Datasets:

eu_regulatory_ir

like 2

32003L0111

2003

Commission Directive 2003/111/EC of 26 November 2003 amending Annex II to Directive 92/34/EEC on the marketing of fruit plant propagating material and fruit plants intended for fruit production (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production(1), and in particular Article 1(3) thereof, Whereas: (1) Directive 92/34/EEC establishes Community provisions for the marketing of fruit plant propagating material and fruit plants intended for fruit production within the Community. It applies to the genera and species listed in Annex II to that Directive. (2) Certain fruit genera and species which are not currently included in Annex II to Directive 92/34/EEC have increased in economical importance. Accordingly, it is appropriate that they be now included in the genera and species listed in Annex II to that Directive. The following genera and species should be included: Castanea sativa Mill., Ficus carica L., Fortunella Swingle, Poncirus Raf. and Vaccinium L. In addition, the Citrus species, the Fragaria species, the Pyrus species, the Ribes species, and the Rubus species should be added to Citrus sinensis (L.) Osbeck, C. limon (L) Burm. f., C. reticulata Blanco, C. paradisi Macf., C. aurantifolia (Christm.) Swing, Fragaria x ananassa Duch. (strawberry), Pyrus communis L., Ribes (redcurrant) and Rubus (blackberry), and Cydonia Mill. should be replaced by Cydonia oblonga Mill. (3) In the interests of clarity, the list in Annex II to Directive 92/34/EEC should be replaced by a new list including all the genera and species in alphabetical order with their botanical name. (4) Directive 92/34/EEC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Plant of Fruit Genera and Species, Article 1 Annex II to Directive 92/34/EEC is replaced by the text 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 by 31 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0112

2003

Commission Directive 2003/112/EC of 1 December 2003 amending Council Directive 91/414/EEC to include paraquat as an active substance (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 2003/84/EC(2), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes paraquat. (2) For paraquat, the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifier. Pursuant to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the United Kingdom was designated as rapporteur Member State. The United Kingdom submitted the relevant assessment reports and recommendations to the Commission on 31 October 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. (3) This assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 October 2003 in the format of the Commission review report for paraquat. (4) The report on paraquat and further information were also submitted to the Scientific Committee for Plants. The Committee was asked to comment on the relevance for consumers and operators of the ocular and pulmonary changes, which were observed in the long-term rat study, on the risk for operators, taking into particular account potential inhalatory and dermal exposure, on potential long-term effects to soil-dwelling organisms, and on the risks the intended uses might pose to reproducing birds and hares. In its opinion(7), the Scientific Committee concluded that neither the pulmonary lesions observed in animals after oral administration of paraquat nor the systemic effects on the eye, observed in rats and not in other species, are relevant to the risk assessment for operators and consumers. Based on the field exposure studies, corroborated by information on health surveys on operators, the Committee found that when paraquat is used as a plant protection product as recommended under prescribed good working practices, its use does not pose any significant health risk for the operators. The Committee also noted that uses at recommended field rates are unlikely to pose a significant risk to soil-dwelling organisms. However, a more detailed appraisal of the likely effects of paraquat on the rate of degradation of organic material in soil was requested in view of remaining uncertainty. This information was subsequently delivered and evaluated by the rapporteur Member State. Furthermore, the Scientific Committee concluded that available studies indicate a hazard to ground-breeding birds but further information on realistic exposures is needed for a definitive assessment of the risk. This information was subsequently provided and the evaluation within the Standing Committee on the Food Chain and Animal Health concluded that there are several situations where exposure to ground-nesting birds is negligible. However, there are also scenarios where exposure may occur. The evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable, provided appropriate risk-mitigation measures are applied. Finally, the Scientific Committee concluded that paraquat may be expected to cause lethal and sublethal effects for hares, but the available data are inadequate to estimate the proportion of hares affected. The views of the Scientific Committee were taken into consideration when drafting this Directive and the review report. The evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable if appropriate risk-mitigation measures were applied. (5) It has appeared from the various examinations made that there are uses of plant protection products containing paraquat which may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, provided appropriate risk-mitigation measures and restrictions are applied. It is therefore appropriate to include paraquat in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. However some uses of plant protection products containing paraquat pose an unacceptable risk and should therefore not be authorised. Moreover, it is considered appropriate to ensure that Member States impose that the notifier and any other authorisation holder of paraquat establish a stewardship programme particularly for operator safety, and that they report to the Commission yearly on incidences of operator health problems as well as possible impacts on hares. This should enable a verification of whether the risk-mitigation measures imposed by Member States really limit the possible risks for operators and hares to an acceptable level, and, if appropriate, a re-evaluation, in line with scientific progress, of the properties and potentially related risks to humans and the environment. (6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (7) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing paraquat, and, in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (8) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 30 April 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 May 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing paraquat to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 April 2005 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant protection product containing paraquat as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC, by 31 October 2004 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 July 2008 at the latest, they shall amend or withdraw the authorisation. Article 4 Member States shall ensure that the authorisation holders report at the latest on 31 March 2008 on the effects of risk-mitigation measures to be applied through a stewardship programme and the implementation of advances in paraquat formulations. Member States shall submit this information without delay to the Commission. The Commission shall submit to the Standing Committee on the Food Chain and Animal Health a report on the application of the present Directive indicating whether the requirements for Annex I inclusion continue to be satisfied and may propose any amendment, including if necessary the withdrawal from Annex I, to the present Directive that it deems necessary to comply with its provisions. Article 5 This Directive shall enter into force on 1 November 2004. Article 6 This Directive is addressed to the Member States.

32003L0113

2003

Commission Directive 2003/113/EC of 3 December 2003 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance) 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), as last amended by Commission Directive 2003/62/EC(2), and in particular Article 10 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(3), as last amended by Commission Directive 2003/60/EC(4), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(5), as last amended by Commission Directive 2003/69/EC(6), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(7), as last amended by Commission Directive 2003/84/EC(8), and in particular Article 4(1)(f) thereof, Whereas: (1) The existing active substances 2,4-DB linuron and pendimethalin, were included in Annex I to Council Directive 91/414/EEC by Commission Directive 2003/31/EC(9). (2) The new active substances imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid were included in Annex I to Council Directive 91/414/EEC by Commission Directive, 2003/23/EC(10). (3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed. (4) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised. (5) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The assessment reports for the substances mentioned were finalised on the dates as mentioned in the Commission Directives cited under (1) and (2). These reports fixed the Acceptable Daily Intake (ADI) and if necessary, the Acute Reference Dose (ARfD) for the substances concerned. The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation(11) and the opinion of the Scientific Committee for Plants(12) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded. (6) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination. (7) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances in this Directive in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (8) It is therefore necessary to add all of the pesticide residues arising from use of these plant protection products to the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (9) This Directive is in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The maximum pesticide residue levels for 2,4-DB, linuron, pendimethalin, imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as shown in Annex I to this Directive are added to Part A of Annex II to Directive 86/362/EEC. Article 2 The maximum pesticide residue levels for pendimethalin, as shown in Annex II to this Directive are added to Annex IIA to Directive 86/363/EEC. The maximum pesticide residue levels for 2,4-DB and oxasulfuron as shown in Annex III to this Directive are added to Annex IIB to Directive 86/363/EEC. Article 3 The maximum pesticide residue levels for 2,4-DB, linuron, pendimethalin, imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as shown in Annex IV to this Directive are added to Annex II to Directive 90/642/EEC. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive six months after publication of this Directive in the Official Journal of the European Union at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 4 June 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 5 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32003L0116

2003

Commission Directive 2003/116/EC of 4 December 2003 amending Annexes II, III, IV and V to Council Directive 2000/29/EC as regards the harmful organism Erwinia amylovora (Burr.) Winsl. et al. Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 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 Council Directive 2003/47/EC(2), and in particular points (c) and (d) of the second paragraph of Article 14 thereof, After consulting the Member States concerned, Whereas: (1) The provisions against Erwinia amylovora (Burr.) Winsl. et al. should cover the whole range of host plants capable of spreading this harmful organism. Some known host plants for Erwinia amylovora (Burr.) Winsl. et al. are not covered by the current provisions. This list should therefore be extended to cover the whole range of host plants for Erwinia amylovora (Burr.) Winsl. et al. (2) The provisions on "buffer zones" should be improved to reduce the risk of short distance spreading of Erwinia amylovora (Burr.) Winsl. et al. To that end the "buffer zones" should be clearly delimited and a strict control regime should be applied which includes the removal of plants showing symptoms of Erwinia amylovora (Burr.) Winsl. et al. (3) Before plants from an area where Erwinia amylovora (Burr.) Winsl. et al. is known to occur may be introduced or moved into the relevant "protected zones", the fields of production of those plants and a zone surrounding those fields, should be found to be totally free from Erwinia amylovora (Burr.) Winsl. et al. during the last complete cycle of vegetation preceding the introduction or movement. This should be confirmed by visual inspections carried out at appropriate times and laboratory tests for the possible detection of latent infections. (4) The movement of beehives to and within protected zones should be regulated, because it may be an important factor of spreading Erwinia amylovora (Burr.) Winsl. et al. (5) Specific arrangements should be made for plants which are produced and maintained on fields located in officially designated "buffer zones" in accordance with the provisions of Directive 2000/29/EC, and which meet the relevant requirements as regards fields and "buffer zones" thereof, before 1 April 2004. (6) Directive 2000/29/EC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes II, III, IV and V to Directive 2000/29/EC are 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 by 31 March 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0119

2003

Commission Directive 2003/119/EC of 5 December 2003 amending Council Directive 91/414/EEC to include mesosulfuron, propoxycarbazone and zoxamide as active substances (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 2003/84/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC, the authorities of France received on 15 December 2000 an application from Aventis Cropscience France (now Bayer CropScience) for the inclusion of the active substance mesosulfuron (in the form of mesosulfuron methyl) in Annex I to Directive 91/414/EEC. Commission Decision 2001/287/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) Germany received an application under Article 6(2) of Directive 91/414/EEC on 25 January 2000, an application from Bayer AG (now Bayer CropScience) concerning propoxycarbazone (in the form of propoxycarbazone sodium; former name: MKH 65 61). This application was declared complete by Commission Decision 2000/463/EC(4). (3) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 2 June 1999 from Rohm and Haas France SA (now: Dow AgroSciences) concerning zoxamide (former name: RH-7281). This application was declared complete by Commission Decision 2000/540/EC(5). (4) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 12 December 2001 (mesosulfuron), 26 March 2001 (propoxycarbazone) and 10 August 2001 (zoxamide). (5) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 October 2003 in the format of the Commission review report for mesosulfuron, propoxycarbazone and zoxamide. (6) The review of mesosulfuron, propoxycarbazone and zoxamide did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (7) It has appeared from the various examinations made, that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include mesosulfuron, propoxycarbazone and zoxamide in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (8) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing mesosulfuron, propoxycarbazone and zoxamide and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 30 September 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 October 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 1. Member States shall review the authorisation for each plant protection product containing mesosulfuron, propoxycarbazone or zoxamide to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 September 2004 at the latest. 2. For each authorised plant protection product containing mesosulfuron, propoxycarbazone or zoxamide as the only active substance, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 August 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. 3. For each plant protection product containing mesosulfuron, propoxycarbazone or zoxamide together with one or more active substances which are all listed in Annex I to Directive 91/414/EEC, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to that Directive, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary, they shall amend or withdraw the authorisation for each such plant protection product, by the deadline defined for such an amendment or withdrawal in the respective Directives which amended Annex I so as to add the relevant substances to it. Where the respective Directives set different deadlines, the deadline shall be the latest of the dates defined. Article 4 This Directive shall enter into force on 1 April 2004. Article 5 This Directive is addressed to the Member States.

32003L0120

2003

Commission Directive 2003/120/EC of 5 December 2003 amending Directive 90/496/EEC on nutrition labelling for foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(1), and in particular Article 5(2) thereof, After consulting the Scientific Committee on Food, Whereas: (1) The placing on the market of salatrims as novel food ingredients for use in energy-reduced bakery products and confectionery was authorised by Commission Decision 2003/867(2), under Regulation (EC) No 258/97 of the European Parliament and of the Council(3), as last amended by Regulation (EC) No 1882/2003(4). (2) The Scientific Committee on Food in its opinion on the safety assessment of salatrims for use as reduced calorie fats alternative as a novel food ingredient, expressed on 13 December 2001, noted that the energy provided by salatrims lies between 5 and 6 kcal/gram. (3) Under current rules, the energy provided by salatrims, considered to be fats, should be calculated by using the conversion factor for fat, provided for in Article 5(1) of Directive 90/496/EEC, namely 9 kcal/gram. The use of this conversion factor for the declared energy content of a product would misrepresent its reduced energy content achieved by the use of salatrims in its manufacture and would thus result in a failure to fully inform the consumer. Therefore it is necessary to adopt the appropriate conversion factor for salatrims to be used for the calculation of the declared energy value of foodstuffs. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The following is added at the end of Article 5(1) of Directive 90/496/EEC: ">TABLE>" Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0108

2003

Directive 2003/108/EC of the European Parliament and of the Council of 8 December 2003 amending Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee(1), After consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(2), Whereas: (1) During the adoption procedure concerning Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE)(3) concerns were raised about the possible financial implications of the wording of Article 9 of that Directive for producers of the equipment concerned. (2) At the meeting of the Conciliation Committee of 10 October 2002 on that Directive the European Parliament, Council and Commission expressed their intention in a Joint Declaration to examine the issues relating to Article 9 of Directive 2002/96/EC, concerning financing in respect of WEEE from users other than private households, at the earliest opportunity. (3) In accordance with the Joint Declaration, the Commission has examined the financial implications for producers following from the actual wording of Article 9 of Directive 2002/96/EC, and has found that the take-back obligation for WEEE put on the market in the past creates a retroactive liability for which no provision was made and which is likely to expose certain producers to serious economic risks. (4) In order to prevent such risks, the financial responsibility for the collection, treatment, re-use, recovery and recycling of WEEE from users other than private households put on the market before 13 August 2005 should be borne by producers when supplying new products replacing products of equivalent type or fulfilling the same functions. Where such waste is not replaced by new products, the responsibility should be borne by those users. Member States, producers and users should have the possibility to make alternative arrangements. (5) Pursuant to Article 17 of Directive 2002/96/EC, Member States are to bring into force the laws, regulations and administrative provisions necessary to comply with that Directive by 13 August 2004. In order to avoid having to amend Member States' legislation adopted by that date, this Directive should be adopted as soon as possible and implemented in Member States' legislation at the same time as Directive 2002/96/EC. (6) Directive 2002/96/EC should be amended accordingly, Article 1 Article 9 of Directive 2002/96/EC shall be replaced by the following: "Article 9 Financing in respect of WEEE from users other than private households 1. Member States shall ensure that, by 13 August 2005, the financing of the costs for the collection, treatment, recovery and environmentally sound disposal of WEEE from users other than private households from products put on the market after 13 August 2005 is to be provided for by producers. Member States shall ensure that, by 13 August 2005, for WEEE from products put on the market before 13 August 2005 (historical waste), the financing of the costs of management is as set out in the third and fourth subparagraphs. For historical waste being replaced by new equivalent products or by new products fulfilling the same function, the financing of the costs shall be provided for by producers of those products when supplying them. Member States may, as an alternative, provide that users other than private households also be made, partly or totally, responsible for this financing. For other historical waste, the financing of the costs shall be provided for by the users other than private households. 2. Producers and users other than private households may, without prejudice to this Directive, conclude agreements stipulating other financing methods." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 August 2004. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0121

2003

Commission Directive 2003/121/EC of 15 December 2003 amending Directive 98/53/EC laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(2), as last amended by Regulation (EC) No 1425/2003(3), fixes specific maximum limits for maize to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs. (2) Sampling plays a crucial part in the precision of the determination of the levels of aflatoxins, which are very heterogeneously distributed in a lot. Commission Directive 98/53/EC(4), as amended by Directive 2002/27/EC(5), should be amended to include specific provisions for maize to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs. (3) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the Union. These interpretation rules should be of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply. (4) Directive 98/53/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 98/53/EC is amended as set out in Annex I to this Directive. Annex II to Directive 98/53/EC is amended as set out in Annex II to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0105

