable conditions ensuring, as far as he is concerned, the security of transactions of conditional access system operators. Where television sets contain an integrated digital decoder such sets must allow for the option of fitting at least one standardized socket permitting connection of conditional access and other elements of a digital television system of the digital decoder; (e) without prejudice to any action that the Commission or any Member State may take pursuant to the Treaty, Member States shall ensure that any party having an unresolved dispute concerning the application of the provisions established in this Article shall have easy, and in principle inexpensive, access to appropriate dispute resolution procedures with the objective of resolving such disputes in a fair, timely and transparent manner. This procedure shall not preclude action for damages from either side. If the Commission is asked to give its opinion on the application of the Treaty, it shall do so at the earliest opportunity. Article 5 Wide-screen 16:9 television services, within the meaning of Article 2, which are received by, and redistributed on, cable television systems shall be redistributed on such systems at least in the wide-screen 16:9 format. Article 6 Before 1 July 1997, and every two years thereafter, the Commission shall examine the implementation of this Directive and the development of the market for digital television services throughout the European Union and submit a report to the European Parliament, to the Council and to the Economic and Social Committee. This report shall cover market developments, in particular relating to developments in digital technology and services and also to technical and commercial market developments on conditional access to digital television services. If necessary the Commission shall make a proposal to the Council to adapt this Directive to these developments. Article 7 Directive 92/38/EEC is hereby repealed with effect nine months after the date of the entry into force of this Directive. Article 8 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive within nine months of its entry into force. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive. Article 9 This Directive shall enter into force on the date of ist publication in the Official Journal of the European Communities. Article 10 This Directive is addressed to the Member States.

31995L0046

1995

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), (1) Whereas the objectives of the Community, as laid down in the Treaty, as amended by the Treaty on European Union, include creating an ever closer union among the peoples of Europe, fostering closer relations between the States belonging to the Community, ensuring economic and social progress by common action to eliminate the barriers which divide Europe, encouraging the constant improvement of the living conditions of its peoples, preserving and strengthening peace and liberty and promoting democracy on the basis of the fundamental rights recognized in the constitution and laws of the Member States and in the European Convention for the Protection of Human Rights and Fundamental Freedoms; (2) Whereas data-processing systems are designed to serve man; whereas they must, whatever the nationality or residence of natural persons, respect their fundamental rights and freedoms, notably the right to privacy, and contribute to economic and social progress, trade expansion and the well-being of individuals; (3) Whereas the establishment and functioning of an internal market in which, in accordance with Article 7a of the Treaty, the free movement of goods, persons, services and capital is ensured require not only that personal data should be able to flow freely from one Member State to another, but also that the fundamental rights of individuals should be safeguarded; (4) Whereas increasingly frequent recourse is being had in the Community to the processing of personal data in the various spheres of economic and social activity; whereas the progress made in information technology is making the processing and exchange of such data considerably easier; (5) Whereas the economic and social integration resulting from the establishment and functioning of the internal market within the meaning of Article 7a of the Treaty will necessarily lead to a substantial increase in cross-border flows of personal data between all those involved in a private or public capacity in economic and social activity in the Member States; whereas the exchange of personal data between undertakings in different Member States is set to increase; whereas the national authorities in the various Member States are being called upon by virtue of Community law to collaborate and exchange personal data so as to be able to perform their duties or carry out tasks on behalf of an authority in another Member State within the context of the area without internal frontiers as constituted by the internal market; (6) Whereas, furthermore, the increase in scientific and technical cooperation and the coordinated introduction of new telecommunications networks in the Community necessitate and facilitate cross-border flows of personal data; (7) Whereas the difference in levels of protection of the rights and freedoms of individuals, notably the right to privacy, with regard to the processing of personal data afforded in the Member States may prevent the transmission of such data from the territory of one Member State to that of another Member State; whereas this difference may therefore constitute an obstacle to the pursuit of a number of economic activities at Community level, distort competition and impede authorities in the discharge of their responsibilities under Community law; whereas this difference in levels of protection is due to the existence of a wide variety of national laws, regulations and administrative provisions; (8) Whereas, in order to remove the obstacles to flows of personal data, the level of protection of the rights and freedoms of individuals with regard to the processing of such data must be equivalent in all Member States; whereas this objective is vital to the internal market but cannot be achieved by the Member States alone, especially in view of the scale of the divergences which currently exist between the relevant laws in the Member States and the need to coordinate the laws of the Member States so as to ensure that the cross-border flow of personal data is regulated in a consistent manner that is in keeping with the objective of the internal market as provided for in Article 7a of the Treaty; whereas Community action to approximate those laws is therefore needed; (9) Whereas, given the equivalent protection resulting from the approximation of national laws, the Member States will no longer be able to inhibit the free movement between them of personal data on grounds relating to protection of the rights and freedoms of individuals, and in particular the right to privacy; whereas Member States will be left a margin for manoeuvre, which may, in the context of implementation of the Directive, also be exercised by the business and social partners; whereas Member States will therefore be able to specify in their national law the general conditions governing the lawfulness of data processing; whereas in doing so the Member States shall strive to improve the protection currently provided by their legislation; whereas, within the limits of this margin for manoeuvre and in accordance with Community law, disparities could arise in the implementation of the Directive, and this could have an effect on the movement of data within a Member State as well as within the Community; (10) Whereas the object of the national laws on the processing of personal data is to protect fundamental rights and freedoms, notably the right to privacy, which is recognized both in Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms and in the general principles of Community law; whereas, for that reason, the approximation of those laws must not result in any lessening of the protection they afford but must, on the contrary, seek to ensure a high level of protection in the Community; (11) Whereas the principles of the protection of the rights and freedoms of individuals, notably the right to privacy, which are contained in this Directive, give substance to and amplify those contained in the Council of Europe Convention of 28 January 1981 for the Protection of Individuals with regard to Automatic Processing of Personal Data; (12) Whereas the protection principles must apply to all processing of personal data by any person whose activities are governed by Community law; whereas there should be excluded the processing of data carried out by a natural person in the exercise of activities which are exclusively personal or domestic, such as correspondence and the holding of records of addresses; (13) Whereas the acitivities referred to in Titles V and VI of the Treaty on European Union regarding public safety, defence, State security or the acitivities of the State in the area of criminal laws fall outside the scope of Community law, without prejudice to the obligations incumbent upon Member States under Article 56 (2), Article 57 or Article 100a of the Treaty establishing the European Community; whereas the processing of personal data that is necessary to safeguard the economic well-being of the State does not fall within the scope of this Directive where such processing relates to State security matters; (14) Whereas, given the importance of the developments under way, in the framework of the information society, of the techniques used to capture, transmit, manipulate, record, store or communicate sound and image data relating to natural persons, this Directive should be applicable to processing involving such data; (15) Whereas the processing of such data is covered by this Directive only if it is automated or if the data processed are contained or are intended to be contained in a filing system structured according to specific criteria relating to individuals, so as to permit easy access to the personal data in question; (16) Whereas the processing of sound and image data, such as in cases of video surveillance, does not come within the scope of this Directive if it is carried out for the purposes of public security, defence, national security or in the course of State activities relating to the area of criminal law or of other activities which do not come within the scope of Community law; (17) Whereas, as far as the processing of sound and image data carried out for purposes of journalism or the purposes of literary or artistic expression is concerned, in particular in the audiovisual field, the principles of the Directive are to apply in a restricted manner according to the provisions laid down in Article 9; (18) Whereas, in order to ensure that individuals are not deprived of the protection to which they are entitled under this Directive, any processing of personal data in the Community must be carried out in accordance with the law of one of the Member States; whereas, in this connection, processing carried out under the responsibility of a controller who is established in a Member State should be governed by the law of that State; (19) Whereas establishment on the territory of a Member State implies the effective and real exercise of activity through stable arrangements; whereas the legal form of such an establishment, whether simply branch or a subsidiary with a legal personality, is not the determining factor in this respect; whereas, when a single controller is established on the territory of several Member States, particularly by means of subsidiaries, he must ensure, in order to avoid any circumvention of national rules, that each of the establishments fulfils the obligations imposed by the national law applicable to its activities; (20) Whereas the fact that the processing of data is carried out by a person established in a third country must not stand in the way of the protection of individuals provided for in this Directive; whereas in these cases, the processing should be governed by the law of the Member State in which the means used are located, and there should be guarantees to ensure that the rights and obligations provided for in this Directive are respected in practice; (21) Whereas this Directive is without prejudice to the rules of territoriality applicable in criminal matters; (22) Whereas Member States shall more precisely define in the laws they enact or when bringing into force the measures taken under this Directive the general circumstances in which processing is lawful; whereas in particular Article 5, in conjunction with Articles 7 and 8, allows Member States, independently of general rules, to provide for special processing conditions for specific sectors and for the various categories of data covered by Article 8; (23) Whereas Member States are empowered to ensure the implementation of the protection of individuals both by means of a general law on the protection of individuals as regards the processing of personal data and by sectorial laws such as those relating, for example, to statistical institutes; (24) Whereas the legislation concerning the protection of legal persons with regard to the processing data which concerns them is not affected by this Directive; (25) Whereas the principles of protection must be reflected, on the one hand, in the obligations imposed on persons, public authorities, enterprises, agencies or other bodies responsible for processing, in particular regarding data quality, technical security, notification to the supervisory authority, and the circumstances under which processing can be carried out, and, on the other hand, in the right conferred on individuals, the data on whom are the subject of processing, to be informed that processing is taking place, to consult the data, to request corrections and even to object to processing in certain circumstances; (26) Whereas the principles of protection must apply to any information concerning an identified or identifiable person; whereas, to determine whether a person is identifiable, account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the said person; whereas the principles of protection shall not apply to data rendered anonymous in such a way that the data subject is no longer identifiable; whereas codes of conduct within the meaning of Article 27 may be a useful instrument for providing guidance as to the ways in which data may be rendered anonymous and retained in a form in which identification of the data subject is no longer possible; (27) Whereas the protection of individuals must apply as much to automatic processing of data as to manual processing; whereas the scope of this protection must not in effect depend on the techniques used, otherwise this would create a serious risk of circumvention; whereas, nonetheless, as regards manual processing, this Directive covers only filing systems, not unstructured files; whereas, in particular, the content of a filing system must be structured according to specific criteria relating to individuals allowing easy access to the personal data; whereas, in line with the definition in Article 2 (c), the different criteria for determining the constituents of a structured set of personal data, and the different criteria governing access to such a set, may be laid down by each Member State; whereas files or sets of files as well as their cover pages, which are not structured according to specific criteria, shall under no circumstances fall within the scope of this Directive; (28) Whereas any processing of personal data must be lawful and fair to the individuals concerned; whereas, in particular, the data must be adequate, relevant and not excessive in relation to the purposes for which they are processed; whereas such purposes must be explicit and legitimate and must be determined at the time of collection of the data; whereas the purposes of processing further to collection shall not be incompatible with the purposes as they were originally specified; (29) Whereas the further processing of personal data for historical, statistical or scientific purposes is not generally to be considered incompatible with the purposes for which the data have previously been collected provided that Member States furnish suitable safeguards; whereas these safeguards must in particular rule out the use of the data in support of measures or decisions regarding any particular individual; (30) Whereas, in order to be lawful, the processing of personal data must in addition be carried out with the consent of the data subject or be necessary for the conclusion or performance of a contract binding on the data subject, or as a legal requirement, or for the performance of a task carried out in the public interest or in the exercise of official authority, or in the legitimate interests of a natural or legal person, provided that the interests or the rights and freedoms of the data subject are not overriding; whereas, in particular, in order to maintain a balance between the interests involved while guaranteeing effective competition, Member States may determine the circumstances in which personal data may be used or disclosed to a third party in the context of the legitimate ordinary business activities of companies and other bodies; whereas Member States may similarly specify the conditions under which personal data may be disclosed to a third party for the purposes of marketing whether carried out commercially or by a charitable organization or by any other association or foundation, of a political nature for example, subject to the provisions allowing a data subject to object to the processing of data regarding him, at no cost and without having to state his reasons; (31) Whereas the processing of personal data must equally be regarded as lawful where it is carried out in order to protect an interest which is essential for the data subject's life; (32) Whereas it is for national legislation to determine whether the controller performing a task carried out in the public interest or in the exercise of official authority should be a public administration or another natural or legal person governed by public law, or by private law such as a professional association; (33) Whereas data which are capable by their nature of infringing fundamental freedoms or privacy should not be processed unless the data subject gives his explicit consent; whereas, however, derogations from this prohibition must be explicitly provided for in respect of specific needs, in particular where the processing of these data is carried out for certain health-related purposes by persons subject to a legal obligation of professional secrecy or in the course of legitimate activities by certain associations or foundations the purpose of which is to permit the exercise of fundamental freedoms; (34) Whereas Member States must also be authorized, when justified by grounds of important public interest, to derogate from the prohibition on processing sensitive categories of data where important reasons of public interest so justify in areas such as public health and social protection - especially in order to ensure the quality and cost-effectiveness of the procedures used for settling claims for benefits and services in the health insurance system - scientific research and government statistics; whereas it is incumbent on them, however, to provide specific and suitable safeguards so as to protect the fundamental rights and the privacy of individuals; (35) Whereas, moreover, the processing of personal data by official authorities for achieving aims, laid down in constitutional law or international public law, of officially recognized religious associations is carried out on important grounds of public interest; (36) Whereas where, in the course of electoral activities, the operation of the democratic system requires in certain Member States that political parties compile data on people's political opinion, the processing of such data may be permitted for reasons of important public interest, provided that appropriate safeguards are established; (37) Whereas the processing of personal data for purposes of journalism or for purposes of literary of artistic expression, in particular in the audiovisual field, should qualify for exemption from the requirements of certain provisions of this Directive in so far as this is necessary to reconcile the fundamental rights of individuals with freedom of information and notably the right to receive and impart information, as guaranteed in particular in Article 10 of the European Convention for the Protection of Human Rights and Fundamental Freedoms; whereas Member States should therefore lay down exemptions and derogations necessary for the purpose of balance between fundamental rights as regards general measures on the legitimacy of data processing, measures on the transfer of data to third countries and the power of the supervisory authority; whereas this should not, however, lead Member States to lay down exemptions from the measures to ensure security of processing; whereas at least the supervisory authority responsible for this sector should also be provided with certain ex-post powers, e.g. to publish a regular report or to refer matters to the judicial authorities; (38) Whereas, if the processing of data is to be fair, the data subject must be in a position to learn of the existence of a processing operation and, where data are collected from him, must be given accurate and full information, bearing in mind the circumstances of the collection; (39) Whereas certain processing operations involve data which the controller has not collected directly from the data subject; whereas, furthermore, data can be legitimately disclosed to a third party, even if the disclosure was not anticipated at the time the data were collected from the data subject; whereas, in all these cases, the data subject should be informed when the data are recorded or at the latest when the data are first disclosed to a third party; (40) Whereas, however, it is not necessary to impose this obligation of the data subject already has the information; whereas, moreover, there will be no such obligation if the recording or disclosure are expressly provided for by law or if the provision of information to the data subject proves impossible or would involve disproportionate efforts, which could be the case where processing is for historical, statistical or scientific purposes; whereas, in this regard, the number of data subjects, the age of the data, and any compensatory measures adopted may be taken into consideration; (41) Whereas any person must be able to exercise the right of access to data relating to him which are being processed, in order to verify in particular the accuracy of the data and the lawfulness of the processing; whereas, for the same reasons, every data subject must also have the right to know the logic involved in the automatic processing of data concerning him, at least in the case of the automated decisions referred to in Article 15 (1); whereas this right must not adversely affect trade secrets or intellectual property and in particular the copyright protecting the software; whereas these considerations must not, however, result in the data subject being refused all information; (42) Whereas Member States may, in the interest of the data subject or so as to protect the rights and freedoms of others, restrict rights of access and information; whereas they may, for example, specify that access to medical data may be obtained only through a health professional; (43) Whereas restrictions on the rights of access and information and on certain obligations of the controller may similarly be imposed by Member States in so far as they are necessary to safeguard, for example, national security, defence, public safety, or important economic or financial interests of a Member State or the Union, as well as criminal investigations and prosecutions and action in respect of breaches of ethics in the regulated professions; whereas the list of exceptions and limitations should include the tasks of monitoring, inspection or regulation necessary in the three last-mentioned areas concerning public security, economic or financial interests and crime prevention; whereas the listing of tasks in these three areas does not affect the legitimacy of exceptions or restrictions for reasons of State security or defence; (44) Whereas Member States may also be led, by virtue of the provisions of Community law, to derogate from the provisions of this Directive concerning the right of access, the obligation to inform individuals, and the quality of data, in order to secure certain of the purposes referred to above; (45) Whereas, in cases where data might lawfully be processed on grounds of public interest, official authority or the legitimate interests of a natural or legal person, any data subject should nevertheless be entitled, on legitimate and compelling grounds relating to his particular situation, to object to the processing of any data relating to himself; whereas Member States may nevertheless lay down national provisions to the contrary; (46) Whereas the protection of the rights and freedoms of data subjects with regard to the processing of personal data requires that appropriate technical and organizational measures be taken, both at the time of the design of the processing system and at the time of the processing itself, particularly in order to maintain security and thereby to prevent any unauthorized processing; whereas it is incumbent on the Member States to ensure that controllers comply with these measures; whereas these measures must ensure an appropriate level of security, taking into account the state of the art and the costs of their implementation in relation to the risks inherent in the processing and the nature of the data to be protected; (47) Whereas where a message containing personal data is transmitted by means of a telecommunications or electronic mail service, the sole purpose of which is the transmission of such messages, the controller in respect of the personal data contained in the message will normally be considered to be the person from whom the message originates, rather than the person offering the transmission services; whereas, nevertheless, those offering such services will normally be considered controllers in respect of the processing of the additional personal data necessary for the operation of the service; (48) Whereas the procedures for notifying the supervisory authority are designed to ensure disclosure of the purposes and main features of any processing operation for the purpose of verification that the operation is in accordance with the national measures taken under this Directive; (49) Whereas, in order to avoid unsuitable administrative formalities, exemptions from the obligation to notify and simplification of the notification required may be provided for by Member States in cases where processing is unlikely adversely to affect the rights and freedoms of data subjects, provided that it is in accordance with a measure taken by a Member State specifying its limits; whereas exemption or simplification may similarly be provided for by Member States where a person appointed by the controller ensures that the processing carried out is not likely adversely to affect the rights and freedoms of data subjects; whereas such a data protection official, whether or not an employee of the controller, must be in a position to exercise his functions in complete independence; (50) Whereas exemption or simplification could be provided for in cases of processing operations whose sole purpose is the keeping of a register intended, according to national law, to provide information to the public and open to consultation by the public or by any person demonstrating a legitimate interest; (51) Whereas, nevertheless, simplification or exemption from the obligation to notify shall not release the controller from any of the other obligations resulting from this Directive; (52) Whereas, in this context, ex post facto verification by the competent authorities must in general be considered a sufficient measure; (53) Whereas, however, certain processing operation are likely to pose specific risks to the rights and freedoms of data subjects by virtue of their nature, their scope or their purposes, such as that of excluding individuals from a right, benefit or a contract, or by virtue of the specific use of new technologies; whereas it is for Member States, if they so wish, to specify such risks in their legislation; (54) Whereas with regard to all the processing undertaken in society, the amount posing such specific risks should be very limited; whereas Member States must provide that the supervisory authority, or the data protection official in cooperation with the authority, check such processing prior to it being carried out; whereas following this prior check, the supervisory authority may, according to its national law, give an opinion or an authorization regarding the processing; whereas such checking may equally take place in the course of the preparation either of a measure of the national parliament or of a measure based on such a legislative measure, which defines the nature of the processing and lays down appropriate safeguards; (55) Whereas, if the controller fails to respect the rights of data subjects, national legislation must provide for a judicial remedy; whereas any damage which a person may suffer as a result of unlawful processing must be compensated for by the controller, who may be exempted from liability if he proves that he is not responsible for the damage, in particular in cases where he establishes fault on the part of the data subject or in case of force majeure; whereas sanctions must be imposed on any person, whether governed by private of public law, who fails to comply with the national measures taken under this Directive; (56) Whereas cross-border flows of personal data are necessary to the expansion of international trade; whereas the protection of individuals guaranteed in the Community by this Directive does not stand in the way of transfers of personal data to third countries which ensure an adequate level of protection; whereas the adequacy of the level of protection afforded by a third country must be assessed in the light of all the circumstances surrounding the transfer operation or set of transfer operations; (57) Whereas, on the other hand, the transfer of personal data to a third country which does not ensure an adequate level of protection must be prohibited; (58) Whereas provisions should be made for exemptions from this prohibition in certain circumstances where the data subject has given his consent, where the transfer is necessary in relation to a contract or a legal claim, where protection of an important public interest so requires, for example in cases of international transfers of data between tax or customs administrations or between services competent for social security matters, or where the transfer is made from a register established by law and intended for consultation by the public or persons having a legitimate interest; whereas in this case such a transfer should not involve the entirety of the data or entire categories of the data contained in the register and, when the register is intended for consultation by persons having a legitimate interest, the transfer should be made only at the request of those persons or if they are to be the recipients; (59) Whereas particular measures may be taken to compensate for the lack of protection in a third country in cases where the controller offers appropriate safeguards; whereas, moreover, provision must be made for procedures for negotiations between the Community and such third countries; (60) Whereas, in any event, transfers to third countries may be effected only in full compliance with the provisions adopted by the Member States pursuant to this Directive, and in particular Article 8 thereof; (61) Whereas Member States and the Commission, in their respective spheres of competence, must encourage the trade associations and other representative organizations concerned to draw up codes of conduct so as to facilitate the application of this Directive, taking account of the specific characteristics of the processing carried out in certain sectors, and respecting the national provisions adopted for its implementation; (62) Whereas the establishment in Member States of supervisory authorities, exercising their functions with complete independence, is an essential component of the protection of individuals with regard to the processing of personal data; (63) Whereas such authorities must have the necessary means to perform their duties, including powers of investigation and intervention, particularly in cases of complaints from individuals, and powers to engage in legal proceedings; whereas such authorities must help to ensure transparency of processing in the Member States within whose jurisdiction they fall; (64) Whereas the authorities in the different Member States will need to assist one another in performing their duties so as to ensure that the rules of protection are properly respected throughout the European Union; (65) Whereas, at Community level, a Working Party on the Protection of Individuals with regard to the Processing of Personal Data must be set up and be completely independent in the performance of its functions; whereas, having regard to its specific nature, it must advise the Commission and, in particular, contribute to the uniform application of the national rules adopted pursuant to this Directive; (66) Whereas, with regard to the transfer of data to third countries, the application of this Directive calls for the conferment of powers of implementation on the Commission and the establishment of a procedure as laid down in Council Decision 87/373/EEC (1); (67) Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994; (68) Whereas the principles set out in this Directive regarding the protection of the rights and freedoms of individuals, notably their right to privacy, with regard to the processing of personal data may be supplemented or clarified, in particular as far as certain sectors are concerned, by specific rules based on those principles; (69) Whereas Member States should be allowed a period of not more than three years from the entry into force of the national measures transposing this Directive in which to apply such new national rules progressively to all processing operations already under way; whereas, in order to facilitate their cost-effective implementation, a further period expiring 12 years after the date on which this Directive is adopted will be allowed to Member States to ensure the conformity of existing manual filing systems with certain of the Directive's provisions; whereas, where data contained in such filing systems are manually processed during this extended transition period, those systems must be brought into conformity with these provisions at the time of such processing; (70) Whereas it is not necessary for the data subject to give his consent again so as to allow the controller to continue to process, after the national provisions taken pursuant to this Directive enter into force, any sensitive data necessary for the performance of a contract concluded on the basis of free and informed consent before the entry into force of these provisions; (71) Whereas this Directive does not stand in the way of a Member State's regulating marketing activities aimed at consumers residing in territory in so far as such regulation does not concern the protection of individuals with regard to the processing of personal data; (72) Whereas this Directive allows the principle of public access to official documents to be taken into account when implementing the principles set out in this Directive, CHAPTER I GENERAL PROVISIONS Article 1 Object of the Directive 1. In accordance with this Directive, Member States shall protect the fundamental rights and freedoms of natural persons, and in particular their right to privacy with respect to the processing of personal data. 2. Member States shall neither restrict nor prohibit the free flow of personal data between Member States for reasons connected with the protection afforded under paragraph 1. Article 2 Definitions For the purposes of this Directive: (a) 'personal data' shall mean any information relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity; (b) 'processing of personal data' ('processing') shall mean any operation or set of operations which is performed upon personal data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction; (c) 'personal data filing system' ('filing system') shall mean any structured set of personal data which are accessible according to specific criteria, whether centralized, decentralized or dispersed on a functional or geographical basis; (d) 'controller' shall mean the natural or legal person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data; where the purposes and means of processing are determined by national or Community laws or regulations, the controller or the specific criteria for his nomination may be designated by national or Community law; (e) 'processor' shall mean a natural or legal person, public authority, agency or any other body which processes personal data on behalf of the controller; (f) 'third party' shall mean any natural or legal person, public authority, agency or any other body other than the data subject, the controller, the processor and the persons who, under the direct authority of the controller or the processor, are authorized to process the data; (g) 'recipient' shall mean a natural or legal person, public authority, agency or any other body to whom data are disclosed, whether a third party or not; however, authorities which may receive data in the framework of a particular inquiry shall not be regarded as recipients; (h) 'the data subject's consent' shall mean any freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed. Article 3 Scope 1. This Directive shall apply to the processing of personal data wholly or partly by automatic means, and to the processing otherwise than by automatic means of personal data which form part of a filing system or are intended to form part of a filing system. 2. This Directive shall not apply to the processing of personal data: - in the course of an activity which falls outside the scope of Community law, such as those provided for by Titles V and VI of the Treaty on European Union and in any case to processing operations concerning public security, defence, State security (including the economic well-being of the State when the processing operation relates to State security matters) and the activities of the State in areas of criminal law, - by a natural person in the course of a purely personal or household activity. Article 4 National law applicable 1. Each Member State shall apply the national provisions it adopts pursuant to this Directive to the processing of personal data where: (a) the processing is carried out in the context of the activities of an establishment of the controller on the territory of the Member State; when the same controller is established on the territory of several Member States, he must take the necessary measures to ensure that each of these establishments complies with the obligations laid down by the national law applicable; (b) the controller is not established on the Member State's territory, but in a place where its national law applies by virtue of international public law; (c) the controller is not established on Community territory and, for purposes of processing personal data makes use of equipment, automated or otherwise, situated on the territory of the said Member State, unless such equipment is used only for purposes of transit through the territory of the Community. 2. In the circumstances referred to in paragraph 1 (c), the controller must designate a representative established in the territory of that Member State, without prejudice to legal actions which could be initiated against the controller himself. CHAPTER II GENERAL RULES ON THE LAWFULNESS OF THE PROCESSING OF PERSONAL DATA Article 5 Member States shall, within the limits of the provisions of this Chapter, determine more precisely the conditions under which the processing of personal data is lawful. SECTION I PRINCIPLES RELATING TO DATA QUALITY Article 6 1. Member States shall provide that personal data must be: (a) processed fairly and lawfully; (b) collected for specified, explicit and legitimate purposes and not further processed in a way incompatible with those purposes. Further processing of data for historical, statistical or scientific purposes shall not be considered as incompatible provided that Member States provide appropriate safeguards; (c) adequate, relevant and not excessive in relation to the purposes for which they are collected and/or further processed; (d) accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that data which are inaccurate or incomplete, having regard to the purposes for which they were collected or for which they are further processed, are erased or rectified; (e) kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data were collected or for which they are further processed. Member States shall lay down appropriate safeguards for personal data stored for longer periods for historical, statistical or scientific use. 2. It shall be for the controller to ensure that paragraph 1 is complied with. SECTION II CRITERIA FOR MAKING DATA PROCESSING LEGITIMATE Article 7 Member States shall provide that personal data may be processed only if: (a) the data subject has unambiguously given his consent; or (b) processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract; or (c) processing is necessary for compliance with a legal obligation to which the controller is subject; or (d) processing is necessary in order to protect the vital interests of the data subject; or (e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller or in a third party to whom the data are disclosed; or (f) processing is necessary for the purposes of the legitimate interests pursued by the controller or by the third party or parties to whom the data are disclosed, except where such interests are overridden by the interests for fundamental rights and freedoms of the data subject which require protection under Article 1 (1). SECTION III SPECIAL CATEGORIES OF PROCESSING Article 8 The processing of special categories of data 1. Member States shall prohibit the processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, and the processing of data concerning health or sex life. 2. Paragraph 1 shall not apply where: (a) the data subject has given his explicit consent to the processing of those data, except where the laws of the Member State provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject's giving his consent; or (b) processing is necessary for the purposes of carrying out the obligations and specific rights of the controller in the field of employment law in so far as it is authorized by national law providing for adequate safeguards; or (c) processing is necessary to protect the vital interests of the data subject or of another person where the data subject is physically or legally incapable of giving his consent; or (d) processing is carried out in the course of its legitimate activities with appropriate guarantees by a foundation, association or any other non-profit-seeking body with a political, philosophical, religious or trade-union aim and on condition that the processing relates solely to the members of the body or to persons who have regular contact with it in connection with its purposes and that the data are not disclosed to a third party without the consent of the data subjects; or (e) the processing relates to data which are manifestly made public by the data subject or is necessary for the establishment, exercise or defence of legal claims. 3. Paragraph 1 shall not apply where processing of the data is required for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, and where those data are processed by a health professional subject under national law or rules established by national competent bodies to the obligation of professional secrecy or by another person also subject to an equivalent obligation of secrecy. 4. Subject to the provision of suitable safeguards, Member States may, for reasons of substantial public interest, lay down exemptions in addition to those laid down in paragraph 2 either by national law or by decision of the supervisory authority. 5. Processing of data relating to offences, criminal convictions or security measures may be carried out only under the control of official authority, or if suitable specific safeguards are provided under national law, subject to derogations which may be granted by the Member State under national provisions providing suitable specific safeguards. However, a complete register of criminal convictions may be kept only under the control of official authority. Member States may provide that data relating to administrative sanctions or judgements in civil cases shall also be processed under the control of official authority. 6. Derogations from paragraph 1 provided for in paragraphs 4 and 5 shall be notified to the Commission. 7. Member States shall determine the conditions under which a national identification number or any other identifier of general application may be processed. Article 9 Processing of personal data and freedom of expression Member States shall provide for exemptions or derogations from the provisions of this Chapter, Chapter IV and Chapter VI for the processing of personal data carried out solely for journalistic purposes or the purpose of artistic or literary expression only if they are necessary to reconcile the right to privacy with the rules governing freedom of expression. SECTION IV INFORMATION TO BE GIVEN TO THE DATA SUBJECT Article 10 Information in cases of collection of data from the data subject Member States shall provide that the controller or his representative must provide a data subject from whom data relating to himself are collected with at least the following information, except where he already has it: (a) the identity of the controller and of his representative, if any; (b) the purposes of the processing for which the data are intended; (c) any further information such as - the recipients or categories of recipients of the data, - whether replies to the questions are obligatory or voluntary, as well as the possible consequences of failure to reply, - the existence of the right of access to and the right to rectify the data concerning him in so far as such further information is necessary, having regard to the specific circumstances in which the data are collected, to guarantee fair processing in respect of the data subject. Article 11 Information where the data have not been obtained from the data subject 1. Where the data have not been obtained from the data subject, Member States shall provide that the controller or his representative must at the time of undertaking the recording of personal data or if a disclosure to a third party is envisaged, no later than the time when the data are first disclosed provide the data subject with at least the following information, except where he already has it: (a) the identity of the controller and of his representative, if any; (b) the purposes of the processing; (c) any further information such as - the categories of data concerned, - the recipients or categories of recipients, - the existence of the right of access to and the right to rectify the data concerning him in so far as such further information is necessary, having regard to the specific circumstances in which the data are processed, to guarantee fair processing in respect of the data subject. 2. Paragraph 1 shall not apply where, in particular for processing for statistical purposes or for the purposes of historical or scientific research, the provision of such information proves impossible or would involve a disproportionate effort or if recording or disclosure is expressly laid down by law. In these cases Member States shall provide appropriate safeguards. SECTION V THE DATA SUBJECT'S RIGHT OF ACCESS TO DATA Article 12 Right of access Member States shall guarantee every data subject the right to obtain from the controller: (a) without constraint at reasonable intervals and without excessive delay or expense: - confirmation as to whether or not data relating to him are being processed and information at least as to the purposes of the processing, the categories of data concerned, and the recipients or categories of recipients to whom the data are disclosed, - communication to him in an intelligible form of the data undergoing processing and of any available information as to their source, - knowledge of the logic involved in any automatic processing of data concerning him at least in the case of the automated decisions referred to in Article 15 (1); (b) as appropriate the rectification, erasure or blocking of data the processing of which does not comply with the provisions of this Directive, in particular because of the incomplete or inaccurate nature of the data; (c) notification to third parties to whom the data have been disclosed of any rectification, erasure or blocking carried out in compliance with (b), unless this proves impossible or involves a disproportionate effort. SECTION VI EXEMPTIONS AND RESTRICTIONS Article 13 Exemptions and restrictions 1. Member States may adopt legislative measures to restrict the scope of the obligations and rights provided for in Articles 6 (1), 10, 11 (1), 12 and 21 when such a restriction constitutes a necessary measures to safeguard: (a) national security; (b) defence; (c) public security; (d) the prevention, investigation, detection and prosecution of criminal offences, or of breaches of ethics for regulated professions; (e) an important economic or financial interest of a Member State or of the European Union, including monetary, budgetary and taxation matters; (f) a monitoring, inspection or regulatory function connected, even occasionally, with the exercise of official authority in cases referred to in (c), (d) and (e); (g) the protection of the data subject or of the rights and freedoms of others. 2. Subject to adequate legal safeguards, in particular that the data are not used for taking measures or decisions regarding any particular individual, Member States may, where there is clearly no risk of breaching the privacy of the data subject, restrict by a legislative measure the rights provided for in Article 12 when data are processed solely for purposes of scientific research or are kept in personal form for a period which does not exceed the period necessary for the sole purpose of creating statistics. SECTION VII THE DATA SUBJECT'S RIGHT TO OBJECT Article 14 The data subject's right to object Member States shall grant the data subject the right: (a) at least in the cases referred to in Article 7 (e) and (f), to object at any time on compelling legitimate grounds relating to his particular situation to the processing of data relating to him, save where otherwise provided by national legislation. Where there is a justified objection, the processing instigated by the controller may no longer involve those data; (b) to object, on request and free of charge, to the processing of personal data relating to him which the controller anticipates being processed for the purposes of direct marketing, or to be informed before personal data are disclosed for the first time to third parties or used on their behalf for the purposes of direct marketing, and to be expressly offered the right to object free of charge to such disclosures or uses. Member States shall take the necessary measures to ensure that data subjects are aware of the existence of the right referred to in the first subparagraph of (b). Article 15 Automated individual decisions 1. Member States shall grant the right to every person not to be subject to a decision which produces legal effects concerning him or significantly affects him and which is based solely on automated processing of data intended to evaluate certain personal aspects relating to him, such as his performance at work, creditworthiness, reliability, conduct, etc. 2. Subject to the other Articles of this Directive, Member States shall provide that a person may be subjected to a decision of the kind referred to in paragraph 1 if that decision: (a) is taken in the course of the entering into or performance of a contract, provided the request for the entering into or the performance of the contract, lodged by the data subject, has been satisfied or that there are suitable measures to safeguard his legitimate interests, such as arrangements allowing him to put his point of view; or (b) is authorized by a law which also lays down measures to safeguard the data subject's legitimate interests. SECTION VIII CONFIDENTIALITY AND SECURITY OF PROCESSING Article 16 Confidentiality of processing Any person acting under the authority of the controller or of the processor, including the processor himself, who has access to personal data must not process them except on instructions from the controller, unless he is required to do so by law. Article 17 Security of processing 1. Member States shall provide that the controller must implement appropriate technical and organizational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing. Having regard to the state of the art and the cost of their implementation, such measures shall ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected. 2. The Member States shall provide that the controller must, where processing is carried out on his behalf, choose a processor providing sufficient guarantees in respect of the technical security measures and organizational measures governing the processing to be carried out, and must ensure compliance with those measures. 3. The carrying out of processing by way of a processor must be governed by a contract or legal act binding the processor to the controller and stipulating in particular that: - the processor shall act only on instructions from the controller, - the obligations set out in paragraph 1, as defined by the law of the Member State in which the processor is established, shall also be incumbent on the processor. 4. For the purposes of keeping proof, the parts of the contract or the legal act relating to data protection and the requirements relating to the measures referred to in paragraph 1 shall be in writing or in another equivalent form. SECTION IX NOTIFICATION Article 18 Obligation to notify the supervisory authority 1. Member States shall provide that the controller or his representative, if any, must notify the supervisory authority referred to in Article 28 before carrying out any wholly or partly automatic processing operation or set of such operations intended to serve a single purpose or several related purposes. 2. Member States may provide for the simplification of or exemption from notification only in the following cases and under the following conditions: - where, for categories of processing operations which are unlikely, taking account of the data to be processed, to affect adversely the rights and freedoms of data subjects, they specify the purposes of the processing, the data or categories of data undergoing processing, the category or categories of data subject, the recipients or categories of recipient to whom the data are to be disclosed and the length of time the data are to be stored, and/or - where the controller, in compliance with the national law which governs him, appoints a personal data protection official, responsible in particular: - for ensuring in an independent manner the internal application of the national provisions taken pursuant to this Directive - for keeping the register of processing operations carried out by the controller, containing the items of information referred to in Article 21 (2), thereby ensuring that the rights and freedoms of the data subjects are unlikely to be adversely affected by the processing operations. 3. Member States may provide that paragraph 1 does not apply to processing whose sole purpose is the keeping of a register which according to laws or regulations is intended to provide information to the public and which is open to consultation either by the public in general or by any person demonstrating a legitimate interest. 4. Member States may provide for an exemption from the obligation to notify or a simplification of the notification in the case of processing operations referred to in Article 8 (2) (d). 5. Member States may stipulate that certain or all non-automatic processing operations involving personal data shall be notified, or provide for these processing operations to be subject to simplified notification. Article 19 Contents of notification 1. Member States shall specify the information to be given in the notification. It shall include at least: (a) the name and address of the controller and of his representative, if any; (b) the purpose or purposes of the processing; (c) a description of the category or categories of data subject and of the data or categories of data relating to them; (d) the recipients or categories of recipient to whom the data might be disclosed; (e) proposed transfers of data to third countries; (f) a general description allowing a preliminary assessment to be made of the appropriateness of the measures taken pursuant to Article 17 to ensure security of processing. 2. Member States shall specify the procedures under which any change affecting the information referred to in paragraph 1 must be notified to the supervisory authority. Article 20 Prior checking 1. Member States shall determine the processing operations likely to present specific risks to the rights and freedoms of data subjects and shall check that these processing operations are examined prior to the start thereof. 2. Such prior checks shall be carried out by the supervisory authority following receipt of a notification from the controller or by the data protection official, who, in cases of doubt, must consult the supervisory authority. 3. Member States may also carry out such checks in the context of preparation either of a measure of the national parliament or of a measure based on such a legislative measure, which define the nature of the processing and lay down appropriate safeguards. Article 21 Publicizing of processing operations 1. Member States shall take measures to ensure that processing operations are publicized. 2. Member States shall provide that a register of processing operations notified in accordance with Article 18 shall be kept by the supervisory authority. The register shall contain at least the information listed in Article 19 (1) (a) to (e). The register may be inspected by any person. 3. Member States shall provide, in relation to processing operations not subject to notification, that controllers or another body appointed by the Member States make available at least the information referred to in Article 19 (1) (a) to (e) in an appropriate form to any person on request. Member States may provide that this provision does not apply to processing whose sole purpose is the keeping of a register which according to laws or regulations is intended to provide information to the public and which is open to consultation either by the public in general or by any person who can provide proof of a legitimate interest. CHAPTER III JUDICIAL REMEDIES, LIABILITY AND SANCTIONS Article 22 Remedies Without prejudice to any administrative remedy for which provision may be made, inter alia before the supervisory authority referred to in Article 28, prior to referral to the judicial authority, Member States shall provide for the right of every person to a judicial remedy for any breach of the rights guaranteed him by the national law applicable to the processing in question. Article 23 Liability 1. Member States shall provide that any person who has suffered damage as a result of an unlawful processing operation or of any act incompatible with the national provisions adopted pursuant to this Directive is entitled to receive compensation from the controller for the damage suffered. 2. The controller may be exempted from this liability, in whole or in part, if he proves that he is not responsible for the event giving rise to the damage. Article 24 Sanctions The Member States shall adopt suitable measures to ensure the full implementation of the provisions of this Directive and shall in particular lay down the sanctions to be imposed in case of infringement of the provisions adopted pursuant to this Directive. CHAPTER IV TRANSFER OF PERSONAL DATA TO THIRD COUNTRIES Article 25 Principles 1. The Member States shall provide that the transfer to a third country of personal data which are undergoing processing or are intended for processing after transfer may take place only if, without prejudice to compliance with the national provisions adopted pursuant to the other provisions of this Directive, the third country in question ensures an adequate level of protection. 2. The adequacy of the level of protection afforded by a third country shall be assessed in the light of all the circumstances surrounding a data transfer operation or set of data transfer operations; particular consideration shall be given to the nature of the data, the purpose and duration of the proposed processing operation or operations, the country of origin and country of final destination, the rules of law, both general and sectoral, in force in the third country in question and the professional rules and security measures which are complied with in that country. 3. The Member States and the Commission shall inform each other of cases where they consider that a third country does not ensure an adequate level of protection within the meaning of paragraph 2. 4. Where the Commission finds, under the procedure provided for in Article 31 (2), that a third country does not ensure an adequate level of protection within the meaning of paragraph 2 of this Article, Member States shall take the measures necessary to prevent any transfer of data of the same type to the third country in question. 5. At the appropriate time, the Commission shall enter into negotiations with a view to remedying the situation resulting from the finding made pursuant to paragraph 4. 6. The Commission may find, in accordance with the procedure referred to in Article 31 (2), that a third country ensures an adequate level of protection within the meaning of paragraph 2 of this Article, by reason of its domestic law or of the international commitments it has entered into, particularly upon conclusion of the negotiations referred to in paragraph 5, for the protection of the private lives and basic freedoms and rights of individuals. Member States shall take the measures necessary to comply with the Commission's decision. Article 26 Derogations 1. By way of derogation from Article 25 and save where otherwise provided by domestic law governing particular cases, Member States shall provide that a transfer or a set of transfers of personal data to a third country which does not ensure an adequate level of protection within the meaning of Article 25 (2) may take place on condition that: (a) the data subject has given his consent unambiguously to the proposed transfer; or (b) the transfer is necessary for the performance of a contract between the data subject and the controller or the implementation of precontractual measures taken in response to the data subject's request; or (c) the transfer is necessary for the conclusion or performance of a contract concluded in the interest of the data subject between the controller and a third party; or (d) the transfer is necessary or legally required on important public interest grounds, or for the establishment, exercise or defence of legal claims; or (e) the transfer is necessary in order to protect the vital interests of the data subject; or (f) the transfer is made from a register which according to laws or regulations is intended to provide information to the public and which is open to consultation either by the public in general or by any person who can demonstrate legitimate interest, to the extent that the conditions laid down in law for consultation are fulfilled in the particular case. 2. Without prejudice to paragraph 1, a Member State may authorize a transfer or a set of transfers of personal data to a third country which does not ensure an adequate level of protection within the meaning of Article 25 (2), where the controller adduces adequate safeguards with respect to the protection of the privacy and fundamental rights and freedoms of individuals and as regards the exercise of the corresponding rights; such safeguards may in particular result from appropriate contractual clauses. 3. The Member State shall inform the Commission and the other Member States of the authorizations it grants pursuant to paragraph 2. If a Member State or the Commission objects on justified grounds involving the protection of the privacy and fundamental rights and freedoms of individuals, the Commission shall take appropriate measures in accordance with the procedure laid down in Article 31 (2). Member States shall take the necessary measures to comply with the Commission's decision. 4. Where the Commission decides, in accordance with the procedure referred to in Article 31 (2), that certain standard contractual clauses offer sufficient safeguards as required by paragraph 2, Member States shall take the necessary measures to comply with the Commission's decision. CHAPTER V CODES OF CONDUCT Article 27 1. The Member States and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper implementation of the national provisions adopted by the Member States pursuant to this Directive, taking account of the specific features of the various sectors. 2. Member States shall make provision for trade associations and other bodies representing other categories of controllers which have drawn up draft national codes or which have the intention of amending or extending existing national codes to be able to submit them to the opinion of the national authority. Member States shall make provision for this authority to ascertain, among other things, whether the drafts submitted to it are in accordance with the national provisions adopted pursuant to this Directive. If it sees fit, the authority shall seek the views of data subjects or their representatives. 3. Draft Community codes, and amendments or extensions to existing Community codes, may be submitted to the Working Party referred to in Article 29. This Working Party shall determine, among other things, whether the drafts submitted to it are in accordance with the national provisions adopted pursuant to this Directive. If it sees fit, the authority shall seek the views of data subjects or their representatives. The Commission may ensure appropriate publicity for the codes which have been approved by the Working Party. CHAPTER VI SUPERVISORY AUTHORITY AND WORKING PARTY ON THE PROTECTION OF INDIVIDUALS WITH REGARD TO THE PROCESSING OF PERSONAL DATA Article 28 Supervisory authority 1. Each Member State shall provide that one or more public authorities are responsible for monitoring the application within its territory of the provisions adopted by the Member States pursuant to this Directive. These authorities shall act with complete independence in exercising the functions entrusted to them. 2. Each Member State shall provide that the supervisory authorities are consulted when drawing up administrative measures or regulations relating to the protection of individuals' rights and freedoms with regard to the processing of personal data. 3. Each authority shall in particular be endowed with: - investigative powers, such as powers of access to data forming the subject-matter of processing operations and powers to collect all the information necessary for the performance of its supervisory duties, - effective powers of intervention, such as, for example, that of delivering opinions before processing operations are carried out, in accordance with Article 20, and ensuring appropriate publication of such opinions, of ordering the blocking, erasure or destruction of data, of imposing a temporary or definitive ban on processing, of warning or admonishing the controller, or that of referring the matter to national parliaments or other political institutions, - the power to engage in legal proceedings where the national provisions adopted pursuant to this Directive have been violated or to bring these violations to the attention of the judicial authorities. Decisions by the supervisory authority which give rise to complaints may be appealed against through the courts. 4. Each supervisory authority shall hear claims lodged by any person, or by an association representing that person, concerning the protection of his rights and freedoms in regard to the processing of personal data. The person concerned shall be informed of the outcome of the claim. Each supervisory authority shall, in particular, hear claims for checks on the lawfulness of data processing lodged by any person when the national provisions adopted pursuant to Article 13 of this Directive apply. The person shall at any rate be informed that a check has taken place. 5. Each supervisory authority shall draw up a report on its activities at regular intervals. The report shall be made public. 6. Each supervisory authority is competent, whatever the national law applicable to the processing in question, to exercise, on the territory of its own Member State, the powers conferred on it in accordance with paragraph 3. Each authority may be requested to exercise its powers by an authority of another Member State. The supervisory authorities shall cooperate with one another to the extent necessary for the performance of their duties, in particular by exchanging all useful information. 7. Member States shall provide that the members and staff of the supervisory authority, even after their employment has ended, are to be subject to a duty of professional secrecy with regard to confidential information to which they have access. Article 29 Working Party on the Protection of Individuals with regard to the Processing of Personal Data 1. A Working Party on the Protection of Individuals with regard to the Processing of Personal Data, hereinafter referred to as 'the Working Party', is hereby set up. It shall have advisory status and act independently. 2. The Working Party shall be composed of a representative of the supervisory authority or authorities designated by each Member State and of a representative of the authority or authorities established for the Community institutions and bodies, and of a representative of the Commission. Each member of the Working Party shall be designated by the institution, authority or authorities which he represents. Where a Member State has designated more than one supervisory authority, they shall nominate a joint representative. The same shall apply to the authorities established for Community institutions and bodies. 3. The Working Party shall take decisions by a simple majority of the representatives of the supervisory authorities. 4. The Working Party shall elect its chairman. The chairman's term of office shall be two years. His appointment shall be renewable. 5. The Working Party's secretariat shall be provided by the Commission. 6. The Working Party shall adopt its own rules of procedure. 7. The Working Party shall consider items placed on its agenda by its chairman, either on his own initiative or at the request of a representative of the supervisory authorities or at the Commission's request. Article 30 1. The Working Party shall: (a) examine any question covering the application of the national measures adopted under this Directive in order to contribute to the uniform application of such measures; (b) give the Commission an opinion on the level of protection in the Community and in third countries; (c) advise the Commission on any proposed amendment of this Directive, on any additional or specific measures to safeguard the rights and freedoms of natural persons with regard to the processing of personal data and on any other proposed Community measures affecting such rights and freedoms; (d) give an opinion on codes of conduct drawn up at Community level. 2. If the Working Party finds that divergences likely to affect the equivalence of protection for persons with regard to the processing of personal data in the Community are arising between the laws or practices of Member States, it shall inform the Commission accordingly. 3. The Working Party may, on its own initiative, make recommendations on all matters relating to the protection of persons with regard to the processing of personal data in the Community. 4. The Working Party's opinions and recommendations shall be forwarded to the Commission and to the committee referred to in Article 31. 5. The Commission shall inform the Working Party of the action it has taken in response to its opinions and recommendations. It shall do so in a report which shall also be forwarded to the European Parliament and the Council. The report shall be made public. 6. The Working Party shall draw up an annual report on the situation regarding the protection of natural persons with regard to the processing of personal data in the Community and in third countries, which it shall transmit to the Commission, the European Parliament and the Council. The report shall be made public. CHAPTER VII COMMUNITY IMPLEMENTING MEASURES Article 31 The Committee 1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. It that event: - the Commission shall defer application of the measures which it has decided for a period of three months from the date of communication, - the Council, acting by a qualified majority, may take a different decision within the time limit referred to in the first indent. FINAL PROVISIONS Article 32 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest at the end of a period of three years from the date of its adoption. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall ensure that processing already under way on the date the national provisions adopted pursuant to this Directive enter into force, is brought into conformity with these provisions within three years of this date. By way of derogation from the preceding subparagraph, Member States may provide that the processing of data already held in manual filing systems on the date of entry into force of the national provisions adopted in implementation of this Directive shall be brought into conformity with Articles 6, 7 and 8 of this Directive within 12 years of the date on which it is adopted. Member States shall, however, grant the data subject the right to obtain, at his request and in particular at the time of exercising his right of access, the rectification, erasure or blocking of data which are incomplete, inaccurate or stored in a way incompatible with the legitimate purposes pursued by the controller. 3. By way of derogation from paragraph 2, Member States may provide, subject to suitable safeguards, that data kept for the sole purpose of historical research need not be brought into conformity with Articles 6, 7 and 8 of this Directive. 4. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field covered by this Directive. Article 33 The Commission shall report to the Council and the European Parliament at regular intervals, starting not later than three years after the date referred to in Article 32 (1), on the implementation of this Directive, attaching to its report, if necessary, suitable proposals for amendments. The report shall be made public. The Commission shall examine, in particular, the application of this Directive to the data processing of sound and image data relating to natural persons and shall submit any appropriate proposals which prove to be necessary, taking account of developments in information technology and in the light of the state of progress in the information society. Article 34 This Directive is addressed to the Member States.

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Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organization of official inspections in the field of animal nutrition Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas animal nutrition has become a very important aspect of Community agriculture; Whereas fixing at Community level the principles governing the organization of official inspections in the field of animal nutrition helps safeguard animal health, human health and the environment, ensure the fairness of commercial transactions and protect the interests of consumers; Whereas rules must be laid down for the organization of official inspections of feedingstuffs in view of the very wide range of products used, the large volume of consignments of goods commercially traded, the integrated structure of the sector and, in particular, the need to ensure both the wholesomeness of the feedingstuff to be consumed by animals and the quality of the foodstuff; Whereas, in order to attain the desired objective, the rules laid down in this Directive must cover all products and substances used in animal nutrition in the Community; whereas inspections should therefore be organized to cover products imported into or released for free circulation in the Community; Whereas the definition of 'competent authority` does not prevent Member States from delegating in whole or in part the responsibility of the authority for the purpose of carrying out officials checks in the field of animal nutrition, provided that inspections continue to be carried out under their authority; Whereas, to be effective, inspections must be carried out regularly; whereas they must not be restricted as to the subject, stage or moment at which they are carried out; whereas they must take the most suitable forms to ensure their effectiveness; Whereas, in order to ensure that inspection procedures are not evaded, it is necessary to provide that Member States shall not exclude a product from appropriate inspection on the grounds that it is intended for export outside the Community; Whereas products from third countries must be subject to random documentary and identity checks on entry into the Community territory; Whereas provision should be made for Member States to have the possibility of designating entry points in order to ensure the efficient conduct of inspections of imported products, without prejudice to the provisions laid down in other relevant Community legislation, in particular Directives 90/675/EEC (4) and 92/118/EEC (5) concerning veterinary checks and animal health and public health requirements; Whereas principles should be laid down to govern the organization of and steps to be taken following the physical checks to be carried out by the competent authorities; Whereas, as regards intra-Community trade, emphasis should be placed on the checks to be carried out at the place of origin; whereas, however, in the event of a presumption of irregularity, the check may, exceptionally, be carried out while the products are in transit or at the place of destination; Whereas this solution requires greater confidence in the inspections carried out by the Member State of dispatch; whereas the Member State of dispatch must ensure that such checks are carried out in an appropriate fashion; Whereas provision should be made for action to be taken where a check discloses that a consignment is irregular; Whereas, for reasons of effectiveness, it is for the Member State of dispatch to ensure that the products comply with Community rules; whereas, in the event of infringements, the Commission must be able to take action, in cooperation with the Member States concerned, particularly by making on-the-spot visits and adopting measures appropriate to the situation; Whereas, in accordance with Council Directive 70/373/EEC (1), all methods of sampling and methods of analysis necessary for carrying out official checks on feedingstuffs should be adopted at Community level; Whereas, although undertakings should not have the right to oppose inspections, their legitimate rights must nevertheless be preserved, in particular the right to manufacturing secrecy and the right of appeal; Whereas the authorities responsible for inspections may differ from one Member State to another; whereas it is therefore desirable to publish a list of the competent authorities in the field in each Member State, with an indication of the territories for which they are competent and the laboratories authorized to carry out analyses in connection with such inspections; Whereas, although it is primarily for the Member States to lay down their inspection programmes, it is necessary, with a view to the proper functioning of the internal market, to arrange also for coordinated programmes at Community level; Whereas the Commission should be entrusted with the task of adopting measures for applying this Directive, CHAPTER I INTRODUCTORY PROVISIONS Article 1 1. This Directive sets out the principles governing the organization of official inspections in the field of animal nutrition. 2. This Directive shall apply without prejudice to more specific Community rules, in particular Community customs rules and Community veterinary rules. Article 2 1. For the purposes of this Directive the following definitions shall apply: (a) 'official inspection in the field of animal nutrition`, hereinafter called 'inspection`, means an inspection by the competent authorities to check compliance with the Community provisions laid down in: - Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (2), - Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (3), - Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs (4), - Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (5), - Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (6), - Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (7), and - any other rules in the field of animal nutrition in which provision is made for official inspections to be carried out in accordance with the provisions of this Directive; (b) 'documentary check` means verification of the documents accompanying a product or of any other information provided on the product; (c) 'identity check` means verification, by visual inspection only, for consistency between the documents, the labelling and the products; (d) 'physical check` means a check of the product itself, including, where appropriate, sampling and laboratory testing; (e) 'product` means feedingstuffs and all substances used in animal nutrition; (f) 'competent authority` means the Member State's authority responsible for carrying out official checks in the field of animal nutrition; (g) 'establishment` means any undertaking which produces or manufactures a product or which holds the product at an intermediate stage before marketing or which markets the products; (h) 'marketing` means the holding of products with a view to their sale or other forms of disposal to others, by way of gift or in return for payment, and also sale and other forms of disposal themselves. 2. The definitions given in the Community legislation relating to the field of animal nutrition shall apply where appropriate. Article 3 1. Member States shall take all the necessary measures to ensure that inspections are carried out in accordance with this Directive. 2. Member States shall not exclude a product from appropriate inspection on the grounds that it is intended for export. Article 4 1. Inspections shall be carried out: (a) at regular intervals; (b) where non-compliance is suspected; (c) using means proportionate to the desired objective and particularly in the light of the risks and of experience gained. 2. Inspections shall cover all stages of production and manufacture, the intermediate stages prior to marketing, including importation, and the use of products. The competent authority shall select the stage or stages most apporpriate for the intended purpose of the inspection. 3. As a general rule, inspections shall be carried out without prior warning. 4. Inspections shall also cover uses prohibited in relation to animal nutrition. CHAPTER II IMPORTS FROM THIRD COUNTRIES Article 5 Notwithstanding Article 4 (1), Member States shall take all the necessary steps to ensure that when products are introduced into the customs territory of the Community they are subjected by the competent authorities to a documentary check of each batch and to random identity checks in order to verify: - their nature, - their origin, - their geographical destination, so as determine the customs procedure applicable to them. Article 6 For the purpose of the checks provided for in Article 5, Member States may designate particular entry points in their territory for the various types of products. To the same end they may require notice to be given to them of arrival of products at a particular entry point. Article 7 Member States shall ensure the conformity of products by means of random physical checks before they are marketed. Article 8 1. Where the checks show that products do not meet the requirements of the rules, the Member State shall prohibit their entry or marketing and order their redispatch out of Community territory; it shall immediately inform the Commission and the other Member States that it has rejected the products, indicating the infringements found. 2. Notwithstanding paragraph 1, Member States may authorize the carrying out, under the conditions laid down by the competent authority, of one of the following operations: - bringing the products into line with the requirements within a deadline to be determined, or - decontamination where appropriate, or - processing in any other suitable manner, or - use for other purposes, or - destruction of the products. Member States shall ensure that the operations listed in the first subparagraph do not give rise to any adverse effects on human and animal health or on the environment. 3. The costs incurred in the measures taken in accordance with paragraphs 1 and 2 shall be borne by the authorization holder or his representative. Article 9 1. Where products are not marketed in the territory of the Member State which carries out the checks referred to in Article 5 and, where appropriate, a physical check, that Member State shall provide the person concerned with a document indicating the type of check carried out and its outcome. Commercial documents shall contain a reference to this document. However, the right of the Member State of destination to carry out random checks on products shall not be affected. 2. A standard document and, where appropriate, detailed rules for the application of paragraph 1 shall be adopted in accordance with the procedure laid down in Article 23 before the 30 April 1998. CHAPTER III TRADE WITHIN THE COMMUNITY Article 10 Member States shall take all necessary measures to ensure that products intended for dispatch to another Member State are inspected with the same care as those intended to be marketed in their own territory. Section 1 Checks at source Article 11 1. Member States shall ensure that the competent authority carries out checks on establishments in order to satisfy itself that they meet their obligations under Community rules and that products intended to be marketed comply with Community requirements. 2. Where there are grounds for suspecting that requirements are not being met, the competent authority shall carry out the necessary checks and, if the suspicion is confirmed, take the appropriate measures. Section 2 Control at destination Article 12 1. The competent authority of the Member State of destination may, at places of destination, check the compliance of products with the provisions of Article 2 (1) (a) by means of non-discriminatory random checks. 2. However, where the competent authority of the Member State of transit or the Member State of destination has information leading it to suspect an infringement, checks may also be carried out during the transport of products in its territory. Article 13 1. If, during a check carried out at the place of destination of a consignment or during transport, a Member State establishes the non-compliance of the products with the provisions of Article 2 (1) (a), it shall take the appropriate measures and formally require the consignor, the consignee or any other person entitled to carry out, under the conditions laid down by the competent authority, one of the following operations: - bringing of the products into compliance within a deadline to be determined, or - decontamination where appropriate, or - processing in any other suitable manner, or - use for other purposes, or - redispatch to the country of origin, after informing the competent authority of the country of the establishment of origin, or - destruction of the products. 2. The costs incurred in the measures taken in accordance with paragraph 1 shall be borne by the consignor or any other person entitled, including where appropriate the consignee. Section 3 Cooperation in the event of infringements Article 14 In the event of the destruction, use for other purposes, redispatch to the country of origin or decontamination of the products as provided for in Article 13 (1), the Member State of destination shall contact the Member State of dispatch without delay. In other cases, the Member State of destination may contact the Member State of dispatch. The Member State of dispatch shall take all necessary measures and notify the Member State of destination of the nature and outcome of the checks carried out, the decisions taken and the reasons for such decisions. If the Member State of destination fears that such measures are inadequate, the two Member States shall together seek ways and means of remedying the situation; if appropriate this may involve a joint on-the-spot inspection. Where the checks carried out in accordance with Article 12 show repeated irregularities, the Member State of destination shall inform the Commission and the other Member States. Article 15 1. At the request of the Member State of destination or on its own initiative, taking into account the nature of the infringements established, the Commission may: - send representatives, in cooperation with the Member State concerned, to the establishment in question, - request the Member State of dispatch to intensify its checks on the products of the establishment concerned. 2. The Commission shall inform the Member States concerned of its findings. Pending the Commission's findings, the Member State of dispatch must, if so requested by the Member State of destination, intensify checks on products coming from the establishment in question. The Member State of destination may, for its part, intensify checks on products coming from the same establishment. 3. The Commission may review the situation within the Committee referred to in Article 23. It may adopt the necessary decisions, including those relating to intra-Community movements of products, in accordance with the procedure laid down in the same Article. Section 4 Inspections on holdings Article 16 Member States shall ensure that the competent authority has access to places where agricultural production is carried on and where the products are manufactured or used in order to carry out the prescribed checks. CHAPTER IV GENERAL PROVISIONS Article 17 1. Member States shall ensure that inspections are carried out in such a way that delays in the delivery of products are minimized and that inspections do not result in unjustified obstacles to the marketing thereof. 2. Member States shall provide that officials responsible for inspection are subject to professional confidentiality. Article 18 1. Where products are sampled for the purpose of analysis, Member States shall adopt the provisions necessary: - to ensure that those subject to checks are entitled to a second opinion, - to ensure that officially sealed reference samples are preserved. 2. Member States shall draw up a list of laboratories responsible for carrying out analyses; they shall ensure that such laboratories are designated on account of their capabilities. 3. Member States shall ensure that sampling and analysis are carried out in accordance with Community rules. However, in the absence of Community rules and methods, Member States shall take all necessary steps to satisfy themselves that inspections are carried out: - in accordance with standards recognized by international bodies, - in the absence of such standards, in accordance with scientifically recognized national rules which comply with the general principles of the Treaty. 4. Detailed rules for the application of this Article may be adopted in accordance with the procedure laid down in Article 23. Article 19 Each Member State shall take the measures required to ensure that all the provisions of this Directive are applied in full. Penalties must be laid down for the event of a failure to comply with those measures. Such penalties shall be effective, shall be commensurate with their purpose and shall have an adequate deterrent effect. Article 20 Rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive. Decisions taken by the competent authority where an infringement has been found and the reasons for such decisions must be notified to the operator concerned by such decisions or his representative. If the operator concerned or his representative so requests, the said decisions and reasons must be communicated to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State performing the checks and of the procedure and time limits applicable. Article 21 Each Member State shall communicate to the Commission one year after this Directive enters into force: - the competent authority or authorities, their geographical coverage and their sphere of competence, - the laboratory or laboratories referred to in Article 18 (2), - where appropriate, the list of entry points referred to in Article 6. This information, together with subsequent amendments, shall be published in the 'C` series of the Official Journal of the European Communities. Article 22 1. By 1 October 1998 at the latest, Member States shall drawn up programmes setting out the national measures to be taken to achieve the aim of this Directive. These programmes must take into account the specific situation of each Member State and specify the type and frequency of the inspections, which must be performed regularly. 2. Before 1 April each year and before 1 April 2000 for the first time, the Member States shall transmit to the Commission all relevant information concerning the implementation of the programmes referred to in paragraph 1 during the previous year, specifying: - the criteria used in drawing up the programmes, - the number and type of inspections carried out, - the results of the inspections, in particular the number and type of infringements found, - action taken where infringements have been found. 3. Before 1 October each year and before 1 October 2000 for the first time, the Commission shall submit an overall summary report on the results of inspections carried out at Community level, together with a proposal for a recommendation concerning a coordinated inspection programme for the following year, for adoption in accordance with the procedure under Article 23. This recommendation may be amended at a later date as required by the implementation of the coordinated programme. The coordinated programme shall indicate, in particular, the priority criteria to be followed for its implementation. The information provided for in paragraph 2 shall contain a separate section specifically concerning implementation of the coordinated programme. Article 23 1. The Commission shall be assisted by the Standing Committee for Feedingstuffs, set up by Decision 70/372/EEC (1), hereinafter referred to as 'the Committee`. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 24 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 April 1998. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the area covered by this Directive. Article 25 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 26 This Directive is addressed to the Member States.