2003

Directive 2003/105/EC of the European Parliament and of the Council of 16 December 2003 amending Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 22 October 2003(3), Whereas: (1) Directive 96/82/EC(4) aims at the prevention of major accidents which involve dangerous substances and the limitation of their consequences for man and the environment, with a view to ensuring high levels of protection throughout the Community in a consistent and effective manner. (2) In the light of recent industrial accidents and studies on carcinogens and substances dangerous for the environment carried out by the Commission at the Council's request, the scope of Directive 96/82/EC should be extended. (3) The cyanide spill that polluted the Danube following the accident at Baia Mare in Romania in January 2000 has demonstrated that certain storage and processing activities in mining, especially tailings disposal facilities, including tailing ponds or dams, have potential to produce very serious consequences. The Commission communications on the safe operation of mining activities and on the sixth environment action programme of the European Community have therefore highlighted the need for an extension of the scope of Directive 96/82/EC. In its resolution of 5 July 2001(5) on the Commission Communication on the safe operation of mining activities, the European Parliament also welcomed the extension of the scope of that Directive to cover risks arising from storage and processing activities in mining. (4) The proposal for a directive on the management of waste from the extractive industries may be a relevant framework for measures relating to those waste management facilities which present an accident risk but which are not covered by the present Directive. (5) The "fireworks accident" at Enschede in the Netherlands in May 2000 has demonstrated the major accident potential arising from storage and manufacture of pyrotechnic and explosive substances. The definition of such substances in Directive 96/82/EC should therefore be clarified and simplified. (6) The explosion at a fertiliser plant in Toulouse in September 2001 has raised awareness of the accident potential arising from the storage of ammonium nitrate and ammonium nitrate-based fertilisers, in particular of material rejected during the manufacturing process or returned to the manufacturer (off-specs). The existing categories of ammonium nitrate and ammonium nitrate-based fertilisers in Directive 96/82/EC should therefore be reviewed with a view to include "off-specs" material. (7) Directive 96/82/EC should not be applied to sites of end-users where ammonium nitrate and ammonium nitrate-based fertilisers, which on delivery conformed to the specification in that Directive but subsequently have become degraded or contaminated, are temporarily present prior to removal for reprocessing or destruction. (8) Studies carried out by the Commission in close cooperation with the Member States support extending the list of carcinogens with appropriate qualifying quantities and significantly lowering the qualifying quantities assigned to substances dangerous for the environment in Directive 96/82/EC. (9) For establishments which subsequently fall within the scope of Directive 96/82/EC, it has been shown necessary to introduce minimum periods for notifications and the establishment of major accident prevention policies, safety reports and emergency plans. (10) The experience and knowledge of relevant staff in the establishment can greatly assist in the drawing up of emergency plans, and all staff in an establishment and persons likely to be affected should be appropriately informed on safety measures and actions. (11) The adoption of Council Decision 2001/792/EC, Euratom of 23 October 2001 establishing a Community mechanism to facilitate reinforced cooperation in civil protection assistance interventions(6) highlights the need to facilitate reinforced cooperation in civil protection assistance interventions. (12) It is useful, in order to facilitate land-use planning, to draw up guidelines defining a database to be used for assessing the compatibility between the establishments covered by Directive 96/82/EC and the areas described in Article 12(1) of that Directive. (13) There should be an obligation on Member States to supply the Commission with minimum information concerning the establishments covered by Directive 96/82/EC. (14) It is appropriate at the same time to clarify certain passages in Directive 96/82/EC. (15) The measures provided for in this Directive have been the subject of a public consultation process involving interested parties. (16) Directive 96/82/EC should therefore be amended accordingly, Article 1 Directive 96/82/EC is hereby amended as follows: 1. Article 4 is amended as follows: (a) Points (e) and (f) are replaced by the following: "(e) the exploitation (exploration, extraction and processing) of minerals in mines, quarries, or by means of boreholes, with the exception of chemical and thermal processing operations and storage related to those operations which involve dangerous substances, as defined in Annex I; (f) the offshore exploration and exploitation of minerals, including hydrocarbons;" (b) The following point shall be added: "(g) waste land-fill sites, with the exception of operational tailings disposal facilities, including tailing ponds or dams, containing dangerous substances as defined in Annex I, in particular when used in connection with the chemical and thermal processing of minerals." 2. Article 6 is amended as follows: (a) The following indent is added in paragraph 1: "- for establishments which subsequently fall within the scope of this Directive, within three months after the date on which this Directive applies to the establishment concerned, as laid down in the first subparagraph of Article 2(1)." (b) The following indent is inserted after the first indent of Article 6(4): "- modification of an establishment or an installation which could have significant repercussions on major accident hazards, or". 3. The following paragraph is inserted in Article 7: "1a. For establishments which subsequently fall within the scope of this Directive, the document referred to in paragraph 1 shall be drawn up without delay, but at all events within three months after the date on which this Directive applies to the establishment concerned, as laid down in the first subparagraph of Article 2(1)." 4. Article 8(2)(b) is replaced by the following: "(b) provision is made for cooperation in informing the public and in supplying information to the authority responsible for the preparation of external emergency plans." 5. Article 9 is amended as follows: (a) The first subparagraph of paragraph 2 is replaced by the following: "2. The safety report shall contain at least the data and information listed in Annex II. It shall name the relevant organisations involved in the drawing up of the report. It shall also contain an updated inventory of the dangerous substances present in the establishment." (b) The following indent is inserted between the third and fourth indents of paragraph 3: "- for establishments which subsequently fall within the scope of this Directive, without delay, but at all events within one year after the date on which this Directive applies to the establishment concerned, as laid down in the first subparagraph of Article 2(1)." (c) In paragraph 4, the reference to "the second, third, and fourth indents" becomes "the second, third, fourth and fifth indents" respectively. (d) The following point is added to Article 9(6): "(d) The Commission is invited to review by 31 December 2006 in close cooperation with the Member States, the existing 'Guidance on the Preparation of a Safety Report'." 6. Article 11 is amended as follows: (a) The following indent is added to points (a) and (b) of paragraph 1: "- for establishments which subsequently fall within the scope of this Directive, without delay, but at all events within one year after the date on which this Directive applies to the establishment concerned, as laid down in the first subparagraph of Article 2(1)." (b) Paragraph 3 is replaced by the following: "3. Without prejudice to the obligations of the competent authorities, Member States shall ensure that the internal emergency plans provided for in this Directive are drawn up in consultation with the personnel working inside the establishment, including long-term relevant subcontracted personnel, and that the public is consulted on external emergency plans when they are established or updated." (c) The following paragraph is inserted: "4a. With regard to external emergency plans, Member States should take into account the need to facilitate enhanced cooperation in civil protection assistance in major emergencies." 7. Article 12 is amended as follows: (a) The second subparagraph of paragraph 1 is replaced by the following:"Member States shall ensure that their land-use and/or other relevant policies and the procedures for implementing those policies take account of the need, in the long term, to maintain appropriate distances between establishments covered by this Directive and residential areas, buildings and areas of public use, major transport routes as far as possible, recreational areas and areas of particular natural sensitivity or interest and, in the case of existing establishments, of the need for additional technical measures in accordance with Article 5 so as not to increase the risks to people." (b) The following paragraph is inserted: "1a. The Commission is invited by 31 December 2006, in close cooperation with the Member States, to draw up guidelines defining a technical database including risk data and risk scenarios, to be used for assessing the compatibility between the establishments covered by this Directive and the areas described in paragraph 1. The definition of this database shall as far as possible take account of the evaluations made by the competent authorities, the information obtained from operators and all other relevant information such as the socioeconomic benefits of development and the mitigating effects of emergency plans." 8. Article 13 is amended as follows: (a) The first subparagraph of paragraph 1 is replaced by the following: "1. Member States shall ensure that information on safety measures and on the requisite behaviour in the event of an accident is supplied regularly and in the most appropriate form, without their having to request it, to all persons and all establishments serving the public (such as schools and hospitals) liable to be affected by a major accident originating in an establishment covered by Article 9." (b) Paragraph 6 is replaced by the following: "6. In the case of establishments subject to the provisions of Article 9, Member States shall ensure that the inventory of dangerous substances provided for in Article 9(2) is made available to the public subject to the provisions of paragraph 4 of this Article and Article 20." 9. The following paragraph is inserted in Article 19: "1a. For establishments covered by this Directive, Member States shall supply the Commission with at least the following information: (a) the name or trade name of the operator and the full address of the establishment concerned; and (b) the activity or activities of the establishment. The Commission shall set up and keep up to date a database containing the information supplied by the Member States. Access to the database shall be reserved to persons authorised by the Commission or the competent authorities of the Member States." 10. Annex I is amended as set out in the Annex. 11. In Annex II, point IV part B is replaced by the following: "B. Assessment of the extent and severity of the consequences of identified major accidents including maps, images or, as appropriate, equivalent descriptions, showing areas which are liable to be affected by such accidents arising from the establishment, subject to the provisions of Articles 13(4) and 20." 12. In Annex III, point (c) is amended as follows: (a) point (i) is replaced by the following: "(i) organisation and personnel - the roles and responsibilities of personnel involved in the management of major hazards at all levels in the organisation. The identification of training needs of such personnel and the provision of the training so identified. The involvement of employees and of subcontracted personnel working in the establishment." (b) point (v) is replaced by the following: "(v) Planning for emergencies - adoption and implementation of procedures to identify foreseeable emergencies by systematic analysis, to prepare, test and review emergency plans to respond to such emergencies and to provide specific training for the staff concerned. Such training shall be given to all personnel working in the establishment, including relevant subcontracted personnel." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such 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 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 Union. Article 4 This Directive is addressed to the Member States.

32003L0122

2003

Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31(2) 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, in accordance with Article 31 of the Treaty, After consulting the European Economic and Social Committee, Having regard to the opinion of the European Parliament(1), Whereas: (1) Article 30 of the Treaty requires basic standards to be laid down within the Community for the protection of the health of workers and the general public against the dangers arising from ionising radiation. (2) 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 ionising radiation(2), continues the line of directives laying down basic safety standards since 1959. (3) Article 4(1)(e) of Directive 96/29/Euratom requires prior authorisation for, amongst other practices, the use of radioactive sources for industrial radiography or processing of products or research or the exposure of persons for medical treatment. It is appropriate to extend this requirement to all practices involving high-activity radioactive sources in order further to reduce the likelihood of accidents involving such sources. (4) Prior to authorisation, adequate arrangements and provision for the safe management of sources should exist. (5) The International Atomic Energy Agency (IAEA) issues regulations for the safe transport of radioactive material that include activity limits for the requirements of the regulations, which should provide an appropriate basis for defining high-activity sealed radioactive sources within the scope of this Directive(3). (6) In Directive 96/29/Euratom exemption values were laid down for the reporting of a practice to the authorities. These values were defined in that Directive on the basis of a negligible level of risk. As the requirements of this Directive should not put an administrative burden on the holders of small sources that is not commensurate with the possible health detriment, the definition of high activity radioactive sources should not be extended to the exemption levels of Directive 96/29/Euratom. (7) Shipments of sealed sources between Member States are subject to the procedure established by Council Regulation (Euratom) No 1493/93 of 8 June 1993 on shipments of radioactive substances between Member States(4). (8) Although the legal requirements deriving from existing legislation at Community and at national level ensure basic protection, high-activity sources still imply considerable potential risks for human health and for the environment and therefore need to be subject to a strict control from the time they are manufactured to the time they are placed in a recognised installation for their long-term storage or disposal. (9) Prevention of radiological accidents and injuries requires the location of each high-activity source to be known, recorded and verified from the time the source is manufactured or imported into the Community to the time it is placed in a recognised installation for its long-term storage or disposal or it is exported from the Community. Changes in the situation of a high-activity source, e.g. its location or use, should also be recorded and notified. Physical or financial obstacles should not hinder any appropriate reuse, recycling or disposal of such sources when disused under any reasonably foreseeable circumstances. (10) Cases of unintentional exposure should be notified to the competent authority. (11) Movements within the Community of high-activity sources make it necessary to harmonise the control of and information on such sources through the application of minimum criteria. (12) Experience shows that, despite the existence of an appropriate regulatory framework, control of high-activity sources may nevertheless be lost. Furthermore, the existence of orphan sources resulting from past activities requires that specific initiatives be undertaken. (13) Accordingly, it is necessary to provide for the identification, marking and recording of each high-activity source as well as for the specific training and informing of all those involved in activities relating to the use of sources. However, the marking of existing high-activity sources by engraving or stamping by persons other than the manufacturer could be problematic and should be avoided. It is also advisable to provide appropriate training and information for those who may deal accidentally with orphan sources. (14) It is also necessary to provide for suitable means of dealing with orphan high-activity sources for international cooperation and exchange of information in this area, for inspection and, finally, for making financial provision for cases in which the original holder either cannot be identified or, even if identified, is found to be insolvent. (15) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented; those penalties should be effective, proportionate and dissuasive, Article 1 Purpose and scope 1. The purpose of this Directive is to prevent exposure of workers and the public to ionising radiation arising from inadequate control of high-activity sealed radioactive sources and orphan sources and to harmonise controls in place in the Member States by defining specific requirements ensuring that each such source is kept under control. 2. This Directive applies to high-activity sources as defined in Article 2. Member States may exclude sources from the scope of this Directive once their activity has fallen below the exemption levels specified in Directive 96/29/Euratom. 3. The minimum obligations resulting from this Directive supplement those set out in Directive 96/29/Euratom. Article 2 Definitions For the purpose of this Directive, the following definitions shall apply: (a) "orphan source" means a sealed source, the activity level of which, at the time of its discovery, is above the exemption level referred to in Article 3(2)(a) of Directive 96/29/Euratom, and which is not under regulatory control, either because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or transferred, without proper notification of the competent authority, to a new holder or without informing the recipient; (b) "high-activity source", hereinafter referred to as "source", means a sealed source containing a radionuclide whose activity at the time of manufacture or, if this is not known, of the first placing on the market is equal to or exceeds the relevant activity level specified in Annex I; (c) "practice" has the meaning given to it by Directive 96/29/Euratom; (d) "authorisation" means permission granted in a document by competent authorities, on request, to carry out a practice involving a source; (e) "competent authority" means any authority designated by a Member State to carry out tasks in accordance with this Directive; (f) "disused source" means a source which is no longer used or intended to be used for the practice for which authorisation was granted; (g) "holder" means any natural or legal person who is responsible under national law for a source, including manufacturers, suppliers and users of sources but excluding "recognised installations"; (h) "manufacturer" means any natural or legal person who manufactures a source; (i) "recognised installation" means a facility located in the territory of a Member State authorised by the competent authorities of that State in accordance with national law for the long-term storage or disposal of sources or an installation duly authorised under national law for the interim storage of sources; (j) "exposed worker" has the meaning given to it by Directive 96/29/Euratom; (k) "sealed source" has the meaning given to it by Directive 96/29/Euratom and includes the capsule, where applicable, enclosing the radioactive material as an integral part of the source; (l) "supplier" means any natural or legal person who supplies or makes available a source; (m) "transfer" of a source means a transfer of a source from one holder to another one; (n) "source container" means the containment of a sealed source not being an integral part of the source, but meant for transport, handling, etc. Article 3 Authorisation 1. Member States shall require the holder to obtain prior authorisation for any practice involving a source, including taking possession of a source. 2. Member States shall ensure that, before issuing authorisation: (a) adequate arrangements, including those arising from this Directive, have been made for the safe management of sources, including when they become disused sources. These latter arrangements may provide for the transfer of these sources to the supplier or their placement in a recognised installation or an obligation for the manufacturer or the supplier to receive these sources; (b) adequate provision, by way of a financial security or any other equivalent means appropriate to the source in question, have been made for the safe management of sources when they become disused sources, including the case where the holder becomes insolvent or goes out of business. 3. Member States shall ensure that the authorisation covers: (a) responsibilities; (b) minimum staff competencies, including information and training; (c) minimum source, source container and additional equipment performance criteria; (d) requirements for emergency procedures and communication links; (e) work procedures to be followed; (f) maintenance of equipment, sources and containers; (g) adequate management of disused sources, including agreements regarding the transfer, if appropriate, of disused sources to a supplier, another authorised holder or a recognised installation. Article 4 Transfers Member States shall set up a system to enable them to be adequately informed of individual transfers of sources. Article 5 Records 1. The holder shall keep records of all sources under his responsibility, their location and their transfer. The records shall include the information set out in Annex II. This information may be recorded on a standard record sheet pursuant to paragraph 5. 2. The holder shall provide the competent authority with an electronic or written copy of all or part of the records referred to in paragraph 1, as required by the Member State concerned, - without undue delay, at the time of the establishment of such records, which should be as soon as possible after the source is acquired, - at intervals, to be determined by Member States/competent authorities, of not more than 12 months thereafter, - if the situation indicated on the information sheet has changed, - without undue delay on the closure of the records for a specific source when the holder no longer holds this source; in this case the name of the holder or recognised installation to which the source is transferred shall be included, - without undue delay on the closure of such records when the holder no longer holds any sources, and - whenever so requested by the competent authority. The holder's records shall be available for inspection by the competent authority. 3. The competent authorities shall keep records of authorised holders and of the sources they hold. These records shall include the radionuclide involved, the activity at the time of manufacture, or if this activity is not known, the activity at the time of the first placing on the market or at the time the holder acquired the source, and the type of source. 4. The competent authorities shall keep the records up to date, taking transfers into account, among other factors. 5. The Commission shall make available in electronic format the standard record sheet for the records set out in Annex II. 6. The Commission may, in accordance with the procedure referred to in Article 17, update the required information set out in Annex II and the standard record sheet for the records set out in Annex II. Article 6 Requirements for holders Each holder of sources shall: (a) ensure that suitable tests, such as leak tests based on international standards, are undertaken regularly in order to check and maintain the integrity of each source; (b) regularly verify, at specific intervals which may be determined by Member States, that each source and, where relevant, the equipment containing the source, is still present and in apparently good condition at its place of use or of storage; (c) ensure that each fixed and mobile source is subject to adequate documented measures, such as written protocols and procedures, aimed at preventing unauthorised access to or loss or theft of the source or its damage by fire; (d) promptly notify the competent authority of any loss, theft or unauthorised use of a source, arrange for a check on the integrity of each source after any event, including fire, that may have damaged the source and, if appropriate, inform the competent authority thereof and of the measures taken; (e) return each disused source to the supplier or place it in a recognised installation or transfer it to another authorised holder unless otherwise agreed by the competent authority, without undue delay after termination of the use; (f) ascertain that, before a transfer is made, the recipient holds appropriate authorisation; (g) promptly notify the competent authority of any incident or accident resulting in unintentional exposure of a worker or a member of the public. Article 7 Identification and marking 1. The manufacturer shall identify or, in the case of sources imported from outside the Community, the supplier shall ensure that each source is identified by a unique number. This number shall be engraved or stamped on the source, where practicable. This number shall also be engraved or stamped on the source container. If this is not feasible or in the case of reusable transport containers, the source container shall at least have information on the nature of the source. The manufacturer or the supplier shall ensure that the source container and, where practicable, the source are marked and labelled with an appropriate sign to warn people of the radiation hazard. The manufacturer shall provide a photograph of each manufactured source design type and of the typical source container. 2. The holder shall ensure that each source is accompanied by written information indicating that the source is identified and marked in compliance with paragraph 1 and that the markings and labels referred to in paragraph 1 remain legible. The information shall include photographs of the source, source container, transport packaging, device and equipment as appropriate. Article 8 Training and information 1. When arranging information and training in the field of radiation protection in compliance with Article 22 of Directive 96/29/Euratom, the holder shall ensure that such training includes specific requirements for the safe management of sources. The information and training shall place particular emphasis on the necessary safety requirements and shall contain specific information on possible consequences of the loss of adequate control of sources. The information and training shall be repeated at regular intervals and documented, with a view to preparing the relevant workers adequately for such events. The relevant information and training shall be addressed to exposed workers. 2. Member States shall provide encouragement to ensure that the management and workers in installations where orphan sources are most likely to be found or processed (e.g. large metal scrap yards and major metal scrap recycling plants), and the management and workers in significant nodal transit points (e.g. customs posts), are (a) informed of the possibility that they may be confronted with a source; (b) advised and trained in the visual detection of sources and of their containers; (c) informed of basic facts about ionising radiation and its effects; (d) informed of and trained in the action to be taken on site in the event of the detection or suspected detection of a source. Article 9 Orphan sources 1. Member States shall ensure that the competent authorities are prepared, or have made provision, including assignment of responsibilities, to recover orphan sources and to deal with radiological emergencies due to orphan sources and have drawn up appropriate response plans and measures. 2. Member States shall ensure that specialised technical advice and assistance is promptly made available to the persons, not normally involved in operations subject to radiation protection requirements, who suspect the presence of an orphan source. The primary aim of advice and assistance shall be the protection of workers and members of the public from radiation and the safety of the source. 3. Member States shall encourage the establishment of systems aimed at detecting orphan sources in places such as large metal scrap yards and major metal scrap recycling installations where orphan sources may generally be encountered, or at significant nodal transit points, wherever appropriate, such as customs posts. 4. Member States shall ensure that campaigns are organised, as appropriate, to recover orphan sources left behind from past activities. The campaigns may include the financial participation of Member States in the costs of recovering, managing and disposing of the sources and may also include surveys of historical records of authorities, such as customs, and of holders, such as research institutes, material testing institutes or hospitals. Article 10 Financial security for orphan sources Member States shall ensure that, on the basis of arrangements to be decided by Member States, a system of financial security is established or any other equivalent means to cover intervention costs relating to the recovery of orphan sources and which may result from implementation of the requirements set out in Article 9. Article 11 International cooperation and information exchange Each Member State shall promptly exchange information and cooperate with other relevant Member States or third countries and with relevant international organisations as regards loss, removal, theft or discovery of sources and as regards related follow-up or investigations, without prejudice to relevant confidentiality requirements and relevant national regulations. Article 12 Inspections Member States shall establish or maintain a system of inspection to enforce the provisions introduced in compliance with this Directive. Article 13 Competent authority 1. Member States shall designate the competent authority to carry out tasks in accordance with this Directive. 2. Member States shall forward to the Commission the name and the address of the competent authority and all necessary information for rapidly communicating with such authorities. 3. Where Member States have more than one competent authority, they shall designate one point of contact to act as an interface with correspondents in other Member States. 4. Member States shall forward to the Commission any changes to the data referred to in paragraphs 2 and 3. 5. The Commission shall communicate the information referred to in paragraphs 2, 3 and 4 to all competent authorities in the Community and shall publish it periodically in the Official Journal of the European Union, at intervals of no more than two years. Article 14 Report on experience By 31 December 2010, Member States shall report to the Commission on the experience gained in the implementation of this Directive, including consideration of any effect which Article 1(2) may have had. On that basis, the Commission shall submit a report to the European Parliament, the Council and the European Economic and Social Committee. Article 15 Penalties Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties shall be effective, proportionate and dissuasive. Article 16 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 December 2005. Member States may provide, as regards sources placed on the market before the date referred to in the first subparagraph, that: (a) Articles 3 to 6 shall not apply until 31 December 2007; (b) Article 7 shall not apply, with the exception of the following requirements which shall apply by 31 December 2007 at the latest: - the holder shall ensure that, if practicable, each such source and the source container are accompanied by written information to identify the source and its nature, - the holder shall ensure that, if practicable, each such source, if practicable, and the source container are labelled with an appropriate sign to warn people of the radiation hazard. Where these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such 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 covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 17 Committee The Commission shall be assisted in performing the tasks laid down in Article 5(6) by an Advisory 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, if necessary by taking a vote. The opinion of the Committee 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 take into account. Article 18 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 19 This Directive is addressed to the Member States.