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1995

Commission Directive 95/54/EC of 31 October 1995 adapting to technical progress Council Directive 72/245/EEC on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles and amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 93/81/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 72/245/EEC of 20 June 1972 on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles (3), as amended by Commission Directive 89/491/EEC (4), and in particular Article 4 thereof, Whereas Directive 72/245/EEC is one of the separate directives of the EEC type-approval procedure which was established pursuant to Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate directive to have attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas Directive 72/245/EEC contained the earliest measures endeavouring to bring about a basic electromagnetic compatibility regarding radio interference, since which time technical progress has increased the complexity and diversity of electrical and electronic equipment; Whereas, in view of the increasing concern about the technological developments in electrical and electronic equipment and the need to ensure the general compatibility of different electrical and electronic equipment, Council Directive 89/336/EEC (5), as last amended by Directive 93/68/EEC (6), laid down general provisions regarding electromagnetic compatibility for all products; Whereas Directive 89/336/EEC established the rule that, in so far as protection requirements specified in that Directive were harmonized, its general provisions would not apply or would cease to apply with regard to apparatus covered by specific directives; Whereas in the field of vehicles, their components and separate technical units, it is necessary to envisage a specific directive within the framework of the system for European type-approval which provides for approvals granted by designated national authorities to harmonized technical requirements; Whereas Directive 72/245/EEC should become such a specific directive; Whereas reference is made to electromagnetic compatibility in other directives relating to vehicles, their components and separate technical units, within the framework of Directive 70/156/EEC; Whereas the technical requirements relating to the radio interference (electromagnetic compatibility) of vehicles, their components and systems should be governed from 1 January 1996 solely by the provisions of Directive 72/245/EEC; Whereas it is necessary to amend Directive 70/156/EEC to reflect the extension of Directive 72/245/EEC to all vehicle categories; Whereas it is necessary to refer to Council Directive 72/306/EEC (1), as amended by Directive 89/491/EEC, in order to distinguish between spark and compression ignition engines; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 72/245/EEC is hereby amended as follows: 1. the title shall be replaced by the following: 'Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference (electromagnetic compatibility) of vehicles'; 2. Article 1 shall be replaced by the following: 'Article 1 For the purpose of this Directive, "vehicle" means any vehicle as defined in Directive 70/156/EEC.'; 3. Article 2 shall be replaced by the following: 'Article 2 No Member State may refuse to grant EEC type-approval or national type-approval of a vehicle, component or separate technical unit on grounds relating to electromagnetic compatibility if the requirements of this Directive are fulfilled.'; 4. Article 3 shall be replaced by the following: 'Article 3 1. This Directive shall constitute a "specific directive" for the purposes of Article 2 (2) of Council Directive 89/336/EEC (*) with effect from 1 January 1996. 2. Vehicles, components or separate technical units approved pursuant to this Directive shall be considered to fulfil the provisions of other directives, cited in Annex IV to Council Directive 92/53/EEC (**), which refer to electromagnetic compatibility. (*) OJ No L 139, 23. 5. 1989, p. 19. (**) OJ No L 225, 10. 8. 1992, p. 1.'; 5. The Annexes shall be replaced by the Annex to this Directive. Article 2 1. With effect from 1 December 1995, Member States may not, on grounds relating to electromagnetic compatibility: - refuse, in respect of any given type of vehicle, to grant EEC type-approval or national type-approval, - refuse, in respect of any given type of component or separate technical unit, to grant EEC component or technical unit type-approval, or - prohibit the registration, sale or entry into service of vehicles, - prohibit the sale or use of components or separate technical units, if the vehicles, components or separate technical units comply with the requirements of Directive 72/245/EEC as amended by this Directive. 2. With effect from 1 January 1996, Member States: - shall no longer grant EEC vehicle type-approval, EEC component type-approval or EEC separate technical unit type-approval, and - may refuse to grant national type-approval, for any type of vehicle, component or separate technical unit on grounds relating to electromagnetic compatibility, if the requirements of Directive 72/245/EEC, as amended by this Directive, are not fulfilled. 3. Paragraph 2 shall not apply to vehicle types approved before 1 January 1996 pursuant to Directive 72/306/EEC nor to any subsequent extensions to these approvals. 4. With effect from 1 October 2002, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, - may refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, and - may refuse the sale and entry into service of new electrical/electronic sub-assemblies as components or separate technical unit, if the requirements of this Directive are not fulfilled. 5. With effect from 1 October 2002 the requirements of Directive 72/245/EEC, relating to electrical/electronic sub-assemblies as components or separate technical units, as amended by this Directive, are applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. 6. Notwithstanding paragraphs 2 and 5, for the purposes of replacement parts, Member States shall continue to grant EEC type approval and to permit the sale and entry into service of components or separate technical units intended for use on vehicle types which have been approved before 1 January 1996 pursuant to either Directive 72/245/EEC or Directive 72/306/EEC and, where applicable, subsequent extensions to these approvals. Article 3 Item No 10 of Part I of Annex IV to Directive 70/156/EEC shall be amended to include an 'X' in each of the columns for vehicle category 0 under the heading 'Applicability'. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 December 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31995L0056

1995

Commission Directive 95/56/EC, Euratom of 8 November 1995 adapting to technical progress Council Directive 74/61/EEC relating to devices to prevent the unauthorized use of motor vehicles Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 70/156/EEC of 6 February 1970 relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 93/81/EEC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 74/61/EEC of 17 December 1973 on the approximation of the laws of the Member States relating to devices to prevent the unauthorized use of motor vehicles (3), and in particular Article 5 thereof, Whereas Directive 74/61/EEC is one of the separate Directives within the EEC type-approval procedure which has been established by Council Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC concerning vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Article 3 (4) and Article 4 (3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas, in view of experience gained and of the state of the art, and in particular of the corresponding regulation of the United Nations Economic Commission for Europe, it is now appropriate to adapt the requirements for the above devices by adding requirements for alarm systems and immobilizers; Whereas, the audible signal of the alarm device can be emitted by audible warning devices as established by Council Directive 70/388/EEC (4); Whereas other measures, such as those relating to the locking of the doors and of the luggage boot, will be taken at a later date with a view to strengthening more the means of dissuasion against an unauthorized use of the vehicles; whereas, in addition, the provisions of this Directive should be re-examined after a short period with a view to strengthening them further, inter alia, to cover other vehicles; whereas the Commission will draw up a report on these questions by December 1996 at the latest, accompanied, where appropriate, by new proposals; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 1. Directive 74/61/EEC shall be amended as follows: - Article 1 to replace '. . ., with or without bodywork, . . .' by '. . ., being complete or incomplete, . . .' and '. . . rails, agriculture tractors and machinery and engineering plant.' by '. . . rails and of agricultural and forestry tractors and all mobile machinery.', - in Article 2 and 3, replace 'Annex I' by 'the relevant Annexes', - in Article 4, replace 'item 2.2 of Annex I' by 'the relevant Annexes', - in Article 5, replace 'Annexes I and II' by 'the Annexes'. 2. A list of Annexes shall be added before the Annexes, and the Annexes to Directive 74/61/EEC shall be replaced by the Annexes to this Directive. Article 2 1. With effect from 1 May 1996 Member States may not: - refuse, in respect of a type of motor vehicle, a type of immobilizer or a type of alarm system, to grant EEC type-approval or to grant national type-approval, or - prohibit the registration, sale or placing in service of vehicles or the sale or entry into service of immobilizers or alarm systems, on grounds relating to devices to prevent the unauthorized use of motor vehicles, if those devices comply with the requirements of Directive 74/61/EEC as amended by this Directive. 2. With effect from 1 January 1997, the Member States: - shall no longer grant EEC type-approval, and - may refuse to grant national type-approval, for a type of vehicle on grounds relating to devices to prevent unauthorized use or for a type of immobilizer or for a type of alarm system, if the requirements of Directive 74/61/EEC, as amended by this Directive, are not fulfilled. 3. With effect from 1 October 1998, the Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, and - may refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, - may refuse the sale and entry into service of new immobilizers or new alarm systems, on grounds relating to devices to prevent unauthorized use, if the requirements of Directive 74/61/EEC, as amended by this Directive, are not fulfilled. 4. With effect from 1 October 1998 the requirements of this Directive relating to immobilizers and to alarm systems as component or separate technical unit are applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 May 1996. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 3. Member States shall communicate to the Commission the texts of the main provisions of national law that they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31995L0058

1995

Directive 95/58/EC of the European Parliament and of the Council of 29 November 1995 amending Directive 79/581/EEC on consumer protection in the indication of the prices of foodstuffs and Directive 88/314/EEC on consumer protection in the indication of the prices of non-food products Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas the programmes of the Community for a consumer protection and information policy (4) provided for the establishment of common principles for indicating prices; Whereas these principles were established by Directive 79/581/EEC (5) and Directive 88/314/EEC (6) concerning the indication of prices of foodstuffs and non-food products; Whereas these Directives also provided for the obligation to indicate the unit price of products marketed in bulk and of certain pre-packaged products as well as a number of exemptions to this obligation, when products are marketed in ranges of pre-packaged quantities, when this unit-price indication does not provide meaningful information to the consumer or when it represents an excessive burden for certain small retail businesses; Whereas these Directives provided for a transitional period for implementing exemptions to the indication of the unit price for certain pre-packaged products; whereas this transitional period expired on 7 June 1995; Whereas, however, application of these Directives has proved extremely complex, in the light of trade practices which vary from one Member State to another; Whereas account should be taken of all the difficulties encountered in implementing the enacting terms of these Directives and it is appropriate to propose new and simplified enacting terms; Whereas the Commission should, to this end, submit within the year a proposal for simplified enacting terms, having as its basis the general obligation to indicate the price and unit price of all products; Whereas, however, these new enacting terms could not be adopted before June 1995; Whereas it is appropriate to anticipate the period of transposition by Member States of the proposed new enacting terms; Whereas, accordingly, the transitional period provided for in the first paragraph of Article 10 of Directives 79/581/EEC and 88/314/EEC should be extended by two years, Article 1 1. In the first sentence of Article 10 of Directive 79/581/EEC the terms 'a period of seven years` shall be replaced by 'a period of nine years`. 2. In the first sentence of Article 10 of Directive 88/314/EEC the terms 'a period of seven years` shall be replaced by 'a period of nine years`. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. The provisions adopted shall be applicable as of 7 June 1995. 2. When Member States adopt the provisions, these shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods for making such reference shall be laid down by Member States. 3. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31995L0061

1995

Council Directive 95/61/EC of 29 November 1995 amending Annex II to Directive 90/642/EEC relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels of pesticide residues in and on certain products of plant origin, including fruit and vegetables (1), and in particular Article 1 (1) thereof, Having regard to the proposal from the Commission, Whereas Directive 90/642/EEC was amended for the first time by Directive 93/58/EEC (2) which, amongst other provisions, provided for the establishment of a first list of maximum levels for certain pesticide residues; Whereas, however, available data were insufficient at that time to set finite maximum residue levels for certain pesticide - crop combinations; whereas in such cases a period of four years for the generation of the necessary data was prescribed after which, in the continued absence of satisfactory data, levels would normally be established at the appropriate limit of determination; Whereas the Commission and the Council agreed at the time of adoption of Directive 93/58/EEC that the Member States should obtain undertakings within one year from all interested parties that the necessary data would be generated; whereas in certain cases no undertakings have been given and it is therefore already possible to lay down appropriate provisions, Article 1 Annex II of Directive 90/642/EEC is hereby amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force not later than 31 October 1996 the laws, regulations or administrative provisions necessary to comply with this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The method of making such a reference shall be laid down by the Member State. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0062

1995

Directive 95/62/EC of the European Parliament and of the Council of 13 December 1995 on the application of open network provision (ONP) to voice telephony Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), (1) Whereas Council Directive 90/387/EEC of 28 June 1990 on the establishment of the internal market for telecommunications services through the implementation of open network provision (4) provides inter alia for the adoption of a specific Directive establishing open network provision conditions for the voice telephony service; (2) Whereas in accordance with Directive 90/387/EEC, open network provision (ONP) applies to public telecommunications networks and, where applicable, public telecommunications services; whereas therefore the application of ONP to the voice telephony service must also include the application of ONP to the network over which the voice telephony service is provided; (3) Whereas ONP conditions for access to and use of the fixed public telephone networks and services must apply to all the network technologies currently in use in Member States, including analogue telephone networks, digital networks and the integrated services digital network (ISDN); (4) Whereas this Directive does not apply to mobile telephony services; whereas it does apply to the use of fixed public telephone networks by operators of public mobile telephony services, in particular with respect to the interconnection of mobile telephone networks with the fixed public telephone network in a single Member State, in order to achieve comprehensive Community-wide services; whereas this Directive does not apply to direct interconnection between operators of public mobile telephony services; (5) Whereas this Directive does not apply to services or facilities provided at network termination points located outside the Community; (6) Whereas Commission Directive 90/388/EEC of 28 June 1990 on competition in the markets for telecommunications services (5) requires Member States to abolish exclusive rights for the supply of telecommunications services other than voice telephony; whereas Directive 90/388/EEC does not apply to telex, mobile radiotelephony and paging services; (7) Whereas some Member States have abolished exclusive rights for the provision of voice telephony and the public telecommunications network; whereas those Member States should ensure that all users can subscribe to harmonized telephony services in accordance with this Directive; whereas the provisions of this Directive should not hinder entry to markets for voice telephony or the provision of the public telecommunications network; (8) Whereas the voice telephony service has become important for social and economic reasons, and everyone in the Community should have the right to subscribe to this service; whereas in application of the principle of non-discrimination, voice telephony service must be offered and provided on request without discrimination to all users; whereas the principle of non-discrimination applies to, inter alia, availability of technical access, tariffs, quality of service, delivery period, fair distribution of capacity in the event of scarcity, repair time, availability of network information and customers' information, subject to relevant legislation concerning the protection of personal data and privacy; (9) Whereas in accordance with Directive 90/388/EEC, Member States which maintain exclusive rights for the provision and operation of public telecommunications networks must take the necessary measures to make the conditions governing access to and use of the network objective and non-discriminatory and to publish them; whereas it is necessary to harmonize which specifications should be published and in what form, in order to facilitate the provision of telecommunications services within and between Member States, and in particular the provision of services by companies, firms or natural persons established in a Member State other than that of the company, firm or natural person for which or for whom the services are intended; (10) Whereas in conformity with the principle of separation of regulatory and operational functions, national regulatory authorities have been created in the Member States; whereas in application of the principle of subsidiarity, the national regulatory authority of each Member State should play an important role in the implementation of this Directive, particularly in matters relating to the publication of targets and performance statistics, dates for the implementation of new facilities, adequate consultation with users/consumers and user/consumer organizations, the control of numbering plans, the supervision of conditions of use, and the resolution of disputes and in ensuring that users are given fair treatment throughout the Community; whereas they should have the necessary means to carry out these tasks fully; (11) Whereas quality of service as perceived by users is an essential aspect of the service provided, and quality-of-service parameters and achieved performance levels should be published for the benefit of users; whereas harmonized quality-of-service parameters and common measurement methods are required in order to assess Community-wide convergence of quality of service; whereas different categories of user require different levels of quality of service, for which different tariffs may be appropriate; (12) Whereas users of the fixed public telephone network should have at least similar rights when dealing with telecommunications organizations as they have with the providers of other goods and services, and telecommunications organizations should not have any undue legal protection when dealing with users of the fixed public telephone network; (13) Whereas agreement between the parties involved can constitute a contract; whereas, in order to avoid unfair contractual clauses, it is necessary that national regulatory authorities have the right to require modifications of conditions imposed by telecommunications organizations on users in their contracts; whereas Member States may decide whether their national regulatory authority shall check these contractual conditions either before their use by telecommunications organizations, or at any time at the user's request; (14) Whereas Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (1) already provides general protection for consumers with regard to contractual terms; whereas nevertheless for the purpose of this Directive it is necessary to complete this general protection by adding more specific rules which should apply to all users; (15) Whereas in addition to the basic voice telephony service made available to users it is desirable to ensure that, subject to technical feasibility and economic viability, a harmonized minimum set of advanced voice telephony facilities is offered to users for communications both within and between Member States; (16) Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994; (17) Whereas the provision of other voice telephony facilities, provided in response to market demand in addition to the harmonized minimum set of voice telephony facilities described herein, should not impede the provision of the basic voice telephony facilities and should not lead to unreasonable increases in the prices for basic voice telephony service; (18) Whereas harmonized conditions for the voice telephony service should allow Member States flexibility to determine the timescales for implementation, given the different situations with regard to technical development of the network and market demand; (19) Whereas the Commission has issued Guidelines on the application of Community competition rules in the telecommunications sector (2) in order inter alia to clarify the application of Community competition law when telecommunications organizations cooperate in order to implement Community-wide interconnectivity between public networks and services; (20) Whereas, in order to provide efficient and effective telecommunications services, and to offer new applications, telecommunications service providers and other users may, in accordance with the principles of Community law, request access to the fixed public telephone network at points other than the network termination points offered to the majority of telephone users; whereas such requests must be reasonable in terms of technical feasibility and economic viability; whereas procedures must be introduced to provide a balance between the requirements of users and the justified concerns of telecommunications organizations; whereas it is essential that in making full and efficient use of the fixed public telephone network via such special network access, the integrity of the public network is maintained; (21) Whereas in accordance with the definition in Directive 90/387/EEC, the network termination point may be located on the premises of a telecommunications organization; whereas installation of equipment owned by service providers on the premises of a telecommunications organization is not specifically called for in this Directive; (22) Whereas it is necessary for adequate safeguards to be implemented by national regulatory authorities in order to ensure that telecommunications organizations do not discriminate against service providers with whom they are in competition, including, in particular, safeguards to ensure fair access to network interfaces; whereas the tariffs which apply to telecommunications organizations when using the fixed public telephone network for the provision of telecommunications services should be the same as the tariffs which apply to other users; (23) Whereas users should benefit from economies of scope and scale which may result from new intelligent network architectures; whereas the development of the Community market in telecommunications services calls for the widest availability of facilities such as those defined in this Directive; whereas the principle of non-discrimination should be applied in a manner that does not hinder the development of advanced telecommunications services; (24) Whereas telecommunications organizations should be encouraged to establish the necessary cooperation mechanisms in order to ensure full Community-wide interconnectivity between public networks, in particular for the voice telephony service; whereas national regulatory authorities should facilitate such cooperation; whereas such interconnection should be subject to regulatory supervision in order to safeguard the interests of users throughout the Community and ensure compliance with Community law, where appropriate in compliance with the existing international regulatory framework within the scope of the International Telecommunications Union (ITU); whereas therefore national regulatory authorities should have the right of access to full information about network interconnection agreements where required; whereas the Commission may request from Member States details of special network access agreements and interconnection agreements in so far as Community law so provides; (25) Whereas interconnection of public telephone networks is essential for the provision of Community-wide voice telephony services; whereas it is the responsibility of national regulatory authorities to ensure that the conditions governing interconnection with the fixed public telephone networks, including interconnection by telecommunications organizations from other Member States and operators of public mobile telephony services, are objective and non-discriminatory in accordance with Directive 90/387/EEC; (26) Whereas where the fixed public telephone network in a Member State is operated by more than one telecommunications organization, appropriate supervision of interconnection arrangements by national regulatory authorities is necessary in order to guarantee Community-wide provision of the voice telephony service; whereas such interconnection arrangements should take due account of the principles laid down in this Directive; (27) Whereas the principle of non-discrimination in relation to interconnection primarily aims at preventing abuse of a dominant position by telecommunications organizations; (28) Whereas in accordance with Directive 90/387/EEC common, efficient tariff principles, based on objective criteria and cost orientation, should be applied throughout the Community; whereas a reasonable transition period may be necessary in order to implement these tariff principles fully; whereas tariffs must nevertheless be transparent and properly published, must be sufficiently unbundled in accordance with the competition rules of the Treaty, and must be non-discriminatory and guarantee equality of treatment; whereas application of the principle of cost orientation should take account of the objective of universal service and may take account of town and country planning policies aimed at ensuring cohesion within a Member State; (29) Whereas national regulatory authorities should have responsibility for supervising tariffs; whereas tariff structures should evolve in response to technological development and user demand; whereas the requirement for cost-oriented tariffs means that telecommunications organizations should implement within a reasonable time limit cost accounting systems by which costs can be allocated to services as accurately as possible on the basis of a transparent cost accounting system; whereas such requirements can be fulfilled for example by implementation of the principle of fully distributed costing; (30) Whereas, within the overall principle of cost orientation, some flexibility is needed, under supervision of the national regulatory authority, in order to allow discount schemes for certain uses, or socially desirable tariffs for particular groups of people, for particular types of call, or at particular times of day; whereas discount schemes must be compatible with the competition rules of the Treaty, and in particular with the general principle that the conclusion of contracts must not be subject to acceptance of unrelated supplementary obligations; whereas, in particular, discount schemes must not link the supply of services provided under special or exclusive rights with services provided competitively; (31) Whereas users must be able to check the correctness of their bills by being given the possibility of itemized bills with a degree of detail compatible with user needs and with relevant legislation on data protection and privacy; (32) Whereas directories of users who subscribe to the voice telephony service should be readily available, since they are an important element for use of the voice telephony service; whereas directory information should be made available on fair and non-discriminatory terms; whereas users should have the choice of being included or excluded from directories, in conformity with relevant legislation on data protection and privacy; whereas this Directive does not change the regulatory situation regarding the supply of directories; (33) Whereas public pay-telephones provide an important means of access to the voice telephony service, especially in emergencies, and it is desirable to ensure that they are available to meet the reasonable needs of users; (34) Whereas, recognizing that users would benefit from a single type of telephone payment card usable in all Member States, the Commission has given the uropean Committee for Standardization (CEN)/the European Committee for Electrotechnical Standardization (Cenelec) a mandate to develop suitable standards; whereas, in addition to these standards, commercial agreements are needed to ensure that pre-payment cards issued in one Member State can be used in other Member States; (35) Whereas, within each Member State, measures may be taken to assist groups of people with special needs; whereas this may include provisions relating to the voice telephony service, because it is recognized as an important service for disabled people; (36) Whereas the Commission has requested the European Telecommunications Standards Institute (ETSI) to study the technical feasibility and economic viability of a harmonized single line network interface suitable for access to and use of the fixed public telephone network in all Member States; whereas, to ensure harmonized access for ISDN terminal equipment, it is desirable to set requirements for the corresponding network termination point, including specifications for the socket; (37) Whereas national telephone numbers are a resource which should be controlled by national regulatory bodies; whereas numbering schemes should be developed in close consultation with telecommunications organizations and in harmony with a long-term Europe-wide numbering framework and the international numbering scheme; whereas number changes are expensive for both telecommunications organizations and users, and should be kept to a minimum compatible with national and international long-term requirements; (38) Whereas the Council resolution of 19 November 1992 on the promotion of Europe-wide cooperation on numbering of telecommunications services (1) regards as a major policy goal the strengthening of cooperation on the numbering arrangements for services with pan-European applications; whereas there is a need to create a European numbering area in order to facilitate the implementation and use of Europe-wide voice telephony services, including freephone/green numbers; (39) Whereas in accordance with Directive 90/388/EEC Member States which make the supply of telecommunications services subject to a licensing or declaration procedure must ensure that the conditions for the grant of licences are objective, non-discriminatory and transparent, that reasons are given for any refusal, and that there is a procedure for appealing against any such refusal; whereas conditions for using the fixed public telephone network must be compatible with Community law and in particular Directive 90/387/EEC; whereas in accordance with Council Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines (2), any restrictions aimed at ensuring compliance with the essential requirements should be compatible with Community law and imposed by the national regulatory authorities through regulatory means; whereas no technical restrictions may be introduced or maintained for the interconnection of leased lines and public telephone networks; (40) Whereas in accordance with Directive 90/387/EEC the essential requirements on the basis of which restrictions on access to and use of public telecommunications networks or services are justified are limited to the security of network operations, maintenance of network integrity, interoperability of services in justified cases and protection of data as appropriate; whereas, in addition, the conditions generally applicable to the connection of terminal equipment apply; whereas national regulatory authorities may authorize procedures whereby a telecommunications organization can act immediately in the event of a serious breach of conditions of access or use; (41) Whereas the principle of transparency should apply to the standards upon which voice telephony services are based; whereas in accordance with Directive 90/387/EEC, the harmonization of technical interfaces and access conditions must be based on common technical specifications which take account of international standardization; whereas 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 (1), new national standards must not be developed in areas where harmonized European standards are under development; (42) Whereas, to enable the Commission to monitor effectively the application of this Directive, it is necessary that Member States notify to the Commission which national regulatory authorities will be responsible for the functions created by this Directive and the provision of the relevant information called for in this Directive; (43) Whereas, in addition to the rights of recourse granted under national or Community law, there is a need for a simple conciliation procedure for disputes at both national and Community level; whereas this procedure should be responsive, inexpensive and transparent and should involve all the parties concerned; (44) Whereas telecommunications services are subject to consumer protection legislation, data protection legislation and legislation concerning dissemination of information or material which may be considered offensive by the general public, and therefore no specific additional measures are envisaged in this Directive; (45) Whereas transparency would be improved by regular and systematic dialogue with telecommunications organizations, users, consumers, manufacturers and service providers as regards Community-wide issues raised by this Directive; whereas consultation with trade unions is already covered by Commission Decision 90/450/EEC (2) which set up, to assist the Commission, a Joint Committee on Telecommunications Services consisting of representatives of employers and employees; (46) Whereas given the dynamic development of this sector, the application of open network provision to voice telephony must be a progressive and ongoing process, and the regulatory conditions must be flexible enough to meet the demands of a changing market and changing technology; whereas a responsive procedure for technical adjustment should therefore be established which takes full account of the views of Member States and involves the ONP Committee; (47) Whereas a procedure will probably have to be introduced for ensuring Community-wide convergence by determining harmonized targets and target dates for voice telephony services and facilities; whereas such a convergence procedure should involve the ONP Committee; whereas in such a procedure full account must be taken of the state of network development and market demand in the Community; (48) Whereas the goal of an advanced cost-effective Community-wide voice telephony service - an essential foundation of the internal market - cannot be realized satisfactorily at Member State level, and hence is better achieved at Community level by the adoption of this Directive; (49) Whereas Decision 91/396/EEC (3) requires the introduction in the Community of a single European emergency call number (3); whereas Council Directive 91/263/EEC of 29 April 1991 on the approximation of the laws of the Member States concerning telecommunications terminal equipment, including the mutual recognition of their conformity (4), defines the conditions for connection of terminal equipment to the fixed public telephone network; (50) Whereas Europe is shifting towards an information-based economy; whereas open access to networks is a critical issue at world level; whereas the Council has agreed a timetable for the liberalization of all telecommunication services, networks and infrastructures; whereas a balanced policy of liberalization and harmonization, including accompanying measures for universal service, will continue to ensure that business, industry and the public can access modern, economic and efficient communications infrastructures over which a rich and diverse range of services will be offered; (51) Whereas the Council resolution of 22 July 1993 (5) calls on the Commission to introduce the necessary proposals for legislation by 1 January 1996 and to consider how to adjust open network provision to future developments, Article 1 Scope 1. This Directive concerns the harmonization of conditions for open and efficient access to and use of fixed public telephone networks and public telephony services, and the availability throughout the Community of a harmonized voice telephony service. 2. This Directive does not apply to mobile telephony services in so far as it concerns interconnection between the networks used for public mobile telephony services and the fixed public telephone networks. Article 2 Definitions 1. The definitions given in Directive 90/387/EEC shall apply, where relevant, to this Directive. 2. For the purposes of this Directive: - 'fixed public telephone network' means the public switched telecommunications network which is used, inter alia, for the provision of voice telephony service between network termination points at fixed locations, - 'users' means end-users, including consumers (e.g. residential end-users), and service providers, including telecommunications organizations where the latter provide services which are or may be provided also by others, - 'national regulatory authority' means the body or bodies in each Member State, legally distinct and functionally independent of the telecommunications organizations, entrusted by that Member State, inter alia, with the regulatory functions addressed in this Directive, - 'ONP Committee' means the committee created by Article 9 (1) of Directive 90/387/EEC, - 'public pay-telephone' means a telephone available to the general public, for the use of which the means of payment are coins, credit/debit cards and/or pre-payment cards. Article 3 Provision of service, connection of terminal equipment and use of the network Member States shall ensure that the respective telecommunications organizations separately or jointly provide a fixed public telephone network and a voice telephony service in accordance with the provisions of this Directive, in order to guarantee a harmonized offering throughout the Community. In particular Member States shall ensure that users can: (a) obtain on request a connection to the fixed public telephone network; (b) connect and use approved terminal equipment situated on the users' premises, in accordance with national and Community law. Member States shall ensure that no restrictions other than those referred to in Article 22 are placed on the use made of the connection provided. Article 4 Publication of and access to information 1. National regulatory authorities shall ensure that adequate and up-to-date information on access to and use of the fixed public telephone network and voice telephony service is published according to the list of headings given in Annex I. Changes in existing service offerings and information on new offerings shall be published as soon as possible. The national regulatory authority may lay down a suitable period of notice. 2. The information referred to in paragraph 1 shall be published in such a way as to provide easy access for users to that information. Reference shall be made in the national Official Journal of the Member State concerned to the publication of this information. 3. National regulatory authorities shall notify to the Commission no later than one year after the adoption of this Directive - and thereafter in the event of any change - the manner in which the information referred to in paragraph 1 is made available; the Commission shall regularly publish a corresponding reference to such notifications in the Official Journal of the European Communities. Article 5 Targets for supply time and quality of service 1. National regulatory authorities shall ensure that targets are set and published for the supply-time and quality-of-service indicators listed in Annex II. Definitions, measurement methods and the performance of telecommunications organizations in relation to those targets shall be published annually. Definitions, measurement methods and targets shall be reviewed at least every three years by the national regulatory authority. 2. Publication shall be in the manner laid down in Article 4. 3. Where appropriate, the Commission shall, in consultation with the ONP Committee, acting in accordance with the procedure laid down in Article 30, request ETSI to draw up European standards for common definitions and measurement methods. Article 6 Conditions for the termination of offerings 1. National regulatory authorities shall ensure that service offerings continue for a reasonable period of time and that termination of an offering, or a change that materially alters the use that can be made of it, can take place only after consultation with users affected and an appropriate public notice period set by the national regulatory authority. 2. Without prejudice to other rights of appeal provided for by national law, Member States shall ensure that users, acting where national law provides for this in conjunction with organizations representing user and/or consumer interests, can bring before the national regulatory authority cases where the users affected do not agree with the termination date envisaged by the telecommunications organization. Article 7 User contracts 1. National regulatory authorities shall ensure that users have a contract which specifies the service to be provided by a telecommunications organization. National regulatory authorities shall as a general rule require compensation and/or refund arrangements to be provided if the contracted service quality levels are not met, and shall ensure that any exceptions to this rule are justified by the telecommunications organization or organizations concerned and made clear in the users' contract. 2. Telecommunications organizations shall respond to a request for connection to the fixed public telephone network without delay and shall give the user an estimated date for provision of service. 3. National regulatory authorities shall be able to require alteration of the conditions of contracts and the conditions of any compensation and/or refund schemes used by telecommunications organizations. Users' contracts with telecommunications organizations shall contain a summary of the method of initiating procedures for the settlement of disputes. 4. Member States shall ensure that users have the right to institute proceedings against a telecommunications organization. Article 8 Variation of published conditions Where in response to a particular request a telecommunications organization considers it unreasonable to provide a connection to the fixed public telephone network under its published tariffs and supply conditions, it must seek the agreement of the national regulatory authority to vary those conditions in that case. Article 9 Provision of advance facilities 1. National regulatory authorities shall ensure the provision, subject to technical feasibility and economic viability, of the facilities listed in Annex III (1), in accordance with the technical standards identified in Article 24. 2. National regulatory authorities shall facilitate and encourage provision of the services and facilities listed in Annex III (2), in accordance with the technical standards identified in Article 24, through commercial arrangements between telecommunications organizations and where applicable other persons providing the service or facilities, in compliance with the competition rules of the Treaty and in response to user demand. 3. National regulatory authorities shall ensure that dates for the introduction of the facilities listed in Annex III (1) are set, taking into account the state of network development, market demand and progress with standardization, and are published in the manner laid down in Article 4. They shall similarly encourage the setting and publication of dates for the services and facilities listed in Annex III (2). Article 10 Special network access 1. National regulatory authorities shall ensure that telecommunications organizations respond to reasonable requests from users other than: (a) operators of public mobile telephony services; (b) telecommunications organizations when providing a voice telephony service; for access to the fixed public telephone network at network termination points other than the network termination points referred to in Annex 1. Where in response to a particular request a telecommunications organization considers it unreasonable to provide the special network access requested, it must seek the agreement of the national regulatory authority to restrict or deny that access. Users affected must be given the opportunity to put their case to the national regulatory authority before a decision is taken. Where a request for special network access is denied, the user making the request must be given a prompt and reasoned explanation as to why the request has been refused; however, this provision shall not apply to any action taken under national regimes for the enforcement of licensing conditions in conformity with Community law or to proceedings before a national court. 2. Technical and commercial arrangements for special network access shall be a matter for agreement between the parties involved, subject to intervention by the national regulatory authority as laid down in paragraphs 1, 3 and 4. The agreement may include reimbursement to the telecommunications organization of the costs incurred inter alia in providing the network access requested; these charges shall fully respect the principles of cost orientation set out in Annex II to Directive 90/387/EEC. 3. National regulatory authorities may intervene on their own initiative at any time, and shall do so if requested by either party, in order to set conditions that are non discriminatory, are fair and reasonable for both parties and offer the greatest benefit to all users. 4. National regulatory authorities shall also have the right, in the interest of all users, to ensure that the agreements include conditions that meet the criteria set out in paragraph 3, are entered into and implemented in an efficient and timely manner and include conditions on conformity with relevant standards, compliance with essential requirements and/or the maintenance of end-to-end quality. 5. Conditions set by national regulatory authorities in accordance with paragraph 4 shall be published in the manner laid down in Article 4. 6. National regulatory authorities shall ensure that telecommunications organizations adhere to the principle of non-discrimination when they make use of the fixed public telephone network for providing services which are or may also be supplied by other service providers. 7. The Commission shall, in consultation with the ONP Committee, acting in accordance with the procedure laid down in Article 30, request ETSI to draw up, where appropriate, standards for new types of network access. Reference to such standards shall be published in the Official Journal of the European Communities in accordance with Article 5 (1) of Directive 90/387/EEC. 8. Details of agreements for special network access shall be made available to the national regulatory authority upon request. Article 11 Interconnection 1. National regulatory authorities shall ensure that reasonable requests for interconnection with the fixed public telephone network from the organizations listed below are met, in particular to ensure Community-wide provision of voice telephony services: (a) telecommunications organizations providing fixed public telephone networks in other Member States, whose names have been notified in accordance with Article 26 (3); (b) operators of public mobile telephony services in the same Member State. No request for interconnection shall be refused by a telecommunications organization without the prior agreement of its national regulatory authority. Interconnection with the fixed public telephone network of operators of public mobile telephony services in other Member States, whose names have been notified in accordance with Article 26 (3), may also be agreed between the parties involved. No request for such interconnection shall be refused by a telecommunications organization without the prior agreement of its national regulatory authority. 2. Technical and commercial arrangements for interconnection shall be a matter for agreement between the parties involved, subject to intervention by the national regulatory authority as laid down in Article 10 (3) and (4). 3. National regulatory authorities shall ensure that telecommunications organizations adhere to the principle of non-discrimination when they enter into interconnection agreements with others. 4. If interconnection agreements include specific compensation provisions for the telecommunications organization in situations where different operating conditions, e.g. price controls or universal service obligations, are imposed upon the respective parties, such compensation provisions shall be cost-oriented, non-discriminatory and fully justified, and shall only be applied with the approval of the national regulatory authority acting in accordance with Community law. 5. Details of interconnection agreements shall be made available, upon request, to the national regulatory authorities concerned. Article 12 Tariff principles and transparency 1. National regulatory authorities shall ensure that tariffs for use of the fixed public telephone network and the voice telephony service follow the basic principles of transparency and cost orientation set out in Annex II to Directive 90/387/EEC, and comply with the provisions of this Article. 2. Without prejudice to application of the principle of cost orientation, national regulatory authorities may impose on telecommunications organizations tariff constraints relating to the objectives of universal telephone-service accessibility, including town and country planning aspects. 3. Tariffs for access to and use of the fixed public telephone network shall be independent of the type of application which the users implement, except to the extent that they require different services or facilities. 4. Tariffs for facilities additional to the provision of connection to the fixed public telephone network and provision of voice telephony service shall, in accordance with Community law, be sufficiently unbundled, so that the user is not required to pay for facilities which are not necessary for the service requested. 5. Tariffs shall normally contain the following elements, each of which should be itemized separately for the user: - an initial charge for connection to the fixed public telephone network and subscription to the voice telephony service, - a periodic rental charge based on the type of service and facilities selected by the user, - usage charges which may, inter alia, take account of peak and off-peak periods. Where other tariff elements are applied, they must be transparent and based on objective criteria. 6. Tariffs shall be published in the manner laid down in Article 4. 7. Tariff changes shall be implemented only after an appropriate period of public notice set by the national regulatory authority. Article 13 Cost accounting principles 1. Member States shall ensure that their telecommunications organizations notified in accordance with Article 26 (2) operate by 31 December 1996 at the latest a cost accounting system suitable for the implementation of Article 12 and that compliance with such a system is verified by a competent body which is independent of those organizations. A statement concerning compliance shall be published periodically. 2. National regulatory authorities shall ensure that a description of the cost accounting system showing the main categories under which costs are gathered and the rules used for the allocation of costs to the voice telephony service is made available on request. National regulatory authorities shall submit, on request, to the Commission information on the cost accounting systems applied by the telecommunications organizations. 3. Without prejudice to the last subparagraph of this paragraph, the system referred to in paragraph 1 shall include the following elements: (a) the costs of the voice telephony service shall in particular include the direct costs incurred by the telecommunications organizations in setting up, operating and maintaining the voice telephony service and in marketing and billing the service. (b) common costs, that is to say costs which can be directly assigned to neither the voice telephony service nor other activities, shall be allocated as follows: (i) whenever possible, common cost categories shall be allocated on the basis of direct analysis of the origin of the costs themselves; (ii) when direct analysis is not possible, common cost categories shall be allocated on the basis of an indirect linkage to another cost category or group of cost categories for which a direct assignment or allocation is possible; the indirect linkage shall be based on comparable cost structures; (iii) when neither direct nor indirect measures of cost allocation can be found, the cost category shall be allocated on the basis of a general allocator, computed by using the ratio of all expenses directly or indirectly asigned or allocated, on the one hand, to the voice telephony service and, on the other hand, to other services. Other cost accounting systems may be applied if they are suitable for the implementation of Article 12 and have been approved as such by the national regulatory authority for application by the telecommunications organizations, subject to the Commission being informed prior to their application. 4. Detailed accounting information shall be made available to the national regulatory authority on request and in confidence. 5. Member States shall ensure that the financial accounts of those telecommunications organizations notified in accordance with Article 26 are drawn up, published and submitted for audit in accordance with the provisions of national legislation. Article 14 Discounts, low-usage schemes and other specific tariff provisions 1. National regulatory authorities may agree that bulk discount schemes can be offered to users and shall make those schemes subject to supervision by the national regulatory authority. 2. National regulatory authorities may agree special tariffs for the provision of socially useful services such as emergency services, or for low-usage users or specific social groups. 3. National regulatory authorities shall ensure that tariff structures allow for reduced-rate calls within the Community at off-peak times, including night-time and weekends if appropriate. 4. National regulatory authorities shall ensure that, where special tariffs are introduced for voice telephony services provided in connection with specific projects of limited duration, they shall be subject to prior notification to the national regulatory authority. Article 15 Itemized billing National regulatory authorities shall ensure that targets are set and published for the provision of itemized billing as a facility available to users on request, taking into account the state of network development and market demand. Subject to the following paragraph and the level of detail permitted under relevant legislation on the protection of personal data and privacy, itemized bills shall show the composition of the charges incurred. Calls which are free of charge to the caller, including calls to helplines, shall not be identified in the caller's itemized bill. Within this framework, different levels of detail may be offered to users at reasonable tariffs. Article 16 Directory services Subject to the requirements of relevant legislation on the protection of personal data and privacy, national regulatory authorities shall ensure that: (a) directories of subscribers to the voice telephony service are made available to users in either printed or electronic form, and are updated on a regular basis; (b) users have the right to have or not to have an entry in publicly available directories; (c) telecommunications organizations make available on request public directory information concerning the voice telephony service on published terms which are fair, reasonable and non-discriminatory. Article 17 Provision of public pay-telephones National regulatory authorities shall ensure that public pay-telephones are provided to meet the reasonable needs of users, in terms of both numbers and geographical coverage, and that it is possible to make emergency calls from such telephones. Calls to the single European emergency call number referred to in Decision 91/396/EEC shall be free of charge. Article 18 Telephone pre-payment cards 1. The Commission shall ensure that standards for a harmonized telephone pre-payment card suitable for use in pay-telephones in all Member States, and associated network interface standards, are drawn up by ETSI and/or CEN/Cenelec, in order to make it possible for pre-payment cards issued in one Member State to be used in other Member States. A reference to these standards and to associated standards shall be published in the Official Journal of the European Communities. 2. National regulatory authorities shall encourage the progressive introduction of public pay-telephones conforming to these standards. Article 19 Specific conditions for disabled users and people with special needs National regulatory authorities may draw up specific conditions to aid disabled users and people with special needs in their use of the voice telephony service. Article 20 Specifications for network access, including the socket 1. Where appropriate, the Commission shall, in consultation with the ONP Committee, acting in accordance with the procedure laid down in Article 30, request ETSI to draw up standards for new types of harmonized network access, in accordance with the reference framework set out in Annex II (2) to Directive 90/387/EEC. References to these standards shall be published in the Official Journal of the European Communities. 2. Where voice telephony service is supplied to users over the ISDN network at the S/T reference point, national regulatory authorities shall ensure that, after the implementation of this Directive, the introduction of a new network termination point complies with the relevant physical interface specifications, in particular those for the socket, referenced in the list of standards published in the Official Journal of the European Communities. Article 21 Numbering 1. Member States shall ensure that national telephone numbering plans are controlled by national regulatory authorities, in order to ensure fair competition. In particular the procedures for allocating individual numbers and numbering ranges shall be transparent, equitable and timely and the allocation shall be carried out in an objective, transparent and non-discriminatory manner. 2. National regulatory authorities shall ensure that the main elements of the national numbering plan and all subsequent additions or amendments to them are published, subject only to limitations imposed on the grounds of national security. 2. National regulatory authorities shall encourage appropriate use of any European numbering schemes for the provision of the facilities identified in Annex III (2). Article 22 Conditions of access and use and essential requirements 1. Member States shall ensure that conditions which restrict access to and use of fixed public telephone networks or voice telephony services are based only on the grounds given in paragraphs 3, 4 and 5, and are subject to the agreement of the national regulatory authority. 2. National regulatory authorities shall draw up procedures in order to decide, on a case-by-case basis and as soon as possible, whether or not to allow telecommunications organizations to take measures such as the refusal to provide access to the fixed public telephone network or the interruption or reduction in availability of voice telephony service, on the grounds of a user's alleged failure to comply with the conditions of use. These procedures may also provide for the possibility of the national regulatory authority authorizing a priori specified measures in the event of defined infringements of the conditions of use. The national regulatory authority shall ensure that these procedures provide for a transparent decision-making process which respects the rights of the parties. The decision shall be taken after both parties have been given the opportunity to state their case. The decision shall be duly substantiated and notified to the parties within one week of its adoption. A summary of these procedures shall be published in the manner laid down in Article 4. This provision shall not prejudice the rights of the parties concerned to apply to the courts. 3. Any restrictions placed upon users on the basis of special or exclusive rights for voice telephony shall be imposed through regulatory means and shall be published in accordance with Article 4. 4. Conditions for connection of terminal equipment to the fixed public telephone network shall comply with Directive 91/263/EEC and shall be published in accordance with Article 4 of this Directive. Without prejudice to the provisions of Directive 91/263/EEC, where a user's terminal equipment does not comply or no longer complies with its approval conditions, or where it malfunctions in a way which adversely affects the integrity of the network, or where there is a danger of physical injury to persons, national regulatory authorities shall ensure that the following procedure is followed: - service provision may be interrupted by the telecommunications organization until the terminal is disconnected from the network termination point, - the telecommunications organization shall immediately inform the user about the interruption, giving the reasons for it, - as soon as the user has ensured that the terminal equipment is disconnected from the network termination point, service provision shall be restored. 5. When access to or use of the fixed public telephone network is restricted on the basis of essential requirements, national regulatory authorities shall ensure that the relevant national provisions identify which of the essential requirements set out in (a) to (d) below are the basis of such restrictions. Restrictions imposed on the basis of essential requirements shall be published in the manner laid down in Article 4. Restrictions derived from essential requirements shall be imposed through regulatory means. Without prejudice to Articles 3 (5) and 5 (3) of Directive 90/387/EEC, the essential requirements specified in Article 3 (2) of that Directive shall apply to the fixed public telephone network and voice telephony service in the following manner: (a) Security of network operations There shall be no restrictions on access to and use of the fixed public telephone network on the grounds of security of network operations except in emergency situations, when a telecommunications organization may take the following measures in order to safeguard the security of network operations: - interruption of service, - limitation of service features, - denial of access to the network and service for new users. An emergency situation in this context means catastrophic network breakdown or an exceptional case of force majeure, such as extreme weather, flood, lightning or fire, industrial action or lockout, war, military operations or civil disorder. In an emergency situation the telecommunications organization shall make every endeavour to ensure that service is maintained to all users. National regulatory authorities shall ensure that telecommunications organizations have procedures in place whereby users and the national regulatory authority are immediately informed of the beginning and the end of the emergency, as well as the nature and extent of temporary service restrictions. (b) Maintenance of network integrity National regulatory authorities shall ensure that restrictions on access to and use of the fixed public telephone network on the grounds of maintenance of network integrity, in order to protect inter alia network equipment, software or stored data, are kept to the minimum necessary to provide for normal operation of the network. Restrictions shall be based on published, objective criteria and shall be applied in a non-discriminatory manner. (c) Interoperability of services When terminal equipment has been approved and is operating in compliance with Directive 91/263/EEC, no further restrictions on use shall be imposed on the grounds of interoperability of services. Where the national regulatory authority imposes conditions concerning interoperability of services in contracts relating to interconnection of public networks or special network access, those conditions shall be published in the manner laid down in Article 4. (d) Protection of data Member States may restrict access to and use of the fixed public telephone network on the grounds of protection of data only to the extent necessary to ensure compliance with relevant regulatory provisions on the protection of data, including protection of personal data, the confidentiality of information transmitted or stored, and the protection of privacy, in a manner compatible with Community law. 6. National regulatory authorities shall ensure that, where appropriate, users are informed in advance by appropriate means by the telecommunications organizations of periods when access to or use of the fixed public telephone network may be restricted or denied as a result of planned maintenance activity. Article 23 Non-payment of bills Member States shall authorize specified measures, which shall be published in the manner laid down in Article 4, to cover non-payment of bills and any consequent service interruption of disconnection. These measures shall ensure that any service interruption is confined to the service concerned, as far as is technically feasible, and that due warning is given to the user beforehand. Article 24 Technical standards 1. National regulatory authorities shall encourage the provision of services according to the standards listed below: - standards published in the Official Journal of the European Communities, in accordance with Article 5 (1) of Directive 90/387/EEC, or, in the absence of such standards, - European standards adopted by ETSI, or CEN/Cenelec, or, in the absence of such standards, - international standards or recommendations adopted by the International Telecommunications Union (ITU), the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC), or, in the absence of such standards, - national standards or specifiations, without prejudice to reference to European standards, which reference may be made compulsory under Article 5 (3) of Directive 90/387/EEC. 2. National regulatory authorities shall ensure that telecommunications organizations inform users on request of standards or specifications, including any European and/or international standards which are implemented through national standards, in accordance with which the services and facilities in this Directive are provided. Article 25 Provisions for Community-wide convergence 1. On the basis of the reports provided by the national regulatory authorities under Article 26 (5) and the information published under Article 4, the Commission shall review progress towards convergence of targets and implementation of common services and facilities within the Community. 2. If implementation of the requirements of Articles 5, 9 or 15 appears inadequate to ensure the provision of harmonized services and facilities to users at a Community level, harmonized targets and target dates may be determined in accordance with the procedure laid down in Article 31. The procedure initiated by the Commission shall take full account of the state of network development and market demand in all individual Member States. 3. In particular with regard to those facilities requiring Community-wide cooperation described in Article 9 (2), where commercial agreements between telecommunications organizations cannot be concluded, conditions necessary to achieve the provision of harmonized facilities to users may be recommended. The recommendations shall take due account of the state of network development, the various architectures and market demand in the Community. Article 26 Notification and reporting 1. Member States shall notify the name of their national regulatory authority to the Commission by 13 December 1996. 2. Member States shall notify to the Commission the names of the telecommunications organizations to which this Directive applies, in particular to ensure the provision of the network and service in accordance with Article 3. Without prejudice to the future applicability of ONP measures, Member States which have abolished exclusive rights for voice telephony may apply this Directive to organizations defined on the basis of a significant market share or on the basis of a dominant position in their authorized area of operation, in such a way as to ensure that at every point in their territory at least one organization is subject to the provisions of this Directive. Member States may ensure that telecommunications organizations are obliged to supply the information necessary to determine the application of this Directive. 3. National regulatory authorities shall notify to the Commission the names of the telecommunications organizations in their territory which are authorized to interconnect their fixed networks directly with those of telecommunications organizations in other Member States in order to provide voice telephony service. National regulatory authorities shall notify to the Commission the names of the operators of public mobile telephony services in their territory which are authorized to interconnect directly with the fixed networks of telecommunications organizations in other Member States in order to provide voice telephony service. 4. The Commission shall publish the names referred to in paragraphs 2 and 3 in the Official Journal of the European Communities. 5. National regulatory authorities shall, each for the matters for which it is responsible, make available to the Commission once each calendar year a report covering the progress made in achieving the targets agreed by them under Articles 5, 9 and 15. The annual report shall be sent to the Commission within five months of the end of the year. 6. National regulatory authorities shall keep available and submit to the Commission on request details of individual cases brought before them, other than those covered by Article 23, where access to the public telephone network or voice telephony service or use of the network or service has been restricted or denied, including the measures taken and their justification. However, this provision shall not apply to any action taken under national regimes for the enforcement of licensing conditions in conformity with Community law, or to proceedings before a national court. Article 27 Conciliation of national dispute resolution Without prejudice to: (a) any action that the Commission or any Member State may take pursuant to the Treaty; (b) the rights of the person invoking the procedure in paragraphs 3 and 4, of the telecommunications organizations concerned or of any other person under applicable national law, except in so far as they enter into an agreement for the resolution of disputes between them; (c) the provisions of this Directive which allow the national regulatory authorities to set the terms of contracts between telecommunications organizations and users, the following procedures shall be available to the user: (1) Member States shall ensure that any party, including users, service providers, consumers, or other telecommunications organizations having an unresolved dispute with a telecommunications organization concerning an alleged infringement of the provisions of this Directive, shall have a right of appeal to the national regulatory authority or another independent body. Easily accessible and in principle inexpensive procedures shall be created at national level to resolve such disputes in a fair, transparent and timely manner. These procedures shall also apply in cases where users are in dispute with a telecommunications organization about their telephone bills. (2) A user or a telecommunications organization may, where the dispute involves telecommunications organizations in more than one Member State, invoke the conciliation procedure provided for in paragraphs 3 and 4 by means of a written notification to the national regulatory authority and to the Commission. Member States may also allow their national regulatory authority to invoke the conciliation procedure. (3) Where the national regulatory authority or the Commission finds that there is a case for further examination, following a notification based on paragraph 2, it can refer the matter to the Chairman of the ONP Committee. (4) In the circumstances referred to in paragraph 3, the Chairman of the ONP Committee shall initiate the procedure described below if he is satisfied that all reasonable steps have been taken at national level: (a) the Chairman of the ONP Committee shall convene as soon as possible a working group including at least two members of the ONP Committee and one representative of the national regulatory authorities concerned, and the Chairman of the ONP Committee or another official of the Commission appointed by him. The working group shall be chaired by the representative of the Commission and shall normally meet within ten days of having been convened. The Chairman of the working group may decide, upon proposal by any of the members of the working group, to invite a maximum of two other persons as experts to advise it; (b) the working group shall give the party invoking this procedure, the national regulatory authorities of the Member States involved and the telecommunications organizations involved the opportunity to present their opinions in oral or written form; (c) the working group shall endeavour to reach agreement between the parties involved within three months of the date of receipt of the notification referred to in paragraph 2. The Chairman of the ONP Committee shall inform that Committee of the results of the procedure so that it may express its views. (5) The party invoking the procedure shall bear its own costs of participating in this procedure. Article 28 Deferment of certain obligations 1. When a Member State is unable to or can foresee that it will be unable to fulfil the provisions of Articles 12 and 13, it shall notify the Commission of the reasons. 2. Deferment of obligations under Articles 12 or 13 can be accepted only in cases where the Member States concerned can prove that fulfilment of the obligation would impose an excessive burden on the telecommunications organizations in that Member State. 3. The Member State shall inform the Commission of the date by which the obligation can be fulfilled and of the measures envisaged in order to meet that deadline. 4. When the Commission receives a notification in accordance with paragraph 1, it shall inform the Member State whether the particular situation of the Member State concerned justifies, on the basis of criteria set out in paragraph 2, a deferment for that Member State of the application of Article 12 or Article 13 and until which date such deferment is justified. Article 29 Technical adjustment Modifications necessary to adapt Annex I (2), Annexes II and III to technological developments or to changes in market demand shall be determined in accordance with the procedure laid down in Article 31. Article 30 Advisory Committee procedure 1. The Commission shall be assisted by the Committee set up by Article 9 (1) of Directive 90/387/EEC. The Committee shall, in particular, consult the representatives of the telecommunications organizations, users, consumers, manufacturers and service providers. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account. Article 31 Regulatory Committee procedure 1. Notwithstanding the provisions of Article 30, the following procedure shall apply in respect of the matters covered by Articles 25 and 29. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the EC Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. 4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, within a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 32 Review 1. The European Parliament and the Council shall decide by 1 January 1998, on the basis of a proposal which the Commission will submit to them in good time, on the revision of this Directive to adapt it to the requirements of market liberalization. 2. The Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion not later than 13 December 1998. The report shall be based inter alia on the information provided by the Member States to the Commission and to the ONP Committee. Where necessary, further measures may be proposed in the report for full implementation of the aims of the Directive. Article 33 Implementation 1. Member States shall take the measures necessary to comply with this Directive before 13 December 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall inform the Commission of the main provisions of national law which they adopt in the field governed by this Directive. Article 34 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 35 This Directive is addressed to the Member States.