32003L0114

2003

Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95/2/EC on food additives other than colours and sweeteners Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee(1), Acting in accordance with the procedure laid down in Article 251 of the Treaty(2), Whereas: (1) Food additives may be approved for use in foodstuffs only if they comply with Annex II to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(3). (2) Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners(4) lays down a list of food additives that may be used in the Community and the conditions for their use. (3) There have been technical developments in the field of food additives since the adoption of Directive 95/2/EC. That Directive should be adapted to take account of those developments. (4) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(5) provides for the adoption of a list of additives necessary for the storage and use of flavourings, and the adoption of any special conditions for the use of such additives that may be necessary for the protection of public health and to ensure fair trade. (5) It is desirable to incorporate into Directive 95/2/EC those measures on additives necessary for the storage and use of flavourings, in order to contribute to transparency and consistency of Community legislation, and to facilitate compliance with Community legislation on food additives by food manufacturers, especially by small and medium-sized enterprises. In addition, according to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(6), flavourings fall within the definition of "food". (6) While the use of additives which are necessary to ensure the safety and quality of flavourings and to facilitate their storage and use should be authorised, the levels of additives present in such flavourings should be the minimum required to achieve the intended purpose. In addition, consumers should be guaranteed correct, adequate and non-misleading information on the use of additives. (7) The presence of an additive in a foodstuff, due to the use of a flavouring, is generally low and the additive does not have a technological function in the foodstuff. However, if under certain circumstances the additive does have a technological function in the compound foodstuff, it should be considered as an additive of the compound foodstuff and not as an additive of the flavouring, and the relevant rules relating to the additive in the particular foodstuff should apply, including the labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(7). (8) In accordance with Directive 88/388/EEC, food manufacturers should be informed about the concentrations of all additives in flavourings in order to enable them to comply with Community legislation. That Directive also requires quantitative labelling of each component subject to a quantitative limitation in a foodstuff. A quantitative limitation is expressed either numerically or by the "quantum satis" principle. (9) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring market unity and a high level of consumer protection to lay down rules on the use of additives in flavourings. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. (10) In accordance with a request from a Member State and the opinion of the Scientific Committee on Food, established by Commission Decision 97/579/EC of 23 July 1997 setting up Scientific Committees in the field of consumer health and food safety(8), hydrogenated poly-1-decene, which was authorised at national level under Directive 89/107/EEC, should be authorised at Community level. (11) Biphenyl (E 230), orthophenyl phenol (E 231) and sodium orthophenyl phenol (E 232) are listed as preservatives in and on citrus fruits in Directive 95/2/EC. However, they fall under the definition of "plant protection products" in Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(9). Therefore, they should no longer come within the scope of Directive 95/2/EC. The Member States and the Commission should take all possible steps to ensure that there is no legal vacuum with regard to these substances. Authorisation to place on the market these substances as plant protection products should be dealt with as swiftly as possible. (12) On 4 April 2003, the Scientific Committee on Food stated that the temporary acceptable daily intake for E 214 to E 219 p-hydroxybenzoic acid alkyl esters and their sodium salts should be withdrawn if no further data are submitted in respect of intake and toxicity. (13) Directive 95/2/EC should therefore be amended accordingly. (14) Council Directive 67/427/EEC of 27 June 1967 on the use of certain preservatives for the surface treatment of citrus fruit and on the control measures to be used for the qualitative and quantitative analysis of preservatives in and on citrus fruit(10) lays down the control measures on preservatives in and on citrus fruits. Since those preservatives are no longer authorised for use in citrus fruits by Directive 95/2/EC, it is necessary to repeal Directive 67/427/EEC. (15) The Scientific Committee on Food has been consulted on the adoption of provisions that may have an effect upon public health, pursuant to Article 6 of Directive 89/107/EEC, Article 1 Directive 95/2/EC is hereby amended as follows: 1. Article 1(3)(v) shall be replaced by the following: "(v) 'stabilisers' are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff, substances which stabilise, retain or intensify an existing colour of a foodstuff and substances which increase the binding capacity of the food, including the formation of cross-links between proteins enabling the binding of food pieces into re-constituted food;" 2. Article 3 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The presence of a food additive is permissible: (a) in a compound foodstuff other than one mentioned in Article 2(3), to the extent to which the food additive is permitted in one of the ingredients of the compound foodstuff; (b) in a foodstuff where a flavouring has been added, to the extent to which the food additive is permitted in the flavouring in compliance with this Directive and has been carried over to the foodstuff via the flavouring, provided the food additive has no technological function in the final foodstuff; or (c) 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."; (b) the following paragraph shall be added: "3. The level of additives in flavourings shall be limited to the minimum necessary to guarantee the safety and quality of flavourings and to facilitate their storage. Furthermore, the presence of additives in flavourings must not mislead consumers or present a hazard to their health. If the presence of an additive in a foodstuff, as a consequence of adding flavourings, has a technological function in the foodstuff, it shall be considered as an additive of the foodstuff and not as an additive of the flavouring."; 3. the Annexes shall be amended as set out in the Annex to this Directive. Article 2 1. Before 1 July 2004, the Commission and the European Food Safety Authority shall review the conditions for the use of additives E 214 to E 219. 2. Before 27 January 2006, the Commission shall submit to the European Parliament and the Council a report on the progress of the re-evaluation of additives. This re-evaluation shall in particular focus on E 432 to E 436 (polysorbates) as well as E 251 and E 252 (nitrates) and E 249 and E 250 (nitrites). Article 3 Directive 67/427/EEC shall be repealed. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive in order to: - authorise trade in and use of products conforming with this Directive by 27 July 2005 at the latest, - prohibit trade in and use of products not conforming with this Directive by 27 January 2006 at the latest; 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. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32003L0124

2003

Commission Directive 2003/124/EC of 22 December 2003 implementing Directive 2003/6/EC of the European Parliament and of the Council as regards the definition and public disclosure of inside information and the definition of market manipulation (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse)(1), and in particular the second paragraph of Article 1 and the first, second and third indents of Article 6(10) thereof, After consulting the Committee of European Securities Regulators (CESR)(2) for technical advice, Whereas: (1) Reasonable investors base their investment decisions on information already available to them, that is to say, on ex ante available information. Therefore, the question whether, in making an investment decision, a reasonable investor would be likely to take into account a particular piece of information should be appraised on the basis of the ex ante available information. Such an assessment has to take into consideration the anticipated impact of the information in light of the totality of the related issuer's activity, the reliability of the source of information and any other market variables likely to affect the related financial instrument or derivative financial instrument related thereto in the given circumstances. (2) Ex post information may be used to check the presumption that the ex ante information was price sensitive, but should not be used to take action against someone who drew reasonable conclusions from ex ante information available to him. (3) Legal certainty for market participants should be enhanced through a closer definition of two of the elements essential to the definition of inside information, namely the precise nature of that information and the significance of its potential effect on the prices of financial instruments or related derivative financial instruments. (4) Not only does the protection of investors require timely public disclosure of inside information by issuers, it also requires such disclosure to be as fast and as synchronised as possible between all categories of investors in all Member States in which the issuer has requested or approved admission of its financial instruments to trading on a regulated market, in order to guarantee at Community level equal access of investors to such information and to prevent insider dealing. To this end Member States may officially appoint mechanisms to be used for such disclosure. (5) In order to protect the legitimate interests of issuers, it should be permissible, in closely defined specific circumstances, to delay public disclosure of inside information. However, the protection of investors requires that in such cases the information be kept confidential in order to prevent insider dealing. (6) In order to guide both market participants and competent authorities, signals have to be taken into account when examining possibly manipulative behaviours. (7) The measures provided for in this Directive are in accordance with the opinion of the European Securities Committee, Article 1 Inside information 1. For the purposes of applying point 1 of Article 1 of Directive 2003/6/EC, information shall be deemed to be of a precise nature if it indicates a set of circumstances which exists or may reasonably be expected to come into existence or an event which has occurred or may reasonably be expected to do so and if it is specific enough to enable a conclusion to be drawn as to the possible effect of that set of circumstances or event on the prices of financial instruments or related derivative financial instruments. 2. For the purposes of applying point 1 of Article 1 of Directive 2003/6/EC, "information which, if it were made public, would be likely to have a significant effect on the prices of financial instruments or related derivative financial instruments" shall mean information a reasonable investor would be likely to use as part of the basis of his investment decisions. Article 2 Means and time-limits for public disclosure of inside information 1. For the purposes of applying Article 6(1) of Directive 2003/6/EC, Articles 102(1) and Article 103 of Directive 2001/34/EC of the European Parliament and of the Council(3) shall apply. Furthermore, Member States shall ensure that the inside information is made public by the issuer in a manner which enables fast access and complete, correct and timely assessment of the information by the public. In addition, Member States shall ensure that the issuer does not combine, in a manner likely to be misleading, the provision of inside information to the public with the marketing of its activities. 2. Member States shall ensure that issuers are deemed to have complied with the first subparagraph of Article 6(1) of Directive 2003/6/EC where, upon the coming into existence of a set of circumstances or the occurrence of an event, albeit not yet formalised, the issuers have promptly informed the public thereof. 3. Any significant changes concerning already publicly disclosed inside information shall be publicly disclosed promptly after these changes occur, through the same channel as the one used for public disclosure of the original information. 4. Member States shall require issuers to take reasonable care to ensure that the disclosure of inside information to the public is synchronised as closely as possible between all categories of investors in all Member States in which those issuers have requested or approved the admission to trading of their financial instruments on a regulated market. Article 3 Legitimate interests for delaying public disclosure and confidentiality 1. For the purposes of applying Article 6(2) of Directive 2003/6/EC, legitimate interests may, in particular, relate to the following non-exhaustive circumstances: (a) negotiations in course, or related elements, where the outcome or normal pattern of those negotiations would be likely to be affected by public disclosure. In particular, in the event that the financial viability of the issuer is in grave and imminent danger, although not within the scope of the applicable insolvency law, public disclosure of information may be delayed for a limited period where such a public disclosure would seriously jeopardise the interest of existing and potential shareholders by undermining the conclusion of specific negotiations designed to ensure the long-term financial recovery of the issuer; (b) decisions taken or contracts made by the management body of an issuer which need the approval of another body of the issuer in order to become effective, where the organisation of such an issuer requires the separation between these bodies, provided that a public disclosure of the information before such approval together with the simultaneous announcement that this approval is still pending would jeopardise the correct assessment of the information by the public. 2. For the purposes of applying Article 6(2) of Directive 2003/6/EC, Member States shall require that, in order to be able to ensure the confidentiality of inside information, an issuer controls access to such information and, in particular, that: (a) the issuer has established effective arrangements to deny access to such information to persons other than those who require it for the exercise of their functions within the issuer; (b) the issuer has taken the necessary measures to ensure that any person with access to such information acknowledges the legal and regulatory duties entailed and is aware of the sanctions attaching to the misuse or improper circulation of such information; (c) the issuer has in place measures which allow immediate public disclosure in case the issuer was not able to ensure the confidentiality of the relevant inside information, without prejudice to the second subparagraph of Article 6 (3) of Directive 2003/6/EC. Article 4 Manipulative behaviour related to false or misleading signals and to price securing For the purposes of applying point 2(a) of Article 1 of Directive 2003/6/EC, and without prejudice to the examples set out in the second paragraph of point 2 thereof, Member States shall ensure that the following non-exhaustive signals, which should not necessarily be deemed in themselves to constitute market manipulation, are taken into account when transactions or orders to trade are examined by market participants and competent authorities: (a) the extent to which orders to trade given or transactions undertaken represent a significant proportion of the daily volume of transactions in the relevant financial instrument on the regulated market concerned, in particular when these activities lead to a significant change in the price of the financial instrument; (b) the extent to which orders to trade given or transactions undertaken by persons with a significant buying or selling position in a financial instrument lead to significant changes in the price of the financial instrument or related derivative or underlying asset admitted to trading on a regulated market; (c) whether transactions undertaken lead to no change in beneficial ownership of a financial instrument admitted to trading on a regulated market; (d) the extent to which orders to trade given or transactions undertaken include position reversals in a short period and represent a significant proportion of the daily volume of transactions in the relevant financial instrument on the regulated market concerned, and might be associated with significant changes in the price of a financial instrument admitted to trading on a regulated market; (e) the extent to which orders to trade given or transactions undertaken are concentrated within a short time span in the trading session and lead to a price change which is subsequently reversed; (f) the extent to which orders to trade given change the representation of the best bid or offer prices in a financial instrument admitted to trading on a regulated market, or more generally the representation of the order book available to market participants, and are removed before they are executed; (g) the extent to which orders to trade are given or transactions are undertaken at or around a specific time when reference prices, settlement prices and valuations are calculated and lead to price changes which have an effect on such prices and valuations. Article 5 Manipulative behaviours related to the employment of fictitious devices or any other form of deception or contrivance For the purposes of applying point 2(b) of Article 1 of Directive 2003/6/EC, and without prejudice to the examples set out in the second paragraph of point 2 thereof, Member States shall ensure that the following non-exhaustive signals, which should not necessarily be deemed in themselves to constitute market manipulation, are taken into account when transactions or orders to trade are examined by market participants and competent authorities: (a) whether orders to trade given or transactions undertaken by persons are preceded or followed by dissemination of false or misleading information by the same persons or persons linked to them; (b) whether orders to trade are given or transactions are undertaken by persons before or after the same persons or persons linked to them produce or disseminate research or investment recommendations which are erroneous or biased or demonstrably influenced by material interest. Article 6 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 12 October 2004 at the latest. They shall forthwith communicate to the Commission the text of the provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 7 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 8 Addressees This Directive is addressed to the Member States.

32003L0115

2003

Directive 2003/115/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 94/35/EC on sweeteners for use in foodstuffs Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consultation of the Scientific Committee on Food, pursuant to Article 6 of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs(5) lays down a list of sweeteners that may be used in the Community and their conditions of use. (2) Since 1996, two new sweeteners, sucralose and the salt of aspartame and acesulfame, have been found acceptable for use in food by the Scientific Committee on Food. (3) The opinion of the Scientific Committee on Food on cyclamic acid and its sodium and calcium salts (which led to the establishment of a new acceptable daily intake (ADI)) and recent studies on the intake of cyclamates lead to a reduction of the maximum usable doses of cyclamic acid and its sodium and calcium salts. (4) The designation of certain food categories in Directive 94/35/EC should be adapted to take into account Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(6) and of specific directives adopted for some groups of foodstuffs listed in Annex I to Council Directive 89/398/EEC(7). (5) The use of the food additives concerned complies with the general criteria laid down in Annex II to Directive 89/107/EEC. (6) Articles 53 and 54 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8) establish procedures for taking emergency measures in relation to food of Community origin or imported from a third country. They allow the Commission to adopt such measures in situations where food is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned. (7) The measures necessary for implementation of Directive 94/35/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9). (8) Directive 94/35/EC should therefore be amended accordingly, Article 1 Directive 94/35/EC is hereby amended as follows: 1. Article 4 shall be replaced by the following: "Article 4 It may be decided in accordance with the procedure laid down in Article 7: - where there are differences of opinion as to whether sweeteners can be used in a given foodstuff under the terms of this Directive, whether that foodstuff is to be considered as belonging to one of the categories listed in the third column of the Annex, and - whether a food additive listed in the Annex and authorised at 'quantum satis' is used in accordance with the criteria referred to in Article 2."; 2. a third indent shall be added to Article 5(2): "- salt of aspartame and acesulfame: 'contains a source of phenylalanine'."; 3. Article 7 shall be replaced by the following: "Article 7 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 178/2002(10), hereinafter referred to as 'the Committee'. 2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC(11) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure." 4. the Annex shall be amended in accordance with the Annex to this Directive. Article 2 By 29 January 2006 at the latest, the Commission shall submit a report to the European Parliament and the Council outlining the progress made in the re-evaluations of additives under way and setting out a provisional calendar for future re-evaluations, especially those for sucralose and salt of aspartame-acesulfame. These re-evaluations shall be carried out on the basis of consumer data supplied by the Member States and shall take account of the effects of additives on vulnerable population groups. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive in order to: - authorise trade in and use of products conforming with this Directive by 29 January 2005 at the latest, - prohibit trade in and use of products not conforming with this Directive by 29 July 2005 at the latest; however, products placed on the market before that date which do not comply with this Directive may be marketed until 29 January 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0125