31995L0065

1995

Commission Directive 95/65/EC of 14 December 1995 amending Directive 92/76/EEC recognizing protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/41/EC (2), and in particular the first subparagraph of Article 2 (1) (h) thereof, Having regard to Commission Directive 92/76/EEC of 6 October 1992 recognizing protected zones exposed to particular plant health risks in the Community (3), as last amended by Directive 95/40/EC (4), Whereas pursuant to Directive 92/76/EEC certain zones in the Community were recognized as 'protected zones` in respect of certain harmful organisms for a period expiring on 1 April 1996; Whereas based on a request from Italy to be able to trade all citrus fruits with their leaves and peduncles and not just the fruit of Citrus clementina Hort. ex Tanaka, the protected zones recognized for Greece, France, Italy and Portugal in respect of Citrus tristeza virus (European isolates) should be modified to cover all fruit of Citrus L., Fortunella Swingle, Poncirus Raf. and their hybrids, with leaves and peduncles; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee and Plant Health, Article 1 The Annex to Directive 92/76/EEC is hereby amended as indicated in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 January 1996. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0066

1995

Commission Directive 95/66/EC of 14 December 1995 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/41/EC (2), and in particular Article 13, second subparagraph, third and fourth indents thereof, Whereas certain provisions on fruits of Citrus clementina Hort. ex Tanaka, with leaves and peduncles established for protected zones recognized in respect of Citrus tristeza virus (European isolates) should be modified to take into account the movement of all fruit of Citrus L., Fortunella Swingle, Poncirus Raf. and their hybrids, with leaves and peduncles throughout the Community; Whereas the amendments are in agreement with the requests of the Member States concerned; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee and Plant Health, Article 1 Directive 77/93/EEC is hereby amended as indicated in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. The Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31995L0069

1995

Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), 1. Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (4), lays down the minimum conditions to be met by manufacturers of certain additives, premixtures and compound feedingstuffs containing such additives; 2. Whereas these rules restrict the manufacture or use of certain categories of additives, premixtures and compound feedingstuffs containing such additives and premixtures to those manufacturers who are included on a national list; 3. Whereas individuals holding goods covered by this Directive for the sole purposes of their trade promotion or their transport are not regarded as being intermediaries as defined in this Directive; 4. Whereas with the operation of the internal market in mind, some optional provisions which still allow the Member States to derogate from the Community provisions applying to the sector in question should be abolished and the criteria for approving or registering manufacturers or intermediaries should be specified so as to avoid distortions of competition caused by the MemberStates' different ways of applying and interpreting pre-existing approval conditions and to forestall any potentially adverse effects on animals, humans or the environment, given the risks inherent in using certain additives; 5. Whereas, to forestall certain particularly undesirable substances occurring in feedingstuffs, Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (5), aims to limit their presence in raw materials to an acceptable level; whereas these rules also restrict the use of those raw materials to those persons who have the necessary qualifications, facilities and equipment for the dilution operations which ensure that the maximum levels laid down in the Directive as regards the various types of compound feedingstuffs are complied with; 6. Whereas establishments producing certain substances listed in Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (6), should also be subject to approval, as should intermediaries; 7. Whereas, with a view to ensuring the quality of the product and preventing the occurrence of residues of certain additives in animal products or of high levels of certain undesirable substances which might result from defective manufacture, all manufacturers of additives, premixtures, compound feedingstuffs and certain products covered by Directive 82/471/EEC, and intermediaries should be approved or registered on the basis of standard, specific criteria; 8. Whereas the level of requirements for the exercise of activities laid down in this Directive must be in proportion to the risks involved in the manufacture or use by establishments of additives and premixtures listed in Directive 70/524/EEC,products covered by Directive 82/471/EEC or raw materials containing undesirable substances or products listed in Directive 74/63/EEC; 9. Whereas establishments which intend to manufacture or use products deemed sensitive under the Directive must receive prior approval on the basis of very strict conditions that should safeguard animals, humans and the environment, whereas, however, in exceptional cases Member States may decide not to approve a specific category of establishment, provided such measures do not hinder the free movement of agricultural products in the territory of the Member States; whereas, conversely, for establishments using less sensitive products, mere registration based on an undertaking by the establishment to comply with a number of conditions will suffice; whereas this distinction must also apply to intermediaries which wrap, package, store or put into circulation additives, premixtures of additives or products covered by Directive 82/471/EEC; 10. Whereas, on grounds of equal treatment, the fundamental principles of these new rules must apply both to establishments which put products into circulation and to manufacturers/stock farmers who manufacture feedingstuffs solely for the requirements of their own farms, without any distinction; whereas, nonetheless, some relief should be allowed the latter on account of the particular circumstances in which they exercise their activity; 11. Whereas provision should be made for amending or withdrawing approval if an establishment changes or ceases its activities or if it no longer fulfils one of the essential conditions applicable to its activity; whereas the same rules should apply, mutatis mutandis, to registration; 12. Whereas Member States may be entitled to levy fees for granting approval; whereas the levels of such fees should subsequently be harmonized in order to obviate distortion of competition; whereas such harmonization will fall within the general framework of future Community rules on fees or charges to be levied in the animal feed sector; 13. Whereas it is necessary to give the Commission the task of adopting detailed rules for the application of this Directive, including the conditions for approval and registration of establishments in third countries; 14. Whereas, should the Council confer on the Commission responsibility for implementing the rules laid down on the conditions and arrangements for approving and registering the establishments in question, provision should be made for close cooperation between the Member States and the Commission within the Standing Committee for Feedingstuffs established by Decision 70/372/EEC (1); 15. Whereas to ensure greater transparency the conditions and arrangements relating to the approval and registration of establishments in the animal feed sector should be brought together in a single text; whereas this entails adapting existing legislation; 16. Whereas the requirement for manufacturers to be approved or registered will make it possible for Member States to check on manufacturers and intervene, if necessary, where substances are being used illegally, in particular where prohibited substances such as hormones or beta-agonists are in use; whereas Member States have a duty to check beforehand that establishments requiring approval actually meet the minimum conditions which the Directive lays down for exercise of the relevant activity; whereas national supervisory authorities must also ensure subsequently, by means of appropriate checks, that approved or registered establishments and intermediaries are indeed complying with the conditions imposed upon them; whereas these provisions must apply without prejudice to Community rules governing the organization of official checks on animal feed; 17. Whereas it is necessary to adopt these measures at Community level in order better to achieve the objectives of guaranteeing the quality and safety of feedingstuffs, CHAPTER I SCOPE AND DEFINITIONS Article 1 1. This Directive lays down the conditions and arrangements applicable to certain categories of establishments and intermediaries in the animal feed sector to allow them to exercise the activities described in Articles 2 and 7 and Articles 3 and 8 respectively. 2. This Directive shall apply without prejudice to the Community provisions concerning the organization of official checks on animal feed. 3. For the purposes of this Directive: (a) 'putting into circulation' means holding products for the purposes of sale, including offering for sale, or for the purposes of any other form of transfer, whether or not free of charge, to third parties, and the sale and other forms of transfer themselves; (b) 'establishment' means any unit producing or manufacturing additives, premixtures prepared from additives, compound feedingstuffs or products covered by Directive 82/471/EEC and referred to in Chapter I.1 (a) of the Annex to this Directive; (c) 'intermediary' means any person other than the manufacturer or the person producing for the exclusive requirements of his holding, compound feedingstuffs, who holds additives, premixtures prepared from additives, or one of the products covered by Directive 82/471/EEC and referred to in Chapter I.1 (a) of the Annex to this Directive at an intermediate stage between production and use. 4. The definitions laid down in Community legislation on animal feed shall apply where necessary. CHAPTER II APPROVAL OF ESTABLISHMENTS AND INTERMEDIARIES Article 2 Approval of establishments 1. An establishment wishing to exercise one or more of the activities referred to in paragraph 2 must receive approval for each of its activities. A Member State may decide not to approve establishments referred to in paragraph 2 (f). 2. To be approved by the competent authorities an establishment: (a) manufacturing additives or products covered by Directive 82/471/EEC and referred to in Chapter I.1 (a) of the Annex to this Directive with a view to putting them into circulation, must meet the minimum conditions laid down in Chapter I.1 (b) of the said Annex 1; (b) manufacturing premixtures prepared from additives referred to in Chapter I.2 (a) of the Annex, with a view to putting them into circulation, must meet the minimum conditions laid down in Chapter I.2 (b) of the said Annex; (c) manufacturing compound feedingstuffs containing premixtures prepared from additives referred to in Chapter I.3 (a) of the Annex, with a view to putting them into circulation, must meet the minimum conditions laid down in Chapter I.3 (b) of the Annex; (d) manufacturing compound feedingstuffs, with a view to putting them into circulation, from raw materials referred to in Article 3a (2) of Directive 74/63/EEC which contain high levels of undesirable substances or products, must meet the minimum conditions laid down in Chapter I.4 of the Annex to this Directive; (e) producing, for the exclusive requirements of its holding, compound feedingstuffs containing premixtures which include additives referred to in Chapter I.3 (a) of the Annex must meet the minimum conditions laid down in Chapter I.3 (b) of the Annex, with the exception of the requirements set out in point 7; (f) producing, for the exclusive requirements of its holding, compound feedingstuffs which contain raw materials referred to in Article 3a (2) of Directive 74/63/EEC containing high levels of undesirable substances or products, must meet the minimum conditions laid down in Chapter 1.4 of the Annex to this Directive, with the exception of the requirements set out in point 7. 3. Approval shall be: - withdrawn if an establishment ceases its activities or if it is shown that it no longer fulfils an essential condition applicable to its activities and does not comply with that requirement within a reasonable time, - amended if the establishment has demonstrated its ability to engage in activities which are additional to those for which it was first approved or which replace them. Article 3 Approval of intermediaries 1. Where additives, products covered by Directive 82/471/EEC or premixtures of additives referred to in Chapters I.1 (a) and I.2 (a) of the Annex respectively are put into circulation, intermediaries must be approved. The provisions laid down in point 7 of Chapter I.1 8 (b) or Chapter I.2 (b) of the Annex shall apply, as appropriate, to intermediaries which wrap, package, store or put into circulation additives, premixtures of additives or products covered by Directive 82/471/EEC. 2. Approval shall be: - withdrawn if an intermediary ceases its activities or if it is shown that it no longer fulfils an essential condition applicable to its activities and does not comply with that requirement within a reasonable time; - amended if the intermediary has demonstrated its ability to engage in activities which are additional to those for which it was first approved or which replace them. Article 4 Approval procedure for establishments and intermediaries 1. To obtain approval, establishments referred to in Article 2 and intermediaries referred to in Article 3 which intend to exercise for the first time one or more of the activities referred to in Article 2 and 3 shall, as from 1 April 1998 submit an application to the competent authority of the Member State in which their facilities are located. Member States shall ensure that a decision is taken on applications for approval mentioned in the first subparagraph within six months of their submission. 2. Establishments and intermediaries which, on 1 April 1998, were exercising one or more of the activities referred to in Articles 2 and 3 respectively, may continue their activities until a decision has been taken on their application for approval, on condition that they submit the application before 1 September 1998. Member States shall act on applications for approval from he establishments and intermediaries referred to in the first paragraph before 1 April 2001. Article 5 Register of approved establishments and intermediaries 1. For each activity, the competent authority shall enter the establishments and intermediaries it has approved in accordance with Articles 2 and 3 in a register under an individual approval number which identifies them, once it has established by means of on-the-spot verification that they satisfy the conditions laid down by this Directive. In respect of intermediaries who act solely as dealers without ever holding the product in their facilities, Member States need not carry out on-the-sport verification of compliance with the conditions under point 7 of Chapters I.1 (b) or I.2 (b) of the Annex, providing that those intermediaries lodge with the competent authority a declaration to the effect that they meet the requirements laid down under point 6.2 in the Annex for the exercise of their activity. 2. Member States shall update the entries of establishments and intermediaries in the register in accordance with the decisions referred to in Article 2 (3) and Article 3 (2) to withdraw or amend approval. Article 6 Publication and communication of the list of approved establishments and intermediaries 1. Each Member State shall publish a list of the establishments and intermediaries approved in accordance with Articles 2 and 3 for the first time in November 2001, and then each year, by 30 November at the latest, the list of amendments made during the year; every five years, it shall publish a consolidated list. 2. Before 31 December each year, Member States shall send the Commission the list referred to in paragraph 1. Before 31 December each year, Member States shall send the other Member States a list of the establishments referred to in Article 2 (2) (a) and (b) and of the intermediaries approved in accordance with Article 3 (1). Upon request, Member States shall send the other Member States all or part of the list of establishments referred to in Article 2 (2) (c) to (f). CHAPTER III REGISTRATION OF ESTABLISHMENTS AND INTERMEDIARIES Article 7 Registration of establishments 1. An establishment wishing to exercise one or more of the activities referred to in paragraph 2 must be registered by a Member State for each activity in accordance with this Directive. 2. In order to be registered by the competent authorities an establishment: (a) manufacturing additives for which a prescribed maximum level is set and which are not included in Chapter I.1 (a) of the Annex, with a view to putting them into circulation, must meet the minimum conditions laid down in Chapter II (c) of the Annex; (b) manufacturing premixtures containing additives referred to in Chapter II (a) of the Annex, with a view to putting them into circulation, must meet the minimum conditions laid down in Chapter II (c) of the Annex; (c) manufacturing compound feedingstuffs containing premixtures of additives referred to in Chapter II (b) of the Annex or additives referred to in Chapter II (a) of the Annex with a view to putting them into circulation, must met the minimum conditions laid down in Chapter II (c) of the Annex; (d) manufacturing, for the exclusive requirements of its holding, compound feedingstuffs containing premixtures of additives referred to in Chapter II (b) of the Annex or containing additives referred to in Chapter II (a) of the Annex, must met the minimum conditions laid down in Chapter II (c) of the Annex. 3. Approved establishments exercising the corresponding activities referred to in Article 2 (2) (a), (b), (c) and (e) shall be regarded as satisfying de facto the conditions laid down in paragraph 2 (a), (b), (c) and (d). 4. Registration shall be: - withdrawn if an establishment ceases its activities or if it is shown that it no longer fulfils an essential condition applicable to its activities and does not comply with that requirement within a reasonable time, - amended if the establishment declares that it is engaged in activities which are additional to those for which it was first registered or which replace them. Article 8 Registration of intermediaries 1. Where additives for which a prescribed maximum level is set other than those referred to in Chapter I.1 (a) of the Annex or premixtures of additives referred to in Chapter II (a) of the Annex are put into circulation, intermediaries must be registered. The provisions laid down in point 7 of Chapter II (c) of the Annex shall apply, as appropriate, to intermediaries which wrap, package, store or put into circulation additives or premixtures of additives. 2. Intermediaries approved in accordance with Article 3 shall be regarded as meeting de facto the conditions laid down in paragraph 1. 3. Registration shall be: - withdrawn if an intermediary ceases its activities or if it is shown that it no longer fulfils an essential condition applicable to its activities and does not comply with that requirement within a reasonable time, - amended if the intermediary has declared that it is engaged in activities which are additional to those for which it was first registered or which replace them. Article 9 Registration procedure for establishments and intermediaries 1. In order to be registered, the establishments referred to in Article 7 (2) and the intermediaries referred to in Article 8 (1) shall, as from 1 April 1998, submit a declaration to the competent authority of the Member State in which they intend to exercise their activities. 2. Establishments and intermediaries which, on 1 April 1998, were exercising one or more of the activities referred to in Articles 7 and 8 respectively, may continue their activities on condition that they submitted the declaration referred to in paragraph 1 by 1 September 1998. Article 10 List of registered establishments and intermediaries 1. For each activity, the competent authority shall enter the establishments and intermediaries which it has registered in accordance with Articles 7 and 8 on a list under an individual registration number which identifies them. 2. Member States shall update the entries of establishments and intermediaries on the list in accordance with the decisions referred to in Articles 7 (4) and 8 (3) to withdraw or amend registration. Article 11 Communication of the list of registered establishments and intermediaries 1. Before 31 December each year, Member States shall send the Commission the list of establishments and intermediaries registered during the year in accordance with Articles 7 and 8 and, every five years, they shall send a consolidated list. 2. Upon request, Member States shall send to the other Member States all or part of the lists referred to in paragraph 1. CHAPTER IV COMMON PROVISIONS Article 12 Simplified procedure Where an establishment manufacturing an additive is already authorized to manufacture the same active substance as a veterinary medicinal product within the meaning of Article 24 of Directive 81/851/EEC (1), Member States shall not be obliged to verify that the conditions laid down in Article 2 (2) (a) and contained in Chapter I.1 (b) of the Annex to this Directive have been fulfilled, with the exception of the requirements set out in points 4, 5, 6.2 and 7. Article 13 Checks Member States shall ensure, by means of appropriate checks carried out in establishments and at the premises of intermediaries which they have approved or registered, that the requirements imposed by this Directive are met. Article 14 Fees The Council, acting by a qualified majority on a proposal from the Commission, shall, before 1 April 1998, adopt the amounts of the fees to be charged for the approval of establishments and their intermediaries. Article 15 Detailed arrangements, amendment of the Annex and imports from non-member countries The following shall be adopted in accordance with the procedure laid down in Article 16: (a) before 1 April 1998, practical arrangements for the approval pursuant to Article 2 and registration pursuant to Article 7 of establishments located in a non-member country and putting additives, premixtures, products covered by Directive 82/471/EEC as referred to in Chapter 1.1 (a) of the Annex to this Directive or feedingstuffs into circulation within the Community, so that safeguards are provided equivalent to those supplied by establishments located in the Community. These arrangements shall comprise: - establishment and updating of a list of non-member countries able to provide safeguards equivalent to those offered by the Member States in respect of their own establishments and able to perform the checks referred to in Article 13, - establishment and updating of a list of establishments which have been found by the non-member countries on the list referred to in the first indent to fulfil the conditions laid down in this Directive, - the possibility that experts from the Commission and the Member States may carry out on-the-spot checks if necessary. Such checks shall be performed on behalf of the Community, which will bear the relevant expenses; (b) measures for implementing this Directive, in particular the form of the register and approval numbers; (c) the amendments to be made to the Annexes. Article 16 Standing Committee for Feedingstuffs The Commission shall be assisted by the Standing Committee for Feedingstuffs established by Decision 70/372/EEC, hereinafter referred to as 'the Committee'. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of Decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. CHAPTER V ADAPTATION OF LEGISLATION Article 17 Amendment of Directive 70/524/EEC Article 13 (1) of Directive 70/524/EEC shall be replaced by the following: 'Article 13 1. Member States shall require that additives covered by this Directive, premixtures prepared from these additives with a view to their being incorporated in compound feedingstuffs and compound feedingstuffs containing these premixtures may be put into circulation or used only by the establishments or intermediaries which meet the conditions laid down, as appropriate, in Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (*). (*) OJ No L 332, 30. 12. 1995, p. 15.' Article 18 Amendment of Directive 74/63/EEC Point (a) of Article 3a (2) of Directive 74/63/EEC shall be replaces by the following: '(a) it is intended for use by establishments which meet the conditions of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (*). (*) OJ No L 332, 30. 12. 1995, p. 15.' Article 19 Amendment of Directive 79/373/EEC In Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (1), the following subparagraph shall be added to Article 5 (1): '(k) the approval number allocated to the establishment in accordance with Article 5 of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (*). (*) OJ No L 332, 30. 12. 1995, p. 15.' Article 20 Amendment of Directive 82/471/EEC Directive 82/471/EEC is hereby amended as follows: (1) The following paragraph shall be added to Article 3: '3. Member States shall require that products referred to in Chapter I.1 (a) of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (*) may be put into circulation only by establishments or intermediaries which meet the conditions laid down in Article 2 or Article 3 of that Directive, as appropriate. (*) OJ No L 332, 30. 12. 1995, p. 15.' (2) In the Annex, for the products referred to in Chapter I.1 (a) of this Directive, in column 7 ('special provisions'), the terms 'approval number' shall be added as a final indent to the details to be given on the packaging of the product, on the container or on a label affixed thereto. CHAPTER VI FINAL PROVISIONS Article 21 1. Member States shall adopt, not later than 1 April 1998 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. The measures adopted shall be applicable as from 1 April 1998. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 22 Thise Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Artikel 23 This Directive is addressed to the Member States.

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Council Directive 95/70/EC of 22 December 1995 introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas molluscs are listed in Annex II to the Treaty; whereas the marketing of molluscs constitutes an important source of revenue for the aquaculture sector; Whereas the mollusc diseases referred to in Annex A, list II, to Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (3), have a very serious effect on the shellfish industry; whereas other diseases having a similar effect occur in third countries, whereas a list of such diseases should be drawn up and the Commission should be given the ability to adjust that list in the light of developments in the animal-health field; Whereas an outbreak of such diseases can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable considerably to reduce the profitability of shellfish-farming; Whereas it is therefore necessary to establish at Community level the measures to be taken in the event of outbreaks of disease, in order to ensure rational development of shellfish-farming and to contribute to the protection of animal health in the Community; Whereas Member States should report to the Commission and the other Member States all cases of abnormal mortality observed in bivalve molluscs; Whereas, in such an event, measures must be taken aimed at preventing the spread of the disease, in particular with regard to the removal of live bivalve molluscs from the farms or zones concerned; Whereas a thorough epidemiological investigation is essential to determine the origin of the disease and to prevent further spread; Whereas, in order to ensure an effective system of control, diagnosis of the diseases must be harmonized and carried out under the auspices of responsible laboratories, the coordination of which may be ensured by a reference laboratory designated by the Community; Whereas, in order to ensure uniform implementation of this Directive, a Community inspection procedure should be established; Whereas common measures for the control of diseases form a minimum basis for maintaining a uniform standard of animal health; Whereas the Commission should be entrusted with the task of adopting the necessary implementing measures, Article 1 This Directive establishes minimum Community measures for the control of the diseases affecting bivalve molluscs referred to in this Directive. Article 2 1. For the purposes of this Directive, the definitions laid down in Article 2 of Directive 91/67/EEC and Article 2 of Directive 91/492/EEC (4) shall apply as necessary. 2. In addition, 'observed abnormal mortality' shall mean sudden mortality affecting approximately 15 % of stocks and occurring over a short period between two inspections (confirmed within 15 days). In hatchery a mortality shall be considered abnormal when the farmer cannot obtain larvae during a period which included successive spawns from different broodstocks. In nursery a mortality shall be considered abnormal when a sudden sizeable mortality occurs in a short time on a number of tubes. Article 3 Member States shall ensure that all farms rearing bivalve molluscs: 1. are registered by the official service; this registration must be kept constantly up to date; 2. keep a record of: (a) live bivalve molluscs entering the farm, containing all information relating to their delivery, their number or weight, their size and their origin; (b) bivalve molluscs leaving the farm for reimmersion, containing all information relating to their dispatch, their number or weight, their size and destination; (c) observed abnormal mortality. This record, which shall be open to scrutiny by the official service at all times, on demand, shall be updated regularly and kept for four years. Article 4 1. Member States shall ensure that a monitoring and sampling programme is applied in bivalve mollusc farms, farming areas and harvested natural beds in order to observe whether there is an abnormal mortality and keep track of the health situation of stocks. In addition, the official service may apply the above programme to purification centres and storage tanks which discharge water into the sea. If, during application of this programme, any abnormal mortality is observed, or if the official service has information giving it reason to suspect the presence of diseases, the following measures shall be taken: - a list shall be drawn up of the sites where the diseases referred to in Annex A, list II to Directive 91/67/EEC are present, provided that such diseases are not the subject of a programme approved pursuant to the aforementioned Directive, - a list shall be drawn up of the sites at which abnormal mortality has been observed as a result of the presence of the diseases referred to in Annex D, or on which the official service has information giving it reason to suspect the presence of diseases, - monitoring of the evolution and geographical spread of the diseases referred to in the first and second indents. 2. The detailed rules for implementing this Article, and inter alia the rules to be applied for establishing the programme referred to in paragraph 1, particularly as regards the frequency and timetable of monitoring, procedures for taking samples (statistically representative volume) and methods of diagnosis, shall be adopted in accordance with the procedure provided for in Article 10. Article 5 1. Member States shall ensure that the suspected presence of any diseases referred to in Article 4 and any abnormal mortality rate observed in bivalve molluscs in farms, in farming areas or in harvested natural beds or in purification centres or storage tanks which discharge water into the sea is notified as soon as possible to the official service by the shellfish-farmers or any other person who has made such observations. 2. In the case referred to in paragraph 1, the official service in the Member States shall ensure that: (a) samples are taken for examination in an approved laboratory; (b) pending the result of the examination referred to in (a), no molluscs leave the affected farm, farming area or harvested natural beds or purification centres or storage tanks which discharge water into the sea for relaying or reimmersion in another farm or in the aquatic environment, unless authorized by the official service. 3. If the examination referred to in paragraph 2 (a) fails to demonstrate the presence of a pathogen, the restrictions referred to in paragraph 2 (b) shall be lifted. 4. If the examination referred to in paragraph 2 shows the presence of a pathogen causing the observed abnormal mortality capable of being the cause of that mortality, or of a pathogen of one of the diseases referred to in Article 4, an epizootic investigation must be carried out by the official service in order to determine the possible means of contamination and to investigate whether molluscs have left the farm, the farming area or the harvested natural beds for relaying or reimmersion elsewhere during the period preceding observation of the abnormal mortality. If the epizootic investigation shows that the disease has been introduced into one or more farms, farming areas or harvested natural beds as a result inter alia of molluscs being moved, the provisions of paragraph 2 shall apply. However, by way of derogation from Article 3 (1) (c) of Directive 91/67/EEC, the official service may, within its territory, authorize the movement of live bivalve molluscs to other farms, farming areas or harvested natural beds which are infected with the same disease. If necessary, further appropriate measures may be decided on in accordance with the procedure in Article 10. 5. The official service shall ensure that the Commission and the other Member States are immediately informed, in accordance with the current Community procedures, of any cases of abnormal mortality rates observed involving a pathogen, of any measures taken to analyse and control the situation and of the cause of the mortality. Article 6 1. Sampling and laboratory testing for the determination of the cause of abnormal mortality of bivalve molluscs shall be carried out using the methods established in accordance with the procedure laid down in Article 10. 2. Member States shall ensure that in each Member State a national reference laboratory is designated, with facilities and expert personnel enabling it to carry out the testing referred to in paragraph 1. 3. By way of derogation from paragraph 2, Member States which do not have a national laboratory competent in the matter may use the services of a national laboratory with competence in the matter in another Member State. 4. The list of national reference laboratories for diseases of bivalve molluscs is set out in Annex C. 5. National reference laboratories shall cooperate with the Community reference laboratory referred to in Article 7. Article 7 1. The Community reference laboratory for diseases of bivalve molluscs is indicated in Annex A. 2. Without prejudice to Decision 90/424/EEC of 26 June 1990 (1) on expenditure in the veterinary field and in particular Article 28 thereof, the functions and duties of the laboratory referred to in paragraph 1 shall be those laid down in Annex B. Article 8 1. Commission experts may, to the extent necessary to ensure uniform application of this Directive, carry out on-the-spot checks. In so doing, they may carry out random, non-discriminatory checks to ensure that the competent authority is monitoring compliance with the requirements of this Directive. The Commission shall inform the Member States of the results of these checks. 2. The checks referred to in paragraph 1 shall be carried out in collaboration with the competent authority. 3. The Member State in whose territory the inspections are carried out shall provide the experts with any assistance they require to accomplish their task. 4. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 10. Article 9 Annex A shall be amended as necessary by the Council, acting by a qualified majority on a proposal from the Commission. Annexes B, C and D may be amended as necessary in accordance with the procedure laid down in Article 10. Article 10 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Standing Veterinary Committee, (hereinafter referred to as 'the Committee'), set up by decision 68/361/EEC (2), by its Chairman, either on his own initiative or at the request of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within the time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months, from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 11 By 31 December 1999 at the latest, the Commission shall submit a report to the Council which has been drawn up, if necessary after consulting the Scientific and veterinary Committee, taking account of experience acquired in applying this Directive and of technical and scientific developments, accompanied where appropriate by any proposals for amendments. The Council shall act by a qualified majority on any such proposals. Article 12 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 June 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. However, from the date laid down in paragraph 1, Member States may, subject to the general rules of the Treaty, maintain or apply for their production stricter provisions than those laid down by this Directive. They shall notify the Commission of any such measure. 3. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field governed by this Directive. Article 13 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 14 This Directive is addressed to the Member States.

31995L0071

1995

Council Directive 95/71/EC of 22 December 1995 amending the Annex to Directive 91/493/EEC laying down the health conditions for the production and the placing on the market of fishery products Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (1) and in particular Article 13 thereof, Having regard to the proposal from the Commission, Whereas Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products obtained on board certain vessels in accordance with Article 3 (1) (a) (i) of Directive 91/493/EEC (2) provides that freezer vessels shall be entered in a list kept regularly up to date by the competent authority; Whereas fishery products obtained on board freezer vessels which meet the hygiene requirements laid down in Directive 92/48/EEC should be permitted to be placed on the market on the same identification terms as fishery products frozen in establishments on land; whereas the Annex to Directive 91/493/EEC should therefore be amended accordingly; Whereas certain problems of application reported by the Member States call for the clarification of certain technical aspects of Directive 91/493/EEC, to enable the provisions to be uniformly applied in the Community, especially in connection with the identification of fishery products marketed, Article 1 The Annex to Directive 91/493/EEC is hereby amended as follows: (1) Chapter I (II) (5) shall be replaced by the following: '5. On-board processing of fishery products must be carried out under the conditions of hygiene laid down in Section II, points 2 and 3, Section IV and Section V of Chapter IV of this Annex.' (2) The second sentence of Chapter IV (I) (3) shall be replaced by the following: 'Fillets and slices must not remain on work tables any longer than is necessary for their preparation and must be protected from contamination by appropriate packaging.' (3) Chapter IV (IV), point 1 shall be replaced by the following: 'Fresh, frozen and thawed products used for processing must comply with the requirements set out in I, II or III of this Chapter.' (4) The first sentence of Chapter IV (IV) (4) (d) shall be replaced by the following: '(d) samples must be taken of production each day at predetermined intervals to ensure the efficacy of sealing or of any other method of hermetic closure.' (5) In Chapter IV (V) (3) (c) the verb 'destroy' shall be replaced by the verb 'kill'. (6) The first sentence of the second paragraph of Chapter V (II) (3) (A) (b) shall be replaced by the following: 'These limits apply only to fish species of the following families: scombridae, clupeidae, engraulidae and coryphaenidae.' (7) Chapter VII shall be replaced by the following: 'CHAPTER VII IDENTIFICATION Without prejudice to the provisions of Directive 79/112/EEC, it must be possible to trace for inspection purposes the establishment of dispatch of consignments of fishery products, by means either of labelling or of the accompanying documents. For that purpose, the following information must appear on the packaging or, in the case of a non-packaged product, in the accompanying documents: - the country of dispatch, which may be written out in full or shown as an abbreviation, using capital letters, i. e. for the Member States of the Community, one of the following: B - DK - D - EL - E - F - IRL - I - L - NL - P - UK - AT - FI - SE, - identification of the establishment or factory vessel by its official approval number or, in the case of marketing from a freezer vessel covered by point 7 of Annex II to Directive 92/48/EEC, the identification number of the vessel, or, in the case of separate registering of auction or wholesale markets as laid down in the third subparagraph of Article 7 (1) of this Directive, the registration number of the auction or wholesale market, - one of the following abbreviations: CE - EC - EG - EK - EF - EY. All the letters and figures must be fully legible and grouped together on the packaging in a place where they are visible from the outside without any need to open the said packaging.' Article 2 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. They shall notify the Commission thereof. However, products prepared before the date on which this Directive is brought into effect shall not be covered by the provisions of Chapter VII of Directive 91/493/EEC as amended by this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0001

1996

Directive 96/1/EC of the European Parliament and of the Council of 22 January 1996 amending Directive 88/77/EEC on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from diesel engines for use in vehicles Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas measures should be adopted within the framework of the internal market; Whereas the first programme of action of the European Community on protection of the environment (4), approved by the Council on 22 November 1973, called for account to be taken of the latest scientific advances in combating atmospheric pollution caused by gases emitted from motor vehicles and for Directives adopted previously to be amended accordingly; whereas the fifth programme of action, which in its general approach was approved by the Council and by the Representatives of the Governments of the Member States, meeting within the Member States, in the resolution of 1 February 1993 (5), provides for additional efforts to be made to effect a considerable reduction in the present level of pollutants emitted from motor vehicles; Whereas the objective of reducing the level of pollutant emissions from motor vehicles and the smooth functioning of the internal market for vehicles cannot be sufficiently achieved by individual Member States and can therefore be better achieved by the approximation of the laws of the Member States relating to measures to be taken against air pollution by motor vehicles; Whereas it is recognized that the development of transport in the Community has entailed significant constraints for the environment; whereas a number of official estimates of the increase in traffic density have proved to be lower than the actual figures; whereas for that reason stringent emission standards should be laid down for all motor vehicles; Whereas Directive 88/77/EEC (6) laid down the limit values for the emissions of carbon monoxide, unburnt hydrocarbons and nitrogen oxides from diesel engines for use in motor vehicles on the basis of a test procedure representative for European driving conditions for the vehicles concerned; whereas Directive 91/542/EEC provides for two stages, the first stage (1992/93) coinciding with the implementation dates of the new European emission standards for passenger cars; whereas the second stage (1995/96) established a longer-term guideline for the European motor industry by fixing limit values based on the expected performance of technologies still under development, whilst granting industry a lead time for perfecting such technologies; Whereas under Article 5 (2) of Directive 91/542/EEC the Commission is to report to the Council before the end of 1993 on progress made regarding the availability of technologies for controlling air-polluting emissions from diesel engines, particularly those of 85 kW or less; whereas this report should cover also new statistical methods to monitor production conformity; whereas in the light of the conclusions of this report the Commission is invited, if necessary, to submit a proposal to the Council for revising upwards the limit values for particulate emissions; Whereas, in the opinion of the experts consulted, it is possible to introduce new provisions on production conformity; Whereas the very stringent limit value for particulate emissions set in Directive 91/542/EEC for 'Stage 2` cannot, at the present state of technology, be met by most small diesel engines of 85 kW or less by the date set in that Directive; whereas a considerable reduction in particulate emissions may nevertheless be obtained for these engines as from 1 October 1995; whereas, for small diesel engines with a swept volume of less than 0,7 dm³ and a rated power speed of more than 3 000 min-¹, the limit value for particulate emissions set in Directive 91/542/EEC should not be introduced until 1997; whereas this additional period would allow the industry to make the necessary changes to ensure compliance with the deferred limit value, Article 1 Annex I to Directive 88/77/EEC shall be amended in accordance with 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 before 1 July 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate the main provisions of national law which they adopt in the field covered by this Directive to the Commission. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0003

1996

Commission Directive 96/3/Euratom, ECSC, EC of 26 January 1996 granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (1), and in particular Article 3 (3) thereof, Whereas information shows that the application of the second subparagraph of paragraph 2 of Chapter IV of the Annex to Directive 93/43/EEC relating to the transport of bulk foodstuffs in liquid, granulate or powdered form in receptacles and/or containers/tankers reserved for the transport of foodstuffs, is not practical and imposes an unduly onerous burden on food business when applied to the transport in sea-going vessels of liquid oils and fats intended for, or likely to be used for, human consumption; Whereas, however, it is necessary to ensure that the granting of a derogation provides equivalent protection to public health, by attaching conditions to the terms of such derogation; Whereas the availability of sea-going vessels reserved for the transport of foodstuffs is insufficient to serve the continuing trade in oils and fats intended for or likely to be used for human consumption; Whereas experience acquired during the past years has shown that contamination of liquid oils and fats can be avoided where tanks used for their transport are made of readily cleansible materials or where the three previous cargoes are of such a nature that they do not leave unacceptable contamination; whereas on the other hand it should be established that tanks that have been used previously for transportation have been effectively cleaned; Whereas it is incumbent on Member States by virtue of Article 8 of Directive 93/43/EEC to carry out controls to ensure the application of this Directive; Whereas this specific derogation should be without prejudice to the general provisions of Directive 93/43/EEC; Whereas, pursuant to Article 1 (2) of Directive 93/43/EEC, this derogation should not concern foods to which more specific Community hygiene rules apply; Whereas the measures provided for in this Directive are in compliance with the opinion of the Standing Committee for Foodstuffs, Article 1 This Directive derogates from the second subparagraph of paragraph 2 of Chapter IV of the Annex to Directive 93/43/EEC and lays down equivalent conditions to ensure the protection of public health and the safety and wholesomeness of the foodstuffs concerned. Article 2 1. The bulk transport in sea-going vessels of liquid oils or fats which are to be processed, and which are intended for or likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of foodstuffs, subject to the following conditions: (a) that, where the oil or fat is transported in a stainless steel tank, or tank lined with epoxy resin or technical equivalent, the immediately previous cargo transported in the tank shall have been a foodstuff, or a cargo from the list of acceptable previous cargoes set out in the Annex; (b) that, where the oil or fat is transported in a tank of materials other than those in point (a), the three previous cargoes transported in the tanks shall have been foodstuffs, or from the list of acceptable previous cargoes set out in the Annex. 2. The bulk transport in sea-going vessels of liquid oils or fats which are not to be further processed, and which are intended for or likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of foodstuffs, subject to the following conditions: (a) that the tank shall be of stainless steel or lined with epoxy resin or technical equivalent; (b) that the three previous cargoes transported in the tank shall have been foodstuffs. Article 3 1. The captain of the sea-going vessel transporting, in tanks, bulk liquid oils and fats intended for or likely to be used for human consumption shall keep accurate documentary evidence relating to the three previous cargoes carried in the tanks concerned, and the effectiveness of the cleaning process applied between these cargoes. 2. Where the cargo has been trans-shipped, in addition to the documentary evidence required in paragraph 1, the captain of the receiving vessel shall keep accurate documentary evidence that the transport of the bulk liquid oil or fat complied with the provisions in Article 2 during previous shipment and of the effectiveness of the cleaning process used between these cargoes on the other vessel. 3. Upon request, the captain of the vessel shall provide the competent official control authorities with the documentary evidence described in paragraphs 1 and 2. Article 4 This Directive shall be reviewed where one or more Member States, or the Commission, consider that amendments are necessary in order to take account of scientific or technical developments. In any case the Annex shall be reviewed within one year of the entry into force of this Directive. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 12 February 1996. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 6 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

31996L0004

1996

Commission Directive 96/4/EC, Euratom of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (1), and in particular Article 4 thereof, Whereas given the nature of infant formulae and follow-on formulae the detailed rules as to nutrient declaration on the labelling need to be clarified in order to avoid any problems which may arise from the application of other relevant Community legislation; Whereas new scientific data justify certain modifications to the mandatory essential composition of infant formulae and follow-on formulae specified in Annexes I and II to Commission Directive 91/321/EEC (2), as amended by the Act of Accession of Austria, Finland and Sweden; Whereas nucleotides, being the natural constituents of human milk, have been used to supplement infant formulae and follow-on formulae for many years in Member States and third countries without any negative effects; whereas therefore there is no justification for prohibiting their use in the manufacture of these products; Whereas technological progress has resulted in the production of infant formulae, based on protein partial hydrolysates, which due to their low levels of immunoreactive proteins may be useful; whereas for this reason a claim as to these particular characteristics should be permitted; whereas these products are distinct from semi-elemental diet products based on high degree hydrolysates used for the dietary management of diagnosed medical conditions, which are not covered by this Directive; Whereas Directive 91/321/EEC should be amended accordingly; Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health; Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 91/321/EEC is amended as follows: 1. Article 6 is replaced by the following: 'Article 6 Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay. Microbiological criteria shall also be established as necessary.` 2. Article 7 is amended as follows: (a) Points (d) and (e) of paragraph 2 are replaced by the following: '(d) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use; (e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol, carnitine and taurine, expressed in numerical form, per 100 ml of the product ready for use;` (b) The following is inserted as paragraph 2a: '2a. The labelling may bear: (a) the average quantity of nutrients mentioned in Annex III when such declaration is not covered by the provisions of paragraph 2 (e) of this Article, expressed in numerical form, per 100 ml of the product ready for use; (b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in Annex VIII, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use, provided that the quantities present are at least equal to 15 per cent of the reference values;` 3. The Annexes are amended as shown in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 March 1997. They shall forthwith inform the Commission thereof. Those laws, regulations and administrative provisions shall be applied in such a way as to: - permit trade in products conforming to this Directive no later than 1 April 1997, - prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0005

1996

Commission Directive 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4 thereof, Whereas the Community measures envisaged by this Directive do not exceed what is necessary for the attainment of the objectives already provided for by Directive 89/398/EEC; Whereas processed cereal-based foods and baby foods for infants and young children are used as part of a diversified diet and do not constitute the sole source of nourishment of infants and young children; Whereas there is a great variety of the products in question reflecting the widely varied diet of infants being weaned and young children owing to social and cultural circumstances existing in the Community; Whereas the essential composition of the products in question must be appropriate for the nutritional requirements of infants and young children in good health as established by generally accepted scientific data, account being taken of the abovementioned factors; Whereas the essential nutritional requirements for the composition of the two broad categories of these products, namely processed cereal-based foods and baby foods should be laid down; Whereas although, because of the nature of such products, a number of mandatory requirements and other restrictions as to the level of vitamins, minerals and other nutrients should be imposed, such nutrients may be added voluntarily by manufacturers provided that they use exclusively the substances listed in Annex IV to this Directive; Whereas the use of the products to which such nutrients have been voluntarily added at levels currently observed in the Community do not appear to result in excessive intakes of those nutrients by infants and young children; whereas attention will be paid to any future developments of the situation, and if necessary, appropriate measures will be taken; Whereas the provisions relating to the use of additives in the manufacture of processed cereal-based foods and baby foods will be laid down in a Council Directive; Whereas the use of novel food ingredients will be dealt with horizontally for all foodstuffs in a separate measure; Whereas this Directive reflects current knowledge about these products; whereas any amendment, to allow for innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC; Whereas, in view of the persons for whom the products are intended, the necessary microbiological criteria and maximum levels for contaminants should be laid down without delay; Whereas pursuant to Article 7 of Directive 89/398/EEC the products covered by this Directive are subject to the general rules laid down by 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 (2), as last amended by Commission Directive 93/102/EC (3); Whereas in this Directive the additions and exceptions to those general rules are adopted and expanded upon, where appropriate; Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling showing the energy value and principal nutrients they contain; whereas, on the other hand, the method of use should be specified in accordance with point 8 of Article 3 (1) and Article 10 of Directive 79/112/EEC, in order to prevent inappropriate uses liable to harm the health of infants; Whereas, whilst claims not specifically prohibited may generally be made for the products in question in conformity with the rules applicable for all foodstuffs, such claims should, where appropriate, take into account the compositional criteria specified in this Directive; Whereas the Scientific Committee for Food has, in accordance with Article 4 of Directive 89/398/EEC, been consulted on the provisions liable to affect public health; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 1. This Directive is a 'specific Directive` within the meaning of Article 4 of Directive 89/398/EEC. 2. This Directive covers foodstuffs for particular nutritional use fulfilling the particular requirements of infants and young children in good health in the Community and are intended for use by infants while they are being weaned, and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food. They comprise: (a) 'Processed cereal-based foods` which are divided into the following four categories: (i) simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids; (ii) cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid; (iii) pastas which are to be used after cooking in boiling water or other appropriate liquids; (iv) rusks and biscuits which are to be used either directly or, after pulverization, with the addition of water, milk or other suitable liquids. (b) 'Baby foods` other than processed cereal-based foods. 3. This Directive does not apply to milks intended for young children. 4. For the purpose of this Directive: - 'infants` shall mean children under the age of twelve months, - 'young children` shall mean children aged between 1 and 3 years. Article 2 Member States shall ensure that the products referred to in Article 1 are marketed within the Community only if they conform to the rules laid down in this Directive. Article 3 Processed cereal-based foods and baby foods shall be manufactured from ingredients whose suitability for particular nutritional use by infants and young children has been established by generally accepted scientific data. Article 4 1. Processed cereal-based foods shall comply with the compositional criteria specified in Annex I. 2. Baby foods which are described in Annex II shall comply with the compositional criteria specified therein. Article 5 Only the nutritional substances listed in Annex IV may be added in the manufacture of processed cereal-based foods and baby foods. Within 12 months of the entry into force of this Directive maximum levels, in addition to those already stipulated, shall be laid down where necessary. The purity criteria for those substances shall be laid down at a later stage. Article 6 Processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay. Microbiological criteria shall also be established as necessary. Article 7 1. The labelling of the products concerned shall bear in addition to the particulars provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars: (a) A statement as to the appropriate age from which the product may be used, regard being had to its composition, texture or other particular properties. The stated age shall not be less than four months for any product. Products recommended for use from the age of four months may indicate that they are suitable from that age unless independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, advise otherwise. (b) Information as to the presence or absence of gluten if the indicated age from which the product may be used is below six months. (c) The available energy value expressed in kJ and kcal, and the protein, carbohydrate and lipid content, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption; (d) The average quantity of each mineral substance and of each vitamin governed by a specific level in Annex I and Annex II respectively, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption; (e) Instructions for appropriate preparation, when necessary, and a statement as to the importance of following those instructions. 2. The labelling may bear: (a) the average quantity of the nutrients set out in Annex IV when such declaration is not covered by the provisions of point (d) of paragraph 1, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption; (b) in addition to numerical information, information on vitamins and minerals shown in Annex V, expressed as a percentage of the reference values given therein, per 100 g or 100 ml of the product as sold, and where appropriate, per specified quantity of the product as proposed for consumption, provided that the quantities present are at least equal to 15 % of the reference values. Article 8 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof. Those laws, regulations and administrative provisions shall be applied in such a way as to: - permit trade in products complying with this Directive, by 1 October 1997, - prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 9 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities. Article 10 This Directive is addressed to the Member States.

31996L0006

1996

Commission Directive 96/6/EC of 16 February 1996 amending Council Directive 74/63/EEC on undesirable substances and products in animal nutrition (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 6 thereof, Whereas Directive 74/63/EEC provides for regular updating of its Annexes to take account of advances in scientific and technical knowledge; Whereas it is necessary to reduce the level of aflatoxin B1 in complete feedingstuffs for dairy cattle considering the necessity to prevent the presence of this contaminant in milk; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Annex I to Directive 74/63/EEC is hereby amended as set out in the Annex of this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 July 1996 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0007

1996

Commission Directive 96/7/EC of 21 February 1996 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 95/55/EC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been consolidated by Commission Directive 91/248/EEC (3); Whereas the column 'Chemical formula, description` for the additive 'Salinomycin sodium` should be supplemented further; Whereas it is necessary to amend the specific provisions on the addition of iodine in the feedingstuffs in order to prevent unfavourable effects on certain species; Whereas the specific provisions on labelling for the growth promoter 'Olaquindox` should be supplemented so as better to ensure the health of operatives; Whereas new uses for the additives belonging to the group 'Coccidiostats and other medicinal substances` have been successfully tested in certain Member States; whereas the new uses should be authorized provisionally at national level pending their approval at Community level; Whereas new additives belonging to the 'Micro-organisms` group have been successfully tested in certain Member States; whereas theses new additives should be authorized provisionally at national level pending their approval at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions needed to comply with the Annex to this Directive by 31 July 1996, at the latest. They shall immediately inform the Commission thereof. The provisions adopted by the Member States shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall send the Commission the text of the main provisions of domestic law which they adopt in the subject area governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0008

1996

Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4 thereof, Whereas the Community measures envisaged by this Directive do not exceed what is necessary for the attainment of the objectives already provided for by Directive 89/398/EEC; Whereas the products covered by this Directive are varied and are generally distinguished as those intended to replace the whole of the daily diet and those intended to replace part of the daily diet; Whereas the composition of such products should be such as to fulfil the daily nutritional requirements for essential nutrients, such as to provide a significant part of those requirements, as the case may be, of the persons for whom they are intended; Whereas a number of products have been recently developed to be used as a replacement for snacks and to supply certain quantities of selected essential macronutrients and micronutrients; whereas the essential composition of those products will be adopted at a later date; Whereas, in addition, the energy provided by the products covered by this Directive must be restricted; Whereas the energy content of some products intended to replace the whole of the daily diet is very low; whereas specific rules for these very low energy products will be adopted at a later date; Whereas this Directive reflects current knowledge about these products; whereas any modification to allow innovation based on scientific and technical progress will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC; Whereas pursuant to Article 4 (2) of Directive 89/398/EEC, the provisions relating to the substances with specific nutritional purposes to be used in the manufacture of the products should be laid down in a separate Commission Directive; Whereas the provisions relating to the use of additives in the manufacture of the products should be laid down in the relevant Council Directives; Whereas pursuant to Article 7 of Directive 89/398/EEC, the products covered by this Directive are subject to the general rules laid down by 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 (2), as last amended by Commission Directive 93/102/EC (3); whereas this Directive adopts and expands upon the additions and exceptions to those general rules, where it is appropriate; Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling for the energy value and principal nutrients they contain; Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 1. This Directive is a 'specific Directive` within the meaning of Article 4 of Directive 89/398/EEC and lays down compositional and labelling requirements for foods for particular nutritional uses intended for use in energy restricted diets for weight reduction and presented as such. 2. Foods for use in energy-restricted diets for weight reduction are specially formulated foods which, when used as instructed by the manufacturer, replace the whole or part of the total daily diet. They are divided in two categories: (a) products presented as a replacement for the whole of the daily diet; (b) products presented as a replacement for one or more meals of the daily diet. Article 2 Member States shall ensure that the products referred to in Article 1 may be marketed within the Community only if they conform to the rules laid down in this Directive. Article 3 Foods covered by this Directive shall comply with the compositional criteria specified in Annex 1. Article 4 All individual components making up the products referred to in point (a) of Article 1 (2), as sold, shall be contained in the same package. Article 5 1. The name under which the product is sold shall be: (a) for products covered by point (a) of Article 1 (2), 'Total diet replacement for weight control`; (b) for products covered by point (b) of Article 1 (2), 'Meal replacement for weight control`. 2. The labelling of the products concerned shall bear, in addition to those provided for in Article 3 of Council Directive 79/112/EEC, the following mandatory particulars: (a) the available energy value expressed in kJ and kcal, and the content of proteins, carbohydrates and fat, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption; (b) the average quantity of each mineral and each vitamin for which mandatory requirements are stipulated in paragraph 5 of Annex 1, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption. In addition, for products mentioned in point (b) of Article 1 (2), information on vitamins and minerals listed in the Table of point 5 of Annex I shall also be expressed as a percentage of the values as defined in the Annex to Council Directive 90/496/EEC (4); (c) instructions for appropriate preparation, when necessary and a statement as to the importance of following those instructions; (d) if a product, when used as instructed by the manufacturer, provides a daily intake of polyols in excess of 20 g per day, there shall be a statement to the effect that the food may have a laxative effect; (e) a statement on the importance of maintaining an adequate daily fluid intake; (f) for products mentioned in point (a) of Article 1 (2): (i) a statement that the product provides adequate amounts of all essential nutrients for the day; (ii) a statement that the product should not be used for more than three weeks without medical advice; (g) for products mentioned in point (b) of Article 1 (2), a statement to the effect that the products are useful for the intended use only as part of an energy-restricted diet and that other foodstuffs should be a necessary part of such diet. 3. The labelling, advertising and presentation of the products concerned shall not make any reference to the rate or amount of weight loss which may result from their use or to a reduction in the sense of hunger or an increase in the sense of satiety. Article 6 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof. Those laws, regulations and administrative provisions shall be applied in such a way as to: - permit trade in products complying with this Directive, by 1 October 1997, - prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 7 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 8 This Directive is addressed to the Member States.

31996L0011

1996

Commission Directive 96/11/EC of 5 March 1996 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, After consulting the Scientific Committee for food, Whereas Article 3 (4) of Commission Directive 90/128/EEC (2), as last amended by Directive 95/3/EC (3), provides that, as from 1 January 1997, only those monomers and other starting substances listed in Annex II, Section A shall be used for the manufacture of plastic materials and articles, subject to the restrictions mentioned therein; whereas, however, it may be decided to postpone this time-limit, in some justified cases, for certain substances which may continue to be used at national level in accordance with Annex II, Section B; Whereas there are a certain number of substances for which the data requested by the Scientific Committee for Food have been supplied but not yet evaluated or are currently being or will be evaluated and therefore maintaining them is justified; Whereas there are a certain number of substances for which the data supplied to the Scientific Committee for Food permit the inclusion of these substances in the Community lists without any specific restriction; Whereas the Community measures envisaged by this Directive do not go beyond what is necessary to achieve the objectives already provided for in Directive 89/109/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 90/128/EEC is amended as follows: 1. Article 3 (4) is replaced by the following: '4. As from 1 January 2002, only those monomers and other starting substances listed in Annex II, Section A shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein. However, the substances listed in Annex II, Section B may be deleted before the abovementioned date if the data requested for inclusion in Section A are not supplied in time to permit their evaluation by the Scientific Committee for Food.` 2. Annex II is amended as follows: (a) the substances appearing in Annex I hereto are inserted in Section A in numerical order; (b) the substances appearing in Annex II hereto are deleted from Section B. 3. In Annex III, the substances appearing in Annex III hereto are inserted in numerical order. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1997. They shall immediately inform the Commission thereof. These laws and administrative provisions shall apply as follows: Member States should: - permit, as from 1 January 1997, the trade in and use plastic materials and articles intended to come into contact with foodstuffs complying with this Directive; - prohibit, as from 1 January 1999, the manufacture and importation into the Community of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive. 2. When Member States adopt the provisions provided for in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0012

1996

Commission Directive 96/12/EC of 8 March 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 95/36/EC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I of that Directive and for the authorization of a plant protection product; Whereas it is necessary to indicate, in Annexes II and III to Directive 91/414/EEC, to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files; Whereas it is now possible to introduce more precision with regard to the data requirements concerning ecotoxicological studies on the active substance provided for in Part A, point 8, of Annex II to Directive 91/414/EEC; Whereas it is also now possible to introduce more precision with regard to the data requirements concerning ecotoxicological studies on the plant protection product provided for in Part A, point 10, of Annex III to Directive 91/414/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 91/414/EEC is amended as follows: 1. In Part A of Annex II, point 8 'Ecotoxicological studies on the active substance` is replaced by Annex I hereto; 2. in Part A of Annex III, points 10 'Ecotoxicological studies` and 11 'Summary and evaluation of points 9 and 10` are replaced by Annex II hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 1997. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive shall enter into force on 1 April 1996. Article 4 This Directive is addressed to the Member States.

31996L0014

1996

Commission Directive 96/14/Euratom, ECSC, EC of 12 March 1996 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/66/EC (2), and in particular Article 13, second subparagraph, third and fourth indents thereof, Whereas certain provisions on protective measures in Greece against Phytophthora cinnamomi Rands and the bark beetle Ips typographus Heer, in Spain against the bark beetles Dendroctonus micans Kugelan, Ips amitinus Eichhof, Ips cembrae Heer, Ips duplicatus Sahlberg and Ips typographus Heer and in Italy against Curtobacterium flaccumfaciens pv. flaccumfaciens (Hedges) Collins and Jones, should be modified because it is no longer appropriate to maintain the current provisions set out in the said Directive; Whereas, furthermore certain provisions on protective measures against Dendroctonus micans Kugelan, Ips amitinus Eichhof, Ips cembrae Heer, Ips duplicatus Sahlberg, Ips sexdentatus Boerner, Ips typographus Heer and Pissodes spp. (European) for the relevant protected zones recognized for each type of harmful organism, should be modified to take account of the concern in relation to the relevant host plants of these organisms; Whereas similarly certain provisions on protective measures in Spain against Anthonomus grandis (boh.) should be modified to take into account the concerns in relation to the relevant production areas of Gossypium spp. and in relation to the risk of spread of this organism in unginned cotton; whereas also certain provisions on protective measures in Spain and Portugal against Sternochetus mangiferae Fabricius should be modified to take account of the concern in relation to the relevant production areas of Mangifera spp.; Whereas certain provisions on protective measures in one part of France, in Brittany, against Beet necrotic yellow vein virus should be improved; Whereas the protective measures against Erwinia amylovora (Burr.) Winsl. (et al.) adopted with respect to certain areas in France should be clarified; Whereas therefore the relevant Annexes of the said Directive 77/93/EEC should be amended accordingly; Whereas these amendments are in agreement with the requests of 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 indicated in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 April 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. The Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0019

1996

Commission Directive 96/19/EC of 13 March 1996 amending Directive 90/388/EEC with regard to the implementation of full competition in telecommunications markets Having regard to the Treaty establishing the European Community, and in particular Article 90 (3) thereof, Whereas: (1) According to Commission Directive 90/388/EEC of 28 June 1990 on competition in the markets for telecommunications services (1), as last amended by Directive 96/2/EC (2), telecommunications services, with the exception of voice telephony to the general public and those services specifically excluded from the scope of that Directive, must be open to competition. These services were the telex service, mobile communications and radio and television broadcasting to the public. Satellite communications were included in the scope of the Directive through Commission Directive 94/46/EC (3). Cable television networks were included in the scope of the Directive through Commission Directive 95/51/EC (4), and mobile and personal communications were included in the scope of the Directive through Directive 96/2/EC. Under Directive 90/388/EEC, Member States must take the measures necessary to ensure that any operator is entitled to supply such services. (2) Subsequent to the public consultation organized by the Commission in 1992 on the situation in the telecommunications sector (the 1992 Review), the Council, in its resolution of 22 July 1993 (5), unanimously called for the liberalization of all public voice telephony services by 1 January 1998, subject to additional transitional periods of up to five years to allow Member States with less developed networks, i.e. Spain, Ireland, Greece and Portugal, to achieve the necessary adjustments, in particular tariff adjustments. Moreover, very small networks should, according to the Council also be granted an adjustment period of up to two years where so justified. The Council subsequently unanimously recognized, in its resolution of 22 December 1994 (6), that the provision of telecommunications infrastructure should also be liberalized by 1 January 1998, subject to the same transitional periods as agreed for the liberalization of voice telephony. Furthermore, in its resolution of 18 September 1995 (7), the Council established basic guidelines for the future regulatory environment. (3) Directive 90/388/EEC establishes that the granting of special or exclusive rights to telecommunications services to telecommunications organizations is in breach of Article 90 of the Treaty, in conjunction with Article 59 of the Treaty, since they limit the provision of cross-border services. As far as telecommunications services and networks are concerned such special rights were defined in that Directive. According to Directive 90/388/EEC exclusive rights granted for the provision of telecommunications services are also incompatible with Article 90 (1) of the Treaty, in conjunction with Article 86 of the Treaty, where they are granted to telecommunications organizations which also enjoy exclusive or special rights for the establishment and the provision of telecommunications networks since their grant amounts to the reinforcement or the extension of a dominant position or necessarily leads to other abuses of such position. (4) In 1990, the Commission, however, granted a temporary exception under Article 90 (2) in respect of exclusive and special rights for the provision of voice telephony, since the financial resources for the development of the network still derived mainly from the operation of the telephony service and the opening-up of that service could, at that time, threaten the financial stability of the telecommunications organizations and obstruct the performance of the task of general economic interest assigned to them, consisting in the provision and exploitation of a universal network, i.e. one having general geographic coverage, and that connection to it is being provided to any service provider or user upon request within a reasonable period of time. Moreover, at the time of the adoption of Directive 90/388/EEC, all telecommunications organizations were also in the course of digitalizing their network to increase the range of services which could be provided to the final customers. Today, coverage and digitalization are already achieved in a number of Member States. Taking into account the progress in radio frequency applications and the on-going heavy investment programmes, optic fibre-coverage and network penetration are expected to improve significantly in the other Member States in the coming years. In 1990, concerns were also expressed against immediate introduction of competition in voice telephony while price structures of the telecommunications organizations were substantially out of line with costs, because competing operators could target highly profitable services such as international telephony and gain market share merely on the basis of existing substantially distorted tariff structures. In the meantime efforts have been made to balance differences in pricing and cost structures in preparation for liberalization. The European Parliament and the Council have in the meantime recognized that there are less restrictive means than the granting of special or exclusive rights to ensure this task of general economic interest. (5) For these reasons, and in accordance with the Council resolutions of 22 July 1993 and of 22 December 1994, the continuation of the exception granted with respect of voice telephony is no longer justified. The exception granted by Directive 90/388/EEC should be ended and the Directive, including the definitions used, amended accordingly. In order to allow telecommunications organizations to complete their preparation for competition and in particular to pursue the necessary rebalancing of tariffs, Member States may continue the current special and exclusive rights regarding the provision of voice telephony until 1 January 1998. Member States with less developed networks or with very small networks must be eligible for a temporary exception where this is warranted by the need to carry out structural adjustments and strictly only to the extent necessary for those adjustments. Such Member States should be granted, upon request, an additional transitional period respectively of up to five and of up to two years, provided it is necessary to complete the necessary structural adjustments. The Member States which may request such an exception are Spain, Ireland, Greece and Portugal with regard to less developed networks and Luxembourg with regard to very small networks. The possibility of such transitional periods has also been called for in the Council resolutions of 22 July 1993 and of 22 December 1994. (6) The abolition of exclusive and special rights as regards the provision of voice telephony will in particular allow the current telecommunications organizations from one Member State to directly provide their service in other Member States as from 1 January 1998. These organizations currently possess the skills and the experience required to enter into the markets opened to competition. However, in almost all Member States, they will compete with the national telecommunications organizations which are granted the exclusive or special right to provide not only voice telephony but also to establish and provide the underlying infrastructure, including the acquisition of indefeasible rights of use in international circuits. The flexibility and the economies of scope which this allows will prevent this dominant position being challenged in the normal course of competition once the liberalization of voice telephony takes place. This will make it possible for the telecommunications organizations to maintain their dominant position on their home markets unless the new entrants in the voice telephony market were entitled to the same rights and obligations. In particular, if new entrants are not granted free choice as regards the underlying infrastructure to provide their services in competition with the dominant operator, this restriction would de facto prevent them from entering the market for voice telephony, including for the provision of cross-border services. The maintenance of special rights limiting the number of undertakings authorized to establish and provide infrastructure would therefore limit the freedom to provide services contrary to Article 59 of the Treaty. The fact that the restriction on establishing own infrastructure would apparently apply in the Member State concerned without distinction to all companies providing voice telephony other than the national telecommunications organizations would not be sufficient to remove the preferential treatment of the latter from the scope of Article 59 of the Treaty. Given the fact that it is likely that most new entrants will originate from other Member States such a measure would in practice affect foreign companies to a larger extent than national undertakings. On the other hand, while no justification for these restrictions appears to exist, less restrictive means such as licensing procedures would in any event be available to ensure general interests of a non-economic nature. (7) In addition, the abolition of exclusive and special rights on the provision of voice telephony would have little or no effect, if new entrants would be obliged to use the public telecommunications network of the incumbent telecommunications organizations, with whom they compete in the voice telephony market. Reserving to one undertaking which markets telecommunications services the task of supplying the indispensable raw material, i.e. the transmission capacity, to all its competitors would be tantamount to conferring upon it the power to determine at will where and when services can be offered by its competitors, at what cost, and to monitor their clients and the traffic generated by its competitors, placing that undertaking in a position where it would be induced to abuse its dominant position. Directive 90/388/EEC did not explicitly address the establishment and provision of telecommunications networks, as it granted a temporary exception under Article 90 (2) of the Treaty in respect of exclusive and special rights for the by far most important service in economic terms provided over telecommunications networks, i.e. voice telephony. However, the Directive provided for an overall review by the Commission of the situation in the whole telecommunications sector in 1992. It is true that Council Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines, amended by Commission Decision 94/439/EC (8), harmonizes the basic principles regarding the provision of leased lines, but it only harmonizes the conditions of access and use of leased lines. The aim of that Directive is not to remedy the conflict of interest of the telecommunications organizations as infrastructure and service providers. It does not impose a structural separation between the telecommunications organizations as providers of leased lines and as service providers. Complaints illustrate that even in Member States which have implemented that Directive, telecommunications organizations still use their control of the access conditions to the network at the expense of their competitors in the services market. Complaints show that telecommunications organizations still apply excessive tariffs and that they use information acquired as infrastructure providers regarding the services planned by their competitors, to target clients in the services market. Directive 92/44/EEC only provides for the principle of cost-orientation and does not prevent telecommunications organizations to use the information acquired as capacity provider as regards subscribers' usage patterns, necessary to target specific groups of users, and on price elasticities of demand in each service market segment and region of the country. The current regulatory framework does not resolve the conflict of interest mentioned above. The most appropriate remedy to this conflict of interest is therefore to allow service providers to use own or third party telecommunications infrastructure to provide their services to the final customers instead of the infrastructure of their main competitor. In its resolution of 22 December 1994 the Council also approved the principle that infrastructure provision should be liberalized. Member States should therefore abolish the current exclusive rights on the provision and use of infrastructure which infringe Article 90 (1) of the Treaty, in combination with Articles 59 and 86 of the Treaty, and allow voice telephony providers to use own and/or any alternative infrastructure of their choice. (8) Directive 90/388/EEC states that the rules of the Treaty, including those on competition, apply to telex services. At the same time it establishes that the granting of special or exclusive rights for telecommunications services to telecommunications organizations is in breach of Article 90 (1) of the Treaty, in conjunction with Article 59 of the Treaty, since they limit the provision of cross-border services. However, it was considered in the Directive that an individual approach was appropriate, as a rapid decline of the service was expected. It the meantime it has become clear that the telex service will continue to coexist with new services like facsimile in the forseeable future, given that the telex network is still the only standardized network with worldwide coverage and providing legal proof in Court. It is therefore no longer justified to maintain the initial approach. (9) As regards the access of new competitors to the telecommunications markets, only mandatory requirements can justify restrictions to the fundamental freedoms provided for in the Treaty. These restrictions should be limited to what is necessary to achieve the objective of a non-economic nature pursued. Member States may therefore only introduce licensing or declaration procedures where it is indispensable to ensure compliance with the applicable essential requirements and, with regard to the provision of voice telephony and the underlying infrastructure, introduce requirements in the form of trade regulations where it is necessary in order to ensure, in accordance with Article 90 (2) of the Treaty, the performance in a competitive environment of the particular tasks of public service assigned to the relevant undertakings in the telecommunications field and/or to ensure a contribution to the financing of universal service. Other public service requirements can be included by Member States in certain categories of licences, in line with the principle of proportionality and in conformity with Articles 56 and 66 of the Treaty. The provisions of Directive 90/388/EEC are therefore not to prejudice the applicability of provisions laid down by law, regulation or administrative action providing for the protection of public security and in particular the lawful interception of communications. In the framework of the adoption of authorization requirements under Directive 90/388/EEC, it appeared that certain Member States were imposing obligations on new entrants which where not in proportion with the aims of general interest pursued. To avoid such measures being used to prevent the dominant position of the telecommunications organizations being challenged by competition once the liberalization of voice telephony takes place, thus making it possible for the telecommunications organizations to maintain their dominant position in the voice telephony and public telecommunications networks markets and thereby strengthening the dominant position of the incumbent operator, it is necessary that Member States should notify any licensing or declaration requirements to the Commission, before they are introduced, to enable the latter to assess their compatibility with the Treaty and in particular the proportionality of the obligations imposed. (10) According to the principle of proportionality, the number of licences may only be limited where this is unavoidable to ensure compliance with essential requirements concerning the use of scarce resources. As the Commission stated in its communication on the consultation on the Green Paper on the liberalization of telecommunications infrastructure and cable television networks, the sole reason in this respect should be the existence of physical limitations, imposed by the lack of necessary frequency spectrum. As regards the provision of voice telephony, public fixed telecommunications networks and other telecommunications networks involving the use of radio frequencies, the essential requirements would justify the introduction or maintenance of an individual licensing procedure. In all other cases, a general authorization or a declaration procedure suffices to ensure compliance with the essential requirements. Licensing is not justified when a mere declaration procedure would suffice to attain the relevant objective. As regards the provision of packet- or circuit-switched data services, Directive 90/388/EEC allowed the Member States under Article 90 (2) of the Treaty to adopt specific sets of public service specifications in the form of trade regulations with a view to preserving the relevant public service requirements. The Commission has in the course of 1994 assessed the effects of the measures adopted under this provision. The results of this review were made public in its Communication on the status and the implementation of Directive 90/388/EEC. On the basis of that review, which also took account of the experience in most Member States where the relevant public service objectives were achieved without the implementation of such schemes, there is no justification to continue this specific regime and the current schemes should be abolished accordingly. However, Member States may replace these schemes by a declaration or a general authorization procedure. (11) Newly authorized voice telephony providers will be able to compete effectively with the current telecommunications organizations only if they are granted adequate numbers to allocate to their customers. Moreover, where numbers are allocated by the current telecommunications organizations, the latter will be induced to reserve the best numbers for themselves and to give their competitors insufficient numbers or numbers which are commercially less attractive, for example, because of their length. By maintaining such power in the hands of their telecommunications organizations Member States would therefore induce the former to abuse their power on the market for voice telephony and infringe Article 90 of the Treaty, in conjunction with Article 86 of the Treaty. Consequently, the establishment and administration of the national numbering plan should be entrusted to a body independent from the telecommunications organization, and a procedure for the allocation of numbers should, where required, be drafted, which is based on objective criteria, is transparent and without discriminatory effects. Where a subscriber changes service providers, telecommunications organizations should communicate, in the way and to the extent required by Article 86 of the Treaty, the information on his new number for a sufficient period of time to parties seeking to contact him under his old number. Subscribers changing service providers should also have the possibility of keeping their numbers in return for a reasonable contribution to the cost of transferring the numbers. (12) As Member States are obliged by this Directive to withdraw special and exclusive rights for the provision and operation of fixed public telecommunications networks, the obligation set out in Directive 90/388/EEC to take the necessary measures to ensure objective, non-discriminatory and published access conditions should be adapted accordingly. (13) Subject to reasonable compensation, the right of new providers of voice telephony to interconnect their service for call completion purposes with the existing public telecommunications network at the necessary interconnection points, including access to customer databases necessary for the provision of directory information, is of crucial importance in the initial period after the abolition of the special and exclusive rights regarding voice telephony and telecommunications infrastructure provision. Interconnection should in principle be a matter for negotiation between the parties, subject to the application of the competition rules addressed to undertakings. Given the imbalance in negotiating power of new entrants compared with the telecommunications organizations whose monopoly position results from their special and exclusive rights, it is likely that, as long as a harmonized regulatory framework has not been established by the European Parliament and the Council, interconnection would be delayed by disputes as to terms and conditions to be applied. Such delays would jeopardize the market entry of new entrants and hence prevent the abolition of special and exclusive rights to become effective. The failure by Member States to adopt the necessary safeguards to prevent such a situation would lead to a continuation de facto of the current special and exclusive rights, which as set out above are considered to be incompatible with Article 90 (1) of the Treaty, in conjunction with Articles 59 and 86 of the Treaty. In order to allow for effective market entry and to prevent the de facto continuation of special and exclusive rights contrary to Article 90 (1) of the Treaty, in conjunction with Articles 59 and 86 of the Treaty, Member States should ensure that, during the time period necessary for such entry by competitors, telecommunications organizations publish standard terms and conditions for interconnection to the voice telephony networks which they offer to the public, including interconnect price lists and access points, no later than six months before the actual date of liberalization of voice telephony and telecommunications transmission capacity. Such standard offers should be non-discriminatory and sufficiently unbundled to allow the new entrants to purchase only those elements of the interconnection offer they actually need. Furthermore, they may not discriminate on the basis of the origin of the calls and/or the networks. (14) Moreover in order to allow the monitoring of interconnection obligations under competition law, the cost accounting system implemented with regard to the provision of voice telephony and public telecommunications networks should, during the time period necessary to allow for effective market entry, clearly identify the cost elements relevant for pricing interconnection offerings and, in particular for each element of the interconnection offered, identify the basis for that cost element, in order to ensure in particular that this pricing includes only elements which are relevant, namely the initial connection charge, conveyance charges, the share of the costs incurred in providing equal access and number-portability and of ensuring essential requirements and, where applicable, supplementary charges aimed to share the net cost of universal service, and provisionally, imbalances in voice telephony tariffs. Such cost accounting should also make it possible to identify when a telecommunications organization charges its major users less than providers of voice telephony networks. The absence of a quick, cheap and effective procedure to solve interconnection disputes, and one which would prevent the telecommunications organizations causing delays or using their financial resources to increase the cost of available remedies under applicable national law or Community law, would make it possible for the telecommunications organizations to maintain their dominant position. Member States should therefore establish a specific recourse procedure for interconnection disputes. (15) The obligation to publish standard charges and interconnection conditions is without prejudice to the requirement on undertakings in a dominant position, under Article 86 of the Treaty, to negotiate special or tailor-made agreements for a particular combination or use of unbundled public switched telephony network components and/or the granting of discounts for particular service providers or large users where these are justified and non-discriminatory. Any interconnection discounts should be justified on an objective basis and be transparent. (16) The requirement to publish standard interconnection conditions is also without prejudice to the obligation of dominant undertakings under Article 86 of the Treaty to allow interconnected operators on whose network a call originates to remain responsible for setting the tariff for the customer between the calling and the called party and for routing its clients' traffic up to the interconnection point of its choice. (17) A number of Member States are currently still maintaining exclusive rights with regard to the establishment and provision of telephone directory and enquiry services. These exclusive rights are generally granted either to organizations which are already enjoying a dominant position in providing voice telephony, or to one of their subsidiaries. In such a situation, these rights have the effect of extending the dominant position enjoyed by those organizations and therefore strengthening that position, which, according to the case-law of the Court of Justice of the European Communities, constitutes an abuse of a dominant position contrary to Article 86. The exclusive rights granted in the area of telephone directory services are consequently incompatible with Article 90 (1) of the Treaty, in conjunction with Article 86. These exclusive rights consequently have to be abolished. (18) Directory information constitutes an essential access tool for telephony services. In order to ensure the availability of directory information to subscribers to all voice telephony services, Member States may include obligations for the provision of directory information to the general public within individual licences and general authorizations. Such an obligation should not, however, restrict the provision of such information by new technological means, nor the provision of specialized and/or regional and local directories contrary to Article 90 (1) of the Treaty, in conjunction with point (b) of the second paragraph of Article 86 of the Treaty. (19) In the case where universal service can be provided only at a loss or provided under costs falling outside normal commercial standards, different financing schemes can be envisaged to ensure universal service. The emergence of effective competition by the dates established for full liberalization would, however, be seriously delayed if Member States were to implement a financing scheme allocating too heavy a share of any burden to new entrants or were to determine the size of the burden beyond what is necessary to finance the universal service. Financing schemes disproportionately burdening new entrants and accordingly preventing the dominant position of the telecommunications organizations being challenged by competition once the liberalization of voice telephony takes place, thus making it possible for the telecommunications organizations to entrench their dominant position, would be in breach of Article 90 of the Treaty, in conjunction with Article 86 of the Treaty. Whichever financing scheme they decide to implement, Member States should ensure that only providers of public telecommunications networks contribute to the provision and/or financing of universal service obligations harmonized in the framework of ONP and that the method of allocation amongst them is based on objective and non-discriminatory criteria and is in accordance with the principle of proportionality. This principle does not prevent Member States from exempting new entrants which have not yet achieved any significant market presence. Moreover, the funding mechanisms adopted should seek only to ensure that market participants contribute to the financing of universal service, and not to other activities not directly linked to the provision of the universal service. (20) As regards the cost structure of voice telephony, a distinction must be made between the initial connection, the monthly rental, local calls, regional calls and long distance calls. The tariff structure of voice telephony provided by the telecommunications organizations in certain Member States is currently still out of line with cost. Certain categories of calls are provided at a loss and are cross-subsidized out of the profits from other categories. Artificially low prices, however, impede competition since potential competitors have no incentive to enter into the relevant segment of the voice telephony market and are contrary to Article 86 of the Treaty, as long as they are not justified under Article 90 (2) of the Treaty as regards specific identified end-users or groups of end-users. Member States should phase out as rapidly as possible all unjustified restrictions on tariff rebalancing by the telecommunications organizations and in particular those preventing the adaptation of rates which are not in line with costs and increase the burden of universal service provision. Where this is justified, the proportion of net costs insufficiently covered by the tariff structure may be reapportioned among all parties concerned in a non-discriminatory and transparent manner. (21) As re-balancing could make certain telephone service less affordable in the short term for certain groups of users, Member States may adopt special provisions to soften the impact of re-balancing. In this way, the affordability of the telephone service during the transitional period would be guaranteed while telecommunications operators would still be able to continue their re-balancing process. This is in line with the statement of the Commission concerning the Council resolution on universal service (9), which states that there should be reasonable and affordable prices throughout the territory for initial connection, subscription, periodic rental, access and the use of the service. (22) Where Member States entrust the application of the financing scheme of universal service obligations to their telecommunications organization with the right to recoup a share of it from competitors, the former will be induced to charge a higher amount than justified, if Member States would not ensure that the amount charged to finance universal service is made separate and explicit with respect to interconnection (connection and conveyance) charges. In addition, the mechanism should be closely monitored and efficient procedures for timely appeal to an independent body to settle disputes as to the amount to be paid must be provided, without prejudice to other available remedies under national law or Community law. The Commission should review the situation in Member States five years after the introduction of full competition, to ascertain whether this financing scheme does not lead to situations which are incompatible with Community law. (23) Providers of public telecommunications networks require access to pathways across public and private property to place facilities needed to reach the end users. The telecommunications organizations in many Member States enjoy legal privileges to install their network on public and private land, without charge or at charges set simply to recover incurred costs. If Member States do not grant similar possibilities to new licensed operators to enable them to roll out their network, this would delay them and in certain areas be tantamount to maintaining exclusive rights in favour of the telecommunications organization. Moreover Article 90 of the Treaty, in conjunction with Article 59 of the Treaty, requires that Member States should not discriminate against new entrants, who generally will originate from other Member States, in comparison with their national telecommunications organizations and other national undertakings, which have been granted rights of way facilitating the roll out of their telecommunications networks. Where essential requirements, in particular with regard to the protection of the environment or with regard to town and country planning objectives, would oppose the granting of similar rights of way to new entrants which do not already have their own infrastructure, Member States should at least ensure that the latter have, where it is technically feasible, access, on reasonable terms, to the existing ducts or poles, established under rights of way by the telecommunications organization, where these facilities are necessary to roll out their network. In the absence of such requirements the telecommunications organizations would be induced to limit access by their competitors to these essential facilities and thus abuse their dominant position. A failure to adopt such requirements would therefore be contrary to Article 90 (1) of the Treaty, in conjunction with Article 86 of the Treaty. In addition, pursuant to Article 86, all public telecommunications network operators having essential resources for which competitors do not have economic alternatives are to provide open and non-discriminatory access to those resources. (24) The abolition of special and exclusive rights in the telecommunications markets will allow undertakings enjoying special and exclusive rights in sectors other than telecommunications to enter the telecommunications markets. In order to allow for monitoring under the applicable rules of the Treaty of possible anti-competitive cross-subsidies between, on the one hand, areas for which providers of telecommunications services or telecommunications infrastructures enjoy special or exclusive rights and, on the other, their business as telecommunications providers, Member States should take the appropriate measures to achieve transparency as regards the use of resources from such protected activities to enter in the liberalized telecommunications market. Member States should at least require such undertakings once they achieve a significant turnover in the relevant telecommunications service and/or infrastructure provision market, to keep separate financial records, distinguishing between inter alia, costs and revenues associated with the provision of services under their special and exclusive rights and those provided under competitive conditions. For the time being, a turnover of more than ECU 50 million could be considered as a significant turnover. (25) Most Member States also currently maintain exclusive rights for the provision of telecommunications infrastructure for the supply of telecommunications services other than voice telephony. Under Directive 92/44/EEC, Member States must ensure that the telecommunications organizations make available certain types of leased lines to all providers of telecommunications services. However, the Directive provides only for such offer of a harmonized set of leased lines up to a certain bandwidth. Companies needing a higher bandwidth to provide services based on new high-speed technologies such as SDH (synchronous digital hierarchy) have complained that the telecommunications organizations concerned are unable to meet their demand whilst it could be met by the optic fibre networks of other potential providers of telecommunications infrastructure, in the absence of the current exclusive rights. Consequently, the maintenance of these rights delays the emergence of new advanced telecommunications services and therefore restricts technical progress at the expense of the users contrary to Article 90 (1) of the Treaty, in conjunction with point (b) of the second paragraph of Article 86 of the Treaty. (26) Given that the lifting of such rights will concern mainly services which are not yet provided and does not concern voice telephony, which is still the main source of revenue of those organizations, it will not destabilize the financial situation of the telecommunications organization. There is consequently no justification to maintain exclusive rights on the establishment and use of network infrastructure for services other than voice telephony. In particular, Member States should ensure that all restrictions on the provision of telecommunications services other than voice telephony over networks established by the provider of the telecommunications service, the use of infrastructures provided by third parties and the sharing of networks, other facilities and sites are lifted as from 1 July 1996. In order to take account of the specific situation in Member States with less-developed networks and in Member States with very small networks, the Commission will grant, upon request, additional transitional periods. (27) Whilst Directive 95/51/EC lifted all restrictions with regard to the provision of liberalized telecommunications services over cable television networks, some Member States still maintain restrictions on the use of public telecommunications networks for the provision of cable television capacity. The Commission should assess the situation with regard to such restrictions in the light of the objectives of that Directive once the telecommunications markets approach full liberalization. (28) The abolition of all special and exclusive rights which restrict the provision of telecommunications services and underlying networks by undertakings established in the Community is without regard to the destination or the origin of the communications concerned. However, Directive 90/388/EEC does not prevent measures regarding undertakings, which are not established in the Community, being adopted in accordance with Community law and existing international obligations so as to ensure that nationals of Member States are afforded comparable and effective treatment in third countries. Community undertakings should benefit from effective and comparable access to third country markets and enjoy a similar treatment in a third country as is offered by the Community framework to undertakings owned, or effectively controlled, by nationals of the third country concerned. World Trade Organization telecommunications negotiations should result in a balanced and multilateral agreement, ensuring effective and comparable access for Community operators in third countries. (29) The process of implementing full competition in telecommunications markets raises important issues in the social and employment fields. These are referred to in the Commission's communication on the consultation on the Green Paper on the liberalization of telecommunications infrastructure and cable television networks of 3 May 1995. Always remaining in line with a horizontal policy approach, efforts should now be undertaken to support the transition process to a fully liberalized telecommunications environment; responsibility for such measures rests mainly at Member State level, although Community structures, such as the European Social Fund, may also play a part. In line with existing initiatives, the Community should play a role in facilitating the adaptation and retraining of those whose traditional activities are likely to disappear during the process of industrial restructuring. (30) The establishment of procedures at national level concerning licensing, interconnection, universal service, numbering and rights of way is without prejudice to the harmonization of the latter by appropriate European Parliament and Council legislative instruments, in particular in the framework of open network provision (ONP). The Commission should take whatever measures it considers appropriate to ensure the consistency of these instruments and Directive 90/388/EEC, Article 1 Directive 90/388/EEC is amended as follows: 1. Article 1 is amended as follows: (a) Paragraph 1 is amended as follows: (i) The fourth indent is replaced by the following: '- "public telecommunications network" means a telecommunications network used inter alia for the provision of public telecommunications services; - "public telecommunications service" means a telecommunications service available to the public,`. (ii) The 15th indent is replaced by the following: '- "essential requirements" means the non-economic reasons in the general interest which may cause a Member State to impose conditions on the establishment and/or operation of telecommunications networks or the provision of telecommunications services. These reasons are security of network operations, maintenance of network integrity, and, in justified cases, interoperability of services, data protection, the protection of the environment and town and country planning objectives as well as the effective use of the frequency spectrum and the avoidance of harmful interference between radio based telecommunications systems and other, space-based or terrestrial, technical systems. Data protection may include protection of personal data, the confidentiality of information transmitted or stored as well as the protection of privacy.` (iii) The following indents are added: '- "telecommunications network" means the transmission equipment and, where applicable, switching equipment and other resources which permit the conveyance of signals between defined termination points by wire, by radio, by optical or by other electromagnetic means; - "interconnection" means the physical and logical linking of the telecommunications facilities of organizations providing telecommunications networks and/or telecommunications services, in order to allow the users of one organization to communicate with the users of the same or another organization or to access services provided by third organizations.` (b) Paragraph 2 is deleted. 2. Article 2 is replaced by the following: 'Article 2 1. Member States shall withdraw all those measures which grant: (a) exclusive rights for the provision of telecommunications services, including the establishment and the provision of telecommunications networks required for the provision of such services; or (b) special rights which limit to two or more the number of undertakings authorized to provide such telecommunications services or to establish or provide such networks, otherwise than according to objective, proportional and non-discriminatory criteria; or (c) special rights which designate, otherwise than according to objective, proportional and non-discriminatory several competing undertakings to provide such telecommunications services or to establish or provide such networks. 2. Member States shall take the measures necessary to ensure that any undertaking is entitled to provide the telecommunications services referred to in paragraph 1 or to establish or provide the networks referred to in paragraph 1. Without prejudice to Article 3c and the third paragraph of Article 4, Member States may maintain special and exclusive rights until 1 January 1998 for voice telephony and for the establishment and provision of public telecommunications networks. Member States shall, however, ensure that all remaining restrictions on the provision of telecommunications services other than voice telephony over networks established by the provider of the telecommunications services, over infrastructures provided by third parties and by means of sharing of networks, other facilities and sites are lifted and the relevant measures notified to the Commission no later than 1 July 1996. As regards the dates set out in the second and third subparagraphs of this paragraph, in Article 3 and in Article 4a (2), Member States with less developed networks shall be granted upon request an additional implementation period of up to five years and Member States with very small networks shall be granted upon request an additional implementation period of up to two years, provided it is needed to achieve the necessary structural adjustments. Such a request must include a detailed description of the planned adjustments and a precise assessment of the timetable envisaged for their implementation. The information provided shall be made available to any interested party on demand having regard to the legitimate interest of undertakings in the protection of their business secrets. 3. Member States which make the supply of telecommunications services or the establishment or provision of telecommunications networks subject to a licensing, general authorization or declaration procedure aimed at compliance with the essential requirements shall ensure that the relevant conditions are objective, non-discriminatory, proportionate and transparent, that reasons are given for any refusal, and that there is a procedure for appealing against any refusal. The provision of telecommunications services other than voice telephony, the establishment and provision of public telecommunications networks and other telecommunications networks involving the use of radio frequencies, may be subjected only to a general authorization or a declaration procedure. 4. Member States shall communicate to the Commission the criteria on which licences, general authorizations and declaration procedures are based together with the conditions attached thereto. Member States shall continue to inform the Commission of any plans to introduce new licensing, general authorization and declaration procedures or to change existing procedures.` 3. Article 3 is replaced by the following: 'Article 3 As regards voice telephony and the provision of public telecommunications networks, Member States shall, no later than 1 January 1997, notify to the Commission, before implementation, any licensing or declaration procedure which is aimed at compliance with: - essential requirements, or - trade regulations relating to conditions of permanence, availability and quality of the service, or - financial obligations with regard to universal service, according to the principles set out in Article 4c. Conditions relating to availability can include requirements to ensure access to customer databases necessary for the provision of universal directory information. The whole of these conditions shall form a set of public-service specifications and shall be objective, non-discriminatory, proportionate and transparent. Member States may limit the number of licences to be issued only where related to the lack of availability spectrum and justified under the principle of proportionality. Member States shall ensure, no later than 1 July 1997, that such licensing or declaration procedures for the provision of voice telephony and of public telecommunications networks are published. Before they are implemented, the Commission shall verify the compatibility of these drafts with the Treaty. As regards packet- or circuit-switched data services, Member States shall abolish the adopted set of public-service specifications. They may replace these by the declaration procedures or general authorizations referred to in Article 2.` 4. In Article 3b, the following paragraph is added: 'Member States shall ensure, before 1 July 1997, that adequate numbers are available for all telecommunications services. They shall ensure that numbers are allocated in an objective, non-discriminatory, proportionate and transparent manner, in particular on the basis of individual application procedures.` 5. In Article 4, the first paragraph is replaced by the following: 'As long as Member States maintain special or exclusive rights for the provision and operation of fixed public telecommunications networks they shall take the necessary measures to make the conditions governing access to the networks objective and non-discriminatory and shall publish them.` 6. The following Articles 4a to 4d are inserted: 'Article 4a 1. Without prejudice to future harmonization of the national interconnection regimes by the European Parliament and the Council in the framework of ONP, Member States shall ensure that the telecommunications organizations provide interconnection to their voice telephony service and their public switched telecommunications network to other undertakings authorized to provide such services or networks, on non-discriminatory, proportional and transparent terms, which are based on objective criteria. 2. Member States shall ensure in particular that the telecommunications organizations publish, no later than 1 July 1997, the terms and conditions for interconnection to the basic functional components of their voice telephony service and their public switched telecommunications networks, including the interconnection points and the interfaces offered according to market needs. 3. Furthermore, Member States shall not prevent that organizations providing telecommunications networks and/or services who so request can negotiate interconnection agreements with telecommunications organizations for access to the public switched telecommunications network regarding special network access and/or conditions meeting their specific needs. If commercial negotiations do not lead to an agreement within a reasonable time period, Member States shall upon request from either party and within a reasonable time period, adopt a reasoned decision which establishes the necessary operational and financial conditions and requirements for such interconnection without prejudice to other remedies available under the applicable national law or under Community law. 4. Member States shall ensure that the cost accounting system implemented by telecommunications organizations with regard to the provision of voice telephony and public telecommunications networks identifies the cost elements relevant for pricing interconnection offerings. 5. The measures provided for in paragraphs 1 to 4 shall apply for a period of five years from the date of the effective abolition of special and exclusive rights for the provision of voice telephony granted to the telecommunications organization. The Commission shall, however, review this Article if the European Parliament and the Council adopt a directive harmonizing interconnection conditions before the end of this period. Article 4b Member States shall ensure that all exclusive rights with regard to the establishment and provision of directory services, including both the publication of directories and directory enquiry services, on their territory are lifted. Article 4c Without prejudice to the harmonization by the European Parliament and the Council in the framework of ONP, any national scheme which is necessary to share the net cost of the provision of universal service obligations entrusted to the telecommunications organizations, with other organizations whether it consists of a system of supplementary charges or a universal service fund, shall: (a) apply only to undertakings providing public telecommunications networks; (b) allocate the respective burden to each undertaking according to objective and non-discriminatory criteria and in accordance with the principle of proportionality. Member States shall communicate any such scheme to the Commission so that it can verify the scheme's compatibility with the Treaty. Member States shall allow their telecommunications organizations to re-balance tariffs taking account of specific market conditions and of the need to ensure the affordability of a universal service, and, in particular, Member States shall allow them to adapt current rates which are not in line with costs and which increase the burden of universal service provision, in order to achieve tariffs based on real costs. Where such rebalancing cannot be completed before 1 January 1998 the Member States concerned shall report to the Commission on the future phasing out of the remaining tariff imbalances. This shall include a detailed timetable for implementation. In any case, within three months after the European Parliament and the Council adopt a Directive harmonizing interconnection conditions, the Commission will assess whether further initiatives are necessary to ensure the consistency of both Directives and take the appropriate measures. In addition, the Commission shall, no later than 1 January 2003, review the situation in the Member States and assess in particular whether the financing schemes in place do not limit access to the relevant markets. In this case, the Commission will examine whether there are other methods and make any appropriate proposals. Article 4d Member States shall not discriminate between providers of public telecommunications networks with regards to the granting of rights of way for the provision of such networks. Where the granting of additional rights of way to undertakings wishing to provide public telecommunications networks is not possible due to applicable essential requirements, Member States shall ensure access to existing facilities established under rights of way which may not be duplicated, at reasonable terms.` 7. In the first paragraph of Article 7, the words 'numbers, as well as the` are inserted before the word 'surveillance`. 8. Article 8 is replaced by the following: 'Article 8 Member States shall, in the authorization schemes for the provision of voice telephony and public telecommunications networks, at least ensure that where such authorization is granted to undertakings to which they also grant special or exclusive rights in areas other than telecommunications, such undertakings keep separate financial accounts as concerns activities as providers of voice telephony and/or networks and other activities, as soon as they achieve a turnover of more than ECU 50 million in the relevant telecommunications market.` 9. Article 9 is replaced by the following: 'Article 9 By 1 January 1998, the Commission will carry out an overall assessment of the situation with regard to remaining restrictions on the use of public telecommunications networks for the provision of cable television capacity.` Article 2 Member States shall supply to the Commission, not later than nine months after this Directive has entered into force, such information as will allow the Commission to confirm that points 1 to 8 of Article 1 are complied with. This Directive is without prejudice to existing obligations of the Member States to communicate, no later than 31 December 1990, 8 August 1995 and 15 November 1996 respectively, measures taken to comply with Directives 90/388/EEC, 94/46/EC and 96/2/EC. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0015

1996

Commission Directive 96/15/EC of 14 March 1996 amending Directive 92/76/EEC recognizing protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/66/EC (2), and in particular the first subparagraph of Article 2 (1) (h) thereof, Whereas under Commission Directive 92/76/EEC (3), as last amended by Directive 95/65/EC (4), certain zones in the Community were recognized as 'protected zones` in respect of certain harmful organisms for a period expiring on 1 April 1996; Whereas, based on recent new information provided by Greece, it appears that it is no longer appropriate to maintain the 'protected zone` recognized for Greece in respect of Ips typographus Heer, because this organism seems to be present locally; Whereas also from new information provided by Greece, Italy and Spain it appears that it is no longer appropriate to maintain the 'protected zones` recognized, for Greece in respect of Phytophthora cinnamomi Rands, for Italy in respect of Curtobacterium flaccumfaciens pv. flaccumfaciens (Hedges) Collins and Jones, and for Spain in respect of Dendroctonus micans Kugelan, Ips amitinus Eichhof, Ips cembrae Heer, Ips duplicatus Sahlberg and Ips typographus Heer to take account of the concern in relation to the production and distribution of the relevant host plants of these organisms; whereas, also the extent of the protected zones recognized for Spain in respect of Anthonomus grandis Boh. and for Spain and Portugal in respect of Sternochetus mangiferae Fabricius should be modified to take account of the concern in relation to the relevant production areas of Gossypium spp. and Mangifera spp. respectively; Whereas from new information supplied by France a protected zone should be recognized for France in respect of Beet necrotic yellow vein virus; Whereas, from information supplied by the United Kingdom and from the survey monitoring information gathered by Commission experts it appears that the provisional recognition of the protected zone for the United Kingdom in respect of Beet necrotic yellow vein virus should be extended for a further period to enable the responsible official bodies of the United Kingdom to complete the information on the distribution of Beet necrotic yellow vein virus and to complete their efforts for the eradication of this harmful organism in the East Anglian area of the United Kingdom; Whereas, furthermore, from information supplied by Ireland and Italy and from survey monitoring information gathered by Commission experts it appears that the provisional recognition of the protected zones for Ireland and Italy in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended for a further period to enable the responsible official bodies of Ireland and Italy to complete their efforts to eradicate the harmful organism in the area around Dublin and in the region of Apulia, respectively; Whereas it should be established that the extension of the recognition beyond the dates referred to in Article 1, and any amendment to the list of protected zones referred to in Article 1, shall be made in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC, taking into account the results of appropriate surveys based on Community conditions and monitored by Commission experts; Whereas in absence of any extension of the recognition beyond the dates referred to in Article 1, the relevant protected zones cease on these dates, to be 'protected zones` within the meaning of Directive 77/93/EEC, including its Annexes; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 92/76/EEC is hereby amended as follows: 1. Article 1, first subparagraph shall be replaced as follows: 'The zones in the Community listed in the Annex are hereby recognized as "protected zones" referred to in the first subparagraph of Article 2 (1) (h) of Directive 77/93/EEC, in respect of harmful organism(s) listed against their names in the Annex; in the case of points (a) 17, (b) 3, (c) 5 and (d) 3, the said zones are recognized for a period expiring on 1 April 1996; in the case of (b) 2 for Ireland and the region of Apulia in Italy the said zones are recognized until 31 December 1997; and in the case of point (d) 1, for the United Kingdom, the said zone is recognized until 1 November 1999, and for France, the zone is recognized until 31 December 1997.` 2. In Article 2, the word 'date` shall be replaced by the word 'dates`. 3. The Annex shall be amended as indicated in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 April 1996. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0020

1996

Commission Directive 96/20/EC of 27 March 1996 adapting to technical progress Council Directive 70/157/EEC relating to the permissible sound level and the exhaust system of motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970, on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 95/54/EC (2) and in particular Article 13 (2) thereof, Having regard to Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (3), as last amended by Directive 92/97/EEC (4), and in particular Article 3 thereof, Whereas Directive 70/157/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas, the recent developments in engine technology make it necessary to define more explicitly the testing process, particularly in the case of heavy vehicles, insofar as the feasibility and the repetition of such tests is concerned; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 1. The Articles of Directive 70/157/EEC shall be amended as follows: - Article 1 to read at the end: '. . . rails and of agricultural and forestry tractors and all mobile machinery.`, - in Article 2, second indent, and Article 2a, paragraph 2, replace 'Article 9a` by 'Article 2`, - in Article 3, replace 'the Annex` by 'the Annexes`. 2. The Annexes to Directive 70/157/EEC shall be amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 October 1996 Member States may not, on grounds relating to the permissible sound level or the exhaust system: - refuse, in respect of a type of vehicle or a type of exhaust system, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of exhaust systems, if the vehicles or exhaust systems comply with the requirements of Directive 70/157/EEC, as amended by this Directive. 2. With effect from 1 January 1997 Member States: - shall no longer grant EC type-approval, and - shall refuse to grant national type-approval, for a type of vehicle on grounds relating to its permissible sound level and for a type of exhaust system, if the requirements of Directive 70/157/EEC, as amended by this Directive, are not fulfilled. 3. Notwithstanding paragraph 2, for the purposes of replacement parts, Member States shall continue to grant EC type-approval, and to permit the sale and entry into service, of exhaust systems in accordance with previous versions of Directive 70/157/EEC provided that such exhaust systems: - are intended to be fitted to vehicles already in use, and - comply with the requirements of that Directive which were applicable when the vehicles were first registered. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1996. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force the twentieth day after its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0021

1996

Council Directive 96/21/EC of 29 March 1996 amending Commission Directive 94/54/EC concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Directive 79/112/EEC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), and in particular Article 4 (2) thereof, Having regard to European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs, and in particular Article 6 thereof (2), Having regard to the proposal from the Commission, Whereas Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Directive 79/112/EEC (3) contains a list of foodstuffs for which the labelling must include one or more additional particulars; Whereas the purpose of this Directive is to supplement the said Annex with regard to foodstuffs containing sweeteners; Whereas, having regard to the scope and effects of the proposed action, the Community measures introduced by this Directive are not only necessary but essential if the objectives set are to be attained; whereas those objectives cannot be attained by the Member States acting individually; whereas, moreover, Directive 94/35/EC already provides for the attainment of such objectives at Community level; Whereas, with a view to providing adequate consumer information, the labelling of foodstuffs which contain sweeteners must bear details to that effect; Whereas, moreover, warnings should also be given on the labelling of foodstuffs containing certain categories of sweetener; Whereas, in accordance with the procedure laid down in Article 17 of Directive 79/112/EEC and Article 7 of Directive 94/35/EC, a draft of this Directive was submitted to the Standing Committee on Foodstuffs; whereas the latter was unable to deliver an opinion; whereas in accordance with that same procedure the Commission has submitted a proposal to the Council regarding the measures to be adopted, Article 1 The Annex to Directive 94/54/EC is hereby supplemented as follows: >TABLE> Article 2 Member States shall, where necessary, amend their laws, regulations and administrative provisions before 1 July 1996 so as to: - allow trade in products complying with this Directive by 1 July 1996 at the latest; - prohibit trade in products not complying with this Directive from 1 July 1997. However, products placed on the market or labelled before that date which do not comply with this Directive may be marketed until stocks are exhausted. They shall forthwith inform the Commission thereof. When Member States adopt such provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0022

1996

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), (1) Whereas Directive 81/602/EEC (4) prohibits certain substances having a hormonal action and any substances having a thyrostatic action and whereas Directive 88/146/EEC (5) prohibits the use in stockfarming of certain substances having a hormonal action, whilst conceding derogations; (2) Whereas Council Directive 88/299/EEC (6) lays down the conditions for applying the derogations provided for in Article 7 of Directive 88/146/EEC from the prohibition on trade in certain categories of animals and their meat; (3) Whereas, on account of the residues they leave in meat and other foodstuffs of animal origin, certain substances having a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for consumers and may also affect the quality of foodstuffs of animal origin; (4) Whereas new substances having an anabolizing action such as beta-agonists are used illegally in livestock-rearing with a view to stimulating the growth and yield of animals; (5) Whereas the results of an enquiry conducted by the Commission in the Member States from 1990 to 1992 show that beta-agonists are widely available in the livestock-rearing sector, leading to their illegal use; (6) Whereas the improper use of beta-agonists can be a serious risk to human health; whereas, in the interests of the consumer, the holding, administering to animals of any species and the placing on the market for that purpose of beta-agonists should be prohibited; whereas, moreover, the holding, administering to animals of any species and the placing on the market of stilbenes and thyrostatic substances should be prohibited and the use of other substances regulated; (7) Whereas, however, the administering of medicinal products based on beta-agonists may be authorized for well-defined therapeutic purposes, in the case of certain categories of bovine animals, equidae and pets; (8) Whereas, moreover, it is necessary to ensure that all consumers are able to acquire meat and foodstuffs derived therefrom under the same conditions of supply and that those products correspond as closely as possible to their concerns and expectations; whereas, given consumer sensitivity, this can only bring about an increase in the consumption of the products in question; (9) Whereas the prohibition on the use of hormonal substances for fattening purposes should continue to apply; whereas the use of certain substances for therapeutic or zootechnical purposes may be authorized but must be strictly controlled in order to prevent any misuse; (10) Whereas withdrawal periods are not harmonized at Community level and there are considerable differences between Member States, particularly as regards authorized veterinary medicinal products containing hormonal substances or beta-agonists; whereas, in the interests of harmonization, maximum withdrawal periods should therefore be set for such medicinal products; (11) Whereas, furthermore, live animals so treated for therapeutic or zootechnical purposes and the meat from such animals should not as a general rule be traded, since this could impair the effectiveness of the control arrangements of the scheme as a whole; whereas, however, derogations from the prohibition may, subject to certain conditions, be provided for in respect of intra-Community trade and imports from third countries of animals intended for breeding and breeding animals at the end of their reproductive life; (12) Whereas such derogations may be authorized where adequate guarantees are provided so as to prevent distortion of trade; whereas such guarantees must cover the products which may be used, the conditions governing their use and the checks to ensure that the conditions are complied with, particularly with regard to the necessary withdrawal period; (13) Whereas provision should be made for the effective verification of application of the provisions deriving from this Directive; (14) Whereas Directives 81/602/EEC, 88/146/EEC and 88/299/EEC should be repealed; (15) Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated effectively in all Member States, action will have to be organized at Community level; (16) Whereas, on 18 January 1996, the European Parliament asked the Commission and the Council to continue opposing the importation into the Community of meat treated with hormones, requested the maintenance of the total ban on the use of growth promoters in stockfarming and, to that end, asked the Council to adopt without delay the Commission proposal on which the European Parliament had delivered its opinion on 19 April 1994, Article 1 1. For the purposes of this Directive, the definitions of meat and meat products given in Directives 64/433/EEC (7), 71/118/EEC (8), 77/99/EEC (9), and 91/495/EEC (10), the definitions of aquaculture products given in Directive 91/493/EEC (11) and the definitions of veterinary medicinal products given in Directives 81/851/EEC (12) and 81/852/EEC (13) shall apply. 2. In addition, the following definitions shall apply: (a) 'farm animals` shall mean domestic animals of the bovine, porcine, ovine and caprine species, domestic solipeds, poultry and rabbits, as well as wild animals of those species and wild ruminants which have been raised on a holding; (b) 'therapeutic treatment` shall mean the administering - under Article 4 of this Directive - to an individual farm animal of an authorized substance to treat, after examination by a veterinarian, a fertility problem - including the termination of unwanted gestation - and, in the case of beta-agonists, to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae raised for purposes other than meat production; (c) 'zootechnical treatment` shall mean the administering: (i) to an individual farm animal of any substance authorized under Article 5 of this Directive for synchronizing oestrus and preparing donors and recipients for the implantation of embryos, after examination of the animal by a veterinarian or, in accordance with the second paragraph of Article 5, under his responsibility; (ii) in the case of aquaculture animals, to a group of breeding animals for sex inversion, on a veterinarian's prescription and under his responsibility; (d) 'illegal treatment` shall mean the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation. Article 2 Member States shall prohibit: (a) the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species; (b) the placing on the market of beta-agonists for administering to animals the flesh and products of which are intended for human consumption for purposes other than those provided for in point 2 of Article 4. Article 3 Member States shall prohibit: (a) the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of beta-agonists; (b) the holding, except under official control, of animals referred to in (a) on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals which contain the substances referred to in (a) or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4 or 5; (c) the placing on the market for human consumption of aquaculture animals to which substances referred to in (a) have been administered and of processed products derived from such animals; (d) the placing on the market of meat of the animals referred to in (b); (e) the processing of the meat referred to in (d). Article 4 Notwithstanding Articles 2 and 3, Member States may authorize: 1. the administering to farm animals, for therapeutic purposes, of oestradiol 17 â, testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application. Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Directive 81/851/EEC and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. Treatment of identified animals must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be the one provided for in Directive 81/851/EEC: - type of treatment, - the type of products authorized, - the date of treatment, - the identity of the animals treated. The register must be made available to the competent authority at its request; 2. the administering for therapeutic purposes of authorized veterinary medicinal products containing: (i) allyl trenbolone, administered orally, or beta-agonists to equidae and pets, provided they are used in accordance with the manufacturer's instructions; (ii) beta-agonists, in the form of an injection to induce tocolysis in cows when calving. Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in (i), under his direct responsibility; treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in point 1. Farmers shall be prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis. However, without prejudice to the first subparagraph of point 2 (ii), therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited. Article 5 Notwithstanding Article 3 (a) and without prejudice to Article 2, Member States may authorize the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic, androgenic or gestagenic action which are authorized in accordance with Directives 81/851/EEC and 81/852/EEC. Such veterinary medicinal products must be administered by a veterinarian to clearly identified animals; the treatment must be recorded by the veterinarian responsible in accordance with point 1 of Article 4. However, Member States may allow the synchronization of oestrus and the preparation of donors and recipients for the implantation of embryos to be effected not by the veterinarian direct, but under his responsibility. With regard to aquaculture animals young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorized in accordance with Directives 81/851/EEC and 81/852/EEC. In the cases provided for in this Article, the veterinarian shall make out a non-renewable prescription, specifying the treatment in question and the quantity of the product required and shall record the products prescribed. However, zootechnical treatment of production animals, including during the fattening period for breeding animals at the end of their reproductive life, shall be prohibited. Article 6 1. Hormonal products and beta-agonists the administration of which to farm animals is authorized in accordance with Articles 4 and 5 must meet the requirements of Directives 81/851/EEC and 81/852/EEC. 2. The following may not, however, be authorized in accordance with paragraph 1: (a) the following hormonal products: (i) products acting as a deposit; (ii) products with a withdrawal period of more than 15 days after the end of treatment; (iii) products: - which were authorized under rules that preceded the amendment made by Regulation (EEC) No 2309/93 (14), - whose conditions of use are not known, - for which no reagents or equipment exist for use in the analytical techniques for detecting the presence of residues in excess of the permitted limits, (b) veterinary medicinal products containing beta-agonists which have a withdrawal period of more than 28 days after the end of treatment. Article 7 1. For the purpose of trade, Member States may authorize the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4 and 5 and may authorize the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4 and 5 and the minimum withdrawal periods laid down in Article 6 (2), under (a) (ii) or (b) respectively or the withdrawal periods provided for in the authorization to place on the market are complied with. However, trade in high-value horses, and in particular racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including registered equidae to which veterinary medicinal products containing allyl trenbolone or beta-agonists have been administered for the purposes referred to in Article 4, may take place before the end of the withdrawal period, provided that the conditions governing administration are fulfilled and that the type and date of treatment are entered on the certificate or passport accompanying these animals. 2. Meat or products from animals to which substances having an oestrogenic, androgenic or gestagenic action or beta-agonists have been administered in accordance with the dispensatory provisions of this Directive may not be placed on the market for human consumption unless the animals in question have been treated with veterinary medicinal products complying with the requirements of Article 6 and in so far as the withdrawal period laid down was observed before the animals were slaughtered. Article 8 Member States shall ensure that: 1. at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in Articles 2 and 3 (a), their possession is restricted to the persons authorized by national legislation in accordance with Article 1 of Directive 90/676EEC (15); 2. in addition to the checks provided for in the Directives governing the placing on the market of the various products in question, the official checks provided for in Article 11 of Directive 96/23/EC (16) are carried out by the competent national authorities without prior notice, with a view to ascertaining: (a) the possession or presence of substances or products prohibited under Article 2, intended to be administered to animals for the purpose of fattening; (b) the illegal treatment of animals; (c) failure to observe the withdrawal periods provided for in Article 6; (d) failure to observe the restrictions on the use of certain substances or products laid down in Articles 4 and 5; 3. the tests for the presence of: (a) the substances referred to in point 1 in animals, in the drinking water of animals and in all places where animals are bred or kept; (b) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products are carried out in accordance with Annexes III and IV to Directive 96/23/EC; 4. where the checks provided for in points 2 and 3 reveal: (a) the presence of substances or products the use or possession of which is prohibited, or the presence of residues of substances the administering of which comes under the heading of illegal treatment, such substances or products are confiscated, while any animals treated or the meat therefrom is placed under official supervision until the requisite penalties have been applied; (b) failure to comply with the requirements of points 2 (b) and (c), the competent authority takes appropriate measures consistent with the gravity of the infringement. Article 9 Without prejudice to Directive 81/851/EEC, undertakings buying or producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and beta-agonists, undertakings authorized in any capacity to market such substances and undertakings buying or producing pharmaceutical and veterinary medicinal products from such substances shall be required to keep registers detailing, in chronological order, quantities produced or acquired and those sold or used for the production of pharmaceutical and veterinary medicinal products and the names of the persons to whom such quantities were sold or from whom they were purchased. The above information must be made available to the competent authority at its request and, in the case of computerized records, in the form of a printout. Article 10 Where the results of checks carried out in a Member State show failure to comply with the requirements of this Directive in the country of origin of the animals or products, the competent authority of that Member State shall have recourse to Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (17). Article 11 1. Third countries whose legislation authorizes the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to animals of all species may not appear on any of the lists of countries provided for under Community legislation from which Member States are authorized to import farm or aquaculture animals or meat or products obtained from such animals. 2. Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 1 of: (a) farm or aquaculture animals (i) to which products or substances referred to in point (a) of Article 2 have been administered by any means whatsoever; (ii) to which substances or products referred to in point (a) of Article 3 have been administered, unless those substances or products were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7 and the withdrawal periods allowed in international recommendations have been observed; (b) meat or products obtained from animals the importation of which is prohibited under point (a). 3. However, animals intended for breeding, breeding animals at the end of their reproductive life, or meat therefrom, from third countries may be imported subject to their affording guarantees at least equivalent to those laid down in this Directive, which have been established in accordance with the procedure laid down in Article 33 of Directive 96/23/EC for the purpose of giving effect to Chapter V of that Directive. 4. Checks on imports from third countries shall be carried out in accordance with Article 4 (2) (c) of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries (18) and Article 8 (2) of Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (19). Article 12 The Council, acting by a qualified majority on a proposal from the Commission, may adopt transitional measures necessary for the introduction of the arrangements provided for in this Directive. Article 13 1. Directives 81/602/EEC, 88/146/EEC and 88/299EEC are hereby repealed as from 1 July 1997. 2. References made to the repealed Directives shall be construed as being made to this Directive and should be read in accordance with the correlation table in the Annex. Article 14 1. Member States shall bring into force the laws, regulations and administrative provisions, including any penalties, necessary to comply with this Directive on 1 July 1997, and, for beta-agonists, by 1 July 1997 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. 3. Pending application of the provisions of this Directive as regards beta-agonists, the relevant national rules shall continue to apply in compliance with the general provisions of the Treaty. Article 15 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States.