2003

Commission Directive 2003/125/EC of 22 December 2003 implementing Directive 2003/6/EC of the European Parliament and of the Council as regards the fair presentation of investment recommendations and the disclosure of conflicts of interest (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse)(1), and in particular the sixth indent of Article 6(10) thereof, After consulting the Committee of European Securities Regulators (CESR)(2) for technical advice, Whereas: (1) Harmonised standards are necessary for the fair, clear and accurate presentation of information and disclosure of interests and conflicts of interest, to be complied with by persons producing or disseminating information recommending or suggesting an investment strategy, intended for distribution channels or for the public. In particular, market integrity requires high standards of fairness, probity and transparency when information recommending or suggesting an investment strategy is presented. (2) Recommending or suggesting an investment strategy is either done explicitly (such as "buy", "hold" or "sell" recommendations) or implicitly (by reference to a price target or otherwise). (3) Investment advice, through the provision of a personal recommendation to a client in respect of one or more transactions relating to financial instruments (in particular informal short-term investment recommendations originating from inside the sales or trading departments of an investment firm or a credit institution expressed to their clients), which are not likely to become publicly available, should not be considered in themselves as recommendations within the meaning of this Directive. (4) Investment recommendations that constitute a possible basis for investment decisions should be produced and disseminated in accordance with high standards of care in order to avoid misleading market participants. (5) The identity of the producer of investment recommendations, his conduct of business rules and the identity of his competent authority should be disclosed, since it may be a valuable piece of information for investors to consider in relation to their investment decisions. (6) Recommendations should be presented clearly and accurately. (7) Own interests or conflicts of interest of persons recommending or suggesting investment strategy may influence the opinion that they express in investment recommendations. In order to ensure that the objectivity and reliability of the information can be evaluated, appropriate disclosure should be made of significant financial interests in any financial instrument which is the subject of the information recommending investment strategies, or of any conflicts of interest or control relationship with respect to the issuer to whom the information relates, directly or indirectly. However, this Directive should not require relevant persons producing investment recommendations to breach effective information barriers put in place in order to prevent and avoid conflicts of interest. (8) Investment recommendations may be disseminated in unaltered, altered or summarised form by a person other than the producer. The way in which disseminators handle such recommendations may have an important impact on the evaluation of those recommendations by investors. In particular, the knowledge of the identity of the disseminator of investment recommendations, his conduct of business rules or the extent of alteration of the original recommendation can be a valuable piece of information for investors when considering their investment decisions. (9) Posting of investment recommendations on internet sites should be in accordance with the rules on transfer of personal data to third countries as laid down in 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 movement of such data(3). (10) Credit rating agencies issue opinions on the creditworthiness of a particular issuer or financial instrument as of a given date. As such, these opinions do not constitute a recommendation within the meaning of this Directive. However, credit rating agencies should consider adopting internal policies and procedures designed to ensure that credit ratings published by them are fairly presented and that they appropriately disclose any significant interests or conflicts of interest concerning the financial instruments or the issuers to which their credit ratings relate. (11) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular by Article 11 thereof and Article 10 of the European Convention on Human Rights. In this regard, this Directive does not in any way prevent Member States from applying their constitutional rules relating to freedom of the press and freedom of expression in the media. (12) The measures provided for in this Directive are in accordance with the opinion of the European Securities Committee, CHAPTER I DEFINITIONS Article 1 Definitions For the purposes of this Directive, the following definitions shall apply in addition to those laid down in Directive 2003/6/EC: 1. "investment firm" means any person as defined in Article 1(2) of Council Directive 93/22/EEC(4); 2. "credit institution" means any person as defined in Article 1(1) of Directive 2000/12/EC of the European Parliament and of the Council(5); 3. "recommendation" means research or other information recommending or suggesting an investment strategy, explicitly or implicitly, concerning one or several financial instruments or the issuers of financial instruments, including any opinion as to the present or future value or price of such instruments, intended for distribution channels or for the public; 4. "research or other information recommending or suggesting investment strategy" means: (a) information produced by an independent analyst, an investment firm, a credit institution, any other person whose main business is to produce recommendations or a natural person working for them under a contract of employment or otherwise, that, directly or indirectly, expresses a particular investment recommendation in respect of a financial instrument or an issuer of financial instruments; (b) information produced by persons other than the persons referred to in (a) which directly recommends a particular investment decision in respect of a financial instrument; 5. "relevant person" means a natural or legal person producing or disseminating recommendations in the exercise of his profession or the conduct of his business; 6. "issuer" means the issuer of a financial instrument to which a recommendation relates, directly or indirectly; 7. "distribution channels" shall mean a channel through which information is, or is likely to become, publicly available. "Likely to become publicly available information" shall mean information to which a large number of persons have access; 8. "appropriate regulation" shall mean any regulation, including self-regulation, in place in Member States as referred to by Directive 2003/6/EC. CHAPTER II PRODUCTION OF RECOMMENDATIONS Article 2 Identity of producers of recommendations 1. Member States shall ensure that there is appropriate regulation in place to ensure that any recommendation discloses clearly and prominently the identity of the person responsible for its production, in particular, the name and job title of the individual who prepared the recommendation and the name of the legal person responsible for its production. 2. Where the relevant person is an investment firm or a credit institution, Member States shall require that the identity of the relevant competent authority be disclosed. Where the relevant person is neither an investment firm nor a credit institution, but is subject to self-regulatory standards or codes of conduct, Member States shall ensure that a reference to those standards or codes is disclosed. 3. Member States shall ensure that there is appropriate regulation in place to ensure that the requirements laid down in paragraphs 1 and 2 are adapted in order not to be disproportionate in the case of non-written recommendations. Such adaptation may include a reference to the place where such disclosures can be directly and easily accessed by the public, such as an appropriate internet site of the relevant person. 4. Paragraphs 1 and 2 shall not apply to journalists subject to equivalent appropriate regulation, including equivalent appropriate self regulation, in the Member States, provided that such regulation achieves similar effects as those of paragraphs 1 and 2. Article 3 General standard for fair presentation of recommendations 1. Member States shall ensure that there is appropriate regulation in place to ensure that all relevant persons take reasonable care to ensure that: (a) facts are clearly distinguished from interpretations, estimates, opinions and other types of non-factual information; (b) all sources are reliable or, where there is any doubt as to whether a source is reliable, this is clearly indicated; (c) all projections, forecasts and price targets are clearly labelled as such and that the material assumptions made in producing or using them are indicated. 2. Member States shall ensure that there is appropriate regulation in place to ensure that the requirements laid down in paragraph 1 are adapted in order not to be disproportionate in the case of non-written recommendations. 3. Member States shall require that all relevant persons take reasonable care to ensure that any recommendation can be substantiated as reasonable, upon request by the competent authorities. 4. Paragraphs 1 and 3 shall not apply to journalists subject to equivalent appropriate regulation in the Member States, including equivalent appropriate self regulation, provided that such regulation achieves similar effects as those of paragraphs 1 and 3. Article 4 Additional obligations in relation to fair presentation of recommendations 1. In addition to the obligations laid down in Article 3, where the relevant person is an independent analyst, an investment firm, a credit institution, any related legal person, any other relevant person whose main business is to produce recommendations, or a natural person working for them under a contract of employment or otherwise, Member States shall ensure that there is appropriate regulation in place to ensure that person to take reasonable care to ensure that at least: (a) all substantially material sources are indicated, as appropriate, including the relevant issuer, together with the fact whether the recommendation has been disclosed to that issuer and amended following this disclosure before its dissemination; (b) any basis of valuation or methodology used to evaluate a financial instrument or an issuer of a financial instrument, or to set a price target for a financial instrument, is adequately summarised; (c) the meaning of any recommendation made, such as buy, sell or hold, which may include the time horizon of the investment to which the recommendation relates, is adequately explained and any appropriate risk warning, including a sensitivity analysis of the relevant assumptions, indicated; (d) reference is made to the planned frequency, if any, of updates of the recommendation and to any major changes in the coverage policy previously announced; (e) the date at which the recommendation was first released for distribution is indicated clearly and prominently, as well as the relevant date and time for any financial instrument price mentioned; (f) where a recommendation differs from a recommendation concerning the same financial instrument or issuer, issued during the 12-month period immediately preceding its release, this change and the date of the earlier recommendation are indicated clearly and prominently. 2. Member States shall ensure that, where the requirements laid down in points (a), (b) or (c) of paragraph 1 would be disproportionate in relation to the length of the recommendation distributed, it shall suffice to make clear and prominent reference in the recommendation itself to the place where the required information can be directly and easily accessed by the public, such as a direct Internet link to that information on an appropriate internet site of the relevant person, provided that there has been no change in the methodology or basis of valuation used. 3. Member States shall ensure that there is appropriate regulation in place to ensure that, in the case of non-written recommendations, the requirements of paragraph 1 are adapted so that they are not disproportionate. Article 5 General standard for disclosure of interests and conflicts of interest 1. Member States shall ensure that there is appropriate regulation in place to ensure that relevant persons disclose all relationships and circumstances that may reasonably be expected to impair the objectivity of the recommendation, in particular where relevant persons have a significant financial interest in one or more of the financial instruments which are the subject of the recommendation, or a significant conflict of interest with respect to an issuer to which the recommendation relates. Where the relevant person is a legal person, that requirement shall apply also to any legal or natural person working for it, under a contract of employment or otherwise, who was involved in preparing the recommendation. 2. Where the relevant person is a legal person, the information to be disclosed in accordance with paragraph 1 shall at least include the following: (a) any interests or conflicts of interest of the relevant person or of related legal persons that are accessible or reasonably expected to be accessible to the persons involved in the preparation of the recommendation; (b) any interests or conflicts of interest of the relevant person or of related legal persons known to persons who, although not involved in the preparation of the recommendation, had or could reasonably be expected to have access to the recommendation prior to its dissemination to customers or the public. 3. Member States shall ensure that there is appropriate regulation in place to ensure that the recommendation itself shall include the disclosures provided for in paragraphs 1 and 2. Where such disclosures would be disproportionate in relation to the length of the recommendation distributed, it shall suffice to make clear and prominent reference in the recommendation itself to the place where such disclosures can be directly and easily accessed by the public, such as a direct Internet link to the disclosure on an appropriate internet site of the relevant person. 4. Member States shall ensure that there is appropriate regulation in place to ensure that the requirements laid down in paragraph 1 are adapted in order not to be disproportionate in the case of non-written recommendations. 5. Paragraphs 1 to 3 shall not apply to journalists subject to equivalent appropriate regulation, including equivalent appropriate self regulation, in the Member States, provided that such regulation achieves similar effects as those of paragraphs 1 to 3. Article 6 Additional obligations in relation to disclosure of interests or conflicts of interest 1. In addition to the obligations laid down in Article 5, Member States shall require that any recommendation produced by an independent analyst, an investment firm, a credit institution, any related legal person, or any other relevant person whose main business is to produce recommendations, discloses clearly and prominently the following information on their interests and conflicts of interest: (a) major shareholdings that exist between the relevant person or any related legal person on the one hand and the issuer on the other hand. These major shareholdings include at least the following instances: - when shareholdings exceeding 5 % of the total issued share capital in the issuer are held by the relevant person or any related legal person, or - when shareholdings exceeding 5 % of the total issued share capital of the relevant person or any related legal person are held by the issuer. Member States may provide for lower thresholds than the 5 % threshold as provided for in these two instances; (b) other significant financial interests held by the relevant person or any related legal person in relation to the issuer; (c) where applicable, a statement that the relevant person or any related legal person is a market maker or liquidity provider in the financial instruments of the issuer; (d) where applicable, a statement that the relevant person or any related legal person has been lead manager or co-lead manager over the previous 12 months of any publicly disclosed offer of financial instruments of the issuer; (e) where applicable, a statement that the relevant person or any related legal person is party to any other agreement with the issuer relating to the provision of investment banking services, provided that this would not entail the disclosure of any confidential commercial information and that the agreement has been in effect over the previous 12 months or has given rise during the same period to the payment of a compensation or to the promise to get a compensation paid; (f) where applicable, a statement that the relevant person or any related legal person is party to an agreement with the issuer relating to the production of the recommendation. 2. Member States shall require disclosure, in general terms, of the effective organisational and administrative arrangements set up within the investment firm or the credit institution for the prevention and avoidance of conflicts of interest with respect to recommendations, including information barriers. 3. Member States shall require that for natural or legal persons working for an investment firm or a credit institution, under a contract of employment or otherwise, and who were involved in preparing the recommendation, the requirement under the second subparagraph of paragraph 1 of Article 5 shall include, in particular, disclosure of whether the remuneration of such persons is tied to investment banking transactions performed by the investment firm or credit institution or any related legal person. Where those natural persons receive or purchase the shares of the issuers prior to a public offering of such shares, the price at which the shares were acquired and the date of acquisition shall also be disclosed. 4. Member States shall require that investment firms and credit institutions disclose, on a quarterly basis, the proportion of all recommendations that are "buy", "hold", "sell" or equivalent terms, as well as the proportion of issuers corresponding to each of these categories to which the investment firm or the credit institution has supplied material investment banking services over the previous 12 months. 5. Member States shall ensure that the recommendation itself includes the disclosures required by paragraphs 1 to 4. Where the requirements under paragraphs 1 to 4 would be disproportionate in relation to the length of the recommendation distributed, it shall suffice to make clear and prominent reference in the recommendation itself to the place where such disclosure can be directly and easily accessed by the public, such as a direct Internet link to the disclosure on an appropriate internet site of the investment firm or credit institution. 6. Member States shall ensure that there is appropriate regulation in place to ensure that, in the case of non-written recommendations, the requirements of paragraph 1 are adapted so that they are not disproportionate. CHAPTER III DISSEMINATION OF RECOMMENDATIONS PRODUCED BY THIRD PARTIES Article 7 Identity of disseminators of recommendations Member States shall ensure that there is appropriate regulation in place to ensure that, whenever a relevant person under his own responsibility disseminates a recommendation produced by a third party, the recommendation indicates clearly and prominently the identity of that relevant person. Article 8 General standard for dissemination of recommendations Member States shall ensure that there is appropriate regulation in place to ensure that whenever a recommendation produced by a third party is substantially altered within disseminated information, that information clearly indicates the substantial alteration in detail. Member States shall ensure that whenever the substantial alteration consists of a change of the direction of the recommendation (such as changing a "buy" recommendation into a "hold" or "sell" recommendation or vice versa), the requirements laid down in Articles 2 to 5 on producers are met by the disseminator, to the extent of the substantial alteration. In addition, Member States shall ensure that there is appropriate regulation in place to ensure that relevant legal persons who themselves, or through natural persons, disseminate a substantially altered recommendation have a formal written policy so that the persons receiving the information may be directed to where they can have access to the identity of the producer of the recommendation, the recommendation itself and the disclosure of the producer's interests or conflicts of interest, provided that these elements are publicly available. The first and second paragraphs do not apply to news reporting on recommendations produced by a third party where the substance of the recommendation is not altered. In case of dissemination of a summary of a recommendation produced by a third party, the relevant persons disseminating such summary shall ensure that the summary is clear and not misleading, mentioning the source document and where the disclosures related to the source document can be directly and easily accessed by the public provided that they are publicly available. Article 9 Additional obligations for investment firms and credit institutions In addition to the obligations laid down in Articles 7 and 8, whenever the relevant person is an investment firm, a credit institution or a natural person working for such persons under a contract of employment or otherwise, and disseminates recommendations produced by a third party, Member States shall require that: (a) the name of the competent authority of the investment firm or credit institution is clearly and prominently indicated; (b) if the producer of the recommendation has not already disseminated it through a distribution channel, the requirements laid down in Article 6 on producers are met by the disseminator; (c) if the investment firm or credit institution has substantially altered the recommendation, the requirements laid down in Articles 2 to 6 on producers are met. CHAPTER IV FINAL PROVISIONS Article 10 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 12 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between these provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 11 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 12 Addressees This Directive is addressed to the Member States.

32003L0126

2003

Commission Directive 2003/126/EC of 23 December 2003 on the analytical method for the determination of constituents of animal origin for the official control of feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs(1), and in particular Article 2 thereof, Whereas: (1) Pursuant to Directive 70/373/EEC, official controls of feedingstuffs, for the purpose of checking compliance with the requirements of the laws, regulations and administrative provisions governing their quality and composition, are to be carried out using Community sampling and analysis methods. (2) Provisions on the labelling of feedingstuffs and requirements prohibiting the use of certain types of animal proteins in feedingstuffs for certain categories of animals imply the need to provide for reliable analytical methods to establish their presence and, if appropriate, their percentage. (3) The method described in Commission Directive 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identification and estimation of constituents of animal origin for the official control of feedingstuffs(2) is currently the only method validated to control the presence of animal proteins including these proteins treated at 133 °C/3 Bar/20', in feedingstuffs. (4) An intercomparison study for the determination of processed animal proteins recently demonstrated that the variation in the application of the microscopic tests laid down in Directive 98/88/EC resulted in significant differences in the sensitivity, specificity and accuracy of the method. In order to harmonise and improve determination of processed animal proteins the provisions concerning the microscopic method should be further specified and made mandatory. It is necessary to ensure that analysts performing the method are adequately trained since the performance depends on the skills of the analyst. (5) Directive 98/88/EC should therefore be replaced. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Member States shall provide that where official analysis of feedingstuffs is carried out with a view to officially controlling the presence, identification and/or estimation of the amount of constituents of animal origin in feedingstuffs, in the framework of the coordinated inspection programme in the field of animal nutrition in accordance with Council Directive 95/53/EC(3), it shall be carried out in accordance with the provisions of the Annex to this Directive. Article 2 Member States shall ensure that laboratories carrying out official controls on the presence of animal constituents in feedingstuffs participate periodically in proficiency testing on the analytical methods, and that laboratory personnel carrying out analyses receive adequate training. Article 3 Directive 98/88/EC is repealed. References to the repealed Directive shall be construed as references to this Directive. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32004L0001

2004

Commission Directive 2004/1/EC of 6 January 2004 amending Directive 2002/72/EC as regards the suspension of the use of azodicarbonamide as blowing agent (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, Whereas: (1) Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs(2) authorises the use of azodicarbonamide as a blowing agent in plastic materials and articles intended to come into contact with foodstuffs in accordance with the opinion of the Scientific Committee on Food (SCF). (2) Azodicarbonamide is used as blowing agent in the manufacture of plastic gaskets in metal lids used for the closure of glass jars. New findings have shown that azodicarbonamide decomposes into semicarbazide (SEM) when heated during production of the foamed gasket and during sterilisation of the sealed glass jar. (3) On 8 July 2003 the European Food Safety Authority (hereinafter called "the Authority") was informed by industry that SEM had been found in a number of foods contained in glass jars. The levels of SEM in these foods were variable (up to 25 μg/kg), with the highest concentrations found in baby foods. (4) Based on the existing scientific data, including recent research commissioned by the Authority, the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (hereinafter called "the Panel") concluded, in its statement of 1 October 2003, that SEM has a weak carcinogenic activity in laboratory animals and weak genotoxicity in vitro but that it was not possible according to the current scientific knowledge to conclude whether SEM poses a carcinogenic risk to humans. (5) An ad hoc expert group was specifically commissioned by the Authority to advise further on possible risks to infants, the consumer group for which potential exposure to SEM per body weight is likely to be the highest. In evaluating the possible consequences of SEM in baby foods, the expert group reviewed toxicological aspects alongside microbiological and nutritional considerations. (6) On 9 October 2003 they advised that, taking into account the current available information on the levels of SEM in food, intake and toxicology, the risk to both infants and adults eating foods containing SEM was probably very small. However, the Panel stated that the presence of SEM in baby food was undesirable and recommended that it would be prudent to reduce exposure to SEM as swiftly as technological progress safely allows. (7) Considering the conclusions of the Panel and the ad hoc expert group and the remaining scientific uncertainties it is appropriate, in order to achieve the high level of health protection chosen in the Community, to suspend the use of azodicarbonamide in accordance with the precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(3) (Food law). The suspension of azodicarbonamide from the incomplete list of additives fully harmonised at Community level should apply while the Community seeks more complete information from any source, which could clarify the gaps in the present state of knowledge of SEM. (8) The Commission has been informed that alternatives for azodicarbonamide will become available in the near future. With respect to the possible replacement of azodicarbonamide in packaging materials for baby foods, it is critical that careful consideration and evaluation of seal integrity be carried out prior to their introduction in order not to compromise the microbiological safety of the food. It is therefore necessary to provide for a transitional period of 18 months to allow such evaluation to be carried out over a time period, which takes account of the minimum shelf-life for such packaged foods. (9) A transitional period should also be provided for in respect of materials and articles which are brought into contact with foodstuffs before the deadline for implementation of this Directive. (10) This transitional period should also take into account the requirements of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(4). (11) Directive 2002/72/EC should therefore be amended accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 As regards the additive azodicarbonamide with reference number 36640 the text in column 4 of Section A of Annex III to Directive 2002/72/EC is replaced by the following: ">TABLE>" Article 2 1. Member States shall adopt and publish, by 2 August 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 2. Member States shall apply the provisions referred to in paragraph 1 from 2 August 2005 in such a way as to prohibit the placing on the market 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. However, materials and articles filled before 2 August 2005 may continue to be placed on the market provided that the date of filling appears on the materials and articles. The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive. The first and second subparagraphs shall apply without prejudice to the requirements of Directive 2000/13/EC. When Member States adopt the provisions referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0002