31996L0023

1996

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), (1) Whereas by Directive 96/22/EC (4) the Council decided to maintain the prohibition on the use of certain substances having a hormonal or thyrostatic action, by extending it to beta-agonists having an anabolic effect; (2) Whereas on 9 March 1995 the European Parliament pointed out, inter alia, that the Community urgently needed an effective and uniform monitoring system and asked the Member States to reinforce supervision and monitoring with regard to the use of illegal substances in meat; (3) Whereas, by Directive 85/358/EEC (5), the Council adopted certain rules on the detection and monitoring of substances having a hormonal or thyrostatic action; whereas those rules should be extended to cover other substances which are used in stockfarming to promote growth and productivity in livestock or for therapeutic purposes and which may prove dangerous to the consumer on account of their residues; (4) Whereas by Directive 86/469/EEC (6), the Council introduced certain rules on the monitoring of a certain number of residues of pharmacological substances and of environmental contaminants in farm animals and in the fresh meat obtained from such animals; whereas such monitoring should be extended to cover other animal species and all animal products for human consumption; (5) Whereas Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (7) laid down in its Annexes limits for certain veterinary medicinal products; (6) Whereas the Community legislation on monitoring residues in meat lacks clarity, giving rise to varying interpretations in the different Member States; (7) Whereas there is a need to reinforce the controls carried out by and in the Member States; (8) Whereas producers and others involved in the stockfarming industry should take greater responsibility in future for the quality and safety of meat for human consumption; (9) Whereas the specific penalties in respect of stockfarmers not complying with Community legislation in particular prohibiting the use of certain hormonal and anabolic substances in stockfarming are to be incorporated in the separate provisions governing particular product groups; (10) Whereas Article 4 of Directive 71/118/EEC (8) requires Member States to ensure that checks are conducted to detect residues of substances having a pharmacological action, their derivatives and other substances which may be transmitted to poultrymeat and which may make the consumption of fresh poultrymeat dangerous or harmful to human health; (11) Whereas Directive 91/493/EEC (9) requires a monitoring system to be established by the Member States to detect contaminants present in the aquatic environment; (12) Whereas Directive 92/46/EEC (10) provides that, by 30 June 1993 at the latest, national measures for the detection of residues in raw milk, heat-treated milk and milk-based products shall have been submitted to the Commission by the Member States, the residues to be detected being those in Part A, group III, and Part B, group II, of Annex I to Directive 86/469/EEC; (13) Whereas Directive 89/437/EEC (11) requires Member States to ensure that checks are conducted to detect residues of substances having a pharmacological or hormonal action, antibiotics, pesticides, detergents and other substances harmful or likely to alter the organoleptic characteristics of egg products or make the consumption of such products dangerous or harmful to human health; (14) Whereas Directive 92/45/EEC (12) requires Member States to extend their residue detection plans in order to make wild-game meat subject, where necessary, to sampling checks with a view to detecting the presence of contaminants from the environment and to include rabbits and farmed game in such monitoring; (15) Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated effectively in all Member States, action will have to be organized at Community level; (16) Whereas systems of self-regulation by producer groups can play an important role in combating the illegal use of growth promoters; whereas it is essential for consumers that these systems adequately guarantee the absence of such promoters and whereas a general European approach is essential to safeguard and support self-regulation systems; (17) Whereas, to that end, producer groups should be assisted in developing self-regulation systems to ensure that their meat is free of unauthorized substances or products; (18) Whereas a certain number of provisions of Directives 86/469/EEC and 85/358/EEC and of Decisions 89/187/EEC (13) and 91/664/EEC (14) require clarification in the interests of the effective application of controls and residue detection in the Community; whereas, with a view to immediate and uniform application of the controls provided for, the present rules and amendments to them should be assembled in a single text repealing the aforesaid instruments, CHAPTER I Scope and definitions Article 1 This Directive lays down measures to monitor the substances and groups of residues listed in Annex I. Article 2 For the purposes of this Directive, the definitions in Directive 96/22/EC shall apply. In addition: (a) 'unauthorized substances or products` shall mean substances or products the administering of which to animals is prohibited under Community legislation; (b) 'illegal treatment` shall mean the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation or, where appropriate, in the various national legislations; (c) 'residue` shall mean a residue of substances having a pharmacological action, of their metabolites and of other substances transmitted to animal products and likely to be harmful to human health; (d) 'competent authority` shall mean the central authority of a Member State competent in veterinary matters or any authority to which such central authority has delegated such competence; (e) 'official sample` shall mean a sample taken by the competent authority which bears, for the purposes of examination of the residues or substances listed in Annex I, a reference to the species, the type, the quantity concerned, the method of collection and particulars identifying the sex of the animal and the origin of the animal or of the animal product; (f) 'approved laboratory` shall mean a laboratory approved by the competent authorities of a Member State for the purposes of examining an official sample in order to detect the presence of residues; (g) 'animal` shall mean the species covered by Directive 90/425/EEC (15); (h) 'batch of animals` shall mean a group of animals of the same species, in the same age range, reared on the same holding, at the same time and under the same conditions of rearing; (i) 'beta-agonist` shall mean a beta adrenoceptor agonist. CHAPTER II Monitoring plans for the detection of residues or substances Article 3 The production process of animals and primary products of animal origin shall be monitored in accordance with this Chapter for the purpose of detecting the presence of the residues and substances listed in Annex I in live animals, their excrement and body fluids and in tissue, animal products, animal feed and drinking water. Article 4 1. Member States shall assign the task of coordinating the implementation of the inspections provided for in this Chapter, which are carried out within their national territory, to a central public department or body. 2. The department or body referred to in paragraph 1 shall be responsible for: (a) drawing up the plan provided for in Article 5 to enable the competent departments to carry out the required inspections; (b) coordinating the activities of the central and regional departments responsible for monitoring the various residues. Such coordination shall extend to all departments working to prevent the fraudulent use of substances or products on stock farms; (c) collecting the data needed to evaluate the means used and the results obtained in carrying out the measures provided for in this Chapter; (d) sending the Commission, by not later than 31 March of each year, the data and results referred to in (c), including the results of any surveys undertaken. 3. This Article shall not affect more specific rules applicable to the monitoring of animal nutrition. Article 5 1. By 30 June 1997 at the latest, Member States shall submit a plan to the Commission setting out the national measures to be implemented during the initial year of the plan and subsequently any update of plans previously approved in accordance with Article 8 on the basis of the experience of the preceding year, or years by 31 March at the latest of the year of the update. 2. The plan provided for in paragraph 1 shall: (a) provide for detection of groups of residues or substances according to type of animal, in accordance with Annex II; (b) specify in particular the measures for detection of the presence of: (i) the substances referred to in (a) in the animals, in the drinking water of the animals and in all places where the animals are bred or kept; (ii) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products such as meat, milk, eggs and honey; (c) comply with the sampling rules and levels laid down in Annexes III and IV. Article 6 1. The plan must conform to the sampling levels and frequencies laid down in Annex IV. However, at the request of a Member State the Commission may, in accordance with the procedure provided for in Article 32, adjust the minimum control requirements laid down in Annex IV provided that it is clearly established that such adjustments increase the overall effectiveness of the plan in respect of the Member State concerned and in no way reduce its ability to identify residues of, or cases of illegal treatment with, substances listed in Annex I. 2. Re-examination of the groups of residues to be checked for in accordance with Annex II and determination of the sampling levels and frequencies covering the animals and products referred to in Article 3 and not already laid down in Annex IV shall take place in accordance with the procedure provided for in Article 33 and on the first occasion within a maximum of 18 months of the adoption of this Directive. In doing so, account shall be taken of experience gained under existing national measures and information forwarded to the Commission under existing Community requirements making such specific product groups subject to monitoring for residues. Article 7 The initial plan shall take into account the specific situation of each Member State and specify in particular: - legislation on the use of the substances listed in Annex I and, in particular, provisions on their prohibition or authorization, distribution and placing on the market and the rules governing their administration, in so far as such legislation is not harmonized. - the infrastructure of the relevant departments (in particular, giving details of the type and size of the bodies involved in implementing the plans), - a list of approved laboratories with details of their capacity for processing samples, - national tolerances for authorized substances where no maximum Community residue levels have been set under Regulation (EEC) No 2377/90 and Directive 86/363/EEC (16), - a list of the substances to be detected, methods of analysis, standards for interpreting the findings and, in the case of the substances listed in Annex I, the number of samples to be taken, giving reasons for this number, - the number of official samples to be taken in relation to the number of animals of the species concerned slaughtered in preceding years in accordance with the sampling levels and frequencies laid down in Annex IV, - details of the rules governing the collection of official samples, and in particular the rules concerning the particulars to appear on such official samples, - the type of measures laid down by the competent authorities with regard to animals or products in which residues have been detected. Article 8 1. The Commission shall examine the initial plans forwarded pursuant to Article 5 (1) to ascertain whether they conform to this Directive. The Commission may ask a Member State to modify or supplement these plans to make them conform. Once the Commission has established their conformity, it shall submit the plans for approval in accordance with the procedure provided for in Article 33. In order to take account of changes in the situation in a given Member State or in a region thereof, of the results of national surveys or of investigations carried out in the framework of Articles 16 and 17, the Commission may, at the request of the Member State concerned or on its own initiative, decide, in accordance with the procedure provided for in Article 32, to approve an amendment or addition to a plan previously approved pursuant to paragraph 2. 2. Annual amendments to the initial plans communicated by the Member States, in particular in the light of the results referred to in Article 4 (2) (d), shall be forwarded by the Commission to the other Member States once the Commission has established their conformity with this Directive. Member States shall have 10 working days from receipt of those amendments in which to inform the Commission of any comments. If there are no comments from Member States, the amendments to the plans shall be deemed to be approved. The Commission shall inform the Member States of such approval immediately. Where there are comments from Member States or where the Commission deems the update not to be in conformity or insufficient, the Commission shall submit the updated plans to the Standing Veterinary Committee, which must act under the procedure laid down in Article 33. The provisions laid down in paragraph 3 and 4 shall apply to the updated plans. 3. Every six months, Member States shall inform the Commission and the other Member States within the Standing Veterinary Committee of the implementation of plans approved pursuant to paragraph 2 or of the development of the situation. Where necessary, paragraph 4 shall apply. By not later than 31 March each year, Member States shall forward to the Commission the results of their residue and substance detection plans and of their control measures. Member States shall make public the outcome of the implementation of the plans. The Commission shall inform Member States, within the Standing Veterinary Committee, of developments in the situation in the various regions of the Community. 4. Each year, or whenever it deems it necessary on public health grounds, the Commission shall report to Member States within the Standing Veterinary Committee on the outcome of the checks and surveys referred to in paragraph 3, in particular on: - the implementation of national plans, - developments in the situation in the various regions of the Community. 5. The Commission shall send the European Parliament and the Council a communication each year on the results of action taken at regional, national or Community level, bearing in mind the report and Member States' comments on it. CHAPTER III Self-monitoring and co-responsibility on the part of operators Article 9 A. Member States shall ensure that: 1. any farms which place farm animals on the market and any natural or legal person engaged in trade in such animals register beforehand with the competent authorities and undertake to abide by the relevant Community and national rules, in particular the provisions laid down in Articles 5 and 12 of Directive 90/425/EEC; 2. the owners or persons in charge of the establishment of initial processing of primary products of animal origin take all necessary measures, in particular by carrying out their own checks, to (a) accept - whether by direct delivery or through an intermediary - only those animals for which the producer is able to guarantee that withdrawal times have been observed; (b) satisfy themselves that the farm animals or products brought into the establishment (i) do not contain residue levels which exceed maximum permitted limits; (ii) do not contain any trace of prohibited substances or products; 3. (a) the producers or persons in charge referred to in points 1 and 2 place on the market only: (i) animals to which no unauthorized substances or products have been administered or which have not undergone illegal treatment within the meaning of this Directive; (ii) animals in respect of which, where authorized products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed; (iii) products derived from the animals referred to in (i) and (ii); (b) where an animal is presented at a first-stage processing establishment by a natural or legal person other than the producer, the obligations laid down in (a) are incumbent on the latter. B. For the purposes of applying point A, Member States shall ensure, without prejudice to compliance with the rules laid down in the Directives governing the placing on the market of the various products in question, that: - the principle of quality monitoring of the production chain by the different parties involved is established in their legislation, - the self-monitoring measures to be included in the specifications for trade marks or labels are stepped up. They shall inform the Commission and the other Member States, at their request, of provisions laid down in this regard and in particular of provisions adopted for checks on point A (3) (a) (i) and (ii). Article 10 Member States shall ensure that the terms of reference and responsibilities of veterinarians monitoring farms are extended to monitoring the rearing conditions and the forms of treatment referred to in this Directive. Within this framework, the veterinarian shall enter in a register kept on the farm the date and nature of any treatment prescribed or administered, the identification of the animals treated and the corresponding withdrawal periods. The stockfarmer shall enter in the register, which may be the register provided for in Directive 90/676/EEC (17), the date and nature of the treatment administered. He shall satisfy himself that withdrawal periods have been observed and keep the prescriptions to prove it for five years. Stockfarmers and veterinarians shall be required to supply any information to the competent authority, at its request, and in particular supply information to the official veterinarian of the slaughterhouse, regarding a given farm's compliance with the requirements of this Directive. CHAPTER IV Official control measures Article 11 1. Without prejudice to the checks carried out in connection with implementation of the surveillance plans referred to in Article 5 or to the checks provided for in specific Directives, Member States may have official random checks conducted: (a) during the manufacture of the substances included in Group A in Annex I and during their handling, storage, transport, distribution and sale or acquisition; (b) at any point in the animal feedingstuffs production and distribution chain; (c) throughout the production chain of animals and raw materials of animal origin covered by this Directive. 2. The checks provided for in paragraph 1 must be conducted with a view in particular to detecting the possession or presence of prohibited substances or products which it is intended to administer to animals for the purposes of fattening or illegal treatment. 3. Where fraud is suspected, and in the case of a positive result from any of the checks referred to in paragraph 1, Articles 16 to 19 and the measures provided for in Chapter V shall apply. The checks provided for at the slaughterhouse or on the first sale of aquaculture animals and fishery products can be reduced to take account of the fact that the farm of origin or departure belongs to an epidemiological surveillance network or a quality monitoring system as referred to in the first indent of the first subparagraph of Article 9 (B). Article 12 The checks provided for in this Directive must be carried out by the competent national authorities without prior notice. The owner, the person empowered to dispose of the animals or their representative shall be obliged to facilitate pre-slaughter inspection operations, and in particular to assist the official veterinarian or the authorized staff in any manipulation judged necessary. Article 13 The competent authority shall: (a) where illegal treatment is suspected, ask the owner or person having charge of the animals or the veterinarian in charge of the farm to provide any documentation justifying the nature of the treatment; (b) where this inquiry confirms illegal treatment or where unauthorized substances or products have been used, or where there are grounds for suspecting their use, conduct or have conducted: - spot checks on animals on their farms of origin or departure, in particular with a view to detecting such use and in particular any traces of implants; these checks may include official sampling, - checks to detect substances the use of which is prohibited or of unauthorized substances or products on the farms where the animals are being reared, kept or fattened (including holdings administratively connected with such farms) or on the animals' farms of origin or departure. Official samples of drinking water and feedingstuffs are necessary for that purpose. - spot checks on animals' feedingstuffs on their farms of origin or departure, and on their drinking water or - for aquaculture animals - from the waters in which they are caught, - the checks provided for in Article 11 (1) (a), - any check required to clarify the origin of the unauthorized substances or products or that of the treated animals; (c) where the maximum levels laid down by Community rules or, pending such legislation, the levels set by national legislation have been exceeded, carry out any measure or investigation which it may deem appropriate in relation to the finding in question. Article 14 1. Each Member State shall designate at least one national reference laboratory. A given residue or residue group may not be assigned to more than one national reference laboratory. However, until 31 December 2000, Member States may continue to entrust testing for the same residue or residue group to several national laboratories which they designated prior to the date of adoption of this Directive. A list of such designated laboratories shall be drawn up in accordance with the procedure laid down in Article 33. These laboratories shall be responsible for: - coordinating the work of the other national laboratories responsible for residue analysis, in particular by coordinating the standards and methods of analysis for each residue or residue group concerned, - assisting the competent authority in organizing the plan for monitoring residues, - periodically organizing comparative tests for each residue or residue group assigned to them, - ensuring that national laboratories observe the limits laid down, - disseminating information supplied by Community reference laboratories, - ensuring that their staff are able to take part in further training courses organized by the Commission or by Commission reference laboratories. 2. The Community reference laboratories shall be those designated in Chapter 1 of Annex V. The powers and working conditions of the laboratories shall be as defined in Chapter 2 of Annex V. Article 15 1. Official samples must be taken in accordance with Annexes III and IV in order to be examined in approved laboratories. The detailed rules for the taking of official samples and the routine and reference methods to be employed for the analysis of such official samples shall be specified in accordance with the procedure laid down in Article 33. Whenever an authorization is issued for the placing on the market of a veterinary medicinal product intended for administration to a species the meat or product of which is intended for human consumption, the competent authorities shall forward the routine analysis methods as laid down in Article 5, second subparagraph, point 8 of Directive 81/851/EEC (18) and Article 7 of Regulation (EEC) No 2377/90 to the Community and national reference laboratories for detection of residues. 2. For Group A substances, all positive findings recorded following the application of a routine method instead of a reference method must be confirmed by an approved laboratory using the reference methods laid down in accordance with paragraph 1. For all substances, if challenged on the basis of a contradictory analysis, those results must be confirmed by the national reference laboratory designated in accordance with Article 14 (1) for the substance or residue in question. Such confirmation must be carried out at the plaintiff's cost in the event of confirmation. 3. Where examination of an official sample reveals illegal treatment, Articles 16 to 19 shall apply, together with the measures laid down in Chapter V. Where the examination reveals the presence of residues of authorized substances or contaminants exceeding the levels set by Community rules or, pending such legislation, the levels set by national legislation, Articles 18 and 19 shall apply. Where the examination referred to in this paragraph covers animals or products of animal origin from another Member State, the competent authority of the Member State of origin shall apply Articles 16 (2), 17, 18 and 19 and the measures provided for in Chapter V to the farm or establishment of origin or departure, following the reasoned request of the competent authority having carried out the examination. Where the examination covers products or animals imported from a third country, the competent authority having carried out that examination shall refer the matter to the Commission, which shall take the measures provided for in Article 30. Article 16 Member States shall ensure that, where positive results are obtained as described in Article 15: 1. the competent authority shall obtain without delay: (a) all the information required to identify the animal and farm of origin or departure; (b) full details of the examination and its result. If the controls carried out in a Member State demonstrate the need for an investigation or other action in one or more Member States or third countries, the Member State concerned shall inform the other Member States and the Commission. The Commission shall coordinate the appropriate measures taken in Member States where an investigation or other action proves necessary; 2. the appropriate authority shall carry out: (a) an investigation on the farm of origin or departure, as appropriate, to determine the reasons for the presence of residues; (b) in the case of illegal treatment, an investigation of the source or sources of the substances or products concerned at the stage of manufacture, handling, storage, transport, administration, distribution or sale, as appropriate; (c) any other further investigations which the authority considers necessary; 3. animals from which samples have been taken are clearly identified. They may not in any circumstances leave the farm until the results of the checks are available. Article 17 Where illegal treatment is established, the competent authority must ensure that the livestock concerned in the investigations referred to in point (b) of Article 13 is immediately placed under official control. It must furthermore ensure that all the animals concerned bear an official mark or identification and that, as a first step, an official sample is taken from a statistically representative sample, on internationally recognized scientific bases. Article 18 1. Where there is evidence of residues of authorized substances or products of a level exceeding the maximum limit for residues, the competent authority shall carry out an investigation in the farm of origin or departure, as applicable, to determine why the above limit was exceeded. In accordance with the results of that investigation, the competent authority shall take all necessary measures to safeguard public health which may include prohibiting animals from leaving the farm concerned or products from leaving the farm or establishment concerned for a set period. 2. In the event of repeated infringements of maximum residue limits when animals are placed on the market by a farmer or products are placed on the market by a farmer or a processing establishment, intensified checks on the animals and products from the farm and/or establishment in question must be carried out by the competent authorities for a period of at least six months, products or carcases being impounded pending the results of analysis of the samples. Any results showing that the maximum residue limit has been exceeded must lead to the carcases or products concerned being declared unfit for human consumption. Article 19 1. The costs of the investigations and checks referred to in Article 16 shall be borne by the owner or person having charge of the animals. Where the investigation confirms that suspicion was justified, the costs of analyses carried out under Articles 17 and 18 shall be borne by the owner or person having charge of the animals. 2. Without prejudice to criminal or administrative penalties, the cost of destroying animals which have given a positive result or animals which have been deemed positive in accordance with Article 23 shall be borne by the owner of the animals without indemnity or compensation. Article 20 1. Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (19) shall apply for the purposes of this Directive. 2. Where a Member State considers that, in another Member State, the controls 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 carried out in accordance with point 2 of Article 16, 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 those 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 an on-the-spot inspection. Member States shall inform the Commission of disputes and of solutions arrived at. If the Member States involved in a dispute 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 instruct one or more experts to deliver an opinion. Pending that opinion, the Member State of destination may carry out checks on products coming from the establishment(s) or holding(s) to which the dispute relates and, if the result is positive, take measures similar to those provided for in Article 7 (1) (b) of Directive 89/662/EEC (20). In the light of the experts' opinion, appropriate measures may be taken in accordance with the procedure provided for in Article 32. Those measures may be reviewed in accordance with the same procedure, in the light of a new expert opinion delivered within 15 days. Article 21 1. To the extent necessary to ensure uniform application of this Directive, and in cooperation with the competent authorities of the Member States, the Commission's veterinary experts may verify on the spot that the plans and the system for checking the plans by the competent authorities have been uniformly implemented. A Member State within whose territory a verification 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 verifications carried out. The Member State concerned shall take the measures necessary to take account of the results of these verifications and shall notify the Commission of the measures taken. Where the Commission considers that the measures taken are insufficient, it shall, after consultation with the Member State in question and having regard to the measures necessary to safeguard public health, take appropriate measures in accordance with the procedure laid down in Article 32. 2. The general rules for implementing this Article, especially as regards the frequency and method of carrying out the verifications referred to in the first subparagraph of paragraph 1 (including cooperation with the competent authorities), shall be determined in accordance with the procedure laid down in Article 33. CHAPTER V Measures to be taken in the event of infringement Article 22 Where unauthorized substances or products or substances listed in Group A and Group B (1) and (2) of Annex I are discovered in the possession of non-authorized persons, those unauthorized substances or products must be placed under official control until appropriate measures are taken by the competent authority, without prejudice to the possible imposition of penalties on the offender(s). Article 23 1. During the period in which animals are impounded as provided for in Article 17, animals from the farm in question may not leave the farm of origin or be handed over to any other person except under official control. The competent authority shall take appropriate precautionary measures in accordance with the nature of the substance or substances identified. 2. After sampling has been carried out in accordance with Article 17, if there is confirmation of a case of illegal treatment, the animal or animals found to be positive shall be slaughtered immediately on the spot or taken immediately to the designated slaughterhouse or to the knacker's yard under cover of an official veterinary certificate in order to be slaughtered there. Animals so slaughtered shall be sent to a high-risk processing plant as defined by Directive 90/667/EEC (21). In addition, samples must be taken at the farm's expense from the entire batch of animals belonging to the farm at which checks were carried out and which may be suspect. 3. However, if half or more of the samples taken by representative sampling in accordance with Article 17 are positive, the farmer may be left a choice between a check on all the animals present on the farm which may be suspect, or slaughter of these animals. 4. For a further period of at least 12 months, the farm(s) belonging to the same owner shall be subject to more stringent checks for the residues in question. Where an organized system of self-monitoring has been set up, this facility shall be withdrawn from the farmer for that period. 5. In view of the infringement recorded, the farms or establishments supplying the holding concerned shall be subject to checks in addition to those provided for in Article 11 (1) to determine the origin of the substance in question. The same shall apply to all farms and establishments in the same supply chain of animals and animal feed as the farm of origin or departure. Article 24 The official veterinarian of a slaughterhouse must: 1. if he suspects or has evidence that the animals concerned have been subjected to illegal treatment or that unauthorized substances or products have been administered to them: (a) arrange for the animals to be slaughtered separately from other batches of animals arriving at the slaughterhouse; (b) impound the carcases and offal and carry out all sampling procedures necessary to detect the substances in question; (c) if positive results are obtained, send the meat and offal to a high-risk processing plant as defined by Directive 90/667/EEC, without indemnity or compensation. In that event, Articles 20 to 23 shall apply; 2. if the suspects or has evidence that the animals concerned have been subjected to an authorized treatment but that the withdrawal periods have not been complied with, postpone slaughter of the animals until he can be satisfied that the quantity of residues does not exceed the permitted levels. This period may in no circumstances be less than the withdrawal period laid down in point (b) of Article 6 (2) of Directive 96/22/EC for the substances in question, or than the withdrawal periods provided for in the marketing authorization. However, in an emergency or where required for the well-being of the animals, or if the infrastructure or equipment of the slaughterhouse is such that slaughter cannot be deferred, the animals may be slaughtered before the end of the ban or postponement period. The meat and offal shall be impounded pending the outcome of the official checks carried out by the slaughterhouse's official veterinarian. Only meat and offal containing a quantity of residues not exceeding the permitted levels shall be used for human consumption; 3. declare unfit for human consumption carcases and products in which the residue level exceeds the levels authorized by Community or national regulations. Article 25 Without prejudice to criminal penalties, where the holding, use or manufacture of unauthorized substances or products in a manufacturing establishment is confirmed, any authorizations or official approval arrangements enjoyed by the establishment concerned shall be suspended for a period during which the establishment shall be subjected to more stringent checks. In the case of a repeated offence, such authorizations or approval arrangements shall be permanently withdrawn. Article 26 Rights of appeal allowed by national legislation in force in the Member States against decisions taken by the competent authorities under Articles 23 and 24 shall not be affected by this Directive. Article 27 Without prejudice to criminal penalties, or penalties imposed by professional bodies, appropriate administrative measures must be taken against any person where he is responsible, as the case may be, for the transfer or administering of prohibited substances or products or for the administering of authorized substances or products for purposes other than those laid down in the current legislation. Article 28 Any failure to cooperate with the competent authority and any obstruction by slaughterhouse personnel or the slaughterhouse supervisor or, in the case of a private enterprise, by the slaughterhouse owner or owners, or by the owner of the animals or person having charge of them, during inspection and sampling as required for the implementation of national plans for monitoring residues and during the investigations and checks provided for in this Regulation, shall result in appropriate criminal and/or administrative penalties being imposed by the competent national authorities. If it is proven that a slaughterhouse owner or supervisor is helping to conceal the illegal use of prohibited substances, the Member State shall deny the guilty party any opportunity of receiving or applying for Community aid for a period of 12 months. CHAPTER VI Imports from third countries Article 29 1. Inclusion and retention on the lists of third countries provided for in Community legislation from which Member States are authorized to import animals and animal products covered by this Directive shall be subject to submission by the third country concerned of a plan setting out the guarantees which it offers as regards the monitoring of the groups of residues and substances referred to in Annex I. This plan must be updated at the request of the Commission, particularly when the checks referred to in paragraph 3 render it necessary. The provisions of Article 8 concerning time limits for submission and updating of plans shall apply for plans to be submitted by third countries. The guarantees must have an effect at least equivalent to those provided for in this Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 of this Directive and meet the requirements of Article 11 (2) of Directive 96/22/EC. The Commission shall approve the plan in accordance with the procedure laid down in Article 33. Under the same procedure, guarantees alternative to those resulting from the implementation of this Regulation may be accepted. 2. Where the requirements of paragraph 1 are not complied with, inclusion of a third country on the lists of third countries laid down by Community legislation or as a result of the benefit of pre-listing may be suspended in accordance with the procedure laid down in Article 33, at the request of a Member State or by the Commission on its own initiative. 3. Compliance with the requirements of and adherence to the guarantees offered by the plans submitted by third countries shall be verified by means of the checks referred to in Article 5 of Directive 72/462/EEC (22) and the checks provided for in Directives 90/675/EEC (23) and 91/496/EEC (24). 4. Member States shall inform the Commission each year of the results of residue checks carried out on animals and animal products imported from third countries, in accordance with Directives 90/675/EEC and 91/496/EEC. Article 30 1. Where the checks provided by Directives 90/675/EEC and 91/496/EEC reveal the use of unauthorized products or substances for the treatment of the animals in a given batch - batch within the meaning of Article 2 (2) (e) of Directive 91/496/EEC - or the presence of such products or substances in all or part of a batch originating in the same establishment, the competent authority shall take the following measures in respect of the animals and products involved in such use: - it shall inform the Commission of the nature of the products used and the batch concerned; the Commission shall forthwith inform all frontier posts, - the Member States shall carry out more stringent checks on all batches of animals or products from the same source. In particular, the next 10 batches from the same source must be impounded - and a deposit lodged against inspection costs - at the frontier inspection post for a check on residues by taking a representative sample of each batch or of the part of the batch. Where such additional checks demonstrate the presence of unauthorized substances or products or of residues of such substances or products: (i) the batch or the part of the batch concerned must be returned to the country of origin at the expense of the consignor or his agent with a clear indication on the certificate of the reasons for rejecting the batch; (ii) depending on the nature of the infringement found and the risk associated with such an infringement, it must be left to the consignor to decide whether to send back the batch or part of the batch concerned, to destroy it or to use it for other purposes authorized by Community legislation, without indemnity or compensation; - the Commission shall be informed of the outcome of the more stringent checks and on the basis of this information shall make all necessary investigations, to identify the reasons for and origins of the infringements found. 2. Where the checks provided for by Directive 90/675/EEC reveal that the maximum residue limits have been exceeded, use shall be made of the checks referred to in the second indent of paragraph 1. 3. If, in cases involving third countries which have concluded equivalence agreements with the Community, the Commission, after making enquiries of the competent authorities of the third countries concerned, concludes that they have failed to fulfil their obligations and the guarantees given by the plans referred to in Article 29 (1), it shall cease to allow that country, under the procedure laid down in Article 32, to benefit from the said agreements for the animals and products in question until the third country in question has made good its shortcomings. The suspension shall be revoked under the same procedure. If necessary, in order to re-establish the benefit afforded by the said agreements, a Community deputation including experts from the Member States shall visit the country concerned, at that country's expense, in order to verify that such measures have been taken. CHAPTER VII General provisions Article 31 The Council, acting on a proposal from the Commission, shall amend Directive 85/73/EEC (25) before 1 July 1997 in order to provide for the charging of a fee to cover monitoring carried out pursuant to this Directive. Pending that decision by the Council, Member States shall be authorized to charge national fees to cover the actual costs of such monitoring. Article 32 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC (26), by its Chairman, either on his own initiative or at the request of a Member State. 2. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those matters 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 62 votes. 3. (a) The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. (b) Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If, 15 days 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 33 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Standing Veterinary Committee, by its Chairman, either on his own initiative or at the request of a Member State. 2. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those matters 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 62 votes. 3. (a) The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. (b) Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If, three months after the proposals were submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority. Article 34 Without prejudice to Article 6 (2), Annexes I, III, IV and V may be amended or supplemented by the Council acting by a qualified majority on a proposal from the Commission. In particular, the aforementioned Annexes may be amended within three years of the date of adoption of this Directive, with a view to risk assessment of the following factors: - potential toxicity of residues in foodstuffs of animal origin, - likelihood of residues occurring in foodstuffs of animal origin. Article 35 The Council, acting by a qualified majority on a proposal from the Commission, may adopt transitional measures required for the implementation of the arrangements laid down by this Directive. Article 36 1. Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC are hereby repealed as from 1 July 1997. 2. The following are also repealed as from the said date: (a) Article 4 (3) of Directive 71/118/EEC; (b) Article 5 (3) and (4) of Directive 89/437/EEC; (c) the last subparagraph of point II.3.B of Chapter V of the Annex to Directive 91/493/EEC; (d) Article 11 (1) of Directive 92/45/EEC; (e) Article 15 (1) of Directive 92/46/EEC. 3. References to Directives and Decisions which have been repealed shall be deemed to be references to this Directive and shall be read in accordance with the correlation table in Annex VI. Article 37 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 38 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 39 This Directive is addressed to the Member States.

31996L0025

1996

Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), (1) Whereas, in the framework of the production, processing and consumption of agricultural products feed materials play an important role in agriculture; (2) Whereas, in the light of growing interest in quality, efficiency and the environment, the role of feed materials in agriculture will gain in importance; (3) Whereas, in these circumstances, the rules governing the circulation of feed materials are particularly useful in ensuring sufficient transparency throughout the feed chain while improving the quality of agricultural production, notably livestock production; (4) Whereas Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs (4), lays down rules for the marketing of straight feedingstuffs; whereas Member States still have different traditions as regards regulating the marketing of raw materials; whereas for that reason Directive 77/101/EEC permits Member States to provide for derogations in certain cases; (5) Whereas the result of these derogations is that in some Member States Directive 77/101/EEC governs the marketing of both straight feedingstuffs and raw feed materials and in other Member States only the marketing of straight feedingstuffs, which allows straight feedingstuffs to be sold as raw feed materials not subject to rules; (6) Whereas, with a view to the smooth functioning of the internal market, the discrepancies which can still be noted among the Member States should be removed; whereas, in view of the extent of the sector under consideration, Directive 77/101/EEC should be replaced by new rules; (7) Whereas straight feedingstuffs and raw feed materials are so similar and close, that to ensure a consistent integration of the scope of this Directive they should be placed in one category, namely 'feed materials`; (8) Whereas the new definition 'feed materials` includes the intended purpose of these products, namely the use in oral animal feeding, as provided for in the existing definitions for 'feedingstuffs` and 'compound feedingstuffs`; whereas it is thus guaranteed that the term 'feedingstuffs` can now be used as a generic term for all feed materials and compound feedingstuffs; (9) Whereas this comprehensive definition for 'feedingstuffs` is particularly important for Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (5) and Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (6); whereas in certain cases both terms 'feedingstuffs` and 'feed materials` will be used in order to specify the provisions, since in Directive 74/63/EEC certain provisions only apply to feed materials, whereas other provisions apply to all feedingstuffs including feed materials; (10) Whereas, in order to achieve the desired transparency throughout the entire feed chain, this Directive covers the 'circulation` of feed materials; (11) Whereas satisfactory results in livestock production depend to a large extent on the right use of suitable, good quality feed materials; whereas feed materials must therefore always be sound, genuine and of merchantable quality; whereas they must neither represent a danger to animal or human health nor be marketed in a manner liable to mislead; (12) Whereas, since many products can have either a feed or a non-feed purpose, the feed purpose must be indicated by compulsory ad hoc labelling when the products in question are put into circulation for that purpose; (13) Whereas the circulation of feed materials in many cases occurs in bulk consignments, whether or not split up into several units; whereas such materials are generally accompanied by documents such as invoices and waybills; whereas these papers may serve as 'accompanying documents` within the meaning of Article 5 of this Directive; whereas this is permitted only if identification of (the units of) the consignment and the existence of a common reference and an accompanying document is properly guaranteed at all stages of circulation, for example by the use of reference numbers or signs; (14) Whereas, since feed materials can differ in health and nutritional quality, a clear distinction should be made between the different feed materials by subjecting them, when they are put into circulation, to a labelling requirement indicating their specific names; (15) Whereas the buyers or users of feed materials should throughout the feed chain be given accurate and valid additional information, such as the quantities of analytical constituents having a direct effect on the quality of the feed material; whereas failure by the seller to declare the quantities of analytical constituents should be avoided in order to protect small buyers claiming this information in vain and to avoid the unnecessary costs of a multiplication of analyses immediately before the end of the feed chain; whereas certain Member States experience difficulties in conducting inspections at farm level; whereas under these circumstances it is necessary to adopt provisions requiring the quantities of analytical constituents to be declared at the beginning of the feed chain; (16) Whereas labelling particulars concerning the analytic composition of feed materials are not required if, before the transaction, the purchaser deems that he has no need of such information; whereas this labelling exemption may apply in particular to products stored until such time as they are the subject of a new transaction; (17) Whereas the circulation of feed materials between farmers in the great majority of cases consists of products of vegetable or animal origin, in their natural state, fresh or preserved, whether or not subjected to simple physical treatment such as chopping or grinding and not treated with additives, except for preservatives; whereas for general reasons of knowledge of the characteristics of such products and for practical reasons no declaration referred to in this Directive should be required on an accompanying document such as an invoice; whereas this should nevertheless be required where the products in question are treated with additives as such treatment may change the chemical composition and nutritional value of the products; (18) Whereas feed materials of animal or vegetable origin are sold in small quantities by many retailers, frequently for feeding pet animals; whereas for general reasons of knowledge of the characteristics of such products and for practical reasons no constituent declaration should be required for these products; (19) Whereas, in certain third countries, there are not always the necessary means of carrying out analyses which make it possible to supply the information required by this Directive on the analytic composition of feed materials; whereas Member States should therefore be allowed, on certain conditions, to permit such materials to be put into circulation in the Community accompanied by provisional composition data; (20) Whereas, where reliable definitive data on analytical constituents are not available, in particular of feed materials from third countries put into circulation in the Community for the first time, in order to avoid unnecessary clogging of ports and road/rail links there should be the possibility of giving final confirmation of provisionally declared data within 10 working days; (21) Whereas several basic Community regulations provide for lists of ingredients and straight feedingstuffs; (22) Whereas, for practical reasons and to ensure the necessary legal consistency and efficiency, a list of the main feed materials similar to lists already established in comparable areas should be drawn up; (23) Whereas such a list cannot be exhaustive owing to the great diversity of products and by-products which may be traded and used, the constant development of food technology and the need not to restrict choice for manufacturers and farmers; whereas it is possible to allow the circulation of feed materials other than those included in the abovementioned list provided that they are designated by specific names preventing any confusion with materials qualifying for a name laid down at Community level; (24) Whereas feed materials containing levels of undesirable substances and products higher than those indicated for straight feedingstuffs in Annex I to Directive 74/63/EEC should be supplied only to compound feed manufacturers approved in accordance with the provisions of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (7); whereas this should be stated on compulsory specific labelling indicating the intended use of the product; whereas these undesirable substances and products should be included on the list of Part B of Annex II to Directive 74/63/EEC, with certain exceptions relating to aflatoxin, cadmium and arsenic and feed materials containing these substances, which are already listed in Annex II, Part A to Directive 74/63/EEC; (25) Whereas amendment of the list of the chief feed materials constitutes a scientific measure; (26) Whereas the list in Part B of the Annex to this Directive should be used for the circulation of feed materials, irrespective of intended use, and for the labelling of feed materials used in compound feeds; (27) Whereas Commission Directive 92/87/EEC of 26 October 1992 establishing a non-exclusive list of the main ingredients normally used and marketed for the preparation of compound feedingstuffs intended for animals other than pets (8) draws up for labelling purposes a list of ingredients of compound feedingstuffs; whereas the said Directive should be repealed as from the application of Parts A and B of this Directive; (28) Whereas, in order to improve the unambiguity and comparability at international level of systems for identifying and exchanging data on feed materials, the Commission should be instructed to adopt implementing arrangements, when appropriate, for the introduction of a practical international coding system for feed materials, based on glossaries of the various aspects of feedingstuffs, such as origin, role, process, maturity/quality; (29) Whereas, in order to facilitate the adoption of implementing measures, the procedure introducing cooperation between the Member States and the Commission within the Standing Committee on Feedingstuffs should be followed; (30) Whereas it is important to ensure that, in accordance with this Directive, the accuracy of the declarations made can be officially verified in a uniform way throughout the Community, at all stages of circulation of the feed materials; (31) Whereas the introduction of this Directive entails deletion of the terms 'straight feedingstuffs`, 'raw materials (ingredients)`, 'raw materials` and 'ingredients`; whereas these terms should be replaced in current Community legislation, in particular in Council Directives 70/524/EEC, 74/63/EEC, 82/471/EEC (9) and 93/74/EEC (10) by the terms 'feed materials`, and where appropriate the definition 'feed materials` should be replaced by the definition given in this Directive; whereas this also has an impact on the definition of compound feedingstuffs; whereas Commission Directives 80/511/EEC (11), 82/475/EEC (12) and 91/357/EEC (13) and Commission Decision 91/516/EEC (14) should be amended for the same reason, by means of a Commission act; (32) Whereas it is necessary to ensure that the provisions of the Annexes are continually adjusted to take account of the latest developments in scientific or technical knowledge; whereas such amendments will have to be made swiftly using the procedure laid down by this Directive in order to establish close cooperation between Member States and the Commission within the Standing Committee on Feedingstuffs; (33) Whereas, on grounds of the effective protection of animal and human health and to ensure the smooth functioning of the internal market, action should be taken at Community level, Article 1 1. This Directive shall apply to the circulation of feed materials within the Community. 2. This Directive shall apply without prejudice to other Community provisions in the field of animal nutrition. Article 2 For the purposes of this Directive the following definitions shall apply: (a) 'feed 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 for use in oral animal feeding either directly as such, or after processing, in the preparation of compound feedingstuffs or as carriers of premixtures; (b) 'putting into circulation` ('circulation`): the holding of feed materials for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves. Article 3 Member States shall prescribe that feed materials may circulate in the Community only of they are sound, genuineAA-1 and of merchantable quality. They shall prescribe that such feed materials may represent no danger to animal or human health and may not be put into circulation in a manner liable to mislead. Article 4 Member States shall prescribe that the general provisions laid down in Part A of the Annex shall apply to the putting into circulation of feed materials. Article 5 1. Member States shall prescribe that feed materials may not be put into circulation unless the particulars listed below, which must be properly visible, legible and indelible and for which the producer, packer, importer, seller or distributor, established within the Community, shall be held responsible, are shown on an accompanying document or where appropriate on the packaging, on the container or on a label attached thereto: (a) the words 'feed material`; (b) the name of the feed material and where appropriate the other particulars referred to in Article 7; (c) for feed materials listed in Part B of the Annex, the particulars provided for in the fourth column of Part B of the Annex; (d) for feed materials which are not listed in Part B of the Annex, the particulars provided for in the second column of the table in Part C of the Annex; (e) where appropriate, the particulars provided for in Part A of the Annex; (f) the net quantity expressed in units of mass in the case of solid products, and in units of mass or volume in the case of liquid products; (g) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph. 2. Other information may be given on packaging, containers, labels and accompanying documents provided that such information relates to objective or quantifiable parameters which can be substantiated and that it cannot mislead the purchaser. This information must be separate from the information referred to in paragraph 1. 3. For quantities of feed materials less than or equal to 10 kg, intended for the final user, the particulars provided for in paragraphs 1 and 2 may be given to the purchaser by means of an appropriate notice at the point of sale. 4. If a batch is divided during circulation, the particulars referred to in paragraph 1, together with a reference to the initial batch, must be repeated on the packaging, container or accompanying document of each division of the batch. 5. Where the composition of a feed material in circulation is changed, the particulars referred to in paragraph 1 must be changed accordingly under the responsibility of the person providing the new particulars. Article 6 1. By way of derogation from Article 5, the particulars referred to in Article 5 (1) (c) and (d) and points 2 and 3 of heading V of Part A of the Annex shall not be required where: (a) before each transaction the purchaser has stated in writing that he does not require this information; (b) without prejudice to Directive 90/667/EEC (15), feed materials of animal or vegetable origin, fresh or preserved, whether or not subject to a simple physical treatment, in quantities less than or equal to 10 kg, intended for pet animals and supplied directly to the final user by a seller established in the same Member State, are put into circulation. 2. Where, in the case of feed materials from a third country put into circulation in the Community for the first time, it has not been possible to provide the guarantees regarding composition required in Article 5 (1) (c) and (d) and points 2 and 3 of heading V of Part A of the Annex owing to the absence of means of assuring the analytic measurements necessary in the country concerned, Member States may allow provisional composition data to be supplied by the person responsible referred to in Article 5 (1) (g) provided that: (a) the competent authorities responsible for checks are informed in advance of the arrival of the feed material; (b) the definitive particulars of composition are provided to the purchaser and the competent authorities within 10 working days of the date of its arrival in the Community; (c) the particulars of composition on the documents are accompanied by the following indications in bold type: 'provisional data to be confirmed by . . . (name and address of the laboratory instructed to carry out the analyses) regarding . . . (reference number of the sample to be analysed) before . . . (date)`; (d) Member States inform the Commission of the circumstances in which they applied the derogation referred to in this paragraph. 3. By way of derogation from Article 5: (a) the particulars referred to in Article 5 (1) shall not be required, without prejudice to Directive 90/667/EEC, in the case of products of vegetable or animal origin in their natural state, fresh or preserved, whether or not subjected to a simple physical treatment and not treated with additives, except for preservatives, which are provided by a farmer-producer to a breeder-user, both of whom are established in the same Member State; (b) the particulars referred to in Article 5 (1) (c), (d), (e) and (f) and Part A of the Annex shall not be required where by-products of vegetable or animal origin derived from agro-industrial processing, with a moisture content greater than 50 %, are put into circulation. 4. By way of derogation from Article 5 (1) (a): - in German the designation 'Futtermittel-Ausgangserzeugnis` may be replaced by 'Einzelfuttermittel`, - in Italian the designation 'materie prime per alimenti degli animali` may be replaced by 'mangime semplice`, - in Greek the designation 'ðñþôç ýëç æùïôñïöþí` may be replaced by 'áðëÞ æùïôñïöÞ`. Article 7 1. Member States shall lay down that the feed materials listed in Part B of the Annex may circulate only under the names specified therein and on conditions that they correspond to the descriptions given therein. 2. Member States shall allow the circulation of feed materials other than those on the list referred to in paragraph 1, provided that such materials circulate under names and/or with terms other than those listed in the Annex which cannot mislead the purchaser as to the real identity of the product offered to him. Article 8 Member States shall prescribe that: (a) feed materials containing a level of undesirable substances or products in excess of that permitted for feed materials under Directive 74/63/EEC may be put into circulation only if they are intended for approved establishments manufacturing compound feed entered on a national list in accordance with Directive 95/69/EC; (b) by way of derogation from Article 5 (1) (a), feed materials within the meaning of point (a) of this Article must be labelled 'feed material intended for approved establishments manufacturing compound feed`. Article 6 (4) shall apply. Article 9 For the purpose of circulation within the Community, the indications printed on the accompanying document, on the packaging, on the container or on a label attached thereto shall be written in at least one or several languages which the country of destination shall determine from among the national or official languages of the Community. Article 10 Member States shall ensure that feed materials are not subject, for reasons connected with the provisions of this Directive, to restrictions of circulation other than those laid down in this Directive. Article 11 In accordance with the procedure laid down in Article 14: (a) a numerical coding system for the listed feed materials based on glossaries concerning the origin, part of the product/by-product used, processing and maturity/quality of the feed materials enabling feed to be identified at international level - in particular by name and description - may be adopted; (b) the Annex may be amended in the light of advances in scientific and technical knowledge. Article 12 Member States shall make all necessary arrangements for compliance with the requirements of this Directive to be officially monitored, at least by sampling during circulation. Article 13 1. The Commission shall be assisted by the Standing Committee on Feedingstuffs, set up by Council Decision 70/372/EEC (16), hereinafter referred to as 'the Committee`. 2. Where the procedure laid down in this Article is to be followed, the Chairman shall, without delay, refer the matter to the Committee, either on his own initiative or at the request of the representative of a Member State. 3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter in question. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 4. (a) The Commission shall adopt the intended measures when they are in accordance with the Committee's opinion. (b) When 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 by a qualified majority. If, on the expiry of a period of three months from the date of referral of the proposal to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 14 1. Directive 70/524/EEC is hereby amended as follows: (a) in all cases the term 'straight feedingstuffs` shall be replaced by the term 'feed materials`; (b) Article 2 (f) shall be replaced by the following: '(f) "feed 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 for use in oral animal feeding either directly as such or after processing, in the preparation of compound feedingstuffs or as carriers of premixtures;`; (c) Article 2 (g) shall be replaced by the following: '(g) "compound feedingstuffs": mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;`. 2. Directive 74/63/EEC is hereby amended as follows: (a) in all cases the terms 'straight feedingstuff(s)` shall be replaced by the term 'feed material(s)`; (b) Article 2 (b) shall be replaced by the following: '(b) "feed 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 for use in oral animal feeding, either directly as such or after processing, in the preparation of compound feedingstuffs or as carriers of premixtures;`; (c) Article 2 (h) shall be replaced by the following: '(h) "compound feedingstuffs": mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;`; (d) Article 2 (i) shall be deleted; (e) in all cases the term 'raw material(s)` shall be replaced by 'feed material(s)`. 3. Article 1 (2) of Directive 82/471/EEC is hereby amended as follows: (a) the words 'of straight feedingstuffs and` in point (d) shall be deleted; (b) the following point shall be added: '(g) the circulation of feed materials.`. 4. Directive 93/74/EEC is hereby amended as follows: (a) the term 'ingredients` in Article 5 (8) shall in each case be replaced by the term 'feed materials`; (b) Article 2 (b) shall be replaced by the following: '(b) "compound feedingstuffs": mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;`. Article 15 Directive 77/101/EEC shall be repealed as from 1 July 1998. Article 16 On the basis of information supplied by the Member States, the Commission shall submit a report to the Council before 1 July 2001 on the experience acquired in applying Article 6 (1) (a), (2) and (3) (a) accompanied, when necessary, by appropriate proposals. Article 17 Member States shall bring into force not later than 30 June 1998 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 18 The provisions adopted shall apply as from 1 July 1998. Member States shall, however, lay down that feed materials put into circulation before 1 July 1998 which do not comply with this Directive may remain in circulation until 30 June 1999. Article 19 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 20 This Directive is addressed to the Member States.

31996L0028

1996

Commission Directive 96/28/EC of 10 May 1996 adapting to technical progress Council Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilizers (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (1), as last amended by Directive 89/530/EEC (2), and in particular Article 9 (1) thereof, Whereas Article 7a of the Treaty envisages an area without internal frontiers in which the free circulation of goods, persons, services and capital is assured; Whereas Directive 76/116/EEC laid down rules for the marketing of fertilizers within the internal market; Whereas new fertilizers need to be added to Annex I to Directive 76/116/EEC to enable them to benefit from the Community marking provided for in Annex II to that Directive; Whereas notice 94/C 138/04 (3) establishes a procedure that should be observed by any person (manufacturer or his representative) wanting to apply to a fertilizer the Community marking provided for in Annex II to Directive 76/116/EEC, by way of submitting a technical file to the Member State authorities which will act as rapporteur for the file to the Working Party on Fertilizers of the European Commission; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to trade in Fertilizers, Article 1 Annex I to Directive 76/116/EEC shall be amended as follows: 1. The fertilizer included in Annex I to this Directive shall be added to Part A, point 1 entitled 'Nitrogenous fertilizers` 2. The fertilizers included in Annex II to this Directive shall be added to Part D entitled 'Secondary nutrient fertilizers`. Article 2 The following product and tolerance is added under A.1 in Annex III to Directive 76/116/EEC: >TABLE> Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 May 1997. 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 4 This Directive is addressed to the Member States.

31996L0029

1996

Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof, Having regard to the proposal from the Commission, drawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2) Whereas Article 2b of the Treaty provides for the establishment of uniform basic safety standards to protect the health of workers and of the general public; Whereas Article 30 of the Treaty defines the »basic standards« for the protection of the health of workers and the general public against the dangers arising from ionizing radiation as: (a) maximum permissible doses compatible with adequate safety; (b) maximum permissible levels of exposure and contamination; (c) the fundamental principles governing the health surveillance of workers; Whereas Article 33 of the Treaty requires each Member State to lay down the appropriate provisions, whether by legislation, regulation or administrative action, to ensure compliance with the basic standards which have been established and shall take the necessary measures with regard to teaching, education and vocational training; Whereas in order to perform its task the Community laid down basic standards for the first time in 1959 pursuant to Article 218 of the Treaty by means of Directives of 2 February 1959 laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiations (3); whereas the Directives were revised in 1962 by Directive of 5 March 1962 (4), in 1966 by Directive 66/45/Euratom (5), in 1976 by Directive 76/579Euratom (6), in 1979 by Directive 79/343/Euratom (7), in 1980 by Directive 80/836/Euratom (8) and in 1984 by Directive 84/467/Euratom (9); Whereas the basic standards directives have been supplemented by Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment (10); Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of a radiological emergency (11); Council Regulation (Euratom) No 3954/87 of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (12); Council Directive 89/618Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency (13); Council Directive 90/641/Euratom of 4 December 1990 on the operational protection of outside workers exposed to the risk of ionizing radiation during their activities in controlled areas (14); Council Directive 92/3/Euratom of 3 February 1992 on the supervision and control of shipments of radioactive waste between Member States and into and out of the Community (15); and Council Regulation (Euratom) No 1493/93 of 8 June 1993 on shipments of radioactive substances between Member States (16); Whereas the development of scientific knowledge concerning radiation protection, as expressed in particular in Recommendation No 60 of the International Commission on Radiological Protection, makes it convenient to revise the basic standards and to lay them down in a new legal instrument; Whereas the basic standards are of special significance as to ionizing radiation risks with regard to other Directives concerned with other types of risks and it is important to make progress in applying them in a uniform manner within the Community; Whereas it is desirable to take into account in the scope of the basic standards the practices or work activities which may result in a significant increase in exposure for workers and members of the public, which cannot be disregarded from the radiation protection point of view, due to ionizing radiation from artificial radiation sources or natural radiation sources, as well as appropriate protection in cases of intervention; Whereas the Member States, in order to ensure compliance with the basic standards, are required to submit certain practices involving a hazard from ionizing radiation to a system of reporting and prior authorization or to prohibit certain practices; Whereas a system of radiation protection for practices should continue to be based on the principles of justification of exposure, optimization of protection and dose limitation; whereas, limitations of doses must be fixed taking into account the particular situation of the different groups of persons exposed such as workers, apprentices, students and members of the public; Whereas the operational protection of exposed workers, apprentices and students requires the implementation of measures at the workplace; whereas these measures must include prior evaluation of the hazard involved, classification of workplaces and workers, monitoring of areas and working conditions and medical surveillance; Whereas the Member States should be required to identify work activities involving significantly increased levels of exposure for workers or members of the public to natural radiation sources which cannot be disregarded from a radiation protection point of view; whereas the Member States should take appropriate protective measures in respect of the work activities declared to be of concern; Whereas the operational protection of the population in normal circumstances requires the establishment by Member States of a system of inspection to keep under review the radiation protection of the population and to check compliance with the basic standards; Whereas the Member States should be prepared for the likelihood of potential radiological emergencies on their territory and should cooperate with other Member States and with third countries in order to facilitate the preparedness and management of those situations; Whereas the basic standards directives as last revised by Directive 84/467/Euratom should be repealed with effect from the date that this Directive becomes applicable, TITLE I DEFINITIONS Article 1 For the purpose of this Directive, the following terms have the meaning hereby assigned to them. Absorbed dose (D): the energy absorbed per unit mass D = >NUM>d>START OF GRAPHIC> >END OF GRAPHIC> >DEN>dm Where - d>START OF GRAPHIC> >END OF GRAPHIC> is the mean energy imparted by ionizing radiation to the matter in a volume element, - dm is the mass of the matter in this volume element. In this Directive absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray. Accelerator: apparatus or installation, in which particles are accelerated, emitting ionizing radiation with an energy higher than 1 mega-electron volt (MeV). Accidental exposure: an exposure of individuals as a result of an accident. It does not include emergency exposure. Activation: process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or high-energy gamma rays the material in which it is contained. Activity (A): the activity, A, of an amount of a radionuclide in a particular energy state at a given time is the quotient of dN by dt, where dN is the expectation value of the number of spontaneous nuclear transitions from that energy state in the time interval dt: A = >NUM>dN >DEN>dt The unit of activity is the becquerel. Apprentice: a person receiving training or instruction within an undertaking with a view to exercising a specific skill. Approved dosimetric service: a body responsible for the calibration, reading or interpretation of individual monitoring devices, or for the measurement of radioactivity in the human body or in biological samples, or for assessment of doses, whose capacity to act in this respect is recognized by the competent authorities. Approved medical practioner: a medical practitioner responsible for the medical surveillance of category A workers, as defined in Article 21, whose capacity to act in that respect is recognized by the competent authorities. Approved occupational health services: a body or bodies to which may be assigned responsibility for the radiation protection of exposed workers and/or medical surveillance of category A workers. Its capacity to act in that respect is recognized by the competent authorities. Artificial sources: radiation sources other than natural radiation sources. Authorization: a permission granted in a document by the competent authority, on application, or granted by national legislation, to carry out a practice or any other action within the scope of this Directive. Becquerel (Bq): the special name of the unit of activity. One becquerel is equivalent to one transition per second: 1 Bq = 1 s-1 Clearance levels: values, established by national competent authorities, and expressed in terms of activity concentrations and/or total activity, at or below which radioactive substances or materials containing radioactive substances arising from any practice subject to the requirement of reporting or authorization may be released from the requirements of this Directive. Committed effective dose: (E(ô)): the sum of the committed organ or tissue equivalent dowes (HT(ô)) resulting from an intake, each multiplied by the appropriate tissue weighting factor wT. It is defined by: E(ô) = ÔÓ wTHT(ô) In specifying E(ô), ô is given in the number of years over which the integration is made. The unit for committed effective dose is the sievert. Committed equivalent dose (HT(ô)): the integral over time (t) of the equivalent dose rate in tissue or organ T that will be received by an individual as a result of an intake. It is given by: HT(ô) = t0∫t0 + ô ÇT(t)dtfor an intake at time t0 where - >START OF GRAPHIC> >END OF GRAPHIC> T(t) is the relevant equivalent dose rate in organ or tissue T at time t, - ô is the time over which the integration is performed. In specifying HT(ô), ô is given in years. When ô is not given, a period of 50 years is assumed for adults and up to age 70 for children. The unit for committed equivalent dose is the sievert. Competent authorities: any authority designated by a Member State. Controlled area: an area subject to special rules for the purpose of protection against ionizing radiation or of preventing the spread of radioactive contamination and to which access is controlled. Disposal: the emplacement of waste in a repository, or a given location, without the intention of retrieval. Disposal also covers the approved direct discharge of wastes into the environment, with subsequent dispersion. Dose constraint: a restriction on the prospective doses to individuals which may result from a defined source, for use at the planning stage in radiation protection whenever optimization is involved. Dose limits: maximum references laid down in Title IV for the doses resulting from the exposure of workers, apprentices and students and members of the public to ionizing radiation covered by this Directive that apply to the sum of the relevant doses from external exposures in the specified period and the 50-year committed doses (up to age 70 for children) from intakes in the same period. Effective dose (E): the sum of the weighted equivalent doses in all the tissues and organs of the body specified in Annex II from internal and external irradiation. It is defined by the expression: E = ÔÓ wTHT = ÔÓ wT RÓ wR DT,R where - DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R, - wR is the radiation weighting factor and - wT is the tissue weighting factor for tissue or organ T. The appropriate wT and wR values are specified in Annex II. The unit for effective dose is the sievert. Emergency exposure: an exposure of individuals implementing the necessary rapid action to bring help to endangered individuals, prevent exposure of a large number of people or save a valuable installation or goods, whereby one of the individual dose limits equal to that laid down for exposed workers could be exceeded. Emergency exposure shall apply only to volunteers. Equivalent dose (HT): the absorbed dose, in tissue or organ T weighted for the type and quality of radiation R. It is given by: HT,R = wR DT,R where - DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R, - wR is the radiation weighting factor. When the radiation field is composed of types and energies with different values of WR, the total equivalent dose, HT, is given by: HT = RÓ wR DT,RThe appropriate wR values are specified in Annex II. The unit for equivalent dose is the sievert. Exposed workers: persons, either self-employed or working for an employer, subject to an exposure incurred at work from practices covered by this Directive and liable to result in doses exceeding one or other of the dose levels equal to the dose limits for members of the public. Exposure: the process of being exposed to ionizing radiation. Gray (Gy): the special name of the unit of absorbed dose. One gray is equal to one joule per kilogram: 1 Gy = 1 J kg-1 Health detriment: an estimate of the risk of reduction in length and quality of life occurring in a population following exposure to ionizing radiations. This includes loss arising from somatic effects, cancer and severe genetic disorder. Intake: the activities of radionuclides entering the body from the external environment. Intervention: a human activity that prevents or decreases the exposure of individuals to radiation from sources which are not part of a practice or which are out of control, by acting on sources, transmission pathways and individuals themselves. Intervention level: a value of avertable equivalent dose, avertable effective dose or a derived value, at which intervention measures should be considered. The avertable dose or derived value is solely that associated with the exposure pathway to which the intervention measure is to be applied. Ionizing radiation: the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometer or less or a frequency of 3 ×1015 Hertz or more capable of producing ions directly or indirectly. Members of the public: individuals in the population, excluding exposed workers, apprentices and students during their working hours and individuals during the exposures referred to in Article 6(4)(a), (b) and (c). Natural radiation sources: sources of ionizing radiation from natural terrestrial or cosmic origin. Potential exposure: exposure, that is not expected to be delivered with certainty, with a probability of occurrence that can be estimated in advance. Practice: a human activity that can increase the exposure of individuals to radiation from an artificial source, or from a natural radiation source where natural radionuclides are processed for their radioactive, fissile or fertile properties, except in the case of an emergency exposure. Qualified experts: Persons having the knowledge and training needed to carry out physical, technical or radiochemical tests enabling doses to be assessed, and to give advice in order to ensure effective protection of individuals and the correct operation of protective equipment, whose capacity to act as a qualified expert is recognized by the competent authorities. A qualified expert may be assigned the technical responsibility for the tasks of radiation protection of workers and members of the public. Radioactive contamination: the contamination of any material, surface or environment or of an individual by radioactive substances. In the specific case of the human body, this radioactive contamination includes both external skin contamination and internal contamination, irrespective of route of intake. Radioactive substance: any substance that contains one or more radionuclides the activity or concentration of which cannot be disregarded as far as radiation protection is concerned. Radiological emergency: a situation that requires urgent action in order to protect workers, members of the public or the population either partially or as a whole. Reference group of the population: a group comprising individuals whose exposure to a source is reasonably uniform and representative of that of the individuals in the population who are the more highly exposed to that source. Reporting: requirement of submitting a document to the competent authority to notify the intention to carry out a practice or any other action within the scope of this Directive. Sealed source: a source whose structure is such as to prevent, under normal conditions of use, any dispersion of the radioactive substances into the environment. Sievert: the special name of the unit of equivalent or effective dose. One sievert is equivalent to one joule per kilogram: 1 Sv = 1 J kg-1 Source: an apparatus, a radioactive substance or an installation capable of emitting ionizing radiation or radioactive substances. Supervised area: an area subject to appropriate supervision for the purpose of protection against ionizing radiation. Undertaking: any natural or legal person who carries out the practices or work activities referred to in Article 2 of this Directive and who has the legal responsibility under national law for such practices or work activities. TITLE II SCOPE Article 2 1. This Directive shall apply to all practices which involve a risk from ionizing radiation emanating from an artificial source or from a natural radiation source in cases where natural radionuclides are or have been processed in view of their radioactive, fissile or fertile properties, namely: (a) the production, processing, handling, use, holding, storage, transport, import to and export from the Community and disposal of radioactive substances; (b) the operation of any electrical equipment emitting ionizing radiation and containing components operating at a potential difference of more than 5 kV; (c) any other practice specified by the Member State. 2. In accordance with Title VII it shall also apply to work activities which are not covered by paragraph 1 but which involve the presence of natural radiation sources and lead to a significant increase in the exposure of workers or members of the public which cannot be disregarded from the radiation protection point of view. 3. In accordance with Title IX it shall also apply to any intervention in cases of radiological emergencies or in cases of lasting exposure resulting from the after-effects of a radiological emergency or a past or old practice or work activity. 4. This Directive shall not apply to exposure to radon in dwellings or to the natural level of radiation, i.e. to radionuclides contained in the human body, to cosmic radiation prevailing at ground level or to aboveground exposure to radionuclides present in the undisturbed earth's crust. TITLE III REPORTING AND AUTHORIZATION OF PRACTICES Article 3 Reporting 1. Each Member State shall require the carrying out of the practices referred to in Article 2 (1) to be reported, except as provided for in this Article. 2. No reporting need be required for practices involving the following: (a) radioactive substances where the quantities involved do not exceed in total the exemption values set out in column 2 of Table A to Annex I or, in exceptional circumstances in an individual Member State, different values authorized by the competent authorities that nevertheless satisfy the basic general criteria set out in Annex I; or (b) radioactive substances where the concentration of activity per unit mass do not exceed the exemption values set out in column 3 of Table A to Annex I or, in exceptional circumstances in an individual Member State, different values authorized by the competent authorities that nevertheless satisfy the basic general criteria set out in Annex I; or (c) apparatus containing radioactive substances exceeding the quantities or concentration values specified in subparagraphs (a) or (b), provided that: (i) it is of a type approved by the competent authorities of the Member State; and (ii) it is constructed in the form of a sealed source; and (iii) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSv h-1 at a distance of 0,1 m from any accessible surface of the apparatus; and (iv) conditions for disposal have been specified by the competent authorities; or (d) the operation of any electrical apparatus to which this Directive applies, other than that referred to in subparagraph (e) provided that: (i) it is of a type approved by the competent authorities of the Member State; and (ii) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSv h-1 at a distance of 0,1 m from any accessible surface of the apparatus; or (e) the operation of any cathode ray tube intended for the display of visual images, or other electrical apparatus operating at a potential difference not exceeding 30 kV, provided that this operation does not cause, in normal operating conditions, a dose rate exceeding 1 µSv h-1 at a distance of 0,1 m from any accessible surface of the apparatus; or (f) material contaminated with radioactive substances resulting from authorized releases which competent authorities have declared not to be subject to further controls. Article 4 Authorization 1. Except as provided for in this Article, each Member State shall require prior authorization for the following practices: (a) operation and decommissioning of any facility of the nuclear fuel cycle and exploitation and closure of uranium mining; (b) the deliberate addition of radioactive substances in the production and manufacture of medicinal products and the import or export of such goods; (c) the deliberate addition of radioactive substances in the production and manufacture of consumer goods and the import or export of such goods; (d) the deliberate administration of radioactive substances to persons and, in so far as radiation protection of human beings is concerned, animals for the purpose of medical or veterinary diagnosis, treatment or research; (e) the use of X-ray sets or radioactive sources for industrial radiography or processing of products or research of the exposure of persons for medical treatment and the use of accelerators except electron microscopes; 2. Prior authorization may be required for practices other than those listed in paragraph 1. 3. Member States may specify that a practice shall not require authorization where: (a) in the case of the practices described in paragraph 1 (a), (c) and (e), the practice is exempt from reporting; or (b) in cases where a limited risk of exposure of human beings does not necessitate the examination of individual cases the practice is undertaken in accordance with conditions laid down in national legislation. Article 5 Authorization and clearance for disposal, recycling or reuse 1. The disposal, recycling or reuse of radioactive substances or materials containing radioactive substances arising from any practice subject to the requirement of reporting or authorization is subject to prior authorization. 2. However, the disposal, recycling or reuse of such substances or materials may be released from the requirements of this Directive provided they comply with clearance levels established by national competent authorities. These clearance levels shall follow the basic criteria used in Annex I and shall take into account any other technical guidance provided by the Community. TITLE IV JUSTIFICATION, OPTIMIZATION AND DOSE LIMITATION FOR PRACTICES CHAPTER I GENERAL PRINCIPLES Article 6 1. Member States shall ensure that all new classes or types of practice resulting in exposure to ionizing radiation are justified in advance of being first adopted or first approved by their economic, social or other benefits in relation to the health detriment they may cause. 2. Existing classes or types of practice may be reviewed as to justification whenever new and important evidence about their efficacy or consequences is acquired. 3. In addition each Member State shall ensure that: (a) in the context of optimization all exposures shall be kept as low as reasonably achievable, economic and social factors being taken into account; (b) without prejudice to Article 12, the sum of the doses from all relevant practices shall not exceed the dose limits laid down in this Title for exposed workers, apprentices and students and members of the public. 4. The principle set out in paragraph 3 (a) shall apply to all exposures to ionizing radiation resulting from the practices referred to in Article 2 (1). The principle set out in paragraph 3 (b) shall not apply to any of the following exposures: (a) exposure of individuals as part of their own medical diagnosis or treatment; (b) exposure of individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of patients undergoing medical diagnosis or treatment; (c) exposure of volunteers participating in medical and biomedical research programmes. 5. Member States shall permit neither the deliberate addition of radioactive substances in the production of foodstuffs, toys, personal ornaments and cosmetics nor the import or export of such goods. Article 7 Dose constraints 1. Dose constraints should be used, where appropriate, within the context of optimization of radiological protection. 2. Guidance established by each Member State on the appropriate procedures to be applied to individuals exposed in accordance with Article 6 (4) (b) and (c) may include dose constraints. CHAPTER II LIMITATION OF DOSES Article 8 Age limit for exposed workers Subject to Article 11 (2), persons under 18 years of age may not be assigned to any work which would result in their being exposed workers. Article 9 Dose limits for exposed workers 1. The limit on effective dose for exposed workers shall be 100 millisieverts ('mSv`) in a consecutive five-year period, subject to a maximum effective dose of 50 mSv in any single year. Member States may decide an annual amount. 2. Without prejudice to paragraph 1: (a) the limit on equivalent dose for the lens of the eye shall be 150 mSv in a year; (b) the limit on equivalent dose for the skin shall be 500 mSv in a year. This limit shall apply to the dose averaged over any area of 1 cm², regardless of the area exposed; (c) the limit on equivalent dose for the hands, forearms, feet and ankles shall be 500 mSv in a year. Article 10 Special protection during pregnancy and breastfeeding 1. As soon as a pregnant woman informs the undertaking, in accordance with national legislation and/or national practice, of her condition, the protection of the child to be born shall be comparable with that provided for members of the public. The conditions for the pregnant woman in the context of her employment shall therefore be such that the equivalent dose to the child to be born will be as low as reasonably achievable and that it will be unlikely that this dose will exceed 1 mSv during at least the remainder of the pregnancy. 2. As soon as a nursing woman informs the undertaking of her condition she shall not be employed in work involving a significant risk of bodily radioactive contamination. Article 11 Dose limits for apprentices and students 1. The dose limits for apprentices aged 18 years or over and students aged 18 years or over who, in the course of their studies, are obliged to use sources shall be the same as the dose limits for exposed workers laid down in Article 9. 2. The limit for effective dose for apprentices aged between 16 and 18 years and for students aged between 16 and 18 years who, in the course of their studies, are obliged to use sources shall be 6 mSv per year. Without prejudice to this dose limit: (a) the limit on equivalent dose for the lens of the eye shall be 50 mSv in a year; (b) the limit on equivalent dose for the skin shall be 150 mSv in a year. This limit shall apply to the dose averaged over any area of 1 cm², regardless of the area exposed; (c) the limit on equivalent dose for the hands, forearms, feet and ankles shall be 150 mSv in a year. 3. The dose limits for apprentices and students who are not subject to the provisions of paragraphs 1 and 2 shall be the same as the dose limits for members of the public specified in Article 13. Article 12 Specially authorized exposures 1. In exceptional circumstances, excluding radiological emergencies and evaluated case by case, the competent authorities may, where some specific operation so requires, authorize individual occupational exposures of some identified workers exceeding the dose limits set out in Article 9, provided that such exposures are limited in time, confined to certain working areas and within maximum exposure levels defined for the particular case by the competent authorities. The following conditions shall be taken into account: (a) only category A workers as defined in Article 21 may be subject to specially authorized exposures; (b) apprentices, students, pregnant women and breastfeeding women who are likely to be bodily contaminated shall be excluded from such exposures; (c) the undertaking shall carefully justify these exposures in advance and thoroughly discuss them with the voluntary workers, their representatives, the approved medical practitioner, the approved occupational health services or the qualified expert; (d) information about the risks involved and the precautions to be taken during the operation shall be provided to the relevant workers in advance; (e) all doses relating to such exposures shall be separately recorded in the medical record referred to in Article 34 and the individual record referred to in Article 28. 2. The exceeding of dose limits as a result of specially authorized exposures shall not necessarily constitute a reason by the employer for excluding from his usual occupation or relocating the worker, without the agreement of the worker. Article 13 Dose limits for members of the public 1. Without prejudice to Article 14, the dose limits for members of the public shall be as laid down in paragraphs 2 and 3. 2. The limit for effective dose shall be 1 mSv in a year. However, in special circumstances, a higher effective dose may be authorized in a single year, provided that the average over five consecutive years does not exceed 1 mSv per yeare. 3. Without prejudice to paragraph 2: (a) the limit on equivalent dose for the lens of the eye shall be 15 mSv in a year; (b) the limit on equivalent dose for the skin shall be 50 mSv in a year averaged over any 1 cm² area of skin, regardless of the area exposed. Article 14 Exposure of the population as a whole Each Member State shall take reasonable steps to ensure that the contribution to the exposure of the population as a whole from practices is kept as low as reasonably achievable, economic and social factors being taken into account. The total of all such contributions shall be regularly assessed. TITLE V ESTIMATION OF EFFECTIVE DOSE Article 15 For the estimation of effective and equivalent doses the values and relationships referred to in this Title shall be used. The competent authorities may authorize the use of equivalent methods. Article 16 Without prejudice to the provisions of Article 15: (a) For external radiation, the values and relationships given in Annex II shall be used to estimate the relevant effective and equivalent doses; (b) For internal exposure from a radionuclide or from a mixture of radionuclides, the values and relationships given in Annexes II and III may be used to estimate the effective doses. TITLE VI FUNDAMENTAL PRINCIPLES GOVERNING OPERATIONAL PROTECTION OF EXPOSED WORKERS, APPRENTICES AND STUDENTS FOR PRACTICES Article 17 Operational protection of exposed workers shall be based in particular on the following principles: (a) prior evaluation to identify the nature and magnitude of the radiological risk to exposed workers and implementation of the optimization of radiation protection in all working conditions; (b) classification of workplaces into different areas, where appropriate, by reference to an assessment of the expected annual doses and the probability and magnitude of potential exposures; (c) classification of workers into different categories; (d) implementation of control measures and monitoring relating to the different areas and working conditions, including, where necessary, individual monitoring; (e) medical surveillance. CHAPTER I MEASURES FOR THE RESTRICTION OF EXPOSURE Section 1 Classification and delineation of areas Article 18 Arrangements in workplaces 1. For the purposes of radiation protection, arrangements shall be made as regards all workplaces where there is a possibility of exposure to ionizing radiation in excess of 1 mSv per year on an equivalent dose of 10 of the dose limits for the lens of the eyes, skin and extremities laid down in Article 9 (2). Such arrangements must be appropriate to the nature of the installations and sources and to the magnitude and nature of the risks. The scope of the precautions and monitoring, as well as their type and quality, must be appropriate to the risks associated with the work involving exposure to ionizing radiation. 2. A distinction shall be made between controlled areas and supervised areas. 3. The competent authorities shall establish guidance on the classification of controlled and supervised areas which is relevant to the particular circumstances. 4. The undertaking shall keep under review the working conditions in controlled and supervised areas. Article 19 Requirements for controlled areas 1. The minimum requirements for a controlled area are as follows: (a) the controlled area shall be delineated and access to it shall be restricted to individuals who have received appropriate instructions and shall be controlled in accordance with written procedures provided by the undertaking. Wherever there is a significant risk of the spread of radioactive contamination, specific arrangements shall be made, including access and exit of individuals and goods; (b) taking into account the nature and extent of radiological risks in the controlled area, radiological surveillance of the working environment shall be organized in accordance with the provisions of Article 24; (c) signs indicating type of area, nature of the sources and their inherent risks shall be displayed; (d) working instructions appropriate to the radiological risk associated with the sources and the operations involved shall be laid down. 2. The implementation of these duties will be carried out under the responsibility of the undertaking following consultations with the approved occupational health services or the qualified experts. Article 20 Requirements for supervised areas 1. The requirements for a supervised area are as follows: (a) as a minimum, taking into account the nature and extent of radiological risks in the supervised area, radiological surveillance of the working environment shall be organized in accordance with the provisions of Article 24; (b) if appropriate, signs indicating type of area, nature of the sources and their inherent risks shall be displayed; (c) if appropriate, working instructions appropriate to the radiological risk associated with the sources and the operations involved shall be laid down. 2. The implementation of these duties will be carried out under the responsibility of the undertaking following consultations with the qualified experts or the approved occupational health services. Section 2 Classification of exposed workers, apprentices and students Article 21 Categorization of exposed workers For the purposes of monitoring and surveillance, a distinction shall be made between two categories of exposed workers: (a) category A: those exposed workers who are liable to receive an effective dose greater than 6 mSv per year or an equivalent dose greater than >NUM>3 >DEN>10 of the dose limits for the lens of the eye, skin and extremities laid down in Article 9 (2); (b) category B: those exposed workers who are not classified as exposed category A workers. Article 22 Information and training 1. Member States shall require the undertaking to inform exposed workers, apprentices and students who, in the course of their studies, are obliged to use sources on: (a) the health risks involved in their work: - the general radiation protection procedures and precautions to be taken and, in particular, those involved with operational and working conditions in respect of both the practice in general and each type of work station or job to which they may be assigned, - the importance of complying with the technical, medical and administrative requirements; (b) in the case of women, the need for early declaration of pregnancy in view of the risks of exposure for the child to be born and the risk of contaminating the nursing infant in case of bodily radioactive contamination. 2. Member States shall require the undertaking to arrange for relevant training in the field of radiation protection to be given to exposed workers, apprentices and students. Section 3 Assessment and implementation of arrangements for the radiological protection of exposed workers Article 23 1. The undertaking shall be responsible for assessing and implementing arrangements for the radiological protection of exposed workers. 2. Member States shall require the undertaking to consult the qualified experts or the approved occupational health services on the examination and testing of protective devices and measuring instruments comprising in particular: (a) prior critical examination of plans for installations from the point of view of radiation protection; (b) the acceptance into service of new or modified sources from the point of view of radiation protection; (c) regular checking of the effectiveness of protective devices and techniques; (d) regular calibration of measuring instruments and regular checking that they are serviceable and correctly used. CHAPTER II ASSESSMENT OF EXPOSURE Section 1 Monitoring of the workplace Article 24 1. The radiological surveillance of the working environment referred to in Articles 19 (1) (b) and 20 (1) (a) shall comprise, where appropriate: (a) the measurement of external dose rates, indicating the nature and quality of the radiation in question; (b) the measurement of air activity concentration and surface density of contaminating radioactive substances, indicating their nature and their physical and chemical states. 2. The results of these measurements shall be recorded and shall be used, if necessary, for estimating individual doses, as provided for in Article 25. Section 2 Individual monitoring Article 25 Monitoring - General 1. Individual monitoring shall be systematic for exposed category A workers. This monitoring shall be based on individual measurements which are established by an approved dosimetric service. In cases where category A workers are liable to receive significant internal contamination an adequate system for monitoring should be set up; the competent authorities may provide general guidance for identifying such workers. 2. Monitoring for category B workers shall be at least sufficient to demonstrate that such workers are correctly classified in category B. Member States may require individual monitoring and if necessary individual measurements, established by an approved dosimetric service, for category B workers. 3. In cases where individual measurements are impossible or inadequate, the individual monitoring shall be based on an estimate arrived at either from individual measurements made on other exposed workers or from the results of the surveillance of the workplace provided for in Article 24. Section 3 Monitoring in the case of accidental or emergency exposure Article 26 In the case of accidental exposure the relevant doses and their distribution in the body shall be assessed. Article 27 In the case of emergency exposure, individual monitoring or assessment of the individual doses shall be carried out as appropriate to the circumstances. Section 4 Recording and reporting of results Article 28 1. A record containing the results of the individual monitoring, shall be made for each exposed category A worker. 2. For the purposes of paragraph 1 the following shall be retained during the working life involving exposure to ionizing radiation of exposed workers, and afterwards until the individual has or would have attained the age of 75 years, but in any case not less than 30 years from the termination of the work involving exposure: (a) a record of the exposures measured or estimated, as the case may be, of individual doses pursuant to Articles 12, 25, 26 and 27; (b) in the case of exposures referred to in Articles 26 and 27, the reports relating to the circumstances and the action taken; (c) the results of workplace monitoring used to assess individual doses where necessary. 3. Exposure referred to in Articles 12, 26 and 27 shall be recorded separately in the dose record referred to in paragraph 1. Article 29 1. The results of the individual monitoring required by Articles 25, 26 and 27 shall be: (a) made available to the competent authorities, and to the undertaking; (b) made available to the worker concerned in accordance with Article 38 (2); (c) submitted to the approved medical practitioner or approved occupational health services in order to interpret their implications for human health, as provided for in Article 31. 2. Member States shall determine the arrangements under which the results of individual monitoring are conveyed. 3. In the case of an accidental or emergency exposure, the results of individual monitoring shall be submitted without delay. CHAPTER III MEDICAL SURVEILLANCE OF EXPOSED WORKERS Article 30 The medical surveillance of exposed workers shall be based on the principles that govern occupational medicine generally. Section 1 Medical surveillance of category A workers Article 31 Medical surveillance 1. Notwithstanding the overall responsibility of the undertaking, the medical surveillance of category A workers shall be the responsibility of approved medical practitioners or approved occupational health services. This medical surveillance must allow for ascertaining the state of health of workers under surveillance as regards their fitness for the tasks assigned to them. To this end the approved medical practitioner or approved occupational health services must have access to any relevant information they require including the environmental conditions existing in the working premises. 2. Medical surveillance shall include: (a) a medical examination prior to employment or classification as category A worker. The purpose of this thorough examination shall be to determine the worker's fitness for a post as category A worker for which he is being considered; (b) periodic reviews of health. The state of health of each category A worker shall be reviewed at least once a year, in order to determine whether they remain fit to perform their duties. The nature of these reviews, which can be performed as many times as the approved medical practitioner considers necessary, shall depend on the type of work and on the individual worker's state of health. 3. The approved medical practitioner or approved occupational health services may indicate the need for medical surveillance to continue after cessation of work for as long as they consider it necessary to safeguard the health of the person concerned. Article 32 Medical classification The following medical classification shall be adopted with respect to fitness for work as a category A worker: (a) fit; (b) fit, subject to certain conditions; (c) unfit. Article 33 No worker may be employed or classified for any period in a specific post as a category A worker if the medical findings deem him unfit for that specific post. Article 34 Medical records 1. A medical record shall be opened for each category A worker and kept up to date so long as he remains a worker of that category. Thereafter it shall be retained until the individual has or would have attained the age of 75 years, but in any case not less than 30 years from the termination of the work involving exposure to ionizing radiation. 2. The medical record shall include information regarding the nature of the employment, the results of the medical examinations prior to employment or classification as category A worker, the periodic reviews of health and the record of doses required by Article 28. Section 2 Special surveillance of exposed workers Article 35 1. Special medical surveillance shall be provided in each case where one of the dose limits laid down in Article 9 has been exceeded. 2. Subsequent conditions of exposure shall be subject to the agreement of the approved medical practitioner or approved occupational health services. Article 36 In addition to the medical surveillance of exposed workers provided for in Articles 30 and 31, provision shall be made for any further action in relation to the health protection of the exposed individual considered necessary by the approved medical practitioner or approved occupational health services such as further examinations, decontamination measures or urgent remedial treatment. Section 3 Appeals Article 37 Each Member State shall lay down the procedure for appeal against the findings and decisions made in pursuance of Articles 32, 33 and 35. CHAPTER IV TASKS OF MEMBER STATES IN RESPECT OF PROTECTION OF EXPOSED WORKERS Article 38 1. Each Member State shall establish a system or systems of inspection to enforce the provisions introduced in compliance with this Directive and to initiate surveillance and intervention measures wherever necessary. 2. Each Member State shall require that workers have access at their request to the results of their individual monitoring, including the results of measurements which may have been used in estimating them, or of the assessments of their doses made as a result of workplace measurements. 3. Each Member State shall make the necessary arrangements to recognize, as appropriate, the capacity of: - the approved medical practitioners, - the approved occupational health services, - the approved dosimetric services, - the qualified experts. To this end, each Member State shall ensure that the training of such specialists is arranged. 4. Each Member State shall require that the means necessary for proper radiation protection are placed at the disposal of the units responsible. A specialized radiation protection unit, distinct from production and operation units in the case of an internal unit, authorized to perform radiation protection tasks and provide specific advice shall be required for the installations which the competent authorities consider necessary. This unit may be shared by several installations. 5. Each Member State shall facilitate the exchange amongst competent authorities, or approved medical practitioners, or approved occupational health services, or qualified experts, or approved dosimetric services within the European Community of all relevant information on the doses previously received by a worker in order to perform the medical examination prior to employment or classification as a category A worker pursuant to Article 31 and to control the further exposure of workers. CHAPTER V OPERATIONAL PROTECTION OF APPRENTICES AND STUDENTS Article 39 1. The exposure conditions and operational protection of apprentices and students aged 18 years or over referred to in Article 11 (1) shall be equivalent to that of exposed workers of category A or B as appropriate. 2. The exposure conditions and operational protection of apprentices and students aged between 16 and 18 years referred to in Article 11 (2) shall be equivalent to that of exposed workers of category B. TITLE VII SIGNIFICANT INCREASE IN EXPOSURE DUE TO NATURAL RADIATION SOURCES Article 40 Application 1. This Title shall apply to work activities not covered by Article 2 (1) within which the presence of natural radiation sources leads to a significant increase in the exposure of workers or of members of the public which cannot be disregarded from the radiation protection point of view. 2. Each Member State shall ensure the identification, by means of surveys or by any other appropriate means, of work activities which may be of concern. These include, in particular: (a) work activities where workers and, where appropriate, members of the public and exposed to thoron or radon daughters or gamma radiation or any other exposure in workplaces such as spas, caves, mines, underground workplaces and aboveground workplaces in identified areas; (b) work activities involving operations with, and storage of, materials, not usually regarded as radioactive but which contain naturally occurring radionuclides, causing a significant increase in the exposure of workers and, where appropriate, members of the public; (c) work activities which lead to the production of residues not usually regarded as radioactive but which contain naturally occurring radionuclides, causing a significant increase in the exposure of members of the public and, where appropriate, workers; (d) aircraft operation. 3. Articles 41 and 42 shall apply to the extent that the Member States have declared that exposure to natural radiation sources due to work activities identified in accordance with paragraph 2 of this Article needed attention and had to be subject to control. Article 41 Protection against exposure from terrestrial natural radiation sources For each work activity declared by them to be of concern, the Member States shall require the setting-up of appropriate means for monitoring exposure and as necessary: (a) the implementation of corrective measures to reduce exposure pursuant to all or part of Title IX; (b) the application of radiation protection measures pursuant to all or part of Titles III, IV, V, VI and VIII. Article 42 Protection of air crew Each Member State shall make arrangements for undertakings operating aircraft to take account of exposure to cosmic radiation of air crew who are liable to be subject to exposure to more than 1 mSv per year. The undertakings shall take appropriate measures, in particular: - to assess the exposure of the crew concerned, - to take into account the assessed exposure when organizing working schedules with a view to reducing the doses of highly exposed aircrew, - to inform the workers concerned of the health risks their work involves, - to apply Article 10 to female air crew. TITLE VIII IMPLEMENTATION OF RADIATION PROTECTION FOR THE POPULATION IN NORMAL CIRCUMSTANCES Article 43 Basic principles Each Member State shall create the conditions necessary to ensure the best possible protection of the population based on the principles set out in Article 6 and to apply the fundamental principles governing operational protection of the population. Article 44 Conditions for authorization of practices involving a risk from ionizing radiation for the population Operational protection of the population in normal circumstances from practices subject to prior authorization means all arrangements and surveys for detecting and eliminating the factors which, in the course of any operation involving exposure to ionizing radiation, are liable to create a risk of exposure for the population which cannot be disregarded from the radiation protection point of view. Such protection shall include the following tasks: (a) examination and approval of plans for installations involving an exposure risk, and of the proposed siting of such installations within the territory concerned, from the point of view of radiation protection; (b) acceptance into service of such new installations subject to adequate protection being provided against any exposure or radioactive contamination liable to extend beyond the perimeter, taking into account, if relevant, demographic, meteorological, geological, hydrological and ecological conditions; (c) examination and approval of plans for the discharge of radioactive effluents. These tasks shall be carried out in accordance with rules laid down by the competent authorities on the basis of the extent of the exposure risk involved. Article 45 Estimates of population doses The competent authorities shall: (a) ensure that dose estimates from practices referred to in Article 44 are made as realistic as possible for the population as a whole and for reference groups of the population in all places where such groups may occur; (b) decide on the frequency of assessments and take all necessary steps to identify the reference groups of the population, taking into account the effective pathways of transmission of the radioactive substances; (c) ensure, taking into account the radiological risks, that the estimates of the population doses include: - assessment of the doses due to external radiation, indicating, where appropriate, the quality of the radiation in question, - assessment of the intake of radionuclides, indicating the nature of the radionuclides and, where necessary, their physical and chemical states, and determination of the activity and concentrations of these radionuclides, - assessment of the doses that the reference groups of the population are liable to receive and specification of the characteristics of these groups. (d) require records to be kept relating to measurements of external exposure, estimates of intakes of radionuclides and radioactive contamination as well as the results of the assessment of the doses received by reference groups and by the population. Article 46 Inspection As regards health protection of the population each Member State shall establish a system of inspection to enforce the provisions introduced in compliance with this Directive and to initiate surveillance in the area of radiation protection. Article 47 Responsibilities of undertakings 1. Each Member State shall require the undertaking responsible for practices as referred to in Article 2 to conduct them in accordance with the principles of health protection of the population in the area of radiation protection and in particular to carry out the following tasks within its installations: (a) achieving and maintaining an optimal level of protection of the environment and the population; (b) checking the effectiveness of technical devices for protecting the environment and the population; (c) acceptance into service, from the point of view of surveillance of radiation protection, of equipment and procedures for measuring and assessing, as appropriate, exposure and radioactive contamination of the environment and the population; (d) regular calibration of measuring instruments and regular checking that they are serviceable and correctly used. 2. Qualified experts and, as appropriate, the specialized radiation protection unit referred to in Article 38 (4) shall be concerned in the discharge of these duties. TITLE IX INTERVENTION Article 48 Application 1. This Title shall apply to intervention in cases of radiological emergencies or in cases of lasting exposure resulting from the after-effects of a radiological emergency or a past or old practice or work activity. 2. The implementation and extent of any intervention shall be considered in compliance with the following principles: - intervention shall be undertaken only if the reduction in detriment due to radiation is sufficient to justify the harm and costs, including social costs, of the intervention, - the form, scale and duration of the intervention shall be optimized so that the benefit of the reduction in health detriment less the detriment associated with the intervention, will be maximized, - dose limits, as laid down in Articles 9 and 13, shall not apply to intervention; however, the intervention levels established in application of Article 50 (2) constitute indications as to the situations in which intervention is appropriate; furthermore, in cases of long term exposure covered by Article 53, the dose limits set out in Article 9 should normally be appropriate for workers involved in interventions. Section 1 Intervention in cases of radiological emergency Article 49 Potential exposures The Member States shall, where appropriate, require: - that the possibility of radiological emergencies resulting from practices subject to the system of reporting or authorization laid down in Title III be considered, - that the spatial and temporal distribution of the radioactive substances dispersed in the event of a possible radiological emergency be assessed, - that the corresponding potential exposures be assessed. Article 50 Intervention preparation 1. Each Member State shall ensure that account is taken of the fact that radiological emergencies may occur in connection with practices on or outside its territory and affect it. 2. Each Member State shall ensure that appropriate intervention plans, taking account of the general principles of radiation protection for intervention referred to in Article 48 (2) and of the appropriate intervention levels established by the competent authorities, are drawn up at national or local level, including within installations, in order to deal with various types of radiological emergency and that such plans are tested to an appropriate extent at regular intervals. 3. Each Member State shall ensure, where appropriate, that provision is made for the creation and appropriate training of special teams for technical, medical and health intervention. 4. Each Member State shall seek to cooperate with other Member States or non-Member States in relation to possible radiological emergencies at installations on its own territory which may affect other Member States or non-Member States, in order to facilitate the organization of radiological protection in these States. Article 51 Implementation of intervention 1. Each Member State shall make provision for the immediate notification to its competent authorities by the undertaking responsible for the practices involved of any radiological emergency occurring in its territory and shall require all appropriate action to reduce the consequences. 2. Each Member State shall ensure that in the event of a radiological emergency on its own territory, the undertaking responsible for the practices involved makes an initial provisional assessment of the circumstances and consequences of the emergency and assists with intervention. 3. Each Member State shall ensure that provision is made, if the situation so requires, for intervention related to: - the source, to reduce or stop the direct radiation and emission of radionuclides, - the environment, to reduce the transfer of radioactive substances to individuals, - individuals, to reduce exposure and organize the treatment of victims. 4. In the event of a radiological emergency on or outside its territory, each Member State shall require: (a) the organization of appropriate intervention, taking account of the real characteristics of the emergency; (b) the assessment and recording of the consequences of the radiological emergency and of the effectiveness of the intervention. 5. Each Member State shall, in the event of a radiological emergency occurring at an installation on its territory or being likely to have radiological consequences on its territory, establish relations to obtain cooperation with any other Member State or non-Member State which may be involved. Article 52 Emergency occupational exposure 1. Each Member State shall make provision for situations where workers or intervention personnel involved in different kinds of intervention are liable to be subjected to emergency exposure resulting in doses in excess of the dose limits for exposed workers. To this end, each Member State shall establish exposure levels taking into account the technical obligations and health risks. These levels shall be operational guides. An exposure above these special levels may be admitted exceptionally to save human lives and only for volunteers who are informed about the risks involved in their intervention. 2. Each Member State shall require radiological monitoring and medical surveillance of the special emergency intervention teams. Section II Intervention in cases of lasting exposure Article 53 Where the Member States have identified a situation leading to lasting exposure resulting from the after-effects of a radiological emergency or a past practice, they shall, if necessary and to the extent of the exposure risk involved, ensure that: (a) the area concerned is demarcated; (b) arrangements for the monitoring of exposure are made; (c) any appropriate intervention is implemented, taking account of the real characteristics of the situation; (d) access to or use of land or buildings situated in the demarcated area is regulated. TITLE X FINAL PROVISIONS Article 54 1. This Directive establishes the basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation with the aim of their uniform implementation by Member States. If a Member State is to adopt dose limits which are stricter than those laid down in this Directive, it shall inform the Commission and the Member States. Article 55 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 May 2000. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main laws, regulations or administrative provisions which they adopt in the field governed by this Directive. Article 56 Repeals The Directives of 2 February 1959, the Directive of 5 March 1962, Directives 66/45/Euratom, 76/579/Euratom, 79/343/Euratom, 80/836/Euratom and 84/467/Euratom shall be repealed with effect from 13 May 2000. Article 57 This Directive is addressed to the Member States.

31996L0027

1996

Directive 96/27/EC of the European Parliament and of the Council of 20 May 1996 on the protection of occupants of motor vehicles in the event of a side impact and amending Directive 70/156/EEC Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular Article 13 (4) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the Economic and Social Committee (3), Acting in accordance with the procedures laid down in Article 189b of the Treaty (4), Whereas the total harmonization of technical requirements for motor vehicles is necessary in order fully to achieve the internal market; Whereas in order to reduce the number of road accident casualties in Europe, it is necessary to introduce legislative measures for improving the protection of occupants of motor vehicles in the event of a side impact as much as possible; whereas this Directive introduces side impact test requirements, including biomechanical criteria, to ensure that a reasonable level of side impact resistance is provided; Whereas these requirements should be regarded as an interim measure and will need to be reviewed in the light of further research and experience gained during the first two years of type-approval tests carried out in accordance with this Directive; whereas the establishment of more stringent standards will ensure a higher level of safety in future; Whereas this Directive will be one of the separate directives which must be complied with in order to ensure the conformity of vehicles with the requirements of the EC type-approval procedure established by Directive 70/156/EEC; whereas, therefore, the provisions of Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas the procedure for determining the seating reference point in motor vehicles is given in Annex III to Council Directive 77/649/EEC of 27 September 1977 on the approximation of the laws of the Member States relating to the field of vision of motor vehicle drivers (5); whereas it is therefore unnecessary to repeat it in this Directive; whereas reference should be made in this Directive to Council Directive 70/387/EEC of 27 July 1970 on the approximation of the laws of the Member States relating to the doors of motor vehicles and their trailers (6), Council Directive 74/483/EEC of 17 September 1974 on the approximation of the laws of the Member States relating to the external projections of motor vehicles (7), Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts (8) and to ISO standard 6487:1987; Whereas the technical requirements of this Directive are based on United Nations Economic Commission for Europe document TRANS/SC1/WP29/396, Article 1 For the purposes of this Directive, 'vehicle` shall have the meaning given to it in Article 2 of Directive 70/156/EEC. Article 2 1. No Member State may, on grounds concerning the protection of occupants of vehicles in the event of a side impact resistance: - refuse, in respect of a vehicle type, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of a vehicle, if it complies with the requirements of this Directive. 2. With effect from 1 October 1998, Member States may no longer grant: - EC type-approval for a vehicle type in accordance with Article 4 of Directive 70/156/EEC, - national type-approval for a vehicle type, unless the vehicle satisfies the requirements of this Directive. 3. Paragraph 2 shall not apply to types of vehicle which have been type-approved before 1 October 1998 in application of any two of the following Directives: 70/387/EEC (door latches and hinges), 74/483/EEC (external projections) and 76/115/EEC (anchorages for motor-vehicle safety belts) nor, where appropriate, to subsequent extensions to those type-approvals. 4. With effect from 1 October 2003, Member States must consider certificates of conformity which accompany new vehicles in accordance with Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, if they do not certify that the vehicles conform to the requirements of the Annexes to this Directive. Article 3 In Part 1 of Annex IV to Directive 70/156/EEC the table shall be supplemented as follows: >TABLE> Article 4 In the framework of the adaptation of this Directive to technical progress within two years from the date mentioned in Article 2 (2), a review shall be held by the Commission. It shall be based on a review of the technical criteria and, in particular, the viscous criterion, front seat position and the ground clearance of the barrier. The review criteria will include inter alia accident research data, full scale car-to-car test results and cost-benefit considerations. The review will examine the potential gains in passenger protection and the industrial feasibility of increasing the ground clearance of the barrier. The results of this review will be subject to a report from the Commission to the European Parliament and Council. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 May 1997 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 6 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

31996L0033

1996

Council Directive 96/33/EC of 21 May 1996 amending the Annexes to Directives 86/362/EEC and 86/363/EEC on the fixing of maximum levels for pesticide residues in and on cereals and foodstuffs of animal origin respectively Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in cereals (1), and in particular Article 11 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in foodstuffs of animal origin (2), and in particular Article 11 thereof, Having regard to the proposal from the Commission, Whereas the Commission has received a mandate in the framework of Directives 86/362/EEC and 86/363/EEC to prepare the list of pesticide residues and their maximum levels for approval by the Council; Whereas pesticide residues may arise in cereals and foodstuffs of animal origin as a result of agricultural practices; whereas it is necessary to take into account relevant data for both authorized pesticide uses and as appropriate supervised trials and animal feeding studies; Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where possible, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable; Whereas, in the light of technical and scientific progress and the requirements of public health and agriculture, it is desirable to amend Directives 86/362/EEC and 86/363/EEC by adding provisions relating to further pesticide residues for cereals and foodstuffs of animal origin, namely chlormequat, diazinon, dicofol, disulfoton, endosulfan, fenbutatin oxide, fentin, mecarbam, phorate, propoxur, propyzamide, triazophos and triforine; Whereas, however, data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas, in such cases, a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas, therefore, maximum levels should be established on the basis of such data by 30 April 2000 at the latest; whereas failure to provide satisfactory data will normally result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of the adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme established in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), Article 1 The following pesticide residues shall be added to Part A of Annex II to Directive 86/362/EEC: >TABLE> Article 2 Annex II to Directive 86/363/EEC shall be amended as follows: 1. The following pesticide residues shall be added to Part A: >TABLE> 2. The following pesticide residues shall be added to Part B: >TABLE> Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 April 1997. When Member States adopt those measures, they shall contain references to this Directive or shall be accompanied by such references on the occasion of their publication. The methods of making such references shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0032

1996

Council Directive 96/32/EC of 21 May 1996 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables and Annex II to Directive 90/642/EEC relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 1 thereof, Having regard to the proposal from the Commission, Whereas, in order to establish mandatory maximum levels of pesticide residues at Community level, it is necessary to transfer provisions from Directive 76/895/EEC to Directive 90/642/EEC relating to the pesticides chlormequat, diazinon, dicofol, endosulfan, fentin and propoxur; whereas certain of those provisions should be amended in the light of technical and scientific progress; Whereas the Commission has received a mandate in the framework of Directive 90/642/EEC to prepare the list of pesticide residues and their maximum levels for approval by the Council; Whereas Directive 90/642/EEC provided for the establishment of a list of maximum levels for certain pesticide residues, including a maximum pesticide residue level for the herbicide glyphosate in and on soya bean (3), and for the fungicide fenarimol in and on bananas (4); whereas it is appropriate to amend to maximum pesticide residue levels for soya bean and bananas in order to reflect the authorized uses in certain third countries; whereas the new levels provided for are acceptable from a dietary intake point of view; whereas these levels should facilitate international trade; Whereas Directive 90/642/EEC provided for the establishment of maximum pesticide residue levels for iprodione in and on rhubarb, and for benomyl in and on rhubarb and courgettes; whereas new data are available on these pesticide residue/product combinations; whereas on consideration of these data it is now appropriate to amend the maximum pesticide residue levels for rhubarb and courgettes; whereas the new levels provided for are acceptable from a dietary intake point of view; Whereas pesticide residues may arise in products of plant origin including fruit and vegetables as a result of agricultural practices; whereas it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials; Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where appropriate, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable; Whereas it is now appropriate that maximum levels be fixed for certain pesticide residues in products of plant origin, namely disulfoton, fenbutatin oxide, mecarbam, phorate, propyzamide, triazophos and triforine; whereas, however, it is not possible to establish maximum pesticide residue levels for all pesticide residue product combinations due to insufficient data; Whereas, however, data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas, in such cases, a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas, therefore, maximum levels should be established on the basis of such data by 30 April 2000 at the latest; whereas failure to provide satisfactory data should normally result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of the adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evalutation of active substances provided for in the work programme established in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (5), Article 1 Annex II to Directive 76/895/EEC is hereby amended as follows: 1. The entries relating to the following pesticide residues shall be deleted: chlormequat diazinon dicofol endosulfan fentin propoxur. 2. The following entries shall be inserted: >TABLE> 3. The entries provided for in point 2 shall be deleted no later than 30 April 2000. Article 2 1. Annex II to Directive 90/642/EEC is hereby amended as follows: GLYPHOSATE In the column under the heading 'Glyphosate`, the figure '20,0` shall be added opposite the following product entry: - in group '4. Oil seeds`, 'Soya bean`. FENARIMOL In the column under the heading 'Fenarimol`, the figure '0,3` shall be added opposite the following product entry: - in group '1. (vi) Miscellaneous`, 'Bananas`. IPRODIONE In the column under the heading 'Iprodione`, the figure '0,2` shall be added opposite the following product entry: - in group '2. (vii) Stem vegetables`, 'Rhubarb`. BENOMYL In the column under the heading 'Benomyl`, the figure '2,0` shall be added opposite the following product entry: - in group '2. (vii) Stem vegetables`, 'Rhubarb`. In the column under the heading 'Benomyl`, the figure '0,3` shall be added opposite the following product entry: - in group '2. (iii) Fruiting vegetables`, 'Courgettes`. 2. If maximum residue levels are not adopted for the pesticide/product combinations listed in point 2 of Article 1 by 30 April 2000, a maximum level of 0,05 (6*) shall be introduced for each of those pesticide/product combinations. Article 3 The following pesticide residues shall be added to Annex II to Directive 90/642/EEC: >TABLE> >TABLE> >TABLE> >TABLE> >TABLE> Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 April 1997. When Member States adopt those measures, they shall contain references to this Directive or shall be accompanied by such references on the occasion of their publication. The methods of making such references shall be laid down by the Member States. Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31996L0035

1996

Council Directive 96/35/EC of 3 June 1996 on the appointment and vocational qualification of safety advisers for the transport of dangerous goods by road, rail and inland waterway Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), Whereas over a number of years the quantities of dangerous goods transported nationally and internationally have increased considerably, increasing the risk of accidents; Whereas some of the accidents which occur when dangerous goods are transported may be caused by insufficient knowledge of the risks inherent in such transport; Whereas it is necessary, in the context of the completion of the single market in transport, to adopt measures to improve the prevention of the risks inherent in such transport; Whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (4) does not introduce measures to prevent the risks inherent in the transport of dangerous goods; Whereas undertakings involved in the transport or the related loading or unloading of dangerous goods should be required to comply with the rules on the prevention of the risks inherent in the transport of dangerous goods, whether by road, rail or inland waterway; whereas, to that end, the appointment of safety advisers for the transport of dangerous goods who have received appropriate vocational training should be prescribed; Whereas the objective of the vocational training of such safety advisers must be knowledge of the essential laws, regulations and administrative provisions applicable to such transport; Whereas the Member States must set up a common minimum framework for vocational training attested to by success in an examination; Whereas the Member States must issue Community-type certificates attesting to advisers' vocational qualifications so that the possessors of such certificates may then practise their trade throughout the Community; Whereas the vocational qualification of safety advisers will help to improve the quality of the service they provide in the interests of users; whereas such vocational qualification will also help to minimize the risk of accidents which may cause irreversible damage to the environment and serious injury to other persons who may come into contact with dangerous goods, Article 1 Aim The Member States shall take the necessary measures in accordance with the requirements of this Directive to ensure that no later than 31 December 1999 undertakings the activities of which include the transport, or the related loading or unloading, of dangerous goods by road, rail or inland waterway each appoint one or more safety advisers for the transport of dangerous goods, responsible for helping to prevent the risks inherent in such activities with regard to persons, property and the environment. Article 2 Definitions For the purposes of this Directive: (a) 'undertaking` shall mean any natural person, any legal person, whether profit-making or not, any association or group of persons without legal personality, whether profit-making or not, or any official body, whether it has legal personality itself or is dependent upon an authority that has such personality, that transports, loads or unloads dangerous goods; (b) 'safety adviser for the transport of dangerous goods`, hereinafter referred to as 'adviser`, shall mean any person appointed by the head of an undertaking whose role is to carry out the tasks and fulfil the functions defined in Article 4 and who holds the training certificate provided for in Article 5; (c) 'dangerous goods` shall mean goods defined as such in Annex A to Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (1); (d) 'activities` shall mean the transport of dangerous goods by road, rail or inland waterway with the exception of national inland waterways not connected to the inland waterways of other Member States, together with the related loading and unloading. Article 3 Exemptions The Member States may provide that this Directive shall not apply to undertakings: (a) the activities of which concern the transport of dangerous goods in means of transport that belong to the armed forces or are under their responsibility, (b) the activities of which concern quantities in each transport unit smaller than those defined in marginals 10010 and 10011 in Annex B to Directive 94/55/EC, or (c) the main or secondary activities of which are not the transport or the related loading or unloading of dangerous goods but which occasionally engage in the national transport or the related loading or unloading of dangerous goods posing little danger or risk of pollution. Article 4 The role and appointment of the adviser 1. The main task of the adviser shall be, under the responsibility of the head of the undertaking, to seek by all appropriate means and by all appropriate action, within the limits of the relevant activities of that undertaking, to facilitate the conduct of those activities in accordance with the rules applicable and in the safest possible way. He shall perform the duties listed in Annex I relevant to the undertaking's activities. 2. The adviser may also be the head of the undertaking, a person with other duties in the undertaking, or a person not directly employed by that undertaking, provided that that person is capable of performing the duties of adviser. 3. Each undertaking concerned shall, on request, inform the competent authority or the body designed for that purpose by each Member State of the identity of its adviser. Article 5 Training certificate 1. An adviser shall hold a Community-type vocational-training certificate, hereinafter referred to as 'the certificate`, valid for the mode or modes of transport concerned. That certificate shall be issued by the competent authority or the body designated for that purpose by each Member State. 2. To obtain a certificate a candidate shall undergo training and pass an examination approved by the Member State's competent authority. 3. The main aims of the training shall be to provide candidates with sufficient knowledge of the risks inherent in the transport of dangerous goods, of the laws, regulations and administrative provisions applicable to the modes of transport concerned and of the duties listed in Annex I. 4. The examination shall cover at least the subjects listed in Annex II. 5. The certificate shall take the form laid down in Annex III. 6. The certificate shall be recognized by all Member States. Article 6 The validity of the certificate The certificate shall be valid for five years. The period of validity of a certificate shall be extended automatically for five years at a time where, during the final year before its expiry, its holder has followed refresher courses or passed an examination both of which must be approved by the competent authority. Article 7 Accident reports Whenever an accident affects person, property or the environment or results in damage to property or the environment during transport, loading or unloading carried out by the undertaking concerned, the adviser shall, after collecting all the relevant information, prepare an accident report to the management of the undertaking or to a local public authority, as appropriate. That report shall not replace any report by the management of the undertaking which might be required in the Member States under any other international, Community or national legislation. Article 8 Adaptation of the Directive The amendments necessary to adapt this Directive to scientific and technical progress in the areas within its scope shall be adopted in accordance with the procedure laid down in Article 9. Article 9 1. The Commission shall be assisted by the committee on the transport of dangerous goods established by Article 9 of Directive 94/55/EC, hereinafter referred to as 'the Committee`, which shall consist of representatives of the Member States and shall be chaired by a representative of the Commission. 2. The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on that draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner laid down in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the Committee's opinion. (b) If the measures envisaged are not in accordance with the Committee's opinion or if the Committee does not deliver an opinion the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If within three months of the date of the referral to it the Council has not acted, the Commission shall adopt the measures proposed. Article 10 This Directive shall be without prejudice to the provisions on the safety and health of workers at the workplace laid down in Directive 89/391/EEC and in the individual Directives implementing it. Article 11 1. The Member States shall bring into force the necessary laws, regulations and administrative provisions in order to comply with this Directive no later than 31 December 1999. They shall forthwith inform the Commission thereof. When Member States adopt those measures they shall include references to this Directive or shall accompany them with such references on their official publication. The Member States shall prescribe the manner in which such references shall be made. 2. The Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 12 This Directive is addressed to the Member States.

31996L0036

1996

Commission Directive 96/36/EC of 17 June 1996 adapting to technical progress Council Directive 77/541/EEC relating to safety belts and restraint systems of motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 95/54/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (3), as last amended by Commission Directive 90/628/EEC (4), and in particular Article 10 thereof, Whereas Directive 77/541/EEC is one of the separate Directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas in the light of technical progress it is possible to improve the protection provided for passengers by requiring the installation of three-point belts with retractors for the rear outboard seats of motor vehicles of category M1; Whereas a warning should be fitted to all passenger seating positions where an airbag is installed, to inform the users of the vehicle that an airbag is present and consequently no rearward-facing child restraint should be fitted in that seat; whereas this Directive should be further amended when an optimum design of pictogram has been internationally accepted; Whereas it is possible to improve the protection provided for passengers against ejection in case of an accident by requiring a minimum of lap belts with retractors for all forward and rear-facing seating positions in motor vehicle sof categories M2 and M3, and in the case of certain M2 vehicles lap and diagonal belts, as foreseen in Directive 90/628/EEC (except those vehicles which are designed for both urban use and standing passengers); Whereas the entry force of an amendment to this Directive to require such seat belts in M2 and M3 vehicles is conditional upon the adaptation to technical progress of Council Directive 76/115/EEC (5), as last amended by Commission Directive 90/629/EEC (6), on seat belt anchorages, and Council Directive 74/408/EEC (7) on the strength of seats; Whereas the protection of passengers, especially in the centre rear seating position of cars, against both projection and ejection in the case of an accident must be improved and further modifications to the Directive should be introduced for this purpose; Whereas the effectiveness of the measures set out in this Directive for enhancing the protection of passengers in coaches and buses are dependant on the wearing of the seat belts prescribed; whereas this Directive needs to be complemented by an amendment to Council Directive 91/671/EEC (8) on the wearing of seat belts; Whereas reference is made to Council Directive 74/60/EEC (9), as last amended by Directive 78/632/EEC (10), relating to the interior fittings of motor vehicles; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 77/541/EEC shall be amended as follows: 1. - In Article 2, first paragraph, the words '. . ., or to his authorized representative, . . .` shall be deleted, - Article 4 shall be replaced by the following: 'Article 4 The competent authorities of the Member States shall inform each other, by means of the procedure specified in Article 4 (6) of Directive 70/156/EEC, of each type of safety belt and restraint systems for which an approval has been granted, refused or withdrawn.` - In Article 9, 'Annex I` shall be replaced by 'Annex II A`. 2. A list of Annexes shall be included and the Annexes to Directive 77/541/EEC shall be amended in accordance with the Annex to this Directive. 3. In other languages the former term used for 'type-approval` is replaced by a new term. Article 2 1. With effect from 1 January 1997, no Member State may, on grounds relating to safety belts and restraint systems: - refuse, in respect of a type of motor vehicle, safety belt or restraint system, to grant EC type-approval, or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of safety belts or restraint systems, if the safety belts and restraint systems comply with the requirements of Directive 77/541/EEC as amended by this Directive. 2. Subject to the provisions of paragraph 5, with effect from 1 October 1999 for M2 vehicles of 3,5 tonnes or less and all other vehicles from 1 October 1997, Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval, for a type of vehicle on grounds relating to safety belts and restraint systems, and for a type of safety belt or restraint system, if the requirements of Directive 77/541/EEC, as amended by this Directive, are not fulfilled. 3. 1. Subject to the provisions of paragraph 5, in the case of vehicles in category M2 with a maximum mass not exceeding 3 500 kg with effect from 1 October 2001 and for and all other vehicles in category M from 1 October 1999, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, and - may refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, and - may refuse the sale and entry into service of new safety belts and restraint systems, on grounds relating to safety and restraint systems if the requirements of Directive 77/541/EEC, as amended by this Directive, are not fulfilled. 3. 2. With effect from 1 October 1999 the requirements of Directive 77/541/EEC as amended by this Directive, relating to safety belts and restraint systems as components, are applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. 4. Notwithstanding paragraphs 2 and 3.2 above, for the purposes of replacement parts, Member States shall continue to grant EC type-approval, and to permit the sale and entry into service, of safety belts and restraint systems in accordance with previous versions of Directive 77/541/EEC provided that such safety belts or restraint systems: - are intended to be fitted to vehicles already in use, and - comply with the requirements of that Directive which were applicable when the vehicles were first registered. 5. Notwithstanding paragraphs 2 and 3.1 above, in relation to the provision of an airbag warning label in accordance with item 3.1.11 of Annex I, the provisions of these paragraphs shall apply from 1 January 1997. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1996 and shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the twentieth day following publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0037

1996

Commission Directive 96/37/EC of 17 June 1996 adapting to technical progress Council Directive 74/408/EEC relating to the interior fittings of motor vehicles (strength of seats and of their anchorages) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 95/54/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 74/408/EEC of 22 July 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (strength of seats and of their anchorages) (3), as last amended by Commission Directive 81/577/EEC (4), and in particular Article 5 thereof, Whereas Directive 74/408/EEC is one of the separate Directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerised; Whereas it is possible further to adapt this Directive in the light of technical progress so as to improve the protection provided for passengers in motor vehicles in respect of the strength of the seats and the fitting of head restraints, by requiring compliance with the technical provisions of United Nations Economic Commission for Europe Regulation 17.04 and, in particular, the height of head restraints envisaged for the 05 series of amendments to that Regulation; Whereas it is also possible to require head restraints to be fitted to the outboard front seats in vehicles in categories M1, N1 and M2 with a gross weight not exceeding 3 500 kg so as to minimize the risk of neck injuries in rear-end collisions; Whereas the procedure for determining the H-point of a seat is given in Annex III to Council Directive 77/649/EEC (5), as last amended by Commission Directive 90/630/EEC (6), and consequently it is not necessary to give it again in this Directive; whereas reference is made to Council Directive 74/60/EEC (7), as last amended by Commission Directive 78/632/EEC (8), and to Council Directive 78/932/EEC (9); Whereas future consideration should be given to the development of seat strength requirements specific to M2 vehicles, based on experience and accident research. Whereas future consideration should be given to the performance of seats subject to the combined loading of a restrained occupant and an unrestrained passenger behind; whereas a research programme should be undertaken in the next two years with a view to developing a new static seat test procedure which provides an equivalent level of safety compared with the existing dynamic test; Whereas future consideration should be given to further improvement of the protection provided by head restraints, based on a review of injury patterns, including the possible introduction of neck injury as a performance criterion, based on the use of the Hybrid III test dummy; Whereas the entry into force of an amendment to Council Directive 77/541/EEC (10), as last amended by Commission Directive 90/628/EEC (11), to require seat belts in M2 and M3 vehicles is dependent upon the adaptation to technical progress of Council Directive 76/115/EEC (12), as last amended by Commission Directive 90/629/EEC (13), on the anchorages for seat belts and this Directive on the strength of seats; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 1. The title of Directive 74/408/EEC shall be amended to read: 'Council Directive 74/408/EEC relating to motor vehicles with regard to the seats, their anchorages and head restraints.` 2. The Articles of Directive 74/408/EEC are amended as follows: (1) Article 1 shall read at the end: '. . . with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.`; (2) Article 2 shall read: '. . . on grounds relating to the strength of the seats or their anchorages, or to grant EEC type-approval or national type-approval of a seat on grounds relating to its strength and occupant protection capability, if these meet the requirements set out in Annexes II or III, as applicable, when the vehicle belongs to category M and is equipped with seat belts, and the requirements set out in Annex IV when the vehicle belongs to category M2 or M3 not equipped with seat belts or to category N. The vehicle categories are defined in Annex IIA to Directive 70/156/EEC.`; (3) Article 3 shall read: '. . . on grounds relating to the strength of the seats or their anchorages, or prohibit the sale, entry into service or use of any seat on grounds relating to its strength and occupant protection capability, if these meet the requirements of the relevant Annexes depending on the category to which the vehicle belongs as set out in Article 2.`; (4) In Article 4, replace 'Annex I, 2.2` by 'Annex II, 2.2, Annex III, 2.3 or Annex III, 2.4, as applicable`; (5) In Article 5, replace 'Annexes I to IV` by 'the Annexes`. 3. The Annexes of Directive 74/408/EEC are hereby amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 January 1997 no Member State may, on grounds relating to seats, anchorages and head restraints: - refuse, in respect of a type of motor vehicle or type of seat, to grant EC type-approval, or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of seats, if the seats, their anchorages and head restraints comply with the requirements of Directive 74/408/EEC as amended by this Directive. 2. With effect from 1 October 1999 for vehicles of category M2 with a maximum mass not exceeding 3 500 kg and all other vehicles from 1 October 1997, Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval, for a type of vehicle on grounds relating to the seats, their anchorages and head restraints, and for a type of seat if the requirements of Directive 74/408/EEC, as amended by this Directive, are not fulfilled. 3. With effect from 1 October 2001 for vehicles of category M2 with a maximum mass not exceeding 3 500 kg and all other vehicles in category M and N1 from 1 October 1999, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, - may refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, and - may refuse the sale and entry into service of new seats, on grounds relating to their seats, anchorages and head restraints if the requirements of Directive 74/408/EEC, as amended by this Directive, are not fulfilled. 4. With effect from 1 October 1999 the requirements of Directive 74/408/EEC relating to seats as components, as amended by this Directive, are applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. Article 3 Within two years from the date mentioned in Article 4, a review shall be undertaken by the Commission of the following issues: - the equivalence of static seat testing for the purposes of Annex III, - the requirements for head restraints for the purposes of Annex II, - specific seat strength requirements for M2 vehicles, - strength requirements for seat when subjected to combined loading, - the applicability of seat belts to side-facing seats. On the basis of the results of this review, a further amendment of the Directive may be proposed in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1996 and shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 5 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31996L0038

1996

Commission Directive 96/38/EC of 17 June 1996 adapting to technical progress Council Directive 76/115/EEC relating to anchorages for motor vehicle safety belts (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 relating to the approximation of the laws of the Member States on type-approval of motor vehicles and their trailers (1), as last amended by Commission Directive 95/54/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor vehicle safety belts (3), as last amended by Commission Directive 90/629/EEC (4), and in particular Article 3 thereof, Whereas Directive 76/115/EEC is one of the separate directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas it is possible to improve the protection provided for passengers against ejection in case of an accident by requiring a minimum of lap belts of type 1 with retractors for all forward and rear-facing seating positions in motor vehicles of categories M2 and M3 (except those vehicles which are designed for both urban use and standing passengers), as foreseen in Commission Directive 90/628/EEC (5); Whereas the entry into force of an amendment to Council Directive 77/541/EEC (6), as last amended by Directive 90/628/EEC to require such seat belts in M2 and M3 vehicles is dependent upon the adaptation to technical progress of Council Directive 74/408/EEC (7), as last amended by Directive 81/577/EEC (8), on the strength of seats and this Directive on seat belt anchorages; Whereas reference is made to Council Directive 74/60/EEC (9), as last amended by Commission Directive 78/632/EEC (10), relating to the interior fittings of motor vehicles; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical progress established by Directive 70/156/EEC, Article 1 Directive 76/115/EEC is amended as follows. 1. Article 1 shall read as follows: 'This Directive applies to anchorages for motor vehicle safety belts intended for adult occupants of forward or rear-facing seats.`; 2. in Article 2 'Annex I` is replaced by 'Annex II A`; 3. in Articles 3 and 4 of Directive 76/115/EEC 'Annexes I, III and IV` are replaced by 'the Annexes`; 4. the Annexes are amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 January 1997 no Member State may, on grounds relating to anchorages for safety belts: - refuse, in respect of a type of motor vehicle, to grant EEC type-approval, or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, if the anchorages in this type of vehicle or in these vehicles comply with the requirements of Directive 76/115/EEC as amended by this Directive. 2. With effect from 1 October 1999 for vehicles of category M2 with a maximum mass not exceeding 3 500 kg and all other vehicles from 1 October 1997, Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval, for a type of vehicle on grounds relating to safety belt anchorages if the requirements of Directive 76/115/EEC, as amended by this Directive, are not fulfilled. 3. With effect from 1 October 2001 for vehicles of category M2 with a maximum mass not exceeding 3 500 kg and all other vehicles in category M from 1 October 1999, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, and - may refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, on grounds relating to safety belt anchorages if the requirements of Directive 76/115/EEC, as amended by this Directive, are not fulfilled. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1996 and shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 The Directive shall enter into force the twentieth day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0041

1996

Nineteenth Commission Directive 96/41/EC of 25 June 1996 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 95/34/EC (2), and in particular Article 8 (2) thereof, After consultation of the Scientific Committee on Cosmetology, Whereas the available scientific data indicate that urocanic acid interferes with the immune process in the presence of ultraviolet radiation and, therefore, its use should be prohibited; Whereas calcium hydroxide in combination with a guanidine salt and lithium hydroxide used as hair straighteners, may have undesirable effects if they enter into contact with the eyes; whereas, therefore, their use should be subject to certain restrictions and conditions; Whereas, on the basis of the latest scientific and technical research, chlorphenesin, sodium hydroxymethylglycinate and silver chloride deposited on titanium dioxide may be used as preservatives in cosmetic products; Whereas, on the basis of the latest scientific and technical research, the polymer of N-{-(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide may be used as a UV filter in cosmetic products; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetics Products Sector, Article 1 Directive 76/768/EEC is hereby amended as shown in the Annex. Article 2 1. Member States shall take the necessary measures to ensure that as from 1 July 1997 for the substances set out in the Annex, neither manufacturers or importers established in the Community shall place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances set out in the Annex shall not be sold or otherwise supplied to the final consumer after 30 June 1998. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0040

1996

Commission Directive 96/40/EC of 25 June 1996 establishing a common model for an identity card for inspectors carrying out port State control (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 95/21/EC of 19 June 1995 concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control) (1), and in particular Article 12 (4) thereof, Whereas Directive 95/21/EC provides for the establishment of a common model for an identity card for port State control inspectors; Whereas it is necessary that the identity card contains at least the following information: name of the issuing authority, full name of the holder of the identity card, a picture of the holder of the identity card, the signature of the holder of the identity card and a statement to the effect that the holder is authorized to carry out inspections in accordance with the national legislation adopted pursuant to the Directive; Whereas to serve the purpose of identifying the inspector to the ship master and crew members it is necessary that the identity card contains a translation into the English language if that is not the main language used; Whereas the exact format of the identity card should be left to the Member States; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee set up pursuant to Article 12 of Council Directive 93/75/EEC (2), Article 1 The identity card referred to in Article 12 (4), of Directive 95/21/EC shall comply with the requirements set out in the Annex. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 February 1997. They shall immediately inform the Commission thereof. When these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for making such a reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0043

1996

Council Directive 96/43/EC of 26 June 1996 amending and consolidating Directive 85/73/EEC in order to ensure financing of veterinary inspections and controls on live animals and certain animal products and amending Directives 90/675/EEC and 91/496/EEC Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas live animals and animal products are included in the list of products contained in Annex II to the Treaty; whereas such animals and animal products constitute a source of income for part of the agricultural population; Whereas Council Directive 85/73/EEC of 29 January 1985 on the financing of veterinary inspections and controls of animal products covered by Annex A to Directive 89/662/EEC and by Directive 90/675/EEC (4), laid down the principles governing the charging of fees for such controls; Whereas Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (5), lays down in particular the requirements for veterinary checks to be carried out in the Member State of dispatch for live animals and certain animal products; Whereas Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (6) and Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (7), lay down in particular the requirements for documentary, identity and physical checks to be carried out on animals from third countries; Whereas the financing of such inspections and health checks varies in the different Member States, and is carried out in particular by charging fees which can vary; whereas such differences can affect the conditions of competition between products which are for the most part covered by common organizations of the market; Whereas, in the case of live animals entering the Community from third countries, the fact that operators are charged different fees can lead to deflections of trade; Whereas in order to remedy this situation provision should be made for harmonized rules on the financing of such inspections and checks; Whereas the public authorities are responsible for carrying out such inspections and checks; whereas, however, provision should be made for operators to pay a contribution to the financing of such inspections and checks; Whereas Directives 90/675/EEC and 91/496/EEC should be adapted to take account of these principles; Whereas it is necessary to provide for the financing of the checks laid down in Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/496/EEC and Decisions 89/187/EEC and 91/664/EEC (8); Whereas technical adjustments should also be made to the existing Annexes to Directive 85/73/EEC to take account of experience gained; Whereas for products of animal origin other than meat referred to in Directives 64/433/EEC (9), 71/118/EEC (10) and 72/462/EEC (11), the detailed rules necessary for the financing of veterinary inspections still need to be laid down; Whereas, in order to ensure the effective functioning of the inspection system for fishery products and to avoid distortions of competition in this sector, such detailed rules should be laid down for the fishery products covered by Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and placing on the market of fishery products (12); Whereas the detailed rules proposed take account of the specific nature of fishery products, the nature of the checks provided for in Directive 91/493/EEC and the importance of setting Community fees as regards rules of competition; Whereas these arrangements should not include fishery products the placing on the market of which is not covered by the rules laid down in Directive 91/493/EEC; Whereas, for products of animal origin from third countries, a link should be established with the date as from which the agreements on the equivalence of veterinary guarantees should be concluded, Article 1 The Title, the Articles and the Annexes to Directive 85/73/EEC shall be replaced by the text set out in the Annex to this Directive. Article 2 1. In Article 3 (ii) of Directive 90/675/EEC the terms 'provided for in Directive 96/23/EC (*)` shall be inserted in the first line after '(ii) that the veterinary checks` and before . . . 'have been paid for and that . . .`. '(*) OJ No L 125, 23. 5. 1996, p. 10.` 2. Article 15 of Directive 91/496/EEC shall read as follows: 'Article 15 Member States shall collect a fee for veterinary and health checks when the animals referred to in this Directive are imported, in accordance with Directive 96/23/EC (*). (*) OJ No L 125, 23. 5. 1996, p. 10.` Article 3 Before 1 January 1999 the Council shall review this Directive on the basis of a report from the Commission together with proposals if appropriate. Article 4 1. Member States shall bring into force laws, regulations and administrative provisions necessary to comply with: (i) the provisions of Article 7 and of Chapter I (1) (e) of Annex A by 1 July 1996; (ii) the provisions of Chapter II, Section II of Chapter III of Annex A and Chapter II of Annex C by 1 January 1997; (iii) other amendments by 1 July 1997. Member States shall have a further period which can extend to 1 July 1999 within which to comply with the provisions of Section I of Chapter III of Annex A. When Member States adopt these provisions they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31996L0044

1996

Commission Directive 96/44/EC of 1 July 1996 adapting to technical progress Council Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (1), as last amended by Directive 94/12/EC (2), and in particular Article 5 thereof, Whereas Council Directive 70/220/EEC is one of the separate directives of the EEC type-approval procedure which has been established by Council Directive 70/156/EEC (3), as last amended by Commission Directive 95/54/EC (4); whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to the vehicle systems, components and separate technical units apply to this Directive; Whereas Directive 70/220/EEC lays down the specifications for the testing of the emissions of the motor vehicles covered by its scope, whereas, in view of the experience gained and the state of the art of the laboratory techniques it appears appropriate to adapt these specifications accordingly; Whereas it is equally appropriate to align the test conditions of Directive 70/220/EEC with those of Council Directive 80/1268/EEC of 16 December 1980 on the approximation of the laws of the Member States relating to the emissions of carbon dioxide and the fuel consumption of motor vehicles (5), as last amended by Commission Directive 93/116/EC (6), in particular as far as the relationship between the reference mass of the vehicle and the equivalent inertia which is to be used, is concerned; Whereas this Directive shall bring the provisions of the use of the equivalent inertia of Directive 70/220/EEC into accordance with the provisions of Directive 80/1268/EEC and the wording of the information document and the type-approval certificate of Directive 70/220/EEC into accordance with the wording of Directive 70/156/EEC; Whereas these amendments relate only to the administrative provisions and the techniques of emissions measurement contained in the Directive; whereas it is not necessary therefore to invalidate existing approvals to the Directive nor to prevent the registration, sale and entry into service of new vehicles covered by such approvals; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 The Annexes to Directive 70/220/EEC are amended in accordance with the Annex to this Directive. Article 2 With effect from 1 January 1997, Member States may no longer grant: - EEC type-approval pursuant to Article 4 (1) of Directive 70/156/EEC, or - national type-approval, unless the provisions of Article 8 (2) of Directive 70/156/EEC are invoked, for a new type of vehicle on grounds relating to air pollution by emissions if it fails to comply with the provisions of Directive 70/220/EEC. This Directive will not invalidate any approval previously granted under Directive 70/220/EEC, nor prevent extension of such approvals under the terms of the Directive under which they were originally granted. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1996. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the texts of the main procedure of the national law that they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0045

1996

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 95/34/EC (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 certain methods have already been adopted in Commission Directives 80/1335/EEC (3), as amended by Directive 87/143/EEC (4), 82/434/EEC (5), as amended by Directive 90/207/EEC (6), and by Commission Directives 83/514/EEC (7), 85/490/EEC (8), 93/73/EEC (9) and 95/32/EC (10); Whereas the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in cosmetic products constitute a seventh step; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation of Directive 76/768/EEC to technical progress, Article 1 Member States shall take all the necessary steps to ensure that during official testing of cosmetic products, the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate shall be carried out in accordance with the method described in the Annex. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 30 September 1997. They shall forthwith inform the Commission thereof. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0046

1996

Commission Directive 96/46/EC of 16 July 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 96/12/EC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary to indicate, in Annexes II and III, to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files; Whereas it is now possible to introduce more details with regard to the data requirements concerning analytical methods for the active substance provided for in Section 4 of Part A of Annex II; Whereas it is also now possible to introduce more details with regard to the data requirements concerning analytical methods for the plant protection product provided for in Section 5 of Part A of Annex III; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 91/414/EEC is amended as follows: 1. in Part A of Annex II the section headed '4. Analytical methods` is replaced by Annex I hereto; 2. in Part A of Annex III the section headed '5. Analytical methods` is replaced by Annex II hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 1997. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive shall enter into force on 1 May 1996. Article 4 This Directive is addressed to the Member States.