2004

Commission Directive 2004/2/EC of 9 January 2004 amending Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for fenamiphos (Text with EEA relevance) 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), as last amended by Commission Directive 2003/62/EC(2), and in particular Article 10 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(3), as last amended by Commission Directive 2003/60/EC(4), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(5), as last amended by Commission Directive 2003/69/EC(6), and in particular Article 7 thereof, Whereas: (1) In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides, and where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected. (2) MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data. (3) In the case of fenamiphos, a Member State informed the Commission of its desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC, in the light of concerns about consumer intake. A proposal for the review of Community MRLs was submitted to the Commission. (4) The lifetime and short term exposure of consumers to fenamiphos referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation(7). It is calculated that the MRLs fixed in this Directive will not lead to unacceptable consumer exposure. (5) Where relevant, the acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the MRLs proposed in this Directive will not cause acute toxic effects. (6) Through the World Trade Organisation, the Community's trading partners have been consulted about the MRLs proposed in this Directive and their comments on these levels have been taken into account. (7) The opinions of the Scientific Committee for Plants have been taken into account, in particular its advice and recommendations concerning the methodology to be followed for the protection of consumers of agricultural products treated with pesticides. (8) The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In part A of Annex II to Directive 86/362/EEC the following rows are added: ">TABLE>" Article 2 In part B of Annex II to Directive 86/363/EEC the following row is added: ">TABLE>" Article 3 Annex II to Directive 90/642/EEC is amended as follows: "The MRLs for fenamiphos in the Annex to this directive are added to the MRLs in Annex II to Directive 90/642/EEC." Article 4 Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 July 2004 at the latest. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 August 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 5 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32004L0004

2004

Commission Directive 2004/4/EC of 15 January 2004 amending Directive 96/3/EC 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: (1) It is necessary to amend Commission Directive 96/3/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(2), in order to take account of scientific developments. (2) On the basis of evaluations carried out by the Scientific Committee on Food and, in particular, of its opinion of 20 September 1996, as amended on 12 June 1997 (107th plenary meeting), and the updated opinion of 4 April 2003 on the potential risk to human health arising from the transport in ships' tanks of oils and fats from substances proposed as acceptable previous cargoes, it is necessary to amend the list of acceptable previous cargoes set out in the Annex to Directive 96/3/EC. (3) In the case of cyclohexanol, 2,3-butanediol, iso-butanol and nonane, the information available was inadequate or needed additional clarification to allow a sound scientific assessment of the toxicological properties and the Scientific Committee on Food was unable to carry out the requested evaluations. These substances were considered by the Scientific Committee on Food not acceptable as previous cargoes and therefore should be removed from the list of acceptable previous cargoes. (4) In the case of methyl esters of fatty acids (laurate, palmitate, stearate, oleate), acetic anhydride, ammonium polyphosphate, propylene tetramer, propyl alcohol, sodium silicate, in view of data available, the assessment of the Scientific Committee on Food has resulted in the acceptance of these substances as previous cargoes. These substances should be therefore added to the list of acceptable previous cargoes. (5) In the case of iso-decanol, iso-nonanol, iso-octanol, montan wax, paraffin wax and white mineral oils the information available was inadequate to carry out a complete evaluation. However, according to the opinion of the Scientific Committee on Food, these substances may be considered as provisionally acceptable as previous cargoes considering their unlikely genotoxic potential, their easy removal by tank cleaning procedures and the very low residues expected as a result of these factors and their likely dilution. (6) These provisionally acceptable substances should be reassessed on the basis of new scientific data and the Annex reviewed as appropriate within an adequate period of time. The data needed for the above evaluation should be provided, in particular, by relevant food business operators. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 96/3/EC is replaced by the Annex hereto. Article 2 The substances iso-decanol, iso-nonanol, iso-octanol, montan wax, paraffin wax and white mineral oils, shall be reassessed on the basis of new scientific data and the Annex reviewed as appropriate by 31 December 2006. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0006

2004

Commission Directive 2004/6/EC of 20 January 2004 derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products (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(2) thereof, Whereas: (1) Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses(2) specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of foodstuffs for particular nutritional uses. It provides that Member States are to prohibit trade in products not complying with the Directive with effect from 1 April 2004. (2) At the time of the adoption of Directive 2001/15/EC a number of substances added for specific nutritional purposes to some foods for particular nutritional uses, which are marketed in some Member States, could not be included in the Annex to that Directive because they had not been evaluated by the Scientific Committee on Food (SCF). (3) While the evaluation of those substances is being completed by the European Food Safety Authority their use should continue to be permitted in the manufacture of products marketed before the entry into force of this Directive. (4) The date of 1 April 2004 provided for in Article 3(b) of Directive 2001/15/EC makes it necessary that the present Directive should be transposed within a short deadline. (5) Therefore, a derogation from Directive 2001/15/EC should be provided for. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 By way of derogation from point (b) of the second subparagraph of Article 3 of Directive 2001/15/EC in so far as the requirements of the first subparagraph of Article 1(1) of the Directive apply and until 31 December 2006 Member States may continue to allow in their territory trade in products containing the substances listed in the Annex to this Directive provided that: (a) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of the substance in the manufacture of foods for particular nutritional uses to which Directive 2001/15/EC applies; (b) the substance in question is used in the manufacture of one or more foods for particular nutritional uses marketed in the Community on the date of entry into force of this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0005

2004

Commission Directive 2004/5/EC of 20 January 2004 amending Directive 2001/15/EC to include certain substances in the Annex (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(2) thereof, After consulting the Scientific Committee on Food or the European Food Safety Authority, Whereas: (1) Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses(2) specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of foodstuffs for particular nutritional uses. It provides that Member States are to prohibit trade in products not complying with the Directive with effect from 1 April 2004. (2) At the time of the adoption of Directive 2001/15/EC a number of chemical substances added for specific nutritional purposes in some foods for particular nutritional uses, which are marketed in some Member States, could not be included in the Annex to that Directive because they had not been evaluated by the Scientific Committee on Food (SCF). (3) Those chemical substances that have since been evaluated by the Scientific Committee on Food or by the European Food Safety Authority and have received a favourable scientific evaluation should be included in the Annex to Directive 2001/15/EC. (4) Since products containing those substances are on the market in certain Member States, it is necessary that this Directive be transposed before 1 April 2004, in order to avoid that the prohibition provided for in Directive 2001/15/EC becomes applicable to those substances for a limited period of time, which would cause an undue disruption of the market. (5) Directive 2001/15/EC should be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 2001/15/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 to comply with this Directive by 31 March 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0014

2004

Commission Directive 2004/14/EC of 29 January 2004 amending Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film 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), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council(2), and in particular Article 3 thereof, After consulting the Scientific Committee on Food, Whereas: (1) Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs(3), as amended by Directive 93/111/EC(4), applies to regenerated cellulose film and establishes a list of authorised substances together with restrictions on their use. That Directive covers regenerated cellulose films uncoated or coated with coatings manufactured only with substances listed therein. (2) Further to technological developments, it is necessary to authorise a new type of regenerated cellulose film with a coating consisting of plastics, which is compostable and biodegradable. This new type of regenerated cellulose film is consistent with the environmental requirements of Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste(5), as amended by Regulation (EC) No 1882/2003. Accordingly, such authorisation is in the interest of consistency of Community legislation. (3) The rules to be applied to the regenerated cellulose films should be specific to the nature of the layer in contact with the foodstuff. Accordingly, the requirements for regenerated cellulose films coated with coatings consisting of plastics should be different from those provided for regenerated cellulose films uncoated or coated with coatings derived from cellulose. (4) Only authorised substances should be used in the manufacture of all the types of regenerated cellulose films, including regenerated cellulose films coated with plastics. (5) In the case of regenerated cellulose films coated with coatings consisting of plastics, the layer in contact with foodstuffs consists of a material similar to plastic materials and articles intended to come into contact with foodstuffs. Therefore it is appropriate that the rules provided for in Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs(6) should be applicable also to such films. (6) In the interest of consistency of Community legislation, the verification of compliance of plastic-coated regenerated cellulose films with the migration limits set by Directive 2002/72/EC should be carried out according to the rules laid down in Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs(7), as last amended by Commission Directive 97/48/EC(8), and Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs(9). (7) A number of polymers used as coatings should be deleted from the list of authorised substances set out in Directive 93/10/EEC as they are covered by the rules set out in Directive 2002/72/EC which apply to plastic-coated regenerated cellulose films. (8) Four solvents should also be deleted from the list of authorised substances set out in Directive 93/10/EEC as new data are available showing a risk for reproduction and because they are no longer used in the manufacture of regenerated cellulose films. In addition, some plasticisers, which are no longer used, should also be deleted from that list. (9) In addition, the restriction on the use of 2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2-ethylhexyl ester) set out in Directive 93/10/EEC should be amended to take into account the opinion of the Scientific Committee on Food of 19 March 1998. (10) Directive 93/10/EEC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 93/10/EEC is amended as follows: 1. In Article 1(3), point (a) is deleted. 2. The following Article 1a is inserted: "Article 1a The regenerated cellulose films referred to in Article 1(2) shall belong to one of the following types: (a) uncoated regenerated cellulose film; (b) coated regenerated cellulose film with coating derived from cellulose; or (c) coated regenerated cellulose film with coating consisting of plastics." 3. Article 2(1) is replaced by the following: "1. Regenerated cellulose films referred to in points (a) and (b) of Article 1a shall be manufactured using only substances or groups of substances listed in Annex II subject to the restrictions set out therein." 4. The following Article 2a is inserted: "Article 2a 1. Regenerated cellulose film referred to in Article 1a(c) shall be manufactured, prior to coating, using only substances or groups of substances listed in the first part of Annex II, subject to the restrictions set out therein. 2. The coating to be applied to the regenerated cellulose film referred to in paragraph 1 shall be manufactured using only substances or groups of substances listed in Annexes II to VI to Directive 2002/72/EC, subject to the restrictions set out therein. 3. Without prejudice to paragraph 1, materials and articles made of regenerated cellulose film referred to in Article 1a(c) shall comply with Articles 2, 7 and 8 of Directive 2002/72/EC." 5. Annex II 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 to comply with this Directive by 29 July 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. Member States shall apply those provisions in such a way as to: (a) permit the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs complying with this Directive, from 29 July 2005; (b) prohibit the manufacture and importation into the Community of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not comply with the provisions of this Directive as from 29 January 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0013

2004

Commission Directive 2004/13/EC of 29 January 2004 amending Directive 2002/16/EC on the use of certain epoxy derivatives in 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 European Food Safety Authority, Whereas: (1) Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs(2) lays down certain rules applicable to the use/presence of 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether ("BADGE"), bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers ("BFDGE"), novolac glycidyl ethers ("NOGE"), and some of their derivatives, in materials and articles intended to come into contact with foodstuffs. (2) That Directive provides that the use and/or presence of BADGE in the manufacture of those materials and articles may only be continued until 31 December 2004. (3) The Scientific Committee on Food (SCF) requested toxicological data to permit the evaluation of BADGE within certain deadlines. The SCF also requested that new toxicological data be supplied to evaluate the potential carcinogenicity of chlorinated derivatives which were included in the quantitative restriction to be applied to the migration of BADGE provided for in Annex I to Directive 2002/16/EC. (4) On 4 December 2002, the SCF noted the negative results on the potential carcinogenicity of the chlorinated derivatives of BADGE and the low exposure of the European consumer to BADGE as a consequence of the considerable reduction of the content of BADGE found in canned food in the recent enquiries carried out by the Member States and by the Joint Research Centre of the European Commission. Therefore, it is considered admissible to extend the provisional authorisation of BADGE for one year, pending the submission of the new toxicological data and their evaluation by the European Food Safety Authority. (5) Directive 2002/16/EC provides that the requirements of that Directive concerning BADGE, BFDGE and NOGE do not apply to materials and articles covered by surface coatings, and adhesives, which are brought into contact with foodstuffs before 1 March 2003. Those materials and articles may continue to be placed on the market provided that the date of filling appears on the materials and articles. In the interest of an unequivocal interpretation of how the date of filling should be applied on materials and articles, it is appropriate to provide that this date may be replaced by the "best before" date as provided for by Directive 2000/13/EC of the European Parliament and of the Council(3), or another indication such as the lot number required by Council Directive 89/396/EEC(4) for the foodstuffs packed in such materials and articles. It is, though, necessary that a link is established between such indication and the date of filling so that the latter can be always identified. (6) Directive 2002/16/EC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 2002/16/EC is amended as follows: 1. in Article 2, second paragraph, the date "31 December 2004" is replaced by the date "31 December 2005"; 2. Article 5 is replaced by the following: "Article 5 1. Articles 2, 3 and 4 shall not apply to the materials and articles referred to in points (b) and (c) of the second subparagraph of Article 1(1) which are brought into contact with foodstuffs before 1 March 2003. Those materials and articles may be placed on the market provided that the date of filling appears on the materials and articles. However, the date of filling may be replaced by another indication, provided that this indication permits the identification of the date of filling. Upon request, the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive. 2. Paragraph 1 shall apply without prejudice to the requirements of Directive 2000/13/EC.". Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 January 2005 at latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0003

2004

Directive 2004/3/EC of the European Parliament and of the Council of 11 February 2004 amending Council Directives 70/156/EEC and 80/1268/EEC as regards the measurement of carbon dioxide emissions and fuel consumption of N1 vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Directive 80/1268/EEC of 16 December 1980 relating to the carbon dioxide emissions and fuel consumption of motor vehicles(4) is one of the separate directives under the type-approval procedure laid down by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5). (2) The communication from the Commission to the European Parliament and to the Council on "EU policies and measures to reduce greenhouse gas emissions: towards a European Climate Change Programme (ECCP)", proposes an implementation strategy to reduce the emission of greenhouse gases, including measures in the transport sector. The Green Paper "Towards a European strategy for the security of energy supply" likewise calls for efforts to improve fuel economy of motor vehicles. (3) Under the Community strategy to reduce carbon dioxide (CO2) emissions from passenger cars, as outlined in the communication from the Commission to the European Parliament and to the Council entitled "A Community strategy to reduce CO2 emissions from passenger cars and improve fuel economy", the harmonised measurement methodology, as laid down in Directive 80/1268/EEC, has been used as a basic instrument. With a view to permitting subsequent measures to reduce fuel consumption and CO2 emissions in the sector of light commercial vehicles, it is necessary to extend the scope of that Directive to include vehicles of category N1 as well. (4) As referred to in Decision No 1753/2000/EC of the European Parliament and of the Council of 22 June 2000 establishing a scheme to monitor the average specific emissions of CO2 from new passenger cars(6), the Commission has carried out a study to investigate the possibilities and implications of a harmonised procedure for measuring the specific CO2 emissions from vehicles of category N1. In this respect, it is considered technically acceptable and most cost-effective to apply the existing emissions test of 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(7) also for the measurement of fuel consumption and CO2 emissions for that category of vehicles. (5) Many small-volume manufacturers buy from suppliers engines which are type-approved with respect to emissions according to Council Directive 88/77/EEC of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emissions of gaseous and particulate pollutants from compression ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles(8). A considerable number of those manufacturers do not have the necessary infrastructure or expertise to perform the exhaust or CO2 emissions testing. It is therefore necessary to grant an exemption for small-volume manufacturers, since the additional costs they would incur in order to comply with this Directive would be disproportionately high. (6) Those measures also have an impact on the Annexes to Directive 70/156/EEC. (7) Directives 70/156/EEC and 80/1268/EEC should therefore be amended accordingly, Article 1 Directive 70/156/EEC is hereby amended as follows: (a) row 39 of Annex IV, part I, is replaced by the following: ">TABLE>" (b) in the Community certificate of conformity for complete or completed vehicles of categories N1, N2 and N3 in Annex IX, part I, page 2, the following point shall be added: " >PIC FILE= "L_2004049EN.003701.TIF">" Article 2 Annexes I and II to Directive 80/1268/EEC shall be amended as set out in the Annex to this Directive. Article 3 No later than 19 February 2006, the Commission shall: (a) present a study on the possibilities of obtaining representative CO2 emission and fuel consumption data for completed multistage vehicles and vehicles whose emissions are measured according to Directive 88/77/EEC in order to take into account the "cost-efficiency" aspects of these measurements; (b) present an evaluation of the vehicle family concept introduced in this Directive; (c) if appropriate, present draft measures on the adaptation of this Directive to technical progress to the Committee established by Article 13 of Directive 70/156/EEC. Article 4 Where a vehicle produced by a specialist coach builder falls within the criteria of one of the families of vehicles of the manufacturer of the base vehicle, the coach builder may use the data on fuel efficiency and CO2 production supplied by that manufacturer. Article 5 1. With effect from 19 February 2005 for vehicles of category N1, Member States may not, on grounds relating to CO2 emission or to fuel consumption: (a) refuse, in respect of any given type of motor vehicle, to grant EC type-approval or national type-approval; (b) prohibit the registration, sale or entry into service of vehicles pursuant to Article 7 of Directive 70/156/EEC, if the CO2 emission and fuel consumption figures have been determined in accordance with the requirements of Directive 80/1268/EEC, as amended by this Directive. 2. With effect from 1 January 2005 for vehicles of category N1, Class I, and with effect from 1 January 2007 for vehicles of category N1, Classes II and III, Member States: (a) shall no longer grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC; (b) shall refuse to grant national type-approval, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, if the CO2 emission and fuel consumption figures have not been determined in accordance with the requirements of Directive 80/1268/EEC, as amended by this Directive. 3. With effect from 1 January 2006 for vehicles of category N1, Class I, and with effect from 1 January 2008 for vehicles of category N1, Classes II and III, Member States shall: (a) consider certificates of conformity which accompany new vehicles pursuant to Directive 70/156/EEC to be no longer valid for the purpose of Article 7(1) of that Directive; (b) refuse the registration, sale or entry into service of new vehicles which are not accompanied by a valid certificate of conformity pursuant to Directive 70/156/EEC, except where the provisions of Article 8(2) of that Directive are invoked; if the CO2 emission and fuel consumption figures have not been determined in accordance with the requirements of Directive 80/1268/EEC, as amended by this Directive. 4. For multistage vehicles of category N1, the dates mentioned in paragraphs 2 and 3 shall be postponed by 12 months. 5. For the purposes of this Article: - a vehicle of category N1, Class I, means an N1 vehicle with a reference mass not exceeding 1305 kg, - a vehicle of category N1, Class II, means an N1 vehicle with a reference mass greater than 1305 kg, but not exceeding 1760 kg, - a vehicle of category N1, Class III, means an N1 vehicle with a reference mass in excess of 1760 kg. Article 6 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 19 February 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 7 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 8 This Directive is addressed to the Member States.