31996L0051

1996

Council Directive 96/51/EC of 23 July 1996 amending Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), (1) Whereas application of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (4) has shown that certain basic concepts must be revised to take account of the need to ensure a greater degree of protection of animal and human health and of the environment; (2) Whereas experience has shown that the current rules on the use of additives in feedingstuffs do not provide all the necessary assurances as to safety, particularly because of the circulation in the Community of poor copies of zootechnical additives; whereas it is therefore essential to link the authorization of such additives to the person responsible for putting the additive authorized by the Community into circulation; (3) Whereas a distinction should be made between additives which are widely used and present no particular dangers for the manufacture of feedingstuffs and high technology additives with a very specific composition for which the person responsible for putting them into circulation must receive authorization, in order to avoid copies which might not be in conformity and might therefore be unsafe; (4) Whereas there should be drawn up in the form of an Annex to this Directive, first a list of additives for which authorization to put them into circulation is granted to persons responsible who alone are entitled to put the additives in question into circulation, second, a list of other additives which may be put into circulation by any person provided that they are additives which meet the specifications in the dossiers on the basis of which they have been authorized; (5) Whereas, to facilitate application of Directive 70/524/EEC, the list of definitions should be supplemented and certain definitions should be amended; whereas, in particular, the concept of additives should be defined so as also to take account of their possible effects on feed materials, animal products, animal welfare or the environment; whereas processing aids should be excluded from the scope of this Directive insofar as these substances are used in the processing of feed materials or of feedingstuffs and no longer have any effect in the finished product; (6) Whereas micro-organisms authorized as such in group 0 for improving animal production and in particular influencing gastro-intestinal flora must form colonies; (7) Whereas, where in particular vitamins, trace elements or colouring matter are present in certain raw materials in their natural state, they must not be considered as additives unless products specially enriched with such a substance corresponding to an additive are concerned which cannot therefore be considered as raw materials naturally containing the substances concerned; (8) Whereas the premixtures referred to in this Directive may under no circumstances be regarded as preparations covered by the definition of additive; (9) Whereas experience has shown that the authorization of additives by means of directives causes considerable delays; whereas such delays in the transposition of directives have sometimes resulted in distortions of competition and even created barriers to trade; whereas, to remedy this situation, additives should be authorized by means of regulations; (10) Whereas fees may be charged for the examination of dossiers by the Member State acting as rapporteur; whereas the levels of such fees should be harmonized in order to obviate distortion of competition; whereas such harmonization will fall within the general framework of future Community rules on fees or charges to be levied in the animal feed sector; whereas it will then be necessary to examine whether the levels of fees to be charged should not vary depending on the type of authorization sought or the additive group concerned; whereas it would be fair to charge higher fees, for example for examining dossiers concerning growth promoters than for examining dossiers concerning vitamins; whereas it would be fair not to charge a fee for additives or examining the dossier concerning very simple technological additives; whereas the fee should be paid to the Member State acting as rapporteur at the time of submission of the dossier; (11) Whereas, until the Council has adopted legal provisions regarding fees, a Member State acting as rapporteur should be able to adopt provisions or retain the legal provisions which it has adopted in this area; (12) Whereas the introduction of fees must be accompanied by the assurance that a decision will be reached by a given deadline on the application for authorization to put an additive into circulation; (13) Whereas certain feed additives may reach the human food chain; whereas it is necessary for the Scientific Committee for Animal Nutrition to be able to collaborate with the Scientific Committee for Food on such matters which may influence consumer health; (14) Whereas the search for new additives belonging to the group of substances for which authorization is linked to those persons responsible for putting them into circulation requires costly investment; whereas protection for a period fixed at ten years should therefore be afforded to scientific data or information included in the dossier on the basis of which the first authorization is granted; whereas protection should also be afforded to new data supplied with a view to renewal or alteration of the conditions of the original authorization for a shorter period which is fixed at five years; whereas, during those periods of protection, any new applicant for authorization will be obliged to submit a dossier drawn up in accordance with Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition (5) unless the parties reach agreement on shared use of the data; whereas where two or more persons benefit from the authorization granted to a single additive, they must respond individually or collectively to any request from the Commission for scientific information on pain of losing the benefit of the authorization; (15) Whereas, in order to put an end to the differences between Member States regarding the arrangements for admitting the additives in Annex II onto their territory, the provisional authorization of additives meeting a minimum number of conditions should be extended throughout the Community; whereas such authorizations become definitive for certain additives or are valid for a period of 10 years for other additives when all the conditions for authorization are fulfilled, although that may occur no later than the date of expiry of the period of provisional authorization; (16) Whereas for applications for authorization concerning additives referred to in Article 2 (aaa) and (aaaa) lodged before 1 April 1998 and in respect of which provisional authorization has been given before 1 October 1999, Member States may allow the putting into circulation and use of the additive on their national territory for a period not exceeding five years from the date of adoption of the authorizing regulation; (17) Whereas for applications for authorization concerning additives referred to in Article 2 (aaa) and (aaaa) submitted with effect from 1 April 1998 and in respect of which provisional authorization has been given before 1 October 1999, Member States may allow the putting into circulation and use of the additive for a period not exceeding five years from the date of adoption of the authorizing regulation; (18) Whereas it is necessary to have transitional arrangements for the changeover from the old to the new authorization system; whereas the date of entry into force of the relevant provisions must therefore be brought forward; (19) Whereas account should be taken of developments in techniques for using additives; whereas provision should therefore be made, in certain cases, for the possibility of administering additives, under certain conditions, by means other than incorporation in feedingstuffs; (20) Whereas, in the present state of scientific and technical knowledge and taking account of the methods of inspection, the use of antibiotics, coccidiostats and other medicinal substances and growth promoters should not be authorized by any mode of administration other than incorporation in feedingstuffs; (21) Whereas monographs of zootechnical additives should no longer be published; whereas an information note on the additives in question should be published instead in order to facilitate their identification during controls; (22) Whereas the national authorities should be provided with a standard sample to enable them to carry out checks; (23) Whereas the mixing of additives belonging respectively to the groups of antibiotics, coccidiostats, other medicinal substances and growth promoters with micro-organisms must be prohibited, unless the specific authorization of the micro-organism allows such mixing; (24) Whereas, in view of the deletion of Annexes I and II, in the interests of clarity and transparency, there should be published annually the list of persons responsible for putting the additives referred to in Article 2 (aaa) into circulation and a list of producers who have received from an authorized person the right to manufacture additives as well as a list of all authorized additives, Article 1 Directive 70/524/EEC is hereby amended as follows: 1) Article 1 shall be replaced by the following: 'SCOPE Article 1 1. This Directive shall apply to additives in feedingstuffs. 2. This Directive shall not apply to processing aids used deliberately as substances in the processing of feed materials or of feedingstuffs in order to achieve a certain technological objective during treatment or processing which may result in the unintentional but technically unavoidable presence of residues of the substances or their derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product. 3. Provided they are not products specially enriched with substances corresponding to additives, substances present in their natural state in feed materials which are part of the normal composition of feedingstuffs and which correspond to a substance authorized under this Directive shall not be regarded as additives.`; 2) the following title shall be inserted between Articles 1 and 2: 'DEFINITIONS`; 3) Article 2 shall be amended as follows: (i) point (a) shall be replaced by the following: '(a) additives: substances or preparations used in animal nutrition in order to: - affect favourably the characteristics of feed materials or of compound feedingstuffs or of animal products; or - satisfy the nutritional needs of animals or improve animal production, in particular by affecting the gastro-intestinal flora or the digestibility of feedingstuffs; or - introduce intro nutrition elements conducive to attaining particular nutritional objectives or to meeting the specific nutritional needs of animals at a particular time; or - prevent or reduce the harmful effects caused by animal excretions or improve the animal environment; (aa) "micro-organisms": micro-organisms forming colonies; (aaa) additives subject to authorization linked to the person responsible for putting them into circulation: the additives listed in Part I of Annex C; (aaaa) other additives: additives not subject to authorization linked to the person responsible for putting them into circulation and referred to in Part II of Annex C;` (ii) point (f) shall be replaced by the following: '(f) feed 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 for use in oral animal feeding either directly as such or after processing, in the preparation of compound feedingstuffs or as carriers of premixtures, hereinafter referred to as "feed materials";` (iii) the following points shall be added: '(k) "putting into circulation" or "circulation": the holding of products for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves; (l) person responsible for putting into circulation: the natural or legal person who has responsibility for the conformity of the additive which has been granted Community authorization and for putting it into circulation.`; 4) Articles 3 to 9 shall be replaced by the following: 'PROCEDURE FOR THE AUTHORIZATION OF ADDITIVES Article 3 Member States shall require that no additive may be put into circulation unless a Community authorization has been granted. This authorization shall be granted under a Commission regulation in accordance with the procedure laid down in Article 4. Article 3a Community authorization of an additive shall be given only if: (a) when used in animal nutrition it has one of the effects referred to in Article 2 (a); (b) taking account of the conditions of use, it does not adversely affect human or animal health or the environment, nor harm the consumer by impairing the characteristics of animal products; (c) its presence can be monitored: - as an additive per se, - in premixtures, - in feedingstuffs or, where appropriate, in feed materials; (d) at the level permitted, treatment or prevention of animal disease is excluded; this condition shall not apply to additives belonging to the group of coccidiostats and other medicinal substances; (e) for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes. Article 4 1. In order to obtain the Community authorization for a substance or a preparation as an additive or for a new use in the case of an already authorized additive, the applicant for authorization shall select a Member State to act as rapporteur during the scrutiny procedure on the dossier he has compiled in accordance with the provisions of Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition (*). Where the applicant is established in a third country, he must have a representative in the Community. 2. The Member State acting as rapporteur shall check that: (a) the dossier has been compiled in accordance with Directive 87/153/EEC; (b) the substance or preparation, according to the information given, appears to meet the conditions laid down in Article 3a. 3. The applicant for Community authorization shall dispatch to the Commission, via the Member State acting as rapporteur, an application accompanied by the dossier, sending copies to the other Member States, which shall acknowledge receipt at the earliest opportunity. That dispatch shall be affected no later than one year after the date of submission of the applicant's dossier in the Member State acting as rapporteur, unless the latter is rejected or postponed. The Member State acting as rapporteur shall inform the applicant, the other Member States and the Commission of the reasons for rejection or postponement of the dossier. 4. Member States shall have a period of sixty days from the date on which the dossier was dispatched to them in which to check whether the dossier has been compiled in accordance with Directive 87/153/EEC and, where appropriate, to submit their comments in writing to the Commission and the other Member States. If, on expiry of the period referred to in the first paragraph, no objection has been made, the representative of the Commission shall have a period of thirty days in which to include the authorization application on the agenda for the Standing Committee for Feedingstuffs. 5. If, after consultation of the Standing Committee for Feedingstuffs, it is deemed that the rules on presentation of dossiers have not been complied with, a representative of the Commission shall so notify the applicant for authorization to put into circulation and the Member State acting as rapporteur; where necessary, a new application must be submitted in accordance with the above provisions. 6. The Commission shall ensure that a decision is taken, in accordance with the procedure laid down in Article 23, on the application for Community authorization within 320 days following its inclusion on the agenda for the Standing Committee for Feedingstuffs in accordance with the second subparagraph of paragraph 4. However, this time limit shall be interrupted where a request is made for additional information by a Member State in the Standing Committee for Feedingstuffs, or at the request of the Scientific Committee for Animal Nutrition. Where an application for Community authorization to put an additive into circulation is rejected or the decision on it is postponed, a representative of the Commission shall inform the applicant for authorization and the Member State acting as rapporteur of the reasons for the rejection or postponement of the decision. (*) OJ No L 64, 7. 3. 1987, p. 19. Directive as last amended by Directive 95/11/EC (OJ No L 106, 11. 5. 1995, p. 23). Article 5 Amendments to Directive 87/153/EEC: - which arise from developments in scientific and technical knowledge and - take account of the provisions of Article 9b (1), Article 9c (3), Article 9o and Article 9q (5) shall be adopted in accordance with the procedure laid down in Article 23. Article 6 1. A fee may be charged, according to the additive groups and the nature of the Community authorization requested, by the Member State acting as rapporteur for the examination of dossiers arising from the obligations laid down in Articles 4 (2), 9b (1), 9c (3) and 9g (4). This fee shall be paid at the time of submission of the dossier. 2. Before 1 October 1999, the Council, acting by a qualified majority on a proposal from the Commission, shall fix the level of the fee referred to in paragraph 1. Article 7 1. Member States and the Commission shall ensure that any information which, if disseminated, could affect industrial and commercial property rights is kept confidential. 2. Confidentiality shall not apply to: - the name and composition of the additive, - the physico-chemical and biological characteristics of the additive, - the interpretation of the pharmacological, toxicological and ecotoxicological data relating to the additive, - the analytical methods for monitoring the additive itself and the additive in premixtures, in the feedingstuffs and, where appropriate, in feed materials, - the methods for testing for residues of the additive or metabolites thereof in animal products. Article 7a If an additive contains or consists of genetically modified organisms within the meaning of Article 2 (1) and (2) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*), a specific environmental risk assessment similar to that laid down in the abovementioned Directive shall be carried out; for this purpose, the following documents shall be included in the dossier submitted pursuant to Article 4 of this Directive in order to ensure compliance with the principles set out in Article 3a: - a copy of any written consent or consents of the competent authorities to the deliberate release into the environment of genetically modified organisms for research and development purposes pursuant to Article 6 (4) of Directive 90/220/EEC and the result of the release(s) with respect to the risk in each case to human health and the environment, - the complete technical dossier supplying the information requested in Annexes II and III to Directive 90/220/EEC and the environmental risk assessment resulting from this information; the results of any investigations performed for the purposes of research or development. Articles 11 to 18 of Directive 90/220/EEC shall not apply to additives consisting of or containing genetically modified organisms. (*) OJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/15/EC (OJ No L 103, 22. 4. 1994, p. 20). Article 8 1. The Scientific Committee for Animal Nutrition established by Commission Decision 76/791/EEC (*) shall be responsible for assisting the Commission, at the latter's request, on all scientific questions relating to the use of additives in animal nutrition. 2. At the request of the Commission, the Member State acting as rapporteur shall ensure that all or part of the dossier referred to in Article 4 is officially forwarded to the members of the Committee referred to in paragraph 1. (*) OJ No L 279, 9. 10. 1976, p. 35. Decision as amended by Decision 86/105/EEC (OJ No L 93, 8. 4. 1986, p. 14). ARRANGEMENTS APPLICABLE TO AUTHORIZATIONS FOR ADDITIVES LINKED TO THE PERSON RESPONSIBLE FOR PUTTING THEM INTO CIRCULATION Authorization given for 10 years Article 9 Additives as referred to in Article 2 (aaa) which meet the conditions laid down in Article 3a shall be authorized and included in Chapter I of the list referred to in Article 9t (b). Provisional authorization for a maximum of four years Article 9a 1. In the case of the additives referred to in Article 2 (aaa), provisional authorization may be given at Community level for the use of a new additive or a new use of an additive already authorized, provided that the conditions laid down in Article 3a (b), (c), (d) and (e) are met and it is reasonable to assume, in view of the available results, that the other condition laid down in Article 3a (a) is also met. These additives shall be included in Chapter II of the list referred to in Article 9t (b). 2. Provisional authorization as referred to in paragraph 1 may not exceed four years from the date on which it takes effect. Renewal of authorization after 10 years Article 9b 1. Community authorization of additives referred to in Article 2 (aaa) shall be valid for 10 years from the date on which final authorization takes effect and shall be renewable for 10-year periods. In the event of renewal, the authorization holder shall send to the Commission, via the Member State acting as rapporteur, an application accompanied by a dossier complying with the provisions to be laid down for the renewal of authorizations for additives in Directive 87/153/EEC. The application and the dossier shall be sent, at least one year before the date of expiry of the authorization, to the Commission, which shall acknowledge receipt thereof at the earliest opportunity. A copy of the renewal application, together with the dossier, shall be officially forwarded by the authorization holder via the Member State acting as rapporteur to the other Member States, which shall acknowledge receipt thereof at the earliest opportunity. 2. Articles 3, 3a, 4, 7, and 7a shall apply mutatis mutandis to applications for renewal. 3. Where, for reasons beyond the control of the authorization holder, no decision may be taken on the renewal application before the expiry date of the authorization, the period of authorization of the additive shall be automatically extended until the Commission takes a decision. DATA PROTECTION Article 9c 1. In the case of the additives referred to in Article 2 (aaa), the scientific data and other information in the initial dossier submitted for the purpose of the first authorization may not be used for the benefit of other applicants for a period of 10 years: (a) from the date on which the first authorization by means of regulation takes effect for the additives referred to in Article 9g (1), Article 9h (1) and Article 9i (1), or (b) for other additives from the data on which the first authorization by means of regulation takes effect or counting from 1 October 1999 if the latter date of taking effect is earlier, unless the applicant has agreed with the authorization holder that such data and information may be used. During this period, however, authorizations for putting into circulation may be granted to persons other than the person responsible for first putting the additive into circulation provided that the conditions in Articles 3a and 4 are met. 2. Where additional information is supplied on an additive which has been provisionally authorized under Article 9a, for the purpose of obtaining authorization of the additive under Article 3a, that information shall be considered as an integral part of the initial dossier and shall consequently cease to be protected at the same time as the information in the initial dossier. 3. On expiry of the 10-year period referred to in paragraph 1, the findings of all or part of the evaluation conducted on the basis of the scientific data and information in the dossier which led to authorization of the additive may be used by the Commission or by a Member State for the benefit of another applicant for authorization to put an additive which has already been authorized into circulation. In such a case, an application accompanied by a dossier in accordance with the provisions to be laid down for this purpose in Directive 87/153/EEC shall be addressed by the new applicant, via a Member State acting as rapporteur, to the Commission, which shall acknowledge receipt thereof as quickly as possible. A copy of the application, together with the dossier, shall be officially forwarded by the new applicant, via a Member State acting as rapporteur, to the other Member States, which shall acknowledge receipt thereof at the earliest opportunity. The provisions of Articles 3, 3a, 4, 7 and 7a shall apply mutatis mutandis. 4. The provisions of paragraph 3 shall also apply to the use of data from a dossier concerning an additive which has been the subject of withdrawal of authorization at the request of the holder of that authorization. 5. The additional scientific data and information required for modification of the conditions for listing an additive or for renewal of the authorization in accordance with Article 9b (1) or any new scientific data or information provided during the period of authorization of the additive may not be used by the Commission or by a Member State for the benefit of another applicant for a period of five years from the date on which the authorization of a new use, the renewal or the submission of new scientific data or information takes effect. Where the data-protection period granted for modification of the conditions for listing an additive expires before the end of the period provided for in paragraph 1, the five-year period shall be extended so that both periods expire simultaneously. 6. Without prejudice to paragraph 1, an applicant for an authorization for an additive referred to in Article 2 (3) (aaa) shall, before beginning toxicological tests on vertebrates, check whether his product or its active substance has not already been authorized. If necessary, he shall find out from a Member State's competent authorities whether the product or active substance concerned is the same as that already authorized. If the product or active substance concerned has already been authorized, the applicant and the holder(s) of earlier authorizations shall take all necessary steps to reach agreement on sharing the use of information, in order not to repeat the toxicological tests on vertebrates. If, however, the applicant and the holder(s) of previous authorizations for the same product do not reach agreement on sharing the information, the Member States may take national measures to oblige the applicant and the holder(s) of previous authorizations established within their territories to share the information, in order to avoid repeating toxicological tests on vertebrates undertaken on their territory and may lay down conditions for the use of the information while ensuring a reasonable balance between the interests of the parties concerned. ARRANGEMENTS APPLICABLE TO AUTHORIZATION OF OTHER ADDITIVES Authorization without a time limit Article 9d 1. Additives as referred to in Article 2 (aaaa) which meet the conditions laid down in Article 3a shall be authorized and included in Chapter III of the list referred to in Article 9t (b). 2. Additives as referred to in Article 2 (aaaa) included in Annex I before 1 April 1998 shall be authorized and included in Chapter III of the list referred to in Article 9t (b). Provisional authorization for a maximum of four or five years Article 9e 1. In the case of the additives referred to in Article 2 (aaaa), provisional authorization may be given at Community level for the use of a new additive or a new use of an additive already authorized, provided that the conditions laid down in Article 3a (b), (c), (d) and (e) are met and it is reasonable to assume that the condition laid down in Article 3a (a) is also met. These additives shall be included in Chapter IV of the list referred to in Article 9t (b). 2. Provisional authorization as referred to in paragraph 1 may not exceed four years from the date on which it takes effect. 3. Additives as referred to in Article 2 (aaa), included in Annex II before 1 April 1998, may continue to be the subject of national provisional authorizations; they shall be included in Chapter IV of the list referred to in Article 9t (b). The period of provisional authorization of these additives may not exceed five years taking account of the period of inclusion in Annex II referred to above. TRANSITIONAL ARRANGEMENTS APPLICABLE TO AUTHORIZATIONS FOR ADDITIVES LINKED TO THE PERSON RESPONSIBLE FOR PUTTING THEM INTO CIRCULATION Article 9f Notwithstanding Article 3, Member States shall permit the additives listed in Annex B to be put into circulation. Additives included in Annex I before 1 January 1988 Article 9g 1. Additives as referred to in Article 2 (aaaa) included in Annex I before 1 January 1988 shall be provisionally authorized as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation. 2. With a view to their re-evaluation, the additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization; such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was granted or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof. 3. In accordance with the procedure laid down in Article 23, provisional authorization of the additives shall be withdrawn through the adoption of a Regulation and they shall be deleted from the list in Chapter I of Annex B before 1 October 1999: (a) if the documents prescribed in paragraph 2 are not submitted within the time allowed or (b) if, after scrutiny of the documents, it is established that the monographs and identification notes are not in accordance with the date in the dossier on the basis of which the original authorization was given. 4. Member States shall ensure that the person responsible for putting an additive as referred to in paragraph 1 into circulation submits, as provided for in Article 4 and not later than 30 September 2000, the dossier referred to in Article 4 with a view to re-evaluation. Where he fails to do so, the authorization of the additive in question shall be withdrawn through the adoption of a regulation in accordance with the procedure laid down in Article 23 and it shall be deleted from the list in Chapter I of Annex B. 5. The Commission shall take all necessary measures to ensure that re-evaluation of the dossiers referred to in paragraph 4 is completed no later than three years after the dossier is submitted. In accordance with the procedure laid down in Article 23, authorizations of the additives referred to in Article 1: (a) shall be withdrawn and they shall be deleted from the list in Chapter I of Annex B through the adoption of a regulation, or (b) shall be replaced by authorizations linked to the person responsible for putting them into circulation for a period of 10 years through the adoption of a regulation taking effect no later than 1 October 2003 and included in Chapter I of the list referred to in Article 9t (b). 6. The provisions of Article 9b (3) shall apply mutatis mutandis. Additives included in Annex I after 31 December 1987 Article 9h 1. Additives as referred to in Article 2 (aaa) included in Annex I after 31 December 1987 shall be authorized provisionally as from 1 April 1998 and transferred to Chapter II of Annex B with a view to their authorization for a period of 10 years as additives linked to a person responsible for putting them into circulation in accordance with paragraphs 2 and 3. 2. The additives referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization; such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was given or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof. 3. In accordance with the procedure laid down in Article 23, provisional authorizations of the additives referred to in paragraph 1: (a) shall be withdrawn and they shall be deleted from the list in Chapter II of Annex B, through the adoption of a regulation, if the documents prescribed in paragraph 2 are not submitted within the time allowed or if, after scrutiny of the documents, it is established that the monographs or the identification notes are not in accordance with the data in the dossier on the basis of which the original authorization was given, or (b) shall be replaced by authorizations linked to the person responsible for putting them into circulation, which shall be given for a period of ten years through the adoption of a regulation taking effect no later than 1 October 1999 and included in Chapter I of the list referred to in Article 9t (b). 4. The provisions of Article 9b (3) shall apply mutatis mutandis. Additives included in Annex II before 1 April 1998 Article 9i 1. Additives as referred to in Article 2 (aaa) included in Annex II before 1 April 1998 may continue to be the subject of national provisional authorizations; they shall be authorized and transferred to Chapter III of Annex B with a view to their authorization as additives linked to a person responsible for putting them into circulation; the period of provisional authorization of these additives may not exceed five years taking account of the period of inclusion in Annex II referred to above. 2. The additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization; such applications, accompanied by the monographs and identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was given or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof. 3. In accordance with the procedure laid down in Article 23, provisional authorizations of the additives referred to in paragraph 1: (a) shall be withdrawn and they shall be deleted from the list in Chapter III of Annex B through the adoption of a regulation if the documents prescribed in paragraph 2 are not submitted within the time allowed or if, after scrutiny of the documents, it is established that the monographs and identification notes are not in accordance with the data in the dossier on the basis of which the original authorization was given, or (b) shall be replaced by provisional authorizations as referred to in paragraph 1 linked to the person responsible for putting them into circulation through the adoption of a regulation taking effect no later than 1 October 1999 and the additives shall be included in Chapter II of the list referred to in Article 9t (b). 4. The provisions provided for in Article 9b (3) shall apply mutatis mutandis. Article 9j Applications for authorization to put into circulation submitted between 1 April 1998 and 30 September 1999 in respect of which the Commission has not yet given a ruling at that date shall be examined in accordance with Articles 3, 3a, 7, 7a, 9, 9a, 9b, 9c, 9d, 9e, 9n and 9o, as appropriate. DISTRIBUTION AND USE OF ADDITIVES Article 9k 1. Member States shall ensure that in the field of animal nutrition only additives authorized in accordance with this Directive may be put into circulation and that they may be used only if incorporated in feedingstuffs under the conditions set out in the authorization regulation. 2. Notwithstanding paragraph 1, additives belonging to groups other than "antibiotics", "coccidiostats and other medicinal substances", and growth promoters may be used if administered by a method other than incorporation in feedingstuffs, on condition that that method is provided for in the authorization regulation. 3. Member States shall, in particular, ensure that additives are added to feed materials and to straight feedingstuffs only where their use is expressly provided for in the authorization regulation. REGISTRATION Article 9l 1. Where additives as referred to in Article 2 (aaa) are authorized, the person(s) responsible for putting them into circulation shall be given a registration number and the additive shall be given a Community registration number. 2. Authorized additives as referred to in Article 2 (aaaa) shall be given a Community registration number. WITHDRAWAL OF ADDITIVES Article 9m A regulation shall be adopted to withdraw the authorization of an additive: - at the request of the person responsible for putting the additive into circulation, if the additive is one of those referred to in Article 2 (aaa), - if any of the conditions for the authorization of the additive referred to in Article 3a are no longer met, - if a standard sample of the additive is not supplied to the official authorities which have requested it or if an additive put into circulation does not correspond to the standard sample of the authorized additive, - if a reference sample of the active substance is not supplied to the official authorities which have requested it, - if the person responsible for putting the additive into circulation does not provide, within a given period of time, the information requested by a person responsible at the Commission. However, such additives may continue to be authorized in order to use up stocks for a period of no longer than one year if at least the conditions laid down in Article 3a (b) and (e) continue to be met. MONOGRAPHS AND IDENTIFICATION NOTES Article 9n 1. In accordance with Directive 87/153/EEC, Member States shall ensure that applicants present a monograph for additives as referred to in Article 2 (aaa). 2. During the authorization procedure for additives as referred to in Article 2 (aaa), the Standing Committee for Feedingstuffs shall give an opinion, if appropriate after having made the necessary amendments, on the monograph of the additive presented in the dossier provided for in Article 4. The Commission shall approve the opinion given by the Standing Committee for Feedingstuffs on the monograph and its amendments in accordance with the procedure laid down in Article 23. 3. Monographs may also be approved for additives other than those referred to in paragraph 1 in accordance with the procedure laid down in paragraph 2. 4. The competent authorities of the Member States shall have recourse to the monograph: (a) to determine whether an additive for which authorization to put into circulation has been requested constitutes an innovation or should be considered as a copy; (b) to ascertain whether the additive put into circulation actually corresponds to the additive described in the dossier on the basis of which the Community authorization was granted. 5. Subsequent amendments to be made to monographs on account of developments in scientific and technical knowledge shall be submitted to the Standing Committee for Feedingstuffs for its opinion in accordance with the procedure laid down in Article 23. Article 9o 1. In accordance with Directive 87/153/EEC, Member States shall ensure that the applicant presents an identification note summarizing the characteristics and properties of the additive. In the case of the additives referred to in Article 2 (aaa), or should Article 9n (3) be applied, the identification note shall contain a summary of the most important characteristics and properties given in the monograph referred to in Article 9n. 2. The following shall be adopted in accordance with the procedure laid down in Article 23: - the identification note, - subsequent amendments to the identification note as a result of developments in scientific and technical knowledge. 3. In order to facilitate identification of the additives referred to in paragraph 1 during official checks, the identification note provided for in that paragraph shall be published in the Official Journal of the European Communities. STANDARD SAMPLE Article 9p 1. For the additives referred to in Article 2 (aaa) a standard sample having the characteristics and properties described in the monograph referred to in Article 9n together with a reference sample of the active substance shall be made available, upon request, to the national inspection authorities of the Member States by the person responsible for putting them into circulation. 2. If the characteristics or properties of the additive are modified, a new standard sample corresponding to the new monograph shall be provided. 3. Detailed rules concerning the provision and maintenance of standard samples shall be adopted in accordance with the procedure laid down in Article 23. MIXTURES AND ADDITIVE LEVELS Article 9q 1. The maximum and minimum levels set for certain additives shall refer to complete feedingstuffs with a moisture content of 12 % insofar as no special provisions are laid down in the authorization regulation. If the substance permitted as an additive also exists in the natural state in certain feed materials, the amount of additive to be incorporated shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum level provided for in the authorization regulation. 2. The mixing of additives shall be permitted in premixtures and feedingstuffs only where there is physico-chemical and biological compatibility between the components of the mixture in relation to the effects desired. 3. Unless the mixture concerned is the subject of a specific authorization as an additive, 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 and other medicinal substances 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 medicinal substances may not be mixed together if their effects are similar. 4. Mixing antibiotics, growth promoters, coccidiostats and other medicinal substances with micro-organisms shall be prohibited unless such a mixture is authorized by the regulation authorizing the micro-organisms. 5. By way of derogation from Article 3 and paragraphs 2 and 3 of this Article, Member States may authorize, but only for practical tests conducted for scientific purposes and for non-commercial ends, the use as additives of products which are not authorized at Community level or the use of additives under conditions other than those laid down in the authorization regulation, provided that: - the tests are carried out in accordance with the principles and conditions to be laid down in Directive 87/153/EEC, and - an adequate official inspection has been performed. AMENDMENTS TO THE ANNEXES Article 9r Amendments to be made to the Annexes shall be adopted in accordance with the procedure laid down in Article 23. INFORMATION ON PRODUCERS OF ADDITIVES Article 9s Member State shall ensure that the persons responsible for putting the additives referred to in Article 2 (aaa) into circulation forward to the Commission as quickly as possible the name or corporate name and the address or registered office of the producers to whom they have granted the right to manufacture the additive and, if the producers are established in a third country, also the name or corporate name and the address or registered office of their representatives in the Community. PUBLICATION IN THE OFFICIAL JOURNAL Article 9t The Commission shall publish in the Official Journal of the European Communities, "C" Series, not later than 30 November each year: (a) the list of persons responsible for putting additives into circulation as referred to in Article 9s, the names of the producers to whom they have granted the right to manufacture the additives and their representatives in the Community if such producers are established in a third country; (b) the list of authorized additives subdivided as follows: - Chapter I: list of additives linked to a person responsible for putting them into circulation and authorized for a period of 10 years, - Chapter II: list of additives linked to a person responsible for putting them into circulation and authorized on a provisional basis for no longer than four years or five years in the case of additives which have been the subject of provisional authorization before 1 April 1998, - Chapter III: list of other additives authorized for an unlimited period, - Chapter IV: list of other additives authorized on a provisional basis for no longer than four years or five years in the case of additives which have been the subject of provisional authorization before 1 April 1998.` 5) The following title shall be inserted between Articles 9t and 10: 'PACKAGING`. 6) The following title shall be inserted between Articles 10 and 11: 'SAFEGUARD AND MEASURES`. 7) In Article 11 (1), 'listed in Annex I` shall be replaced by 'authorized`. 8) The following title shall be inserted between Articles 11 and 12: 'ADDITIVE LEVELS IN COMPLEMENTARY FEEDINGSTUFFS`. 9) The following title shall be inserted between Articles 12 and 13: 'RULES FOR THE DISTRIBUTION AND INCORPORATION IN FEEDINGSTUFFS OF ADDITIVES AND PREMIXTURES`. 10) Article 13 shall be replaced by the following: 'Article 13 1. Member States shall require that certain additives covered by this Directive, premixtures prepared from those additives with a view to their being incorporated in compound feedingstuffs and compound feedingstuffs containing those premixtures may be put into circulation or used only by the establishments or intermediaries which meet the conditions laid down, as appropriate, in Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (*). 2. Member States shall require that: (a) additives referred to in Part A of Annex A may be supplied only by approved establishments: (i) to intermediaries or establishments which manufacture premixtures and which have been approved in accordance with the provisions laid down in Article 3 (1) or Article 2 (2) (b) respectively of Directive 95/69/EC, and (ii) in the form of premixtures, only to intermediaries or establishments which manufacture compound feedingstuffs with a view to putting them into circulation or for the exclusive requirements of their holding and which have been approved in accordance with the provisions laid down in Article 3 (1) or Article 2 (2) (c) or (e) respectively of the above Directive; (b) additives listed in Part B of Annex A may be supplied only by approved establishments: (i) to intermediaries or establishments which manufacture premixtures and which have been approved in accordance with the provisions laid down in Article 3 (1) or Article 2 (2) (b) respectively of the above Directive, and (ii) in the form of premixtures, only to: - intermediaries which have been approved in accordance with the provisions laid down in Article 3 of the above Directive, or - establishments which manufacture compound feedingstuffs with a view to putting them into circulation or for the exclusive requirements of their holding and which have been registered in accordance with the provisions laid down in Article 7 (2) (c) or (d) respectively of the said Directive or, as appropriate, approved in accordance with the provisions laid down in Article 2 (2) (c) or (e) of this Directive. 3. Member States shall require that additives referred to in Annex A (a) and (B) may be incorporated in compound feedingstuffs only if they have been prepared beforehand in the form of premixtures containing a carrier substance by establishments which meet the conditions laid down in Article 2 (2) (b) of Directive 95/69/EC. Such premixtures may be incorporated in compound feedingstuffs only in a proportion of at least 0,2 % by weight. By way of derogation from the first subparagraph, Member States may allow premixtures to be incorporated in compound feedingstuffs in a proportion as low as 0,05 % by weight, provided that the quantitative and qualitative composition of the premixture so permits and that they have first established that the establishments satisfy the conditions set out in Chapter I.2 (b) of the Annex, with a view to achieving homogeneous distribution of premixtures and observing the additive levels set for the whole feedingstuff. These manufacturers as referred to in the second paragraph shall be entered on the national list under a special heading as follows: "Manufacturers of compound feedingstuffs authorized to use a minimum proportion of 0,05 % by weight of premixtures". 4. By way of derogation from paragraph 2, Member States shall require that: (a) additives referred to in Annex A (B) may be supplied to approved intermediaries or registered establishments which manufacture compound feedingstuffs for pets and fulfil the conditions laid down, as appropriate, in Article 3 (1) or Article 3 (2) (c) or (d) of Directive 95/69/EC; (b) additives referred to in Annex A (A) or (B) may be delivered at the last stage of circulation to establishments which manufacture compound feedingstuffs, provided that: - the Community regulation authorizing the additive provides, in the case of a specific preparation of the additive, for direct addition to feedingstuffs, and - the manufacturer of compound feedingstuffs is approved in accordance with Article 2 (2) (c) of the above Directive for the additives referred to in Annex A (A) or is registered in accordance with Article 7 (2) (c) of the above Directive for the additives referred to in Annex A (B), and - it has been checked on the spot that the manufacturer is in possession of the appropriate technology defined in Chapter I (3) (b) or Chapter II (c) of the Annex to the above Directive in order to add the preparation in question directly to the compound feedingstuff. Such manufacturers shall appear on the national list under a special heading as follows: "Manufacturers of compound feedingstuffs referred to in point (b) authorized to add antibiotics, cocciodiostats and other medicinal substances, and growth promoters directly to compound feedingstuffs" or "Manufacturers of compound feedingstuffs authorized to add copper, selenium and vitamins A and D directly to compound feedingstuffs". 5. By way of derogation from Article 7 of Directive 95/69/EC and paragraphs 1 and 2 of this Article, Finland and, as regards that part of its territory situated to the north of latitude 60°, Sweden shall be authorized, in view of the special feeding conditions on their farms, to allow premixtures of vitamins, provitamins and chemically well-defined substances having similar effect to be supplied to stock farmers for direct addition to feed materials of vegetable origin, provided that: - the directions for use state precisely the dosage to be complied with according to the species or category of animals and the type of fodder used, and - special measures are taken by Finland and Sweden to monitor use of such premixtures. (*) OJ No L 332, 30. 12. 1995, p. 15.` 11) The following title shall be inserted between Articles 13 and 14: 'LABELLING OF ADDITIVES` 12) Articles 14 to 16 shall be replaced by the following: 'Article 14 1. Member States shall require that authorized additives may be put into circulation 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, with the exception of enzymes and micro-organisms: (a) the specific name given to the additive upon authorization, the EC registration number of the additive and, in the case of an additive within the meaning of Article 2 (aaa), the trade name and the registration number given to the person responsible for putting it into circulation; (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; (d) as applicable, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishment or the intermediary pursuant to Article 10 of the above Directive. B. In addition, with regard to: (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 in the label, the active-substance level, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where appropriate, a safety recommendation regarding use in the case of additives which are the subject of special provisions upon authorization; (b) vitamin E: the alpha-tocopherol level and the 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: the active-substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture; (d) trace elements, colourants including pigments, preserving agents and other additives, with the exception of those belonging to the enzyme and micro-organism groups: the active-substance level. C. For additives belonging to the groups: (a) of enzymes: the specific name of the active component or components in accordance with their enzyme activities, in conformity with the authorization given, the International Union of Biochemistry identification number, units of activity (*) (units of activity per gram or units of activity per millilitre), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, 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 approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization for the additive; (b) of micro-organisms: identification of the strain(s) in accordance with the authorization granted, the file number of the strain(s), the number of colony-forming units (CFU per gram), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, 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 approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate an indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive. 2. Member States shall require that the specific name of the additive may be accompanied, in cases where the indications are not required by virtue of paragraph 1: (a) by the trade name; (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. 3. Member States shall require that information other than that required or authorized pursuant to paragraphs 1 and 2 may appear on packages, containers or labels, provided that they are clearly separated from the abovementioned marking particulars. (*) Units of activity expressed in micromoles of product released per minute, per gram of enzyme preparation. 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) 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; (f) as applicable, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishment or the intermediary pursuant to Article 10 of the above Directive. 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 given to the additive upon authorization, active substance level and expiry date of the guarantee of that level, or storage life from the date of manufacture; (b) substances having antioxidant effects: specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs on authorization of the additive; (c) colourants, including pigments: specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs upon authorization of the additive; (d) vitamin E: specific name given to the additive upon authorization, 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 given to the additive upon authorization, 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 given to the additive upon authorization, and level of the various elements insofar as a maximum level is fixed for complete feedingstuffs upon authorization of the additive; (g) preserving agents: specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs upon authorization of the additive; (h) enzymes: the specific name of the active component(s) according to its (their) enzymatic activity(ies) in accordance with the authorization given, the identification number according to the International Union of Biochemistry, the activity units (activity units per g or activity units per ml), the additive's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive; (i) micro-organisms: the identification of the strain(s) in accordance with the authorization given, the file number of the strain(s) in accordance with the authorization given, the file number of the strain(s), the number of colony-forming units (CFU/g), the additive's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee of the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive; (j) other additives belonging to the groups referred to in (b) or (i) for which no maximum level is laid down and additives belonging to other groups authorized: specific name given to the additive upon authorization 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 may be accompanied by the tradename; (b) 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; (c) the specific name of the additives authorized may be accompanied by the additive's EC registration 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 put into circulation 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: the specific name given to the additive upon authorization, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture, the approval number assigned to the establishment in accordance with Article 5 of Directive 95/69/EC; (b) for substances having antioxidant effects: - in the case of pet foods: use of the words "with antioxidant" followed by the specific name given to the additive upon authorization, - in the case of compound feedingstuffs other than pet foods: the specific name given to the additive upon authorization; (c) for colourants, including pigments provided that these are used for the colouration of feedingstuffs or animal products: - in the case of pet foods: use of the words "colourant" or "coloured with" followed by the specific name given to the additive upon authorization, - in the case of compound feedingstuffs other than pet foods: the specific name given to the additive upon authorization; (d) for vitamin E: the specific name given to the additive upon authorization, the 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: the specific name given to the additive upon authorization, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture; (f) for copper: the specific name given to the additive upon authorization 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 given to the additive upon authorization, - in the case of compound feedingstuffs other than pet foods: the specific name given to the additive upon authorization; (h) for enzymes: the specific name of the active constituent(s) according to its (their) enzymatic activity(ies) in accordance with the authorization given, the identification number according to the International Union of Biochemistry, the activity units (activity units per kilogram or activity unit per litre), the EC registration number of the additive, the expiry date of the guarantee or the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristic due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive; (i) for micro-organisms: the identification of the strain(s) in accordance with the authorization given, the file number of the strain(s), the number of colony-forming units (CFU/kg), the EC registration number of the additive, the expiry date of the guarantee or the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristic due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive. 2. In addition to the particulars provided for by paragraph 1, particulars concerning the proper use of the feedingstuffs may be laid down in the authorization of the additive in accordance with the procedure provided for in Article 23. Member States shall require that these particulars 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 the authorization given 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 the authorization given, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture; 4. Member States shall require that: (a) the details provided for in paragraphs 1 to 3 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 3, such statement shall refer to the amount of additive incorporated in the feedingstuff; (c) the details of additives may be accompanied by the EC registration number of the additive or the trade name where those particulars are not required by virtue of paragraph 1. 5. 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. 6. In the case of feedingstuffs distributed by road tankers or similar vehicles or in bulk, the details provided for in paragraphs 1 to 3 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. 7. Member States shall require that, in the case of pet foods containing colourants, 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 "EC 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. 8. Any reference to additives other than in the form provided for in this Directive shall be prohibited.` 13) In Article 17 (1), the second subparagraph shall be replaced by the following: 'This information must be in accordance with the conditions of use prescribed upon authorization of the additive.`. 14) The following title shall be inserted between Articles 20 and 21: 'INSPECTION MEASURES`. 15) The following shall be added after Article 21: 'MONITORING OF UNDESIRABLE INTERACTIONS Article 21a Where there is found to be unforeseen undesirable interaction between additives referred to in Article 2 (aaa) and other additives or veterinary medicines, Member States shall require that the person responsible for putting the additive into circulation, or his representative within the Community where additives originate in third countries, gathers all the relevant information and forwards it to the competent authorities.`. 16) The following title shall be inserted between Articles 21a and 22: 'EXPORTS TO THIRD COUNTRIES`. 17) The following title shall be inserted between Articles 22 and 23: 'IMPLEMENTATION POWERS OF THE COMMISSION`. 18) The following title shall be inserted between Articles 24 and 25: 'FINAL PROVISIONS`. 19) Annexes I, II and III shall be deleted. 20) The Annexes A, B and C set out in the Annex to this Directive shall be added. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with: (a) the following provisions provided for in Article 1: - point (4): Article 6 (1), Article 9d (2), Article 9e (3), Article 9f, Article 9g, Article 9h, Article 9i, Article 9j, Article 9n, Article 9o, - points 10, 12, 19 and 20, on 1 April 1998; (b) the other provisions of this Directive by 1 October 1999. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States.

31996L0048

1996

Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system Having regard to the Treaty establishing the European Community, and in particular the third paragraph of Article 129d thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Having regard to the opinion of the Committee of the Regions (3), Acting in accordance with the procedure laid down in Article 189c (4), Whereas in order to enable citizens of the Union, economic operators and regional and local authorities to benefit to the full from the advantages deriving from establishing an area without internal frontiers, it is advisable, in particular, to improve the interlinking and interoperability of national high-speed train networks, as well as access thereto; Whereas a high-level working party consisting of representatives of the governments of the Member States, of the European railways and of the European railway industry convened by the Commission in order to meet the request expressed by the Council in its resolution of 4 and 5 December 1989 drew up the master plan for a European high-speed train network; Whereas in December 1990 the Commission sent to the Council a communication on the high-speed train network, and whereas the Council gave a favourable reception to that communication in its resolution of 17 December 1990 (5); Whereas Article 129c of the Treaty provides that the Community shall implement any measures that may prove necessary to ensure network interoperability, in particular in the field of technical standardization; Whereas the commercial operation of high-speed trains requires excellent compatibility between the characteristics of the infrastructure and those of the rolling stock; whereas performance levels, safety, quality of service and cost depend upon such compatibility as does, in particular, the interoperability of the European high-speed rail system; Whereas pursuant to Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways (6) railway companies must have increased access to the rail networks of the Member States, which in turn requires infrastructure, equipment and rolling stock interoperability; Whereas the Member States are responsible for ensuring compliance with the safety, health and consumer protection rules applying to the railway networks in general during the design, construction, placing in service and operation of those railways; whereas, together with the local authorities, they also have responsibilities in respect of rights in land, regional planning and environmental protection; whereas that is also especially pertinent with regard to high-speed train networks; Whereas Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (7) requires an assessment of the impact on the environment of the construction of lines for long-distance rail traffic; Whereas national regulations and the railways' internal rules and the technical specifications which the railways apply contain major differences; whereas those national regulations and internal rules incorporate techniques that are specific to the national industries; whereas they prescribe specific dimensions and devices and special characteristics; whereas this situation runs counter to high-speed trains being able to run normally throughout Community territory; Whereas, over the years, this situation has created very close links between the national railway industries and the national railways, to the detriment of the genuine opening-up of contracts; whereas, in order to enhance their competitiveness at world level those industries require an open, competitive European market; Whereas it is therefore appropriate to define essential requirements for the whole of the Community which will apply to the trans-European high-speed train system; Whereas, in view of the extent and complexity of the trans-European high-speed rail system, it has proved necessary for practical reasons to break it down into subsystems; whereas for each of those subsystems the essential requirements must be specified, the basic parameters laid down and the technical specifications determined for the whole of the Community, particularly in respect of constituents and interfaces, in order to meet those essential requirements; whereas, however, certain subsystems (environment, users and operation) will be subject to technical specifications for interoperability (TSIs) only in so far as is necessary to ensure interoperability in the fields of infrastructure, energy, control-and-command and signalling and rolling-stock; Whereas the introduction of provisions on the interoperability of the trans-European high-speed rail system must not create unjustified cost-benefit barriers to the preservation of the existing rail network of each Member State, but must endeavour to maintain the objective of the circulation of high-speed trains throughout the Community; Whereas individual Member States should be allowed not to apply certain technical specifications for interoperability in specific cases, provided that there are procedures to ensure that such possibilities for derogation are justified; whereas Article 129c of the Treaty requires the Community's activities in the area of interoperability to take into account the potential economic viability of projects; Whereas in order to comply with the appropriate provisions on government procurement procedures in the rail sector and in particular Directive 93/38/EEC (8), contracting entities must include technical specifications in the general documents or the contract documents relating to each contract; whereas it is necessary to build up a body of European specifications to serve as references for those technical specifications; Whereas, within the meaning of Directive 93/38/EEC, a European specification is a common technical specification, a European technical approval or a national standard implementing a European standard; whereas harmonized European standards are to be drawn up by a European standardization body such as the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) or the European Telecommunications Standards Institute (ETSI), to the order of the Commission, and their references published in the Official Journal of the European Communities; Whereas it would be in the Community's interests for there to be an international system of standardization capable of generating standards which are actually used by those involved in international trade and which meet the requirements of Community policy; whereas the European standardization bodies must therefore continue their cooperation with the international standardization bodies; Whereas contracting entities define such further requirements as are necessary to complete European specifications or other standards; whereas those specifications must not prevent the essential requirements that have been harmonized at Community level and which the trans-European high-speed train system must satisfy, from being met; Whereas the procedures governing the assessment of conformity or of suitability of use of constituents must be based on the use of the modules covered by Decision 93/465/EEC (9); whereas, as far as possible and in order to promote the development of the industries concerned, it is appropriate to expand the procedures involving a system of quality assurance; whereas the notion of constituent covers both tangible objects and intangible objects such as software; Whereas the suitability for use of the most critical constituents as regards safety, availability or system economy should be assessed; Whereas in their contract documents, contracting entities, lay down, in particular for constituents, by reference to the European specifications, the characteristics which must be met, in contractual terms, by the manufacturers; whereas, this being the case, constituent conformity is mainly linked to their area of use in order to ensure and guarantee the interoperability of the system, and not only to their free movement on the Community market; Whereas it is therefore not necessary for a manufacturer to affix the CE mark to constituents that are subject to the provisions of this Directive as, on the basis of the assessment of conformity and/or suitability for use conducted in accordance with the procedures provided for that purpose in the Directive, the manufacturer's declaration of conformity is sufficient; whereas that does not affect the obligation on manufacturers to affix the CE mark to certain components in order to certify their compliance with other Community provisions relating to them; Whereas the subsystems constituting the trans-European high-speed rail system must be subjected to a verification procedure; whereas that verification must enable the authorities responsible for authorizing their placing in service to be assured that at the stages of design, construction and placing in service the result is in line with the regulations and technical operational provisions in force; whereas that must also enable manufacturers to be able to count upon equality of treatment whatever the country; whereas it is therefore necessary to lay down a module defining the principles and conditions applying to EC verification of subsystems; Whereas the EC verification procedure is based on TSIs; whereas those TSIs are drawn up to the order of the Commission by the joint body representing the infrastructure managers, the railway companies and the industry; whereas the reference to TSIs is required in order to ensure interoperability of the trans-European high-speed rail system and whereas those TSIs are subject to the provisions of Article 18 of Directive 93/38/EEC; Whereas the notified bodies responsible for examining the conformity assessment procedures or that applying to the use of constituents, together with the procedure for the assessment of subsystems must, particularly in the absence of any European specification, coordinate their decisions as closely as possible; Whereas Council Directive 91/440/EEC requires a separation of activities, in accounting terms, between transport service operation and those concerning railway infrastructure management; whereas, this being the case, the specialized services provided by the railway infrastructure managers designated as notified bodies should be structured in such a way as to meet the criteria which must apply to this type of body; whereas other specialized bodies may be notified where these meet the same criteria; Whereas interoperability within the trans-European high-speed train system is Community wide in scale; whereas the Member States are unable, on an individual basis, to take the action needed in order to achieve that interoperability; whereas it is therefore necessary, pursuant to the principle of subsidiarity, for this action to be taken at Community level, CHAPTER I General provisions Article 1 1. In accordance with Articles 129b and 129c of the Treaty, the aim of this Directive is to establish the conditions to be met in order to achieve interoperability within Community territory of the trans-European high-speed rail system as described in Annex I. 2. These conditions concern projects for and the construction, upgrading and operation of the infrastructures and rolling stock which will contribute to the functioning of the system to be put into service after the date of entry into force of this Directive. Article 2 For the purposes of this Directive: (a) trans-European high-speed rail system means the structure described in Annex I, composed of the railway infrastructures comprising lines and fixed installations, of the trans-European transport network, constructed or upgraded to be travelled on at high speeds, and rolling stock designed for travelling on those infrastructures; (b) interoperability means the ability of the trans-European high-speed rail system to allow the safe and uninterrupted movement of high-speed trains which accomplish the specified levels of performance. This ability rests on all the regulatory, technical and operational conditions which must be met in order to satisfy essential requirements; (c) subsystems means that the trans-European high-speed rail system is subdivided, as described in Annex II, into structural or functional subsystems for which essential requirements must be laid down; (d) interoperability constituents means any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the trans-European high-speed rail system depends either directly or indirectly; (e) essential requirements means all the conditions set out in Annex III which must be met by the trans-European high-speed rail system, subsystems and their interoperability constituents; (f) European specification means a common technical specification, a European technical approval or a national standard implementing a European standard, as defined in points 8 to 12 of Article 1 of Directive 93/38/EEC; (g) technical specifications for interoperability (hereinafter TSIs) means the specifications by which each subsystem is covered in order to meet the essential requirements by establishing the necessary reciprocal functional relations between the subsystems of the trans-European high-speed rail system and by ensuring the latter's compatibility; (h) joint representative body means the body bringing together representatives of the infrastructure managers, railway companies and industry which is responsible for drawing up TSIs. 'Infrastructure managers` means those referred to in Articles 3 and 7 of Directive 91/440/EEC; (i) notified bodies means the bodies which are responsible for assessing the conformity or suitability for use of the interoperability constituents or for appraising the EC procedure for verification of the subsystems. Article 3 1. This Directive applies to the provisions concerning, for each subsystem, the parameters, interoperability constituents, interfaces and procedures as well as the conditions for the overall compatibility of the trans-European high-speed rail system required to achieve its interoperability. 2. The provisions of this Directive shall apply without prejudice to other Community provisions. However, in the case of interoperability constituents, compliance with the essential requirements of this Directive may require the use of the individual European specifications drawn up for that purpose. Article 4 1. The trans-European high-speed rail system, subsystems and their interoperability constituents must meet the relevant essential requirements. 2. The further technical specification referred to in Article 18 (4) of Directive 93/38/EEC, which are necessary to supplement European specifications or other standards in use within the Community, must not conflict with the essential requirements. CHAPTER II Technical specifications for interoperability Article 5 1. Each of the subsystems shall be covered by a TSI. In the case of subsystems concerning the environment, operation or users, TSIs will be drawn up only to the extent necessary to ensure interoperability of the trans-European high-speed rail system in the fields of infrastructure, energy, control and command, signalling and rolling stock. 2. The subsystems must conform to the TSIs; this conformity must be permanently maintained while each subsystem is in use. 3. To the extent necessary in order to achieve interoperability of the trans-European high-speed rail system, the TSIs shall: (a) specify the essential requirements for the subsystems and their interfaces; (b) establish the basic parameters described in Annex II (3) necessary to meet the essential requirements; (c) establish the conditions to be complied with to achieve the specified performances for each of the following categories of line: - lines specially built for high speed; - lines specially upgraded for high speed; - lines specially upgraded for high speed which have special features as a result of topographical, relief or town-planning constraints; (d) establish possible implementing provisions in certain specific cases; (e) determine the interoperability constituents and interfaces which must be covered by European specifications, including European standards, which are needed in order to achieve interoperability within the trans-European high-speed rail system while meeting the essential requirements; (f) state, in each case under consideration, which of the modules defined in Decision 93/465/EEC or, where appropriate, which specific procedures are to be used in order to assess either the conformity or the suitability for use of the interoperability constituents, as well as EC verification of the subsystems. 4. The TSIs shall not be an impediment to decisions by the Member States concerning the use of new or upgraded infrastructures for running other trains. 5. Compliance with all the TSIs shall enable a compatible trans-European high-speed rail system to be set up that will preserve, as appropriate, the compatibility of each Member State's existing rail network. Article 6 1. Draft TSIs shall be drawn up to the order of the Commission, to be established in accordance with the procedure laid down in Article 21 (2) by the joint representative body. TSIs shall be adopted and reviewed by the same procedure. They shall be published by the Commission in the Official Journal of the European Communities. 2. The joint representative body shall be responsible for preparing the review and updating of TSIs and making recommendations to the Committee referred to in Article 21 in order to take account of developments in technology or social requirements. 3. The preparation, adoption and review of TSIs shall take account of the estimated cost of technical solutions by which they may be met, with a view to defining and implementing the most viable solutions. To that end, the joint representative body shall attach to each draft TSI an assessment of the estimated costs and benefits of those technical solutions for all the economic operators and agents concerned. 4. The Committee shall be kept regularly informed of the preparatory work on the TSIs by the joint representative body. The Committee may give the joint body any useful recommendation or brief regarding the design of the TSIs, on the basis of the essential requirements or regarding cost assessment. 5. When each TSI is adopted, the date of its entry into force shall be laid down in accordance with the procedure referred to in Article 21 (2). 6. The joint representative body must work in an open and transparent manner in accordance with general Community standardization procedures. Article 7 A Member State need not apply certain TSIs, including those relating to rolling stock, in the following cases and circumstances: (a) in the case of a project for a new line or upgrading an existing line for high speed which is at an advanced stage of development when the TSIs in question are published. The Member State concerned shall notify its intended derogation to the Commission in advance, shall inform the Commission of the stage the project has reached and shall forward to it a file setting out the TSIs or parts thereof which it wishes not to apply, the provisions it intends to apply in carrying out the project in order to promote its eventual interoperability, and the technical, administrative or economic reasons which justify the derogation; (b) in the case of a project for upgrading an existing line for high speed, where the loading gauge, track gauge or space between the tracks of the line are different from those on the majority of the European rail network, and where the line does not form a direct connection with the high-speed network of another Member State which is a part of the trans-European high-speed network. The Member State concerned shall notify its intended derogation to the Commission in advance and shall forward to it a file setting out the TSIs or parts thereof concerning the physical parameter(s) referred to in the first subparagraph which it wishes not to apply, the provisions it intends to apply in carrying out the project in order to promote its eventual interoperability, the transitional measures it intends to take to guarantee compatibility of operation, and the technical, administrative or economic reasons which justify the derogation; (c) in the case of projects for new lines or upgrading existing lines for high speed carried out in the territory of the Member State concerned where its rail network is not linked to or is isolated by sea from the high-speed rail network of the rest of the Community. The Member State concerned shall notify its intended derogation to the Commission in advance and shall forward to it a file containing the documents specified in the second subparagraph of paragraph (b); (d) in the case of a project for upgrading an existing line for high speed, where application of these TSIs compromises the economic viability of the project. The Member State concerned shall notify its intended derogation to the Commission in advance and shall forward to it a file setting out the technical specifications or parts of specifications for interoperability which it wishes not to apply. The Commission shall examine whether the measures envisaged by the Member State are justified and shall take a decision in accordance with the procedure in Article 21 (2). CHAPTER III Interoperability constituents Article 8 Member States shall take all necessary steps to ensure that interoperability constituents: - are placed on the market only if they enable interoperability to be achieved within the trans-European high-speed rail system while at the same time meeting the essential requirements; - are used in their area of use as intended and are suitably installed and maintained. These provisions do not exclude the placing on the market of these constituents for other purposes, nor their use for conventional railway lines. Article 9 Member States may not, in their territory and on grounds of this Directive, prohibit, restrict or hinder the placing on the market of interoperability constituents for use on the trans-European high-speed rail system if they comply with the Directive. Article 10 1. Member States shall consider as complying with the essential requirements of this Directive applying to them those interoperability constituents which bear the EC declaration of conformity or suitability for use, the components of which are set out in Annex IV. 2. Compliance of an interoperability constituent with the essential requirements applying to it shall be established in relation to any relevant European specifications that may exist. 3. The references to European specifications shall be published in the Official Journal of the European Communities. 4. Member States shall publish the references to the national standards transposing the European standards. 5. In the absence of any European specifications and without prejudice to Article 20 (5), Member States shall inform the other Member States and the Commission of the standards and technical specifications in use in order to implement the essential requirements. Article 11 Where it appears to a Member State or the Commission that European specifications do not meet the essential requirements, partial or total withdrawal of the specifications concerned from the publications containing them, or their amendments, may be decided upon in accordance with the procedure laid down in Article 21 (2) after consultation of the Committee set up under 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 (10) where European standards are concerned. Article 12 1. Where a Member State confirms that an interoperability constituent covered by the EC declaration of conformity or suitability for use, and placed on the market is likely, when used as intended, not to meet the essential requirements, it shall take all necessary steps to restrict its area of application, prohibit its use or withdraw it from the market. That Member State shall forthwith inform the Commission of the measures taken and shall give the reasons for its decision, stating in particular whether the failure to conform is due to: - failure to meet the essential requirements; - incorrect application of the European specifications where application of the specifications is invoked; - inadequacy of the European specifications. 2. The Commission shall consult the parties concerned as quickly as possible. Where, following that consultation, the Commission establishes that the measure is justified, it shall forthwith so inform the Member State that has taken the initiative and the other Member States. Where, following that consultation, the Commission establishes that the measure is unjustified, it shall forthwith so inform the Member State that has taken the initiative and the manufacturer or his authorized representative established within the Community. Where the decision referred to in paragraph 1 is justified by the existence of a gap in the European specifications, the procedure defined in Article 11 shall apply. 3. Where an interoperability constituent bearing the EC declaration of conformity fails to comply, the competent Member State shall take the appropriate measures against whomsoever has drawn up the declaration and shall inform the Commission and the other Member States thereof. 4. The Commission shall ensure that the Member States are kept informed of the progress and the results of that procedure. Article 13 1. In order to draw up the EC declaration of conformity or suitability for use of an interoperability constituent, its manufacturer or his authorized representative established within the Community must apply the provisions laid down in the TSIs referring to it. 2. Where so required by the TSIs, the assessment of conformity or suitability for use of an interoperability constituent shall be appraised by the notified body with which the manufacturer or his authorized representative established within the Community has lodged the application. 3. Where the interoperability constituents are the subject of other Community Directives covering other aspects, the EC declaration of conformity or suitability for use shall, in such instances, state that the interoperability constituents also meet the requirements of those other Directives. 4. Where neither the manufacturer nor his authorized representative established within the Community has met the obligations of the paragraphs 1, 2 and 3, those obligations shall be incumbent on any person who places that interoperability constituent on the market. The same obligations shall apply to any person who assembles interoperability constituents or parts of interoperability constituents having diverse origins or who manufactures the interoperability constituents for his own use, for the purposes of this Directive. 5. Without prejudice to the provisions of Article 12: (a) in each instance where a Member State finds that the EC declaration of conformity has been drawn up improperly, the manufacturer or his authorized representative established within the Community shall be required to ensure that the conformity of the interoperability constituent is re-established and that the infringement ceases under the conditions laid down by that Member State; (b) where non-conformity persists, the Member State shall take all appropriate steps to restrict or prohibit the placing on the market of the interoperability constituent in question, or to ensure that it is withdrawn from the market in accordance with the procedures provided for in Article 12. CHAPTER IV Subsystems Article 14 Each Member State shall authorize the placing in service of those structural subsystems constituting the trans-European high-speed rail system which are located in its territory or operated by railway undertakings established there. For this purpose Member States shall take all necessary steps to ensure that these subsystems may be placed in service only if they are designed, constructed and installed and/or operated in such a way as not to hinder satisfaction of the essential requirements concerning them when integrated into the trans-European high-speed rail system . Article 15 Without prejudice to Article 19, Member States may not, in their territory and on grounds of this Directive, prohibit, restrict or hinder the construction, placing in service and operation of structural subsystems constituting the trans-European high-speed rail system which satisfy the essential requirements. Article 16 1. Member States shall consider as being interoperable and meeting the essential requirements concerning them those structural subsystems constituting the trans-European high-speed rail system which are covered by the EC declaration of verification. 2. Verification of the interoperability, in accordance with the essential requirements, of a structural subsystem constituting the trans-European high-speed rail system shall be established by reference to TSIs where these exist. 3. In the absence of TSIs, Member States shall send the other Member States and the Commission a list of the technical rules in use for implementing the essential requirements. Article 17 If it emerges that the TSIs do not fully meet the essential requirements, the Committee referred to in Article 21 may be consulted at the request of a Member State or on the initiative of the Commission. Article 18 1. In order to draw up the EC declaration of verification, the awarding authority or its official representative shall cause the EC checking procedure to be appraised by the notified body chosen by it for that purpose. 2. The activities of the notified body responsible for the EC verification of a subsystem shall begin at the design stage and shall cover all of the manufacturing period up to the type-approval stage before a subsystem is placed in service. 3. The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file must contain all the necessary documents relating to the characteristics of the subsystem and, where appropriate, all the documents certifying conformity of the constituents of interoperability. It must also contain all of the elements relating to the conditions and limits of use and to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance. Article 19 1. Where a Member State finds that a structural subsystem covered by the EC declaration of verification accompanied by the technical file does not fully comply with this Directive and in particular does not meet the essential requirements, it may request that additional checks be carried out. 2. The Member State making the request shall forthwith inform the Commission of any additional checks requested and set out the reasons which justify them. The Commission shall without delay initiate the procedure provided for in Article 21 (2). CHAPTER V Notified bodies Article 20 1. Member States shall notify the Commission and the other Member States of the bodies responsible for carrying out the procedure for the assessment of conformity or suitability for use referred to in Article 13 and the checking procedure referred to in Article 18, indicating each body's area of responsibility. The Commission shall assign identification numbers to them. It shall publish in the Official Journal of the European Communities the list of bodies, their identification numbers and the tasks entrusted to them, and shall ensure that the list is kept updated. 2. Member States shall apply the criteria provided for in Annex VII for the assessment of the bodies to be notified. Bodies meeting the assessment criteria provided for in the relevant European standards shall be deemed to meet the said criteria. 3. A Member State shall withdraw approval from a body which no longer meets the criteria referred to in Annex VII. It shall forthwith inform the Commission and the other Member States thereof. 4. Should a Member State or the Commission consider that a body notified by another Member State no longer meets the relevant criteria, the matter shall be referred to the Committee provided for in Article 21, which shall deliver its opinion within three months; in the light of the Committee's opinion, the Commission shall inform the Member State concerned of all the changes needed if the notified body is to maintain the status awarded to it. 5. Where appropriate, coordination of the notified bodies shall be implemented in accordance with Article 21 (4). CHAPTER VI Committee Article 21 1. The Commission shall be assisted by a Committee, composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. 3. The Committee may discuss any matter concerning the interoperability of the trans-European high-speed rail system. 4. Should it prove necessary, the Committee may set up working parties to aid it in carrying out its tasks, in particular with a view to coordinating the notified bodies. 5. The Committee shall be set up as soon as this Directive enters into force. CHAPTER VII Final provisions Article 22 Any decision taken pursuant to this Directive concerning the assessment of conformity or suitability for use of interoperability constituents, the checking of subsystems constituting the trans-European high-speed rail system and any decision taken pursuant to Articles 11, 12, 17 and 19 shall set out in detail the reasons on which it is based. It shall be notified as soon as possible to the party concerned, together with an indication of the remedies available under the laws in force in the Member States concerned and of the time limits allowed for the exercise of such remedies. Article 23 1. Member States shall amend and adopt their laws, regulations and administrative provisions so as to authorize the use of interoperability constituents and the putting into service and operation of subsystems which comply with this Directive no later than 30 months after entry into force of this Directive. They shall forthwith inform the Commission thereof. 2. When Member States adopt the provisions referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 24 Every two years the Commission shall report to the European Parliament and the Council on the progress made towards achieving interoperability of the trans-European high-speed rail system. Article 25 This Directive shall enter into force on the 21st day following that of its publication in the Official Journal of the European Communities.