32004L0012

2004

Directive 2004/12/EC of the European Parliament and of the Council of 11 February 2004 amending Directive 94/62/EC on packaging and packaging waste - Statement by the Council, the Commission and the European Parliament Having regard to the Treaty establishing the European Community, and in particular Article 95(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 17 December 2003(3), Whereas: (1) Pursuant to Directive 94/62/EC(4) the Council is required, no later than six months before the end of a five-year phase starting from the date by which that Directive should have been implemented in national law, to fix targets for the next five-year phase. (2) The definition of "packaging" laid down in Directive 94/62/EC should be further clarified through the introduction of certain criteria and an annex containing illustrative examples. It is necessary, in order to achieve the ambitious recycling targets, to encourage the development of innovative, environmentally sound and viable recycling processes. An evaluation of the different recycling methods should be made with a view to drawing up definitions for these methods. (3) Recycling targets for each specific waste material should take account of life-cycle assessments and cost-benefit analysis, which have indicated clear differences both in the costs and in the benefits of recycling the various packaging materials, and should improve the coherence of the internal market for the recycling of these materials. (4) Recovery and recycling of packaging waste should be further increased to reduce its environmental impact. (5) Certain Member States which, on account of their special circumstances, were allowed to postpone the date fixed for achievement of the recovery and recycling targets set in Directive 94/62/EC should be granted a further, but limited, postponement. (6) The European Parliament, the Council and the Commission agree on the need for temporary derogations for the acceding States with respect to the targets of this Directive. This should be decided on the basis of the requests from the acceding States for derogations to run in principle until not later than 2012 for Cyprus, the Czech Republic, Estonia, Hungary, Lithuania, Slovakia and Slovenia; 2013 for Malta; 2014 for Poland and 2015 for Latvia. (7) This agreement will be finalised in accordance with the appropriate legal procedure before the expiry of the deadline for the transposition of this Directive. (8) The management of packaging and packaging waste requires the Member States to set up return, collection and recovery systems. 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. Discrimination against materials on the basis of their weight should be avoided. The operators in the packaging chain as a whole should shoulder their shared responsibility to ensure that the environmental impact of packaging and packaging waste throughout its life cycle is reduced as far as possible. (9) Annual Community-wide data on packaging and packaging waste, including on waste exported for recycling and recovery outside the Community, are needed in order to monitor the implementation of the objectives of this Directive. This requires a harmonised reporting technique and clear guidelines for data providers. (10) The Commission should examine and report on the implementation of this Directive and its impact on both the environment and the internal market. This report should also cover the issues of essential requirements, waste prevention measures, a possible packaging indicator, waste prevention plans, reuse, producer responsibility and heavy metal and should, as appropriate, be accompanied by proposals for revision. (11) Member States should promote relevant consumer information and awareness campaigns and encourage other prevention instruments. (12) In addition to the environmental and internal market objectives of this Directive, recycling may also have the effect of providing jobs which have declined elsewhere in society, and may thus help prevent exclusion. (13) Since the objectives of the proposed action, namely to harmonise national targets for the recycling of packaging waste, taking into account individual circumstances of each Member State, and to provide further clarification on definitions, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5). (15) Directive 94/62/EC should therefore be amended accordingly, Article 1 Directive 94/62/EC is hereby amended as follows: 1. the following subparagraphs shall be added to point 1 of Article 3:"The definition of 'packaging' shall be further based on the criteria set out below. The items listed in Annex I are illustrative examples of the application of these criteria. (i) Items shall be considered to be packaging if they fulfil the abovementioned definition without prejudice to other functions which the packaging might also perform, unless the item is an integral part of a product and it is necessary to contain, support or preserve that product throughout its lifetime and all elements are intended to be used, consumed or disposed of together. (ii) Items designed and intended to be filled at the point of sale and 'disposable' items sold, filled or designed and intended to be filled at the point of sale shall be considered to be packaging provided they fulfil a packaging function. (iii) Packaging components and ancillary elements integrated into packaging shall be considered to be part of the packaging into which they are integrated. Ancillary elements hung directly on, or attached to, a product and which perform a packaging function shall be considered to be packaging unless they are an integral part of this product and all elements are intended to be consumed or disposed of together. The Commission shall, as appropriate, in accordance with the procedure referred to in Article 21, examine and, where necessary, review the illustrative examples for the definition of packaging given in Annex I. As a priority, the following items shall be addressed: CD and video cases, flower pots, tubes and cylinders around which flexible material is wound, release paper of self-adhesive labels and wrapping paper." 2. Article 4 shall be replaced by the following: "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, projects to introduce producer responsibility to minimise the environmental impact of packaging or similar actions adopted, if appropriate in consultation with economic operators, and designed to bring together 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. The standards shall aim to minimise the environmental impact of packaging in accordance with Articles 9 and 10. 3. The Commission shall, as appropriate, present proposals for measures to strengthen and complement the enforcement of the essential requirements and to ensure that new packaging is put on the market only if the producer has taken all necessary measures to minimise its environmental impact without compromising the essential functions of the packaging." 3. Article 6 shall be replaced by the following: "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 30 June 2001 between 50 % as a minimum and 65 % as a maximum by weight of packaging waste will be recovered or incinerated at waste incineration plants with energy recovery; (b) no later than 31 December 2008 60 % as a minimum by weight of packaging waste will be recovered or incinerated at waste incineration plants with energy recovery; (c) no later than 30 June 2001 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; (d) no later than 31 December 2008 between 55 % as a minimum and 80 % as a maximum by weight of packaging waste will be recycled; (e) no later than 31 December 2008 the following minimum recycling targets for materials contained in packaging waste will be attained: (i) 60 % by weight for glass; (ii) 60 % by weight for paper and board; (iii) 50 % by weight for metals; (iv) 22,5 % by weight for plastics, counting exclusively material that is recycled back into plastics; (v) 15 % by weight for wood. 2. Packaging waste exported out of the Community in accordance with Council Regulations (EEC) No 259/93(6), (EC) No 1420/1999(7) and Commission Regulation (EC) No 1547/1999(8), shall only count for the achievement of the obligations and targets of paragraph 1 if there is sound evidence that the recovery and/or recycling operation took place under conditions that are broadly equivalent to those prescribed by the Community legislation on the matter. 3. Member States shall, where appropriate, encourage energy recovery, where it is preferable to material-recycling for environmental and cost-benefit reasons. This could be done by considering a sufficient margin between national recycling and recovery targets. 4. Member States shall, where appropriate, encourage the use of materials obtained from recycled packaging waste for the manufacturing of packaging and other products by: (a) improving market conditions for such materials; (b) reviewing existing regulations preventing the use of those materials. 5. Not later than 31 December 2007, the European Parliament and the Council shall, acting by qualified majority and on a proposal from the Commission, fix targets for the third five-year phase 2009 until 2014, based on the practical experience gained in the Member States in pursuit of the targets laid down in paragraph 1 and the findings of scientific research and evaluation techniques such as life-cycle assessments and cost-benefit analysis. This process shall be repeated every five years. 6. The measures and targets referred to in paragraph 1 shall be published by the Member States and shall be the subject of an information campaign for the general public and economic operators. 7. Greece, Ireland and Portugal may, because of their specific situations, namely 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 30 June 2001, lower targets than those fixed in paragraphs 1(a) and (c), but shall at least attain 25 % for recovery or incineration at waste incineration plants with energy recovery; (b) postpone at the same time the attainment of the targets in paragraphs 1(a) and (c) to a later deadline which shall not, however, be later than 31 December 2005; (c) postpone the attainment of the targets referred to in paragraphs 1(b), (d) and (e) until a date of their own choice which shall not be later than 31 December 2011. 8. The Commission shall, as soon as possible and no later than 30 June 2005, present a report to the European Parliament and the Council on the progress of the implementation of this Directive and its impact on the environment, as well as on the functioning of the internal market. The report shall take into account individual circumstances in each Member State. It shall cover the following: (a) an evaluation of the effectiveness, implementation and enforcement of the essential requirements; (b) additional prevention measures to reduce the environmental impact of packaging as far as possible without compromising its essential functions; (c) the possible development of a packaging environment indicator to render packaging waste prevention simpler and more effective; (d) packaging waste prevention plans; (e) encouragement of reuse and, in particular, comparison of the costs and benefits of reuse and those of recycling; (f) producer responsibility including its financial aspects; (g) efforts to reduce further and, if appropriate, ultimately phase out heavy metals and other hazardous substances in packaging by 2010. This report shall, as appropriate, be accompanied by proposals for revision of the related provisions of this Directive, unless such proposals have, by that time, been presented. 9. The report shall address the issues in paragraph 8 as well as other relevant issues in the framework of the different elements of the Sixth Environmental Action Programme, in particular the thematic strategy on recycling and the thematic strategy on the sustainable use of resources. The Commission and the Member States shall, as appropriate, encourage studies and pilot projects concerning points 8(b), (c), (d), (e) and (f) and other prevention instruments. 10. Member States which have, or will, set programmes going beyond the maximum targets of paragraph 1 and which provide to this effect appropriate capacities for recycling and recovery shall be 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 this Directive. Member States shall inform the Commission of such measures. The Commission shall confirm these measures, after having verified, in cooperation with the Member States, that they are consistent with the abovementioned considerations and do not constitute an arbitrary means of discrimination or a disguised restriction on trade between Member States." 4. Article 8(2) shall be replaced by the following: "2. To facilitate collection, reuse and recovery including recycling, packaging shall indicate for the purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used on the basis of Commission Decision 97/129/EC(9)." 5. The following paragraph shall be added to Article 13:"Member States shall also promote consumer information and awareness campaigns." 6. Article 19 shall be replaced by the following: "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) and Article 10, second subparagraph, last indent), the formats relating to the database system (as referred to in Article 12(3) and Annex III) as well as the illustrative examples on the definition of packaging (as referred to in Annex I) shall be adopted in accordance with the procedure referred to in Article 21(2)." 7. Article 20(1) shall be replaced by the following: "1. The Commission, in accordance with the procedure referred to 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 inert packaging materials, put on the market in very small quantities (i.e. approximately 0,1 % by weight) in the European Union, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging." 8. Article 21 shall be replaced by the following: "Article 21 Committee procedure 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC(10) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure." 9. The following paragraph shall be inserted in Article 22: "3a. Provided that the objectives set out in Article 6 are achieved, Member States may transpose the provisions of Article 7 by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements: (a) agreements shall be enforceable; (b) agreements shall specify objectives with the corresponding deadlines; (c) agreements shall be published in the national official journal or an official document equally accessible to the public, and transmitted to the Commission; (d) the results achieved shall be monitored regularly, reported to the competent authorities and the Commission and made available to the public under the conditions set out in the agreement; (e) the competent authorities shall ensure that the progress achieved under the agreement is examined; (f) in the event of non-compliance with the agreement, Member States shall implement the relevant provisions of this Directive by legislative, regulatory or administrative measures." 10. Annex I shall be replaced by the annex which appears in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 18 August 2005. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0008