31996L0053

1996

Council Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international traffic Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), (1) Whereas Council Directive 85/3/EEC of 19 December 1984 on the weights, dimensions and certain other technical characteristics of certain road vehicles (4) established, in the framework of the common transport policy, common standards permitting improved use of road vehicles in traffic between Member States; (2) Whereas Directive 85/3/EEC has been significantly amended on many occasions; whereas on the occasion of its further amendment it should for reasons of clarity and rationality be recast in a single text together with Council Directive 86/364/EEC of 24 July 1986 relating to proof of compliance of vehicles with Directive 85/3/EEC (5); (3) Whereas differences between standards in force in the Member States with regard to the weights and dimensions of commercial road vehicles could have an adverse effect on the conditions of competition and constitute an obstacle to traffic between Member States; (4) Whereas, under the principle of subsidiarity, action should be taken at Community level in order to remove this obstacle; (5) Whereas the abovementioned standards reflect a balance between the rational and economical use of commercial road vehicles and the requirements of infrastructure maintenance, road safety and the protection of the environment and the fabric of live; (6) Whereas common standards on the dimensions of vehicles intended for the carriage of goods should remain stable in the long term; (7) Whereas additional technical requirements related to the weights and dimensions of vehicles may apply to commercial vehicles registered or put into circulation in a Member State; whereas these requirements must not constitute an obstacle to the circulation of commercial vehicles between Member States; (8) Whereas the definition of 'thick-walled refrigerated vehicle` in Article 2 of Directive 85/3/EEC, as amended by Directive 89/388/EEC (6), should be broadened in order to permit Member States to allow refrigerated vehicles no longer meeting the insulation requirements defined in that Article to circulate in their territory; (9) Whereas it is necessary to clarify the concept of 'indivisible load` in order to ensure uniform application of this Directive in respect of permits for vehicles or vehicle combinations carrying such loads; (10) Whereas the tonne is universally used and understood as the unit of measurement for vehicle weight and is, therefore, applied in this Directive whilst recognizing that the formal unit of weight is the newton; (11) Whereas, in implementation of the internal market, the scope of this Directive should be extended to national transport insofar as it concerns characteristics that significantly affect the conditions of competition in the transport sector and in particular the values relating to the maximum authorized length and width of vehicles and vehicle combinations intended for the carriage of goods; (12) Whereas, for the other vehicle characteristics, Member States are authorized to apply in their territory different values from those laid down in this Directive only to vehicles used in national traffic; (13) Whereas road trains using extensible coupling systems in practice attain a maximum length of 18,75 m when fully extended; whereas the same maximum length should be authorized for road trains using fixed coupling systems; (14) Whereas the maximum authorized width of 2,50 m for vehicles intended for the carriage of goods can leave insufficient internal space for the efficient loading of pallets, which has given rise to the application of different tolerances beyond that level in the legislation of the Member States concerning domestic traffic; whereas a general adaptation to the current situation is therefore necessary in order to provide for clarity in technical requirements, bearing in mind the road safety aspects of these characteristics; (15) Whereas if the maximum width of vehicles intended for the carriage of goods is increased to 2,55 m, that standard should also be applied to buses; whereas, in respect of buses, it is however necessary to provide for a transitional period to allow the manufacturers concerned to adapt industrial plant; (16) Whereas, to prevent excessive road damage and to ensure manoeuvrability, when authorizing and using vehicles preference should be given to pneumatic or equivalent suspension rather than mechanical suspension; whereas certain maximum axle loads should not be exceeded, and the vehicle must be capable of turning through 360° within certain limit values for the path followed; (17) Whereas Member States should be permitted, in national goods transport, to allow vehicles or vehicle combinations with dimensions deviating from those laid down in this Directive to circulate in their territory if the transport operations carried out by such vehicles are defined by this Directive as not significantly affecting international competition in the transport sector, i.e. operations carried out by specialized vehicles and operations carried out according to a modular concept; (18) Whereas, in the case of modular concept operations, there should be provision for a transitional period to enable a Member State to adapt its road infrastructure; (19) Whereas vehicles or vehicle combinations constructed applying new technologies or new concepts, according to standards which deviate from those laid down by this Directive, should be allowed to carry out local transport operations for a trial period to enable profit to be drawn from technical progress; (20) Whereas vehicles which entered into service before the date of implementation of this Directive and which do not comply with the dimension characteristics laid down in this Directive, owing to previously differing national provisions or methods of measurement, should be allowed for a transitional period to continue to provide transport services within the Member State in which the vehicle is registered or put into circulation; (21) Whereas progress has been made towards adopting Type-Approval Directives for vehicle combinations with five or six axles; whereas, the requirements regarding conformity with characteristics other than weights and dimensions as laid down in Annex II of Directive 85/3/EEC should therefore be deleted; (22) Whereas such a modification is also necessary in order to avoid rules conflicting with international conventions on road traffic and circulation; (23) Whereas in order to facilitate the monitoring of compliance with this Directive, it is necessary to ensure that vehicles carry proof of such compliance; (24) Whereas this Directive does not affect the obligations of the Member States concerning the deadlines for transposition into national law and for application of the Directives which this Directive replaces, Article 1 1. This Directive applies to: (a) the dimensions of motor vehicles in categories M2, M3 and N2 and N3 and their trailers in categories 03 and 04, as defined in Annex II to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (7); (b) the weights and certain other characteristics of the vehicles defined in (a) and specified in Annex I (2) to this Directive. 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` shall mean any power-driven vehicle which travels on the road by its own means, - 'trailer` shall mean any vehicle intended to be coupled to a motor vehicle excluding semi-trailers, and constructed and equipped for the carriage of goods, - 'semi-trailer` shall mean any vehicle intended to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle with a substantial part of its weight and of the weight of its load being borne by the motor vehicle, and constructed and equipped for the carriage of goods, - 'vehicle combination` shall mean 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, - 'conditioned vehicle` shall mean any vehicle whose fixed or movable superstructures are specially equipped for the carriage of goods at controlled temperatures and whose side walls, inclusive of insulation, are each at least 45 mm thick, - 'bus` shall mean a vehicle with more than nine seats including the driver's seat, constructed and equipped to carry passengers and their luggage. It may have one or two decks and may also draw a luggage trailer, - 'articulated bus` shall mean a bus consisting of two rigid sections connected to each other by an articulated section. On this type of vehicle the passenger compartments in each of the two rigid sections shall be intercommunicating. The articulated section shall permit the free movement of travellers between the rigid sections. Connection and disconnection of the two sections shall be possible only in a workshop, - 'maximum authorized dimensions` shall mean the maximum dimensions for use of a vehicle, as laid down in Annex I to this Directive, - 'maximum authorized weight` shall mean the maximum weight for use of a laden vehicle in international traffic, - 'maximum authorized axle weight` shall mean the maximum weight for use in international traffic of a laden axle or group of axles, - 'indivisible load` shall mean a load that cannot, for the purpose of carriage by road, be divided into two or more loads without undue expense or risk of damage and which owing to its dimensions or mass cannot be carried by a motor vehicle, trailer, road train or articulated vehicle complying with this Directive in all respects, - 'tonne` shall mean the weight executed by the mass of a tonne and shall correspond to 9,8 kilonewtons (kN), All maximum authorized dimensions specified in Annex I shall be measured in accordance with Annex I to Directive 70/156/EEC, with no positive tolerances. Article 3 1. A Member State may not reject or prohibit the use in its territory: - in international traffic, of vehicles registered or put into circulation in any other Member State for reasons relating to their weights and dimensions, - in national traffic, of goods vehicles registered or put into circulation in any other Member State for reasons relating to their 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 that Member State 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 not referred to in Article 4 (1) exceeding those laid down in Annex I. 2. However, 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. Member States may require conditioned vehicles to carry an ATP certificate or ATP certification plate provided for in the Agreement of 1 September 1970 on the international carriage of perishable foodstuffs and on the special equipment to be used for such carriage. Article 4 1. Member States shall not allow the normal circulation of vehicles or vehicle combinations for the national transport of goods in their territory which are not in conformity with the characteristics set out in points 1.1, 1.2, 1.4 to 1.8, 4.2 and 4.4 of Annex I. 2. Member States may nonetheless allow circulation in their territory of vehicles or vehicle combinations for the national transport of goods freight which are not in conformity with the characteristics set out in 1.3, 2, 3, 4.1 and 4.3 of Annex I. 3. Vehicles or vehicle combinations which exceed the maximum dimensions may only be allowed to circulate on the basis of special permits issued without discrimination by the competent authorities, or on the basis of similar non-discriminatory arrangements agreed on a case-by-case basis with those authorities, where these vehicles or vehicle combinations carry or are intended to carry indivisible loads. 4. Member States may allow vehicles or vehicle combinations used for goods transport which carry out certain national transport operations that do not significantly affect international competition in the transport sector to circulate in their territory with dimensions deviating from those laid down in points 1.1, 1.2, 1.4 to 1.8, 4.2 and 4.4 of Annex I. Transport operations shall be considered not significantly to affect international competition in the transport sector if one of the conditions under (a) and (b) is fulfilled: (a) the transport operations are carried out in a Member State's territory by specialized vehicles or specialized vehicle combinations in circumstances in which they are not normally carried out by vehicles from other Member States, e.g. operations linked to logging and the forestry industry; (b) the Member State which permits transport operations to be carried out in its territory by vehicles or vehicle combinations with dimensions deviating from those laid down in Annex I also permits motor vehicles, trailers and semi-trailers which comply with the dimensions laid down in Annex I to be used in such combinations as to achieve at least the loading length authorized in that Member State, so that every operator may benefit from equal conditions of competition (modular concept). The Member State concerned which has to adapt its road infrastructure in order to be able to fulfil the condition under (b) may nevertheless prohibit, until 31 December 2003 at the latest, the circulation in its territory, in national goods transport operations, of vehicles or vehicle combinations which exceed current national standards on dimensions, provided that national legislation continues to apply to all Community carriers in a non-discriminatory manner. The Member States shall inform the Commission of the measures taken pursuant to this paragraph. 5. Member States may allow vehicles or vehicle combinations incorporating new technologies or new concepts which cannot comply with one or more requirements of this Directive to carry out certain local transport operations for a trial period. Member States shall inform the Commission thereof. 6. Member States may allow vehicles or vehicle combinations used for goods transport and registered or put into circulation before the implementation of this Directive to circulate in their territory until 31 December 2006 with dimensions exceeding those laid down in points 1.1, 1.2, 1.4 to 1.8, 4.2 and 4.4 of Annex I by virtue of differing national provisions or methods of measurement. Article 5 Without prejudice to Article 4 (6): (a) articulated vehicles put into circulation before 1 January 1991 which do not comply with the specifications contained in points 1.6 and 4.4 of Annex I shall be deemed to comply with such specifications for the purposes of Article 3 if they do not exceed a total length of 15,50 m; (b) road trains, the motor vehicle of which was put into circulation before 31 December 1991 and which do not comply with the specifications contained in points 1.7 and 1.8 of Annex I, shall until 31 December 1998 be deemed to comply with such specifications for the purposes of Article 3 if they do not exceed a total length of 18,00 m. Article 6 1. Member States shall take the necessary measures to ensure that Article 1 vehicles referred to in Article 1 and complying with this 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 (8), - the plate relating to dimensions, in accordance with Annex III, 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 this Directive. 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 this Directive. 5. 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 point 2.2.2 (c) of Annex I, the entry '44 tonnes` shall be included in brackets under the maximum authorized weight of the vehicle combination. 6. 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 in the right-hand column. Article 7 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 8 Article 3 shall not apply in Ireland and the United Kingdom until 31 December 1998: (a) as regards the standards referred to in points 2.2, 2.3.1, 2.3.3, 2.4 and 3.3.2 of Annex I: - with the exception of the articulated vehicles referred to in point 2.2.2 where: (i) the total laden weight does not exceed 38 tonnes; (ii) the weight on any tri-axle at the spacing specified in point 3.3.2 does not exceed 22,5 tonnes, - with the exception of the vehicles referred to in points 2.2.3, 2.2.4, 2.3 and 2.4, where the total laden weight does not exceed: (i) 35 tonnes for the vehicles referred to in points 2.2.3 and 2.2.4; (ii) 17 tonnes for the vehicles referred to in point 2.3.1; (iii) 30 tonnes for the vehicles referred to in point 2.3.3, subject to compliance with the conditions specified in that point and in point 4.3; (iv) 27 tonnes for the vehicles referred to in point 2.4, (b) as regards the standard referred to in point 3.4 of Annex I, with the exception of the vehicles referred to in points 2.2, 2.3 and 2.4, where the weight per driving axle does not exceed 10,5 tonnes. Article 9 As regards the standard referred to in point 1.2 (a) of Annex I, a Member State may reject or prohibit the use in its territory, until 31 December 1999, of buses with a width exceeding 2,5 m. Member States shall inform the Commission of the measures taken pursuant to this Article. The Commission shall inform the other Member States thereof. Article 10 The Directive listed in Annex IV, Part A, shall be repealed with effect from the date in Article 11, without prejudice to the obligations of the Member States concerning the deadlines for transposition set out in Annex IV, Part B. References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex V. Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 September 1997. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 12 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 13 This Directive is addressed to the Member States.

31996L0054

1996

Commission Directive 96/54/EC of 30 July 1996 adapting to technical progress for the twenty-second time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 94/69/EC (2), and in particular Article 28 thereof, Whereas Annex I to Directive 67/548/EEC contains a list of dangerous substances, their classification, labelling and where appropriate, their characterization by concentration limits and other parameters enabling their risk to human health and the environment to be assessed; whereas the list of dangerous substances in Annex I needs to be adapted in the light of present scientific and technical knowledge; whereas in consequence it is necessary to amend the foreword to Annex I so as to include notes relating to the labelling of preparations and a new group of organic substances in table B; whereas the list of dangerous substances in Annex I contains substances for which specific temporary classification and labelling derogations have been granted to Austria and Sweden by the Act of Accession of Austria, Finland and Sweden; whereas the Act of Accession provides for the review of the classification and labelling requirements of those substances; whereas the classifications of some of those substances have been reviewed accordingly; Whereas Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of special risks attributed to dangerous substances and preparations; whereas a phrase indicating the danger to health of certain substances and preparations on aspiration needs to be introduced; Whereas Annex V to Directive 67/548/EEC lays down the methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations; whereas the adaptation to technical progress of that Annex is necessary; Whereas Annex VI to Directive 67/548/EEC contains general criteria for the classification and labelling of dangerous substances and preparations; whereas criteria for substances and preparations dangerous to health if aspirated need to be introduced; whereas the criteria for sensitizing substances and preparations need to be amended; whereas criteria for the labelling of gas containers intended for propane, butane or liquefied petroleum gas (LPG) need to be introduced; 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 is amended as follows: (a) nota 4 in the Foreword is replaced by the following text: 'Nota 4 Preparations containing these substances have to be classified as harmful with R65 if they meet the criteria in section 3.2.3 in Annex VI.`; (b) the following nota 5 is added: 'Nota 5 The concentration limits for gaseous preparations are expressed as volume per volume percentage.`; (c) the following special classification for organic substances is added to table B in the foreword to Annex I to Directive 67/548/EEC: '647 Enzimas Enzymer Enzyme ¸íæõìá Enzymes Enzymes Enzimi Enzymen Enzimas Entsyymit Enzymer`; (d) the entries in Annex I to this Directive replace the corresponding entries; (e) the entries in Annex II to this Directive are added for the first time; (f) the entries with the following numbers are deleted: 008-002-00-3 612-045-00-9 648-011-00-5 648-025-00-1 648-157-00-X 648-158-00-5 648-159-00-0 649-192-00-3 (g) the entries shown in Annex III to this Directive are amended by replacing all references to 'R 22` by 'R 65`. 2. The following phrase is added to Annex III: 'R 65 ES: Nocivo: si se ingiere puede causar daño pulmonar. DA: Farlig: kan give lungeskade ved indtagelse. DE: Gesundheitsschädlich: kann beim Verschlucken Lungenschäden verursachen. EL: ÅðéâëáâÝò: ìðïñåß íá ðñïêáëÝóåé âëÜâç óôïõò ðíåýìïíåò óå ðåñßðôùóç êáôÜðïóçò. EN: Harmful: may cause lung damage if swallowed. FR: Nocif: peut provoquer une atteinte des poumons en cas d'ingestion. IT: Nocivo: può causare danni ai polmoni in caso di ingestione. NL: Schadelijk: kan longschade veroorzaken na verslikken. PT: Nocivo: pode causar danos nos pulmões se ingerido. FI: Haitallista: voi aiheuttaa keuhkovaurion nieltäessä. SV: Farligt: kan ge lungskador vid förtäring.` 3. Part B of Annex V is amended as follows: (a) the text in Annex IV.A to this Directive replaces the heading and the general introduction to Part B: Methods for the Determination of Toxicity; (b) the text in Annex IV.B to this Directive is inserted after chapter B.1 bis; (c) the text in Annex IV.C to this Directive replaces chapter B.6; (d) the text in Annex IV.D to this Directive replaces chapter B.7; (e) the text in Annex IV.E to this Directive is added at the end. 4. Annex VI is amended by the texts set out in Annex V to this Directive, as indicated therein. Article 2 1. Without prejudice to paragraph 2, not later than 31 May 1998, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof. 2. Not later than 31 October 1997 the Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Annex V, points F, I and J of this Directive. Member States shall immediately inform the Commission thereof. 3. When Member States adopt the provisions referred to in paragraphs 1 and 2, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0056

1996

Directive 96/56/EC of the European Parliament and the Council of 3 September 1996 amending Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas the abbreviation 'EEC` appears in certain provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (4); Whereas Article G of the Treaty on European Union replaced the term 'European Economic Community` with the term 'European Community`; whereas the abbreviation 'EEC` should therefore be replaced by the abbreviation 'EC` in the abovementioned provisions; Whereas, however, economic operators normally hold large stocks of labels; whereas certain dangerous substances validly provided with labels bearing the abbreviation 'EEC` may be stored on production sites for a relatively long period before being placed on the market; whereas such a change of abbreviation could occasion extra costs for those operators; whereas a reasonable period should therefore be set during which dangerous substances whose labels bear an 'EEC number` and the words 'EEC label` can still be placed on the market; Whereas Directive 67/548/EEC should be amended accordingly, Article 1 Directive 67/548/EEC is hereby amended as follows: (a) in Article 21 (2), the term 'EEC number` is hereby replaced by the term 'EC number`; (b) in Article 23 (2) (f), the term 'EEC number` is hereby replaced by the term 'EC number` and the term 'EEC label` by the term 'EC label`. However, Member States shall permit the placing on the market of substances whose labels bear the 'EEC number` and the words 'EEC label` until 31 December 2000. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 1998 at the latest. They shall forthwith inform the Commission thereof. When these measures are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0057

1996

Directive 96/57/EC of the European Parliament and of the Council of 3 September 1996 on energy efficiency requirements for household electric refrigerators, freezers and combinations thereof Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), (1) Whereas it is important to promote measures aimed at the proper functioning of the internal market; (2) Whereas in its resolution of 15 January 1985 on the improvement of energy-saving programmes in the Member States (4) the Council invited the Member States to pursue and where necessary increase their efforts to promote the more rational use of energy by the further development of integrated energy-saving policies; (3) Whereas household refrigeration appliances account for a significant share of domestic electricity consumption in the Community and thus of total electricity consumption; whereas the various models of refrigeration appliances available on the Community market have very different levels of consumption for a given volume and similar features, i.e. extremely variable energy efficiency; (4) Whereas some Member States are on the point of adopting provisions relating to the efficiency of household refrigerators and freezers, which might create barriers to trade in these products in the Community; (5) Whereas it is appropriate to take as a base a high level of protection in proposals for the approximation of the provisions laid down by law, regulation or administrative action in Member States concerning health, safety, environmental protection and consumer protection; whereas this Directive ensures a high level of protection for both the environment and the consumer, in aiming at a significant improvement of the energy efficiency of these appliances; (6) Whereas the adoption of such measures falls within Community competence; whereas the requirements of this Directive are within the limits of its objectives, thus conforming to the requirements of Article 3b of the Treaty; (7) Whereas, moreover, Article 130r of the Treaty calls for the protection and improvement of the environment and the prudent and rational utilization of natural resources, these two objectives being among those of the Community policy on the environment; whereas electricity generation and consumption account for 30 % of man-made carbon dioxide (CO2) emissions and some 35 % of primary energy consumption in the Community; whereas these percentages are increasing; (8) Whereas, furthermore, Council Decision 89/364/EEC of 5 June 1989 on a Community action programme for improving the efficiency of electricity use (5) has as its twin objectives to encourage consumers to favour appliances and equipment with high electrical efficiency and to improve the efficiency of appliances and equipment; (9) Whereas in its conclusions of 29 October 1990 the Council set an objective of stabilizing carbon dioxide (CO2) emissions in the Community at 1990 levels by the year 2 000; whereas in order to achieve this objective stronger measures are required to stabilize CO2 emissions within the Community; (10) Whereas Decision 91/565/EEC (6) established a programme to promote energy efficiency in the Community (the SAVE programme); (11) Whereas the energy efficiency measures incorporated in the most up-to-date models of refrigeration appliances available do not increase their production costs excessively and can pay for their initial cost through electricity savings within a few years or even more rapidly; whereas this calculation does not take into account the added benefit of the external costs of electricity generation thereby avoided, such as emissions of carbon dioxide (CO2) and other pollutants; (12) Whereas the 'natural` gain in energy efficiency due to market pressures and improved production processes, estimated at around 2 % per year, will contribute to efforts to achieve stricter energy consumption standards; (13) Whereas Directive 92/75/EEC (7) (the framework Directive) and Commission Directive 94/2/EC (8) (the Directive implementing Directive 92/75/EEC), which require the compulsory labelling of appliances and an indication in other forms of the energy consumption, will increase consumers' awareness of the energy efficiency of household refrigeration appliances; whereas this measure will therefore also encourage the various competitors to offer levels of energy efficiency for their appliances higher than the standards required by this Directive; whereas, however, the provision of information to consumers must nevertheless be accompanied by an indication of the standards in order to achieve full benefit and lead to a real improvement in the total average efficiency of the appliances sold; (14) Whereas this Directive, which is aimed at eliminating technical barriers with regard to improving the energy efficiency of household refrigeration appliances, must follow the 'new approach` established by the Council resolution of 7 May 1985 on a new approach to technical harmonization and standards (9) which specifically lays down that legislative harmonization is limited to the adoption, by means of directives, of the essential requirements with which products put on the market must conform; (15) Whereas an effective enforcement system is necessary to ensure that the Directive is implemented properly, guarantee fair conditions of competition for producers and protect consumer rights; (16) Whereas regard should be had to Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking (10), which are intended to be used in the technical harmonization directives; (17) Whereas in the interest of international trade, international standards should be used wherever appropriate; whereas the electricity consumption of a refrigeration appliance is defined by the European Committee for Standardization Standard EN 153 of July 1995 which is based on an international standard; (18) Whereas household refrigeration appliances complying with the energy efficiency requirements of this Directive must bear the 'CE` marking and associated information, in order to enable them to move freely; (19) Whereas this Directive is confined to household refrigeration appliances for foodstuffs, supplied by mains electricity, excluding those manufactured on a one-off basis; whereas refrigeration equipment for commercial use is much more varied and not appropriate for inclusion in this Directive, Article 1 This Directive shall apply to new electric mains-operated household refrigerators, frozen food storage cabinets, food freezers, and combinations of these as defined in Annex I and referred to hereafter as 'refrigeration appliances`. Appliances which can also use other energy sources, particularly accumulators, and household refrigeration appliances working on the absorption principle and appliances manufactured on a one-off basis shall be excluded. Article 2 1. Member States shall take all necessary measures to ensure that refrigeration appliances covered by this Directive can be placed on the Community market only if the electricity consumption of the appliance in question is less than or equal to the maximum allowable electricity consumption value for its category as calculated according to the procedures defined in Annex I. 2. The manufacturer of a refrigeration appliance covered by this Directive, his authorized representative established in the Community or the person responsible for placing the appliance on the Community market shall be responsible for ensuring that each appliance placed on the market conforms with the requirement referred to in paragraph 1. Article 3 1. Member States may not prohibit, restrict or impede the placing on the market in their territory of refrigeration appliances which bear the 'CE` marking attesting to their conformity with all the provisions of this Directive. 2. Unless they have evidence to the contrary, Member States shall presume that refrigeration appliances bearing the 'CE` marking required under Article 5 comply with all the provisions of this Directive. 3. (a) Where refrigeration appliances are subject to other directives covering other aspects which also provide for affixing of the 'CE` marking, the latter shall indicate that the refrigeration appliances in question are also presumed, unless evidence to the contrary exists, to conform to the provisions of those other directives. (b) However, where one or more of those directives allows the manufacturer, during a transitional period, to choose which rules to apply, the 'CE` marking shall indicate conformity solely with the provisions of those directives applied by the manufacturer. In that case, the reference numbers of the directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions accompanying the refrigeration appliances. Article 4 The conformity assessment procedures and the obligations relating to the 'CE` marking of refrigeration appliances are laid down in Annex II. Article 5 1. When appliances are placed on the market, they must bear the 'CE` marking, which shall consist of the initials 'CE`. The form of the marking to be used is shown in Annex III. The 'CE` marking shall be affixed visibly, legibly and indelibly to refrigeration appliances and, where appropriate, to the packaging. 2. The affixing on refrigeration appliances of any markings which are likely to mislead third parties as to the meaning and form of the 'CE` marking shall be prohibited. Any other marking may be affixed to the appliances, their packaging, the instruction sheet or other documents, provided that the 'CE` marking remains visible and legible. Article 6 1. Where a Member State establishes that the 'CE` marking has been affixed improperly, the manufacturer or his authorized representative established within the Community shall be obliged to bring the product into conformity and to end the infringement in accordance with conditions imposed by the Member State. Where neither the manufacturer nor his authorized representative is established within the Community, the person who places the refrigeration appliance on the Community market shall undertake these obligations. 2. Where the product continues not to be in conformity, the Member State shall take all necessary measures pursuant to Article 7 to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market. Article 7 1. Any decision taken pursuant to this Directive which contains a restriction on the placing on the market of refrigeration appliances shall state the precise grounds on which it is based. The party concerned shall be notified without delay of the decision and shall be informed at the same time of the possibilities and time limits regarding the legal remedies available to it under the laws in force in the Member State in question. 2. The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision. The Commission shall make this information known to the other Member States. Article 8 Before the expiry of a period of four years from the adoption of this Directive, the Commission shall make an assessment of the results obtained as compared with those expected. With a view to advancing to a second stage in energy efficiency improvement, the Commission shall then consider, in consultation with the interested parties, the need to lay down a second set of appropriate measures for significantly improving the energy efficiency of household refrigeration appliances. In that case, each energy efficiency measure and the date of its entry into force will be based on energy efficiency levels which can be economically and technically justified in the light of the circumstances at the time. Any other measure judged appropriate to improve the efficiency of household refrigeration appliances shall also be considered. Article 9 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive within a year of its adoption. They shall immediately inform the Commission thereof. Member States shall apply these provisions on the expiry of a period of three years counting from the date of adoption of this Directive. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. 3. During a three-year period following adoption of this Directive, Member States shall permit the placing on the market of refrigeration appliances which comply with the same conditions as those which were applied on their territory at the date of adoption of this Directive. Article 10 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States.

31996L0058

1996

Directive 96/58/EC of the European Parliament and the Council of 3 September 1996 amending Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas Directive 89/686/EEC (4) requires that all personal protective equipment (PPE) bear the 'CE` marking and that this marking be accompanied by additional information corresponding to the year in which the marking was affixed; Whereas this indication of the year is not a factor beneficial to the safety of the user of the PPE; whereas this indication might be confused with the date of obsolescence which must be affixed to PPE subject to ageing; Whereas affixing this indication of the year is a burden on the manufacturers of PPE; whereas the cost of this burden is far from negligible; Whereas, in view of the principle of subsidiarity, the simplification resulting for manufacturers from abolishing the requirement to indicate the year in which the 'CE` marking was affixed can be achieved only by means of a Directive amending Directive 89/686/EEC, Article 1 In Annex IV to Directive 89/686/EEC, the following wording shall be deleted: 'Additional information: - The last two digits of the year in which the CE marking was affixed; this information is not required in the case of the PPE referred to in Article 8 (3).` Article 2 1. Member States shall before 1 January 1997 adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these measures from 1 January 1997. When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0055

1996

Commission Directive 96/55/EC of 4 September 1996 adapting to technical progress for the 2nd time Annex I to Council 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 (chlorinated solvents) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/769/EEC (1) of 27 July 1976 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, as last amended by Directive 94/60/EC (2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC (3), Whereas some chlorinated solvents present a danger to health/environment and should not be marketed to the general public in substances and preparations; Whereas Directive 94/60/EC of the European Parliament and Council, amending for the 14th time Directive 76/769/EEC specified that eight chlorinated solvents may not be used in substances and preparations placed on the market for sale to the general public; Whereas it has since come to light that these chlorinated solvents could also present a danger to health/environment if used in place of currently used solvents in diffusive applications, such as in surface cleaning and cleaning of fabrics; Whereas use of the eight chlorinated solvents should also be prohibited in substances and preparations placed on the market for such diffusive applications; Whereas the restrictions on the use of chlorinated solvents laid down by this Directive take into account the current state of knowledge and techniques regarding safer alternatives; Whereas this Directive is based on a preliminary analysis of the risks posed by the chlorinated solvents and the advantages and drawbacks of restrictions, whereas a general evaluation of the risks to man and the environment of chloroform is being carried out pursuant to Council Regulation (EEC) No 793/93 (4) and Commission Regulation (EC) No 1488/94 (5); Whereas this Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC (6) and in individual directives based thereon, in particular Council Directive 90/394/EEC (7), Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations, Article 1 Annex I to Directive 76/769/EEC is hereby adapted to technical progress as set out in the Annex hereto. Article 2 Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 December 1997 and shall forthwith inform the Commission thereof. They shall apply these provisions as from 30 June 1998. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31996L0062

1996

Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management Having regard to the Treaty establishing the European Community, and in particular Article 130s (1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), Whereas the fifth action programme of 1992 on the environment, the general approach of which was endorsed by the Council and the Representatives of the Governments of the Member States, meeting within the Council, in their resolution 93/C 138/01 of 1 February 1993 (4), envisages amendments to existing legislation on air pollutants; whereas the said programme recommends the establishment of long-term air quality objectives; Whereas, in order to protect the environment as a whole and human health, concentrations of harmful air pollutants should be avoided, prevented or reduced and limit values and/or alert thresholds set for ambient air pollution levels; Whereas, in order to take into account the specific formation mechanisms of ozone, these limit values and alert thresholds may need to be complemented or replaced by target values; Whereas the numerical values for limit values, alert thresholds and, as regards ozone, target values and/or limit values and alert thresholds are to be based on the findings of work carried out by international scientific groups active in the field; Whereas the Commission is to carry out studies to analyse the effects of the combined action of various pollutants or sources of pollution and the effect of climate on the activity of the various pollutants examined in the context of this Directive; Whereas the ambient air quality needs to be assessed against limit values and/or alert thresholds, and, as regards ozone, target values and/or limit values taking into account the size of populations and ecosystems exposed to air pollution, as well as the environment; Whereas, in order for assessment of ambient air quality based on measurements made in Member States to be comparable, the location and number of sampling points and reference methods of measurement used should be specified when values are set for alert thresholds, limit values and target values; Whereas, to allow for the use of other techniques of estimation of ambient air quality besides direct measurement, it is necessary to define the criteria for use and required accuracy of these techniques; Whereas the general measures set up under this Directive have to be supplemented by others specific to individual substances covered; Whereas these specific measures need to be adopted as soon as possible in order to fulfil the overall objectives of this Directive; Whereas preliminary representative data on the levels of pollutants should be collected; Whereas, in order to protect the environment as a whole and human health, it is necessary that Member States take action when limit values are exceeded in order to comply with these values within the time fixed; Whereas the measures taken by Member States must take into account the requirements set by regulations concerning the operation of industrial installations in conformity with Community legislation in the field of integrated prevention and reduction of pollution when this legislation applies; Whereas, because these actions require time to be implemented and become effective, temporary margins of tolerance of the limit value may need to be set; Whereas areas may exist in Member States where pollution levels are greater than the limit value but within the allowed margin of tolerance; whereas the limit value must be complied with within the time specified; Whereas Member States must consult with one another if the level of a pollutant exceeds, or is likely to exceed, the limit value plus the margin of tolerance or, as the case may be, the alert threshold, following significant pollution originating in another Member State; Whereas the setting of alert thresholds at which precautionary measures should be taken will make it possible to limit the impact of pollution episodes on human health; Whereas, in zones and agglomerations where the levels of pollutants are below the limit values, Member States must endeavour to preserve the best ambient air quality compatible with sustainable development; Whereas, in order to facilitate the handling and comparison of data received, such data should be provided to the Commission in standardized form; Whereas the implementation of a wide and comprehensive policy of ambient air quality assessment and management needs to be based on strong technical and scientific grounds and permanent exchange of views between the Member States; Whereas there is a need to avoid increasing unnecessarily the amount of information to be transmitted by Member States; whereas the information gathered by the Commission pursuant to the implementation of this Directive is useful to the European Environment Agency (EEA) and may therefore be transmitted to it by the Commission; Whereas the adaptation of criteria and techniques used for the assessment of the ambient air quality to scientific and technical progress and the arrangements needed to exchange the information to be provided pursuant to this Directive may be desirable; 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; Whereas, in order to promote the reciprocal exchange of information between Member States and the EEA, the Commission, with the assistance of the EEA, is to publish a report on ambient air quality in the Community every three years; Whereas the substances already covered by Council Directive 80/779/EEC of 15 July 1980 on air quality limit values and guide values for sulphur dioxide and suspended particulates (5), Council Directive 82/884/EEC of 3 December 1982 on a limit value for lead in the air (6), Council Directive 85/203/EEC of 7 March 1985 on air quality standards for nitrogen dioxide (7) and Council Directive 92/72/EEC of 21 September 1992 on air pollution by ozone (8) should be dealt with first, Article 1 Objectives The general aim of this Directive is to define the basic principles of a common strategy to: - define and establish objectives for ambient air quality in the Community designed to avoid, prevent or reduce harmful effects on human health and the environment as a whole, - assess the ambient air quality in Member States on the basis of common methods and criteria, - obtain adequate information on ambient air quality and ensure that it is made available to the public, inter alia by means of alert thresholds, - maintain ambient air quality where it is good and improve it in other cases. Article 2 Definitions For the purposes of this Directive: 1. 'ambient air` shall mean outdoor air in the troposphere, excluding work places; 2. 'pollutant` shall mean any substance introduced directly or indirectly by man into the ambient air and likely to have harmful effects on human health and/or the environment as a whole; 3. 'level` shall mean the concentration of a pollutant in ambient air or the deposition thereof on surfaces in a given time; 4. 'assessment` shall mean any method used to measure, calculate, predict or estimate the level of a pollutant in the ambient air; 5. 'limit value` shall mean a level fixed on the basis of scientific knowledge, with the aim of avoiding, preventing or reducing harmful effects on human health and/or the environment as a whole, to be attained within a given period and not to be exceeded once attained; 6. 'target value` shall mean a level fixed with the aim of avoiding more long-term harmful effects on human health and/or the environment as a whole, to be attained where possible over a given period; 7. 'alert threshold` shall mean a level beyond which there is a risk to human health from brief exposure and at which immediate steps shall be taken by the Member States as laid down in this Directive; 8. 'margin of tolerance` shall mean the percentage of the limit value by which this value may be exceeded subject to the conditions laid down in this Directive; 9. 'zone` shall mean part of their territory delimited by the Member States; 10. 'agglomeration` shall mean a zone with a population concentration in excess of 250 000 inhabitants or, where the population concentration is 250 000 inhabitants or less, a population density per km² which for the Member States justifies the need for ambient air quality to be assessed and managed. Article 3 Implementation and responsibilities For the implementation of this Directive, the Member States shall designate at the appropriate levels the competent authorities and bodies responsible for: - implementation of this Directive, - assessment of ambient air quality, - approval of the measuring devices (methods, equipment, networks, laboratories), - ensuring accuracy of measurement by measuring devices and checking the maintenance of such accuracy by those devices, in particular by internal quality controls carried out in accordance, inter alia, with the requirements of European quality assurance standards, - analysis of assessment methods, - coordination on their territory of Community-wide quality assurance programmes organized by the Commission. When they supply it to the Commission, the Member States shall make the information referred to in the first subparagraph available to the public. Article 4 Setting of the limit values and alert thresholds for ambient air 1. For those pollutants listed in Annex I, the Commission shall submit to the Council proposals for the setting of limit values and, as appropriate, alert thresholds according to the following timetable: - no later than 31 December 1996 for pollutants 1 to 5, - in accordance with Article 8 of Directive 92/72/EEC for ozone, - no later than 31 December 1997 for pollutants 7 and 8, - as soon as possible, and no later than 31 December 1999, for pollutants 9 to 13. In fixing the limit values and, as appropriate, alert thresholds, account shall be taken, by way of example, of the factors laid down in Annex II. Regarding ozone, these proposals will take account of the specific formation mechanisms of this pollutant and, to this end, provision may be made for target values and/or limit values. If a target value fixed for ozone is exceeded, Member States shall inform the Commission of the measures taken in order to attain that value. On the basis of this information the Commission shall evaluate whether additional measures are necessary at Community level and, should the need arise, shall submit proposals to the Council. For other pollutants, the Commission shall submit to the Council proposals for fixing limit values and, as appropriate, alert thresholds if, on the basis of scientific progress and taking into account the criteria laid down in Annex III, it appears necessary to avoid, prevent or reduce the harmful effects of such pollutants on human health and/or the environment as a whole within the Community. 2. The Commission shall be responsible, taking account of the most recent scientific-research data in the epidemiological and environmental fields concerned and of the most recent advances in metrology, for re-examining the elements on which the limit values and alert thresholds referred to in paragraph 1 are based. 3. When limit values and alert thresholds are set, criteria and techniques shall be established for: (a) the measurement to be used in implementing the legislation referred to in paragraph 1: - the location of the sampling points, - the minimum number of sampling points, - the reference measurement and sampling techniques; (b) the use of other techniques for assessing ambient air quality, particularly modelling: - spatial resolution for modelling and objective assessment methods, - reference modelling techniques. These criteria and techniques shall be established in respect of each pollutant according to the size of agglomerations or to the levels of pollutants in the zones examined. 4. To take into account the actual levels of a given pollutant when setting limit values and the time needed to implement measures for improving the ambient air quality, the Council may also set a temporary margin of tolerance for the limit value. This margin shall be reduced according to procedures to be defined for each pollutant in order to attain the level of the limit value at the latest at the end of a period to be determined for each pollutant when that value is set. 5. In accordance with the Treaty, the Council shall adopt the legislation provided for in paragraph 1 and the provisions laid down in paragraphs 3 and 4. 6. When a Member State takes more stringent measures than those laid down in the provisions referred to in paragraph 5, it shall inform the Commission thereof. 7. When a Member State intends to set limit values or alert thresholds for pollutants not referred to in Annex I and not covered by Community provisions concerning ambient air quality in the Community, it shall inform the Commission thereof in sufficient time. The Commission shall be required to supply, in sufficient time, an answer to the question of the need to act at Community level following the criteria laid down in Annex III. Article 5 Preliminary assessment of ambient air quality Member States which do not have representative measurements of the levels of pollutants for all zones and agglomerations shall undertake series of representative measurements, surveys or assessments in order to have the data available in time for implementation of the legislation referred to in Article 4 (1). Article 6 Assessment of ambient air quality 1. Once limit values and alert thresholds have been set, ambient air quality shall be assessed throughout the territory of the Member States, in accordance with this Article. 2. In accordance with the criteria referred to in Article 4 (3), and in respect of the relevant pollutants under Article 4 (3), measurement is mandatory in the following zones: - agglomerations as defined in Article 2 (10), - zones in which levels are between the limit values and the levels provided for in paragraph 3, and - other zones where levels exceed the limit values. The measures provided for may be supplemented by modelling techniques to provide an adequate level of information on ambient air quality. 3. A combination of measurements and modelling techniques may be used to assess ambient air quality where the levels over a representative period are below a level lower than the limit value, to be determined according to the provisions referred to in Article 4 (5). 4. Where the levels are below a level to be determined according to the provisions referred to in Article 4 (5), the sole use of modelling or objective estimation techniques for assessing levels shall be possible. This provision shall not apply to agglomerations in the case of pollutants for which alert thresholds have been fixed according to the provisions referred to in Article 4 (5). 5. Where pollutants have to be measured, the measurements shall be taken at fixed sites either continuously or by random sampling; the number of measurements shall be sufficiently large to enable the levels observed to be determined. Article 7 Improvement of ambient air quality General requirements 1. Member States shall take the necessary measures to ensure compliance with the limit values. 2. Measures taken in order to achieve the aims of this Directive shall: (a) take into account an integrated approach to the protection of air, water and soil; (b) not contravene Community legislation on the protection of safety and health of workers at work; (c) have no significant negative effects on the environment in the other Member States. 3. Member States shall draw up action plans indicating the measures to be taken in the short term where there is a risk of the limit values and/or alert thresholds being exceeded, in order to reduce that risk and to limit the duration of such an occurrence. Such plans may, depending on the individual case, provide for measures to control and, where necessary, suspend activities, including motor-vehicle traffic, which contribute to the limit values being exceeded. Article 8 Measures applicable in zones where levels are higher than the limit value 1. Member States shall draw up a list of zones and agglomerations in which the levels of one or more pollutants are higher than the limit value plus the margin of tolerance. Where no margin of tolerance has been fixed for a specific pollutant, zones and agglomerations in which the level of that pollutant exceeds the limit value shall be treated in the same way as the zones and agglomerations referred to in the first subparagraph, and paragraphs 3, 4 and 5 shall apply to them. 2. Member States shall draw up a list of zones and agglomerations in which the levels of one or more pollutants are between the limit value and the limit value plus the margin of tolerance. 3. In the zones and agglomerations referred to in paragraph 1, Member States shall take measures to ensure that a plan or programme is prepared or implemented for attaining the limit value within the specific time limit. The said plan or programme, which must be made available to the public, shall incorporate at least the information listed in Annex IV. 4. In the zones and agglomerations referred to in paragraph 1, where the level of more than one pollutant is higher than the limit values, Member States shall provide an integrated plan covering all the pollutants concerned. 5. The Commission shall regularly check the implementation of the plans or programmes submitted under paragraph 3 by examining their progress and the trends in air pollution. 6. When the level of a pollutant exceeds, or is likely to exceed, the limit value plus the margin of tolerance or, as the case may be, the alert threshold following significant pollution originating in another Member State, the Member States concerned shall consult with one another with a view to finding a solution. The Commission may be present at such consultations. Article 9 Requirements in zones where the levels are lower than the limit value Member States shall draw up a list of zones and agglomerations in which the levels of pollutants are below the limit values. Member States shall maintain the levels of pollutants in these zones and agglomerations below the limit values and shall endeavour to preserve the best ambient air quality, compatible with sustainable development. Article 10 Measures applicable in the event of the alert thresholds being exceeded When the alert thresholds are exceeded, Member States shall undertake to ensure that the necessary steps are taken to inform the public (e.g. by means of radio, television and the press). Member States shall also forward to the Commission on a provisional basis information concerning the levels recorded and the duration of the episode(s) of pollution no later than three months following their occurrence. A list of minimum details to be supplied to the public shall be drawn up together with the alert thresholds. Article 11 Transmission of information and reports After adoption by the Council of the first proposal referred to in the first indent of Article 4 (1): 1. Member States shall notify to the Commission the competent authorities, laboratories and bodies referred to in Article 3 and (a) in the zones referred to in Article 8 (1) shall: (i) inform the Commission of the occurrence of levels exceeding the limit value plus the margin of tolerance, of the dates or periods when such levels were observed and the values recorded in the nine-month period after the end of each year. When no margin of tolerance has been fixed for a given pollutant, the zones and agglomerations where the level of such pollutant exceeds the limit value shall be treated in the same way as the zones and agglomerations referred to in the first subparagraph; (ii) inform the Commission of the reasons for each recorded instance, in the nine-month period after the end of each year; (iii) send to the Commission the plans or programmes referred to in Article 8 (3) no later than two years after the end of the year during which the levels were observed; (iv) inform the Commission every three years of the progress of the plan or programme; (b) shall forward to the Commission annually, and no later than nine months after the end of each year, the list of zones and agglomerations referred to in Article 8 (1) and (2) and in Article 9; (c) shall forward fo the Commission every three years within the framework of the sectoral report referred to in Article 4 of Council Directive 91/692/EEC of 23 December 1991 standardizing and rationalizing reports on the implementation of certain Directives relating to the environment (9), and no later than nine months after the end of each three-year period, information reviewing the levels observed or assessed, as appropriate, in the zones and agglomerations referred to in Article 8 and Article 9; (d) shall inform the Commission of the methods used for the preliminary assessment of air quality provided for in Article 5. 2. the Commission shall publish: (a) annually, a list of the zones and agglomerations referred to in Article 8 (1); (b) every three years, a report on the ambient air quality in the Community. This report shall show in summary form the information received through a mechanism for the exchange of information between the Commission and the Member States. 3. the Commission will call upon as necessary the expertise available in the European Environment Agency in drafting the report referred to in paragraph 2 (b). Article 12 Committee and its functions 1. The amendments necessary to adapt the criteria and techniques referred to in Article 4 (2) to scientific and technical progress, and the detailed arrangements for forwarding the information to be provided under Article 11, and other tasks specified in the provisions referred to in Article 4 (3), shall be adopted in accordance with the procedure laid down in paragraph 2 of this Article. Such adaptation must not have the effect of modifying the limit values or the alert thresholds either directly or indirectly. 2. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 13 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 months after it comes into force with regard to the provisions relating to Articles 1 to 4 and 12 and Annexes I, II, III and IV, and at the latest on the date on which the provisions referred to in Article 4 (5) apply, with regard to the provisions relating to the other Articles. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedures for such a reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 14 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 15 This Directive is addressed to the Member States.

31996L0063

1996

Commission Directive 96/63/EC of 30 September 1996 amending Council Directive 76/432/EEC on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to 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 (1), as last amended by Directive 88/297/EEC (2), and in particular Articles 12 and 13 thereof, Whereas the braking test can be improved by replacing mean deceleration by a formula defining the braking distance as a function of speed; whereas that amendment will be followed by other changes aimed at improving the safety of tractors and the components involved in their use; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 74/150/EEC, Article 1 Annexes I and II to Council Directive 76/432/EEC (3) are hereby amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 October 1997 Member States may not: - refuse, in respect of a type of tractor, to grant EC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 74/150/EEC or to grant national type-approval, or - prohibit the registration, sale or entry into service of tractors, on grounds relating to braking devices, if the tractors comply with the requirements of Directive 76/432/EEC as amended by this Directive. 2. With effect from 1 March 1998 Member States: - shall no longer grant EC type-approval or issue the document referred to in the last indent of Article 10 (1) of Directive 74/150/EEC, and - may refuse to grant national type-approval for a type of tractor on grounds relating to braking devices, if the requirements of Directive 76/432/EEC as amended by this Directive are not complied with. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 1997. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The terms of the reference shall be laid down by the Member States. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0064

1996

Commission Directive 96/64/EC of 2 October 1996 adapting to technical progress Council Directive 77/389/EEC on the approximation of the laws of the Member States relating to motor vehicle towing devices (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/389/EEC of 17 May 1977 on the approximation of the laws of the Member States relating to motor vehicle towing-devices (1), and in particular Article 4 thereof, Whereas Directive 77/389/EEC is one of the separate directives of the EC type-approval procedure which has been established by Directive 70/156/EEC (2), as last amended by Directive 96/27/EC (3); whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerized; Whereas these amendments relate only to the administrative provisions contained in the Directive; whereas it is not necessary therefore to invalidate existing approvals to the Directive nor to prevent the registration, sale and entry into service of new vehicles covered by such approvals; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 1. The Articles of Directive 77/389/EEC are amended as follows: - Article 1 reads as follows: '. . . with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.`, - in Article 2 'Annex` is replaced by 'Annex II`, - in Article 3 'Annex` is replaced by 'Annex II`, - in Article 4 'this Annex` is replaced by 'the Annexes`. 2. The Annex to Directive 77/389/EEC are amended in accordance with the Annex to this Directive. Article 2 With effect from 1 October 1997, Member States: - shall no longer grant EC type-approval pursuant to Article 4 (1) of Directive 70/156/EEC, and - may refuse national type-approval for a new type of vehicle on grounds relating to the towing devices, if it fails to comply with the provisions of Directive 77/389/EEC, as amended by this Directive. This Directive will not invalidate any approval previously granted under Directive 77/389/EEC nor prevent extension of such approvals under terms of Directive under which they were originally granted. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the occasion of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the texts of the main procedure of the national law that they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.