2004

Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of cogeneration based on a useful heat demand in the internal energy market and amending Directive 92/42/EEC Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European 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 251 of the Treaty(4), Whereas: (1) The potential for use of cogeneration as a measure to save energy is underused in the Community at present. Promotion of high-efficiency cogeneration based on a useful heat demand is a Community priority given the potential benefits of cogeneration with regard to saving primary energy, avoiding network losses and reducing emissions, in particular of greenhouse gases. In addition, efficient use of energy by cogeneration can also contribute positively to the security of energy supply and to the competitive situation of the European Union and its Member States. It is therefore necessary to take measures to ensure that the potential is better exploited within the framework of the internal energy market. (2) Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003(5) establishes common rules for the generation, transmission, distribution and supply of electricity within the internal market in electricity. In this context, the development of cogeneration contributes to enhancing competition, also with regard to new market actors. (3) The Green Paper entitled "Towards a European strategy for the security of energy supply" points out that the European Union is extremely dependent on its external energy supplies currently accounting for 50 % of requirements and projected to rise to 70 % by 2030 if current trends persists. Import dependency and rising import ratios heighten the risk of interruption to or difficulties in supply. However, security of supply should not be conceived as merely a question of reducing import dependency and boosting domestic production. Security of supply calls for a wide range of policy initiatives aimed at, inter alia, diversification of sources and technologies and improved international relations. The Green Paper emphasised furthermore that security of energy supply is essential for a future sustainable development. The Green Paper concludes that the adoption of new measures to reduce energy demand is essential both in terms of reducing the import dependence and in order to limit greenhouse gas emissions. In its Resolution of 15 November 2001 on the Green Paper(6), the European Parliament called for incentives to encourage a shift towards efficient energy production plants, including combined heat and power. (4) The Commission's Communication "A Sustainable Europe for a better world - A European Union Strategy for Sustainable Development" presented at the Gothenburg European Council on 15 and 16 June 2001 identified climate change as one of the principal barriers to sustainable development and emphasised the need for increased use of clean energy and clear action to reduce energy demand. (5) The increased use of cogeneration geared towards making primary energy savings could constitute an important part of the package of measures needed to comply with the Kyoto Protocol to the United Nations Framework Convention on Climate Change, and of any policy package to meet further commitments. The Commission in its Communication on the implementation of the first phase of the European Climate Change Programme identified promotion of cogeneration as one of the measures needed to reduce the greenhouse gas emissions from the energy sector and announced its intention to present a proposal for a Directive on the promotion of cogeneration in 2002. (6) In its Resolution of 25 September 2002 on the Commission communication on the implementation of the first phase of the European Climate Change Programme(7), the European Parliament welcomes the idea of submitting a proposal to strengthen Community measures to promote the use of combined heat and power (CHP) and calls for prompt adoption of a Directive on the promotion of CHP. (7) The importance of cogeneration was also recognised by the Council Resolution of 18 December 1997(8) and by the European Parliament Resolution of 15 May 1998(9) on a Community strategy to promote combined heat and power. (8) The Council in its Conclusions of 30 May 2000 and of 5 December 2000 endorsed the Commission's Action Plan on energy efficiency and identified promotion of cogeneration as one of the short-term priority areas. The European Parliament in its Resolution of 14 March 2001 on the Action Plan on energy efficiency(10) called on the Commission to submit proposals establishing common rules for the promotion of cogeneration, where this makes environmental sense. (9) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(11), Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants(12) and Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste(13) highlight the need to evaluate the potential for cogeneration in new installations. (10) Directive 2002/91/EC of the European Parliament and of the Council of 16 December 2002 on the energy performance of buildings(14) requires the Member States to ensure that for new buildings with a total useful floor area of over 1000 m2, the technical, environmental and economic feasibility of alternative systems, such as cogeneration of heat and power, is considered and taken into account before construction starts. (11) High efficiency cogeneration is in this Directive defined by the energy savings obtained by combined production instead of separate production of heat and electricity. Energy savings of more than 10 % qualify for the term "high-efficiency cogeneration". To maximise the energy savings and to avoid energy savings being lost, the greatest attention must be paid to the functioning conditions of cogeneration units. (12) In the context of the evaluation of primary energy savings, it is important to take into account the situation of Member States in which the most of electricity consumption is covered by imports. (13) It is important for transparency to adopt a harmonised basic definition of cogeneration. Where cogeneration installations are equipped to generate separate electricity or heat production, such production should not be specified as cogeneration for issuing a guarantee of origin and for statistical purposes. (14) To ensure that support for cogeneration in the context of this Directive is based on the useful heat demand and primary energy savings, it is necessary to set up criteria to determine and assess the energy efficiency of the cogeneration production identified under the basic definition. (15) The general objective of this Directive should be to establish a harmonised method for calculation of electricity from cogeneration and necessary guidelines for its implementation, taking into account methodologies such as those currently under development by European standardisation organisations. This method should be adjustable to take account of technical progress. Application of the calculations in Annexes II and III to micro-cogeneration units could, in accordance with the principle of proportionality, be based on values resulting from a type testing process certified by a competent, independent body. (16) The definitions of cogeneration and of high-efficiency cogeneration used in this Directive do not prejudge the use of different definitions in national legislation, for purposes other than those set out in this Directive. It is appropriate to borrow in addition the relevant definitions contained in Directive 2003/54/EC and in Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market(15). (17) Measuring the useful heat output at the point of production of the cogeneration plant underlines the need to ensure that advantages of the cogenerated useful heat are not lost in high heat losses from distribution networks. (18) The power to heat ratio is a technical characteristic that needs to be defined in order to calculate the amount of electricity from cogeneration. (19) For the purpose of this Directive, the definition of "cogeneration units" may also include equipment in which only electrical energy or only thermal energy can be generated, such as auxiliary firing and after burning units. The output from such equipment should not be considered as cogeneration for issuing a guarantee of origin and for statistical purposes. (20) The definition of "small scale cogeneration" comprises, inter alia, micro-cogeneration and distributed cogeneration units such as cogeneration units supplying isolated areas or limited residential, commercial or industrial demands. (21) To increase transparency for the consumer's choice between electricity from cogeneration and electricity produced on the basis of other techniques, it is necessary to ensure that, on the basis of harmonised efficiency reference values, the origin of high-efficiency cogeneration can be guaranteed. Schemes for the guarantee of origin do not by themselves imply a right to benefit from national support mechanisms. (22) It is important that all forms of electricity produced from high-efficiency cogeneration can be covered by guarantees of origin. It is important to distinguish guarantees of origin clearly from exchangeable certificates. (23) To ensure increased market penetration of cogeneration in the medium term, it is appropriate to require all Member States to adopt and publish a report analysing the national potential for high-efficiency cogeneration and to include a separate analysis of barriers to cogeneration in the report, and of measures taken to ensure the reliability of the guarantee system. (24) Public support should be consistent with the provisions of the Community guidelines on State aid for environmental protection(16), including as regards the non-cumulation of aid. These guidelines currently allow certain types of public support if it can be shown that the support measures are beneficial in terms of protection of the environment because the conversion efficiency is particularly high, because the measures will allow energy consumption to be reduced or because the production process will be less damaging to the environment. Such support will in some cases be necessary to further exploit the potential for cogeneration, in particular to take account of the need to internalise external costs. (25) Public support schemes for promoting cogeneration should focus mainly on support for cogeneration based on economically justifiable demand for heat and cooling. (26) Member States operate different mechanisms of support for cogeneration at the national level, including investment aid, tax exemptions or reductions, green certificates and direct price support schemes. One important means to achieve the aim of this Directive is to guarantee the proper functioning of these mechanisms, until a harmonised Community framework is put into operation, in order to maintain investor confidence. The Commission intends to monitor the situation and report on experiences gained with the application of national support schemes. (27) For the transmission and distribution of electricity from high-efficiency cogeneration, the provisions of Article 7(1), (2) and (5) of Directive 2001/77/EC as well as relevant provisions of Directive 2003/54/EC should apply. Until the cogeneration producer is an eligible customer under national legislation within the meaning of Article 21(1) of Directive 2003/54/EC, tariffs related to the purchase of additional electricity sometimes needed by cogeneration producers should be set according to objective, transparent and non-discriminatory criteria. Especially for small scale and micro-cogeneration units access to the grid system of electricity produced from high-efficiency cogeneration may be facilitated subject to notification to the Commission. (28) In general, cogeneration units up to 400 kW falling within the definitions of Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels(17) are unlikely to meet the minimum efficiency requirements therein and should therefore be excluded from that Directive. (29) The specific structure of the cogeneration sector, which includes many small and medium-sized producers, should be taken into account, especially when reviewing the administrative procedures for obtaining permission to construct cogeneration capacity. (30) Within the purpose of this Directive to create a framework for promoting cogeneration it is important to emphasise the need for a stabile economical and administrative environment for investments in new cogeneration installations. Member States should be encouraged to address this need by designing support schemes with a duration period of at least four years and by avoiding frequent changes in administrative procedures etc. Member States should furthermore be encouraged to ensure that public support schemes respect the phase-out principle. (31) The overall efficiency and sustainability of cogeneration is dependent on many factors, such as technology used, fuel types, load curves, the size of the unit, and also on the properties of the heat. For practical reasons and based on the fact, that the use of the heat output for different purposes requires different temperature levels of the heat, and that these and other differences influence efficiencies of the cogeneration, cogeneration could be divided into classes such as: "industrial cogeneration", "heating cogeneration" and "agricultural cogeneration". (32) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, general principles providing a framework for the promotion of cogeneration in the internal energy market should be set at Community level, but the detailed implementation should be left to Member States, thus allowing each Member State to choose the regime, which corresponds best to its particular situation. This Directive confines itself to the minimum required in order to achieve those objectives and does not go beyond what is necessary for that purpose. (33) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June laying down the procedures for the exercise of implementing powers conferred on the Commission(18), Article 1 Purpose The purpose of this Directive is to increase energy efficiency and improve security of supply by creating a framework for promotion and development of high efficiency cogeneration of heat and power based on useful heat demand and primary energy savings in the internal energy market, taking into account the specific national circumstances especially concerning climatic and economic conditions. Article 2 Scope This Directive shall apply to cogeneration as defined in Article 3 and cogeneration technologies listed in Annex I. Article 3 Definitions For the purpose of this Directive, the following definitions shall apply: (a) "cogeneration" shall mean the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy; (b) "useful heat" shall mean heat produced in a cogeneration process to satisfy an economically justifiable demand for heat or cooling; (c) "economically justifiable demand" shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions by energy generation processes other than cogeneration; (d) "electricity from cogeneration" shall mean electricity generated in a process linked to the production of useful heat and calculated in accordance with the methodology laid down in Annex II; (e) "back-up electricity" shall mean the electricity supplied through the electricity grid whenever the cogeneration process is disrupted, including maintenance periods, or out of order; (f) "top-up electricity" shall mean the electricity supplied through the electricity grid in cases where the electricity demand is greater than the electrical output of the cogeneration process; (g) "overall efficiency" shall mean the annual sum of electricity and mechanical energy production and useful heat output divided by the fuel input used for heat produced in a cogeneration process and gross electricity and mechanical energy production; (h) "efficiency" shall mean efficiency calculated on the basis of "net calorific values" of fuels (also referred to as "lower calorific values"); (i) "high efficiency cogeneration" shall mean cogeneration meeting the criteria of Annex III; (j) "efficiency reference value for separate production" shall mean efficiency of the alternative separate productions of heat and electricity that the cogeneration process is intended to substitute; (k) "power to heat ratio" shall mean the ratio between electricity from cogeneration and useful heat when operating in full cogeneration mode using operational data of the specific unit; (l) "cogeneration unit" shall mean a unit that can operate in cogeneration mode; (m) "micro-cogeneration unit" shall mean a cogeneration unit with a maximum capacity below 50 kWe; (n) "small scale cogeneration" shall mean cogeneration units with an installed capacity below 1 MWe; (o) "cogeneration production" shall mean the sum of electricity and mechanical energy and useful heat from cogeneration. In addition, the relevant definitions in Directive 2003/54/EC, and in Directive 2001/77/EC shall apply. Article 4 Efficiency criteria of cogeneration 1. For the purpose of determining the efficiency of cogeneration in accordance with Annex III, the Commission shall, in accordance with the procedure referred to in Article 14(2), not later than 21 February 2006, establish harmonised efficiency reference values for separate production of electricity and heat. These harmonised efficiency reference values shall consist of a matrix of values differentiated by relevant factors, including year of construction and types of fuel, and must be based on a well-documented analysis taking, inter alia, into account data from operational use under realistic conditions, cross-border exchange of electricity, fuel mix and climate conditions as well as applied cogeneration technologies in accordance with the principles in Annex III. 2. The Commission shall, in accordance with the procedure referred to in Article 14(2), review the harmonised efficiency reference values for separate production of electricity and heat referred to in paragraph 1, for the first time on 21 February 2011, and every four years thereafter, to take account of technological developments and changes in the distribution of energy sources. 3. Member States implementing this Directive before the establishment by the Commission of harmonised efficiency reference values for separate production of electricity and heat referred to in paragraph 1, should, until the date referred to in paragraph 1, adopt their national efficiency reference values for separate production of heat and electricity to be used for the calculation of primary energy savings from cogeneration in accordance with the methodology set out in Annex III. Article 5 Guarantee of origin of electricity from high-efficiency cogeneration 1. On the basis of the harmonised efficiency reference values referred to in Article 4(1), Member States shall, not later than six months after adoption of these values, ensure that the origin of electricity produced from high-efficiency cogeneration can be guaranteed according to objective, transparent and non-discriminatory criteria laid down by each Member State. They shall ensure that this guarantee of origin of the electricity enable producers to demonstrate that the electricity they sell is produced from high efficiency cogeneration and is issued to this effect in response to a request from the producer. 2. Member States may designate one or more competent bodies, independent of generation and distribution activities, to supervise the issue of the guarantee of origin referred to in paragraph 1. 3. Member States or the competent bodies shall put in place appropriate mechanisms to ensure that the guarantee of origin are both accurate and reliable and they shall outline in the report referred to in Article 10(1) the measures taken to ensure the reliability of the guarantee system. 4. Schemes for the guarantee of origin do not by themselves imply a right to benefit from national support mechanisms. 5. A guarantee of origin shall: - specify the lower calorific value of the fuel source from which the electricity was produced, specify the use of the heat generated together with the electricity and finally specify the dates and places of production, - specify the quantity of electricity from high efficiency cogeneration in accordance with Annex II that the guarantee represents, - specify the primary energy savings calculated in accordance with Annex III based on harmonised efficiency reference values established by the Commission as referred to in Article 4(1). Member States may include additional information on the guarantee of origin. 6. Such guarantees of origin, issued according to paragraph 1, should be mutually recognised by the Member States, exclusively as proof of the elements referred in paragraph 5. Any refusal to recognise a guarantee of origin as such proof, in particular for reasons relating to the prevention of fraud, must be based on objective, transparent and non-discriminatory criteria. In the event of refusal to recognise a guarantee of origin, the Commission may compel the refusing party to recognise it, particularly with regard to objective, transparent and non-discriminatory criteria on which such recognition is based. Article 6 National potentials for high-efficiency cogeneration 1. Member States shall establish an analysis of the national potential for the application of high-efficiency cogeneration, including high-efficiency micro-cogeneration. 2. The analysis shall: - be based on well-documented scientific data and comply with the criteria listed in Annex IV, - identify all potential for useful heating and cooling demands, suitable for application of high-efficiency cogeneration, as well as the availability of fuels and other energy resources to be utilised in cogeneration, - include a separate analysis of barriers, which may prevent the realisation of the national potential for high-efficiency cogeneration. In particular, this analysis shall consider barriers relating to the prices and costs of and access to fuels, barriers in relation to grid system issues, barriers in relation to administrative procedures, and barriers relating to the lack of internalisation of the external costs in energy prices. 3. Member States shall for the first time not later than 21 February 2007 and thereafter every four years, following a request by the Commission at least six months before the due date, evaluate progress towards increasing the share of high-efficiency cogeneration. Article 7 Support schemes 1. Member States shall ensure that support for cogeneration - existing and future units - is based on the useful heat demand and primary energy savings, in the light of opportunities available for reducing energy demand through other economically feasible or environmental advantageous measures like other energy efficiency measures. 2. Without prejudice to Articles 87 and 88 of the Treaty, the Commission shall evaluate the application of support mechanisms used in Member States according to which a producer of cogeneration receives, on the basis of regulations issued by public authorities, direct or indirect support, which could have the effect of restricting trade. The Commission shall consider whether those mechanisms contribute to the pursuit of the objectives set out in Articles 6 and 174(1) of the Treaty. 3. The Commission shall in the report referred to in Article 11 present a well-documented analysis on experience gained with the application and coexistence of the different support mechanisms referred to in paragraph 2 of this Article. The report shall assess the success, including cost-effectiveness, of the support systems in promoting the use of high-efficiency cogeneration in conformity with the national potentials referred to in Article 6. The report shall further review to what extent the support schemes have contributed to the creation of stable conditions for investments in cogeneration. Article 8 Electricity grid system and tariff issues 1. For the purpose of ensuring the transmission and distribution of electricity produced from high-efficiency cogeneration the provisions of Article 7(1), (2) and (5) of Directive 2001/77/EC as well as the relevant provisions of Directive 2003/54/EC shall apply. 2. Until the cogeneration producer is an eligible customer under national legislation within the meaning of Article 21(1) of Directive 2003/54/EC, Member States should take the necessary measures to ensure that the tariffs for the purchase of electricity to back-up or top-up electricity generation are set on the basis of published tariffs and terms and conditions. 3. Subject to notification to the Commission, Member States may particularly facilitate access to the grid system of electricity produced from high-efficiency cogeneration from small scale and micro cogeneration units. Article 9 Administrative procedures 1. Member States or the competent bodies appointed by the Member States shall evaluate the existing legislative and regulatory framework with regard to authorisation procedures or the other procedures laid down in Article 6 of Directive 2003/54/EC, which are applicable to high-efficiency cogeneration units. Such evaluation shall be made with a view to: (a) encouraging the design of cogeneration units to match economically justifiable demands for useful heat output and avoiding production of more heat than useful heat; (b) reducing the regulatory and non-regulatory barriers to an increase in cogeneration; (c) streamlining and expediting procedures at the appropriate administrative level; and (d) ensuring that the rules are objective, transparent and non-discriminatory, and take fully into account the particularities of the various cogeneration technologies. 2. Member States shall - where this is appropriate in the context of national legislation - provide an indication of the stage reached specifically in: (a) coordination between the different administrative bodies as regards deadlines, reception and treatment of applications for authorisations; (b) the drawing up of possible guidelines for the activities referred to in paragraph 1, and the feasibility of a fast-track planning procedure for cogeneration producers; and (c) the designation of authorities to act as mediators in disputes between authorities responsible for issuing authorisations and applicants for authorisations. Article 10 Member States' reporting 1. Member States shall, not later than 21 February 2006, publish a report with the results of the analysis and evaluations carried out in accordance with Articles 5(3), 6(1), 9(1) and 9(2). 2. Member States shall not later than 21 February 2007 and thereafter every four years, following a request by the Commission at least six months before the due date, publish a report with the result of the evaluation referred to in Article 6(3). 3. Member States shall submit to the Commission, for the first time before the end of December 2004 covering data for the year 2003, and thereafter on an annual basis, statistics on national electricity and heat production from cogeneration, in accordance with the methodology shown in Annex II. They shall also submit annual statistics on cogeneration capacities and fuels used for cogeneration. Member States may also submit statistics on primary energy savings achieved by application of cogeneration, in accordance with the methodology shown in Annex III. Article 11 Commission reporting 1. On the basis of the reports submitted pursuant to Article 10, the Commission shall review the application of this Directive and submit to the European Parliament and to the Council not later than 21 February 2008 and thereafter every four years, a progress report on the implementation of this Directive. In particular, the report shall: (a) consider progress towards realising national potentials for high-efficiency cogeneration referred to in Article 6; (b) assess the extent to which rules and procedures defining the framework conditions for cogeneration in the internal energy market are set on the basis of objective, transparent and non-discriminatory criteria taking due account of the benefits of cogeneration; (c) examine the experiences gained with the application and coexistence of different support mechanisms for cogeneration; (d) review efficiency reference values for separate production on the basis of the current technologies. If appropriate, the Commission shall submit with the report further proposals to the European Parliament and the Council. 2. When evaluating the progress referred to in paragraph 1(a), the Commission shall consider to what extent the national potentials for high-efficiency cogeneration, referred to in Article 6, have been or are foreseen to be realised taking into account Member State measures, conditions, including climate conditions, and impacts of the internal energy market and implications of other Community initiatives such as Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC(19). If appropriate, the Commission shall submit further proposals to the European Parliament and Council, notably aiming at the establishment of an action plan for the development of high efficiency cogeneration in the Community. 3. When evaluating the scope for further harmonisation of calculation methods as referred to in Article 4(1), the Commission shall consider the impact of the coexistence of calculations as referred to in Article 12, Annex II and Annex III, on the internal energy market also taking into account the experiences gained from national support mechanisms. If appropriate, the Commission shall submit further proposals to the European Parliament and Council aiming at further harmonisation of the calculation methods. Article 12 Alternative calculations 1. Until the end of 2010 and subject to prior approval by the Commission, Member States may use other methods than the one provided for in Annex II(b) to subtract possible electricity production not produced in a cogeneration process from the reported figures. However, for the purposes referred to in Article 5(1) and in Article 10(3), the quantity of electricity from cogeneration shall be determined in accordance with Annex II. 2. Member States may calculate primary energy savings from a production of heat and electricity and mechanical energy according to Annex III(c), without using Annex II to exclude the non-cogenerated heat and electricity parts of the same process. Such a production can be regarded as high-efficiency cogeneration provided it fulfils the efficiency criteria in Annex III(a) and, for cogeneration units with an electrical capacity larger than 25 MW, the overall efficiency is above 70 %. However, specification of the quantity of electricity from cogeneration produced in such a production, for issuing a guarantee of origin and for statistical purposes, shall be determined in accordance with Annex II. 3. Until the end of 2010, Member States may, using an alternative methodology, define a cogeneration as high-efficiency cogeneration without verifying that the cogeneration production fulfils the criteria in Annex III(a), if it is proved on national level that the cogeneration production identified by such an alternative calculation methodology on average fulfils the criteria in Annex III(a). If a guarantee of origin is issued for such production then the efficiency of the cogeneration production specified on the guarantee shall not exceed the threshold values of the criteria in Annex III(a) unless calculations in accordance with Annex III prove otherwise. However, specification of the quantity of electricity from cogeneration produced in such a production, for issuing a guarantee of origin and for statistical purposes, shall be determined in accordance with Annex II. Article 13 Review 1. The threshold values used for calculation of electricity from cogeneration referred to in Annex II(a) shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2). 2. The threshold values used for calculation of efficiency of cogeneration production and primary energy savings referred to in Annex III(a) shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2). 3. The guidelines for determining the power to heat ratio referred to in Annex II(d) shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2). Article 14 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 15 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 21 February 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The Member States shall lay down the methods of making such reference. Article 16 Amendment to Directive 92/42/EEC The following indent shall be added to Article 3(1) of Directive 92/42/EEC: "- cogeneration units as defined in Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of cogeneration based on useful heat demand in the internal energy market(20)." Article 17 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 18 Addressees This Directive is addressed to the Member States.

32004L0011

2004

Directive 2004/11/EC of the European Parliament and of the Council of 11 February 2004 amending Council Directive 92/24/EEC relating to speed limitation devices or similar speed limitation on-board systems of certain categories of motor vehicles Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee, Acting in accordance with the procedure laid down in Article 251 of the Treaty(1), Whereas: (1) Measures should be adopted for the purpose of ensuring the smooth functioning of the internal market. (2) Council Directive 92/24/EEC(2) is one of the separate directives under the Community approval procedure introduced by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(3). The provisions and definitions laid down in Directive 70/156/EEC concerning vehicles, vehicles systems, components and separate technical units will thus apply to this Directive. (3) Speed limitation devices for vehicles used for the carriage of passengers and for the carriage of goods having a maximum mass exceeding 10 tonnes have shown a positive influence on road safety and reduced the severity of injuries in cases of accidents, while also reducing air pollution and fuel consumption. (4) Council Directive 92/6/EEC of 10 February 1992 on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community(4) has been extended to lighter motor vehicles of categories M2 and N2. It is therefore necessary to amend the scope of Directive 92/24/EEC relating to the construction requirements for speed limiters accordingly to cover the same categories of motor vehicles. (5) Directive 92/24/EEC should therefore be amended accordingly, Article 1 Directive 92/24/EEC is hereby amended as follows: 1. Article 1 shall be replaced by the following: "Article 1 For the purpose of this Directive: - 'vehicle' shall mean any motor vehicle of categories M2, M3, N2 or N3, as defined in Annex II to Directive 70/156/EEC, intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h, - 'speed limitation device' shall mean a speed-limiting appliance intended for use on a vehicle within the scope of this Directive for which type-approval of a separate technical unit within the meaning of Directive 70/156/EEC may be granted. Built-in maximum vehicle speed limitation systems, incorporated into the design of vehicles from the outset, shall meet the same requirements as speed limitation devices."; 2. the first sentence of the third subparagraph of item 1.1. of Annex I shall be replaced by the following: "The purpose of this Directive is to limit to a specified value the maximum road speed of goods vehicles of categories N2 and N3 and of passenger-carrying vehicles of categories M2 and M3." Article 2 1. With effect from 17 November 2004, Member States may not, on grounds relating to speed limitation devices or similar systems: - refuse to grant EC type-approval or national-type approval of a vehicle, a speed limitation device or a speed limitation on-board system, - prohibit the registration, sale or entry into service of a vehicle or refuse the sale or entry into service of a speed limitation device or a speed limitation on-board system, if the vehicles, speed limitation devices or speed limitation on-board systems comply with the provisions of Directive 92/24/EEC. 2. With effect from 1 January 2005, Member States shall, on grounds relating to speed limitation devices or speed limitation on-board systems, prohibit the sale, the registration or the entry into service of vehicles, speed limitation devices or speed limitation on-board systems which do not comply with the provisions of Directive 92/24/EEC. Article 3 1. Member States shall adopt and publish, before 17 November 2004, 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 18 November 2004. 2. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such 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 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 Union. Article 5 This Directive is addressed to the Member States.

32004L0016

2004

Commission Directive 2004/16/EC of 12 February 2004 laying down the sampling methods and the methods of analysis for the official control of the levels of tin in canned foods (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council(2), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(3), as last amended by Regulation (EC) No 242/2004(4) fixes maximum limits for inorganic tin in canned foodstuffs and makes reference to measures laying down the sampling and analysis methods to be used. (2) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(5), as amended by Regulation (EC) No 1882/2003, introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs. (3) It seems necessary to fix general criteria, which the method of analysis has to comply with in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance. It is also of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the European Union. These interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply. (4) The provisions for the sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge. Methods to analyse for total tin are appropriate for controls on inorganic tin. The possible presence of organic forms of tin are considered to be negligible in relation to the maximum levels set for inorganic tin. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of tin in foodstuffs is carried out in accordance with the methods described in Annex I to this Directive. Article 2 The Member States shall take all measures necessary to ensure that sample preparation and methods of analyses used for the official control of the levels of tin in foodstuffs comply with the criteria described in Annex II to this Directive. Article 3 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive by 31 December 2004. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, their provisions shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Directive is addressed to the Member States.

32004L0021

2004

Commission Directive 2004/21/EC of 24 February 2004 relating to restrictions on the marketing and use of "azo colourants" (thirteenth adaptation to technical progress of Council Directive 76/769/EEC) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/61/EC(1) of the European Parliament and of the Council of 19 July 2002 amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants)and in particular Article 2 thereof, Whereas: (1) According to Directive 2002/61/EC amending for the nineteenth time Council Directive 76/769/EEC(2) 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 dangerous substances and preparations certain azocolourants are not to be used in textiles and leather articles. Those textiles or leather articles may not be placed on the market unless they conform to the requirements set out in that Directive. (2) Article 2 of Directive 2002/61/EC requires the adoption of testing methods for the application of point 43 of Annex I to Directive 76/769/EEC. (3) The European Committee for Standardisation (CEN) has developed testing methods, which should be used for testing textile and leather articles in accordance with the application of point 43 of Annex I to Directive 76/769/EEC. (4) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, in particular 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(3), and Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC(4)). (5) 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 amended as set out 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 by 31 December 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, these shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0019

2004

Commission Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72/EC 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 European Food Safety Authority, Whereas: (1) Commission Directive 2002/72/EC(2) sets out rules for plastic materials and articles which are intended to come into contact with foodstuffs. (2) Directive 2002/72/EC establishes a list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive. (3) Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic materials and articles. That list should be amended so as to include other additives evaluated by the European Food Safety Authority (the Authority). (4) For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. (5) The current list of additives is incomplete inasmuch as it does not contain all substances currently accepted in one or more Member States. Those additives continue to be regulated by national laws pending a decision on inclusion into the Community list. (6) The current list of additives should become a positive list in order to harmonise the use of these additives in the Community. For additives which are already placed on the market in one or more of the Member States, sufficient time should be allowed for the submission of the data necessary for the Authority to carry out an evaluation of their safety. Therefore, the deadline for the submission of the data should be set as 31 December 2006. (7) If the data are in compliance with the Authority requirements, it should be possible to continue to use those additives in accordance with national law until their evaluation is completed. If the data are not in compliance with the Authority requirements or are submitted later than 31 December 2006 those additives should not be included in the first positive list. (8) The date when the list of additives is to become a positive list should be established no later than 31 December 2007 as it is impossible to know the number of additives for which the data required by the Authority will be supplied. That date should be fixed taking into account the time needed for the Authority to evaluate all the applications supplied on time. (9) Some substances used to manufacture plastic materials and articles intended to come into contact with food are also added directly to foodstuffs. These substances should not migrate from the materials or articles into the foodstuffs in quantities that could exceed the limits set in the relevant food legislation or in this Directive whichever provides the lower restriction. In any case, these substances should not migrate from the materials or articles into the foodstuffs in quantities having a technological function in the final food. The users of materials and articles which may release these substances into foodstuffs should be appropriately informed in order to be able to comply with other relevant food legislation. (10) Member States should retain the right to lay down rules concerning substances used as active components in active food contact materials and articles until Community provisions are adopted. (11) Directive 2002/72/EC should therefore be amended accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 2002/72/EC is amended as follows: 1. In Article 3, paragraphs 1 and 2 are replaced by the following: "1. Only those monomers and other starting substances listed in Annex II, section A may be used for the manufacture of plastic materials and articles subject to the restrictions set out therein. 2. By way of derogation from paragraph 1, the monomers and other starting substances listed in Annex II, section B may continue to be used until 31 December 2004 at the latest, pending their evaluation by the European Food Safety Authority (hereinafter referred to as the Authority)." 2. Article 4 is replaced by the following: "Article 4 1. A list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions and/or specifications on their use, is set out in Annex III. That list of additives shall be considered to be an incomplete list until the Commission decides, in accordance with Article 4a, that it shall become a positive Community list of authorised additives, to the exclusion of all others. The Commission shall establish, by 31 December 2007 at the latest, the date when that list shall become a positive list. 2. For the additives listed in Annex III, section B, the verification of compliance with the specific migration limits in simulant D or in test media of substitute tests as laid down in Article 3(1), second subparagraph of Directive 82/711/EEC and Article 1 of Directive 85/572/EEC shall apply from 1 July 2006. 3. The lists in Annex III, sections A and B do not yet include the following additives: (a) additives used only in the manufacture of: - surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, - epoxy resins, - adhesives and adhesion promoters, - printing inks; (b) colorants; (c) solvents." 3. The following Articles 4a and 4b are inserted: "Article 4a 1. A new additive may always be added to the list of substances referred to in Article 4(1) following an evaluation of its safety by the Authority. 2. Member States shall provide that any person interested in the inclusion in the list referred to in Article 4(1) of an additive, which is already placed on the market in one or more of the Member States, shall submit data for the evaluation of its safety by the Authority by 31 December 2006 at the latest. For the submission of the required data, the applicant shall consult the 'Guidelines of the European Food Safety Authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation'. 3. If during the examination of the data referred to in paragraph 2, the Authority calls for supplementary information, the additive may continue to be used subject to national law until the Authority has issued an opinion, provided that the information is submitted within the time limits specified by the Authority. 4. The Commission shall establish, by 31 December 2007 at the latest, a provisional list of additives which may continue to be used after 31 December 2007 subject to national law until the Authority has evaluated them. 5. The inclusion of an additive in the provisional list is subject to the following conditions: (a) the additive must be permitted in one or more of the Member States no later than 31 December 2006; (b) the data referred to in paragraph 2 concerning that additive must have been supplied in accordance with the Authority requirements no later than 31 December 2006. Article 4b Without prejudice to Article 4 of Directive 89/109/EEC, Member States may not authorise after 31 December 2006 additives referred to in Article 4(1) which were never evaluated by the Scientific Committee on Food or the Authority." 4. The following Article 5a is inserted: "Article 5a 5. Additives referred to in Article 4, which are authorised as food additives by Council Directive 89/107/EEC(3) or flavourings by Council Directive 88/388/EEC(4) shall not migrate into: (a) foodstuffs in quantities having a technological function in the final foodstuffs; (b) foodstuffs for which their use is authorised as food additives or flavourings, in quantities exceeding the restrictions provided for in Directive 89/107/EEC or in Directive 88/388/EEC or in Article 4 of this Directive, whichever is the lower; (c) foodstuffs for which their use is not authorised as food additives or flavourings, in quantities exceeding the restrictions set out in Article 4 of this Directive. 2. At the marketing stages other than the retail stages, plastic materials and articles which are intended to be placed in contact with foodstuffs and which contain additives referred to in paragraph 1 shall be accompanied by a written declaration containing the information referred to in Article 9(1)(b). 3. By way of derogation from paragraph 1, when the substances referred to in point (a) of paragraph 1 are used as active components of active food contact materials and articles, they may be subject to national provisions pending the adoption of Community provisions." 5. Article 7 is replaced by the following: "Article 7 The specific migration limits in the list set out in Annexes II and III are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases: (a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l; (b) sheet, film or other material or articles which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such material or article and the quantity of food in contact therewith. In those cases, the limits set out in Annexes II and III, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2." 6. In Article 8, paragraph 2 is replaced by the following: "2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if the value of overall migration determination implies that the specific migration limits referred to in that paragraph are not exceeded." 7. Article 9 is amended as follows: (a) paragraph 1 is replaced by the following: "1. At the marketing stages other than the retail stages, plastic materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration, which shall: (a) be in accordance with Article 6(5) of Directive 89/109/EEC; (b) provide, for substances which are subject to a restriction in food, adequate information obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Commission Directives 95/31/EC(5), 95/45/EC(6) and 2002/82/EC(7) to enable the user of these materials and articles to comply with the relevant Community provisions or, in their absence, with national provisions applicable to food."; (b) paragraph 2 is deleted. 8. Annexes II to VI are amended in accordance with Annexes I to V to this Directive. Article 2 1. Member States shall adopt and publish, by 1 September 2005 at the latest, the provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions in such a way as to: (a) permit the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and complying with this Directive, from 1 September 2005; (b) prohibit 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, from 1 March 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0020

2004

Commission Directive 2004/20/EC of 2 March 2004 amending Council Directive 91/414/EEC to include chlorpropham as an active substance (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), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes chlorpropham. (2) For chlorpropham, the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. Pursuant to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(3), the Netherlands was designated as rapporteur Member State. The Netherlands submitted the relevant assessment report and recommendations to the Commission on 30 April 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. (3) This assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) The review was finalised on 28 November 2003 in the format of the Commission review report for chlorpropham. (5) The review for chlorpropham did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (6) It has appeared from the various examinations made that plant protection products containing chlorpropham may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include chlorpropham in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing chlorpropham can be granted in accordance with the provisions of that directive. (7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing chlorpropham, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 July 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 August 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing chlorpropham to ensure that the conditions relating to chlorpropham set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 31 July 2005 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant protection product containing chlorpropham as either the only active substance or as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 January 2005 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 January 2009 at the latest, they shall amend or withdraw the authorisation. Article 4 This Directive shall enter into force on 1 February 2005. Article 5 This Directive is addressed to the Member States.

32004L0030

2004

Commission Directive 2004/30/EC of 10 March 2004 amending Council Directive 91/414/EEC to include benzoic acid, flazasulfuron and pyraclostrobin as active substances (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), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 25 May 1998 an application from Menno Chemie Vertriebs-Ges. for the inclusion of the active substance benzoic acid in Annex I to Directive 91/414/EEC. Commission Decision 98/676/EC(2) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) Spain received an application under Article 6(2) of Directive 91/414/EEC on 16 December 1996 from ISK Biosciences Europe SA concerning flazasulfuron. This application was declared complete by Commission Decision 97/865/EC(3). (3) Germany received an application under Article 6(2) of Directive 91/414/EEC on 28 February 2000 from BASF AG concerning pyraclostrobin (former name: BAS 500F). This application was declared complete by Commission Decision 2000/540/EC(4). (4) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 22 November 2000 (benzoic acid), 1 August 1999 (flazasulfuron) and 23 November 2001 (pyraclostrobin). (5) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 October 2003 in the format of the Commission review report for benzoic acid, flazasulfuron and pyraclostrobin. (6) The review of benzoic acid, flazasulfuron and pyraclostrobin did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (7) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include benzoic acid, flazasulfuron and pyraclostrobin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive. (8) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing benzoic acid, flazasulfuron or pyraclostrobin and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 30 November 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 December 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 1. Member States shall review the authorisation for each plant protection product containing benzoic acid, flazasulfuron or pyraclostrobin to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 November 2004 at the latest. 2. For each authorised plant protection product containing benzoic acid, flazasulfuron or pyraclostrobin as the only active substance, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 30 November 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. 3. For each plant protection product containing benzoic acid, flazasulfuron or pyraclostrobin together with one or more active substances which are all listed in Annex I to Directive 91/414/EEC, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to that Directive, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary, they shall amend or withdraw the authorisation for each such plant protection product, by the deadline defined for such an amendment or withdrawal in the respective Directives which amended Annex I so as to add the relevant substances to it. Where the respective Directives set different deadlines, the deadline shall be the latest of the dates defined. Article 4 This Directive shall enter into force on 1 June 2004. Article 7 This Directive is addressed to the Member States.

32004L0032

2004

Commission Directive 2004/32/EC of 17 March 2004 amending Directive 2001/32/EC as regards certain 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 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular the first subparagraph of Article 2(1)(h) thereof, Having regard to the requests made by Ireland, Italy, Austria and Sweden, Whereas: (1) Under Commission Directive 2001/32/EC of 8 May 2001 recognising certain protected zones exposed to particular plant health risks in the Community and repealing Directive 92/76/EEC(2), Ireland and some areas in Italy and Austria were provisionally recognised as protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al. for a period expiring on 31 March 2004. (2) From information supplied by Ireland and Austria based on surveys, it appears that the provisional recognition of the protected zones for Ireland and Austria in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended for a further limited period. (3) From information supplied by Italy based on surveys, it appears that some areas within Italy should no longer be recognised as protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al., whilst other areas should be recognised as "protected zones" in respect of Erwinia amylovora (Burr.) Winsl. et al. for a further limited period. (4) Under Directive 2001/32/EC, some areas in Sweden were provisionally recognised as protected zones in respect of beet necrotic yellow vein virus for a period expiring on 31 March 2004. (5) From information supplied by Sweden based on surveys, it appears that those areas within Sweden should no longer be recognised as protected zones in respect of beet necrotic yellow vein virus. (6) Directive 2001/32/EC should, therefore, be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 2001/32/EC is amended as follows: 1. Article 1 is amended as follows: (a) the second paragraph is replaced by: "In the case of point (b)(2) of the Annex, for Ireland, for Italy (Apulia, Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Lombardy; Trentino-Alto Adige: autonomous province of Trento; Veneto: except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d'Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes of Palù, Roverchiara, Legnago, Castagnaro, Ronco all'Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), and for Austria (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria, Vienna), the said zones are recognised until 31 March 2006."; (b) the third paragraph is deleted. 2. The Annex is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 20 April 2004 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 21 April 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national laws which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0031

2004

Commission Directive 2004/31/EC of 17 March 2004 amending Annexes I, II, III, IV and V to Council Directive 2000/29/EC 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 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof, After consulting the Member States concerned, Whereas: (1) From information supplied by Sweden based on surveys, it appears that areas in Sweden should not longer be recognised as "protected zones" in respect of Beet necrotic yellow vein virus. (2) Under Directive 2000/29/EC, the introduction into the Community of plants of Vitis L., other than fruits, originating in third countries is prohibited. (3) From information supplied by Switzerland, it appears that the measures Switzerland applies as regards the introduction into and movement within its territory of plants of Vitis L., other than fruits, are equivalent to the measures laid down in Directive 2000/29/EC. Therefore, plants of Vitis L., other than fruits, originating in Switzerland should be allowed to enter the Community. (4) Under Directive 2000/29/EC, the introduction into the areas within the Community recognised as protected zones as regards Erwinia amylovora (Burr.) Winsl. et al. of the host plants, other than fruit and seeds, of this harmful organism, originating in third countries other than those recognised as being free from this harmful organism, or in which pest free areas have been established in relation to this harmful organism, is prohibited. (5) From information supplied by Switzerland, it appears that the measures Switzerland applies as regards the introduction into and movement within its territory of host plants of Erwinia amylovora (Burr.) Winsl. et al., other than fruits and seeds, are largely equivalent to the measures laid down in Directive 2000/29/EC. Therefore, host plants of Erwinia amylovora (Burr.) Winsl. et al., other than fruits and seeds, and other than plants of Cotoneaster Ehrh. and Photinia davidiana (Dcne.) Cardot, originating in Switzerland should be allowed to enter the Community. (6) From information supplied by Italy based on surveys, it appears that some areas in Italy should not longer be recognised as "protected zones" in respect of Erwinia amylovora (Burr.) Winsl. et al. (7) Due to a clerical error in the preparation of Directive 2003/116/EC, current point 21.1 of Part B of Annex IV to Directive 2000/29/EC was erroneously numbered. (8) The current provisions against Tilletia indica Mitra should be amended to take into account the updated information on the presence of this harmful organism in Iran. (9) Directive 2000/29/EC should therefore be amended accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes I, II, III, IV and V to Directive 2000/29/EC are 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 by 20 April 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0033

2004

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(1), and in particular points (b) to (g) of the second paragraph of Article 29 thereof, Whereas: (1) Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection. (2) In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements. (3) This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community(2), certain recommendations of the Council of Europe, the opinion of the Scientific Committee for Medicinal Products and Medical Devices, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products and recommendations of the World Health Organisation (WHO), as well as international experience in this field. (4) Blood and blood components imported from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood and human plasma, should meet the quality and safety requirements set out in this Directive. (5) With regard to blood and blood components collected for the sole purpose of, and exclusive use in, autologous transfusion (autologous donation), specific technical requirements should be laid down, as required by Article 2(2) of Directive 2002/98/EC. Such donations should be clearly identified and kept separate from other donations to ensure that they are not used for transfusion to other patients. (6) It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC. (7) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC, Article 1 Definitions For the purposes of this Directive, the definitions set out in Annex I shall apply. Article 2 Provision of information to prospective donors Member States shall ensure that blood establishments provide prospective donors of blood or blood components with the information set out in Part A of Annex II. Article 3 Information required from donors Member States shall ensure that upon agreement of willingness to commence the donation of blood or blood components, donors provide the information set out in Part B of Annex II to the blood establishment. Article 4 Eligibility of donors Blood establishments shall ensure that donors of whole blood and blood components comply with the eligibility criteria set out in Annex III. Article 5 Storage, transport and distribution conditions for blood and blood components Blood establishments shall ensure that the storage, transport and distribution conditions for blood and blood components comply with the requirements set out in Annex IV. Article 6 Quality and safety requirements for blood and blood components Blood establishments shall ensure that the quality and safety requirements for blood and blood components comply with the requirements set out in Annex V. Article 7 Autologous donations 1. Blood establishments shall ensure that autologous donations comply with the requirements set out in Directive 2002/98/EC and the specific requirements set out in this Directive. 2. Autologous donations shall be clearly identified as such and shall be kept separate from allogeneic donations. Article 8 Validation Member States shall ensure that all testing and processes referred to in Annexes II to V are validated. Article 9 Transposition 1. Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 8 February 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 10 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 11 Addressees This Directive is addressed to the Member States.

32004L0034

2004

Commission Directive 2004/34/EC of 23 March 2004 amending, for the purposes of adapting to technical progress, Annexes I and II to Directive 96/74/EC of the European Parliament and of the Council on textile names (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 96/74/EC of the European Parliament and of the Council of 16 December 1996 on textile names(1), and in particular Article 16(1) thereof, Whereas: (1) Directive 96/74/EC lays down rules governing the labelling or marking of products as regards their textile fibre content, in order to ensure that consumer interests are thereby protected. Textile products may be placed on the market within the Community only if they comply with the provisions of that Directive. (2) In view of recent findings by a technical working group, it is necessary, for the purposes of adapting Directive 96/74/EC to technical progress, to add the fibre polylactide to the list of fibres set out in Annexes I and II to that Directive. (3) Directive 96/74/EC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Committee for Directives relating to Textile Names and Labelling, Article 1 Directive 96/74/EC is amended as follows: 1. In Annex I the following row 33a is inserted: ">TABLE>" 2. In Annex II the following entry 33a is inserted: ">TABLE>" Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0022

2004

Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) A number of measuring instruments are covered by specific Directives, adopted on the basis of Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control(4). Specific Directives that are technically outdated should be repealed and replaced by an independent Directive reflecting the spirit of the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(5). (2) Correct and traceable measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, public health, safety and order, protection of the environment and the consumer, of levying taxes and duties and of fair trading, which directly and indirectly affect the daily life of citizens in many ways, may require the use of legally controlled measuring instruments. (3) Legal metrological control should not lead to barriers to the free movement of measuring instruments. The provisions concerned should be the same in all Member States and proof of conformity accepted throughout the Community. (4) Legal metrological control requires conformity with specified performance requirements. The performance requirements that the measuring instruments must meet should provide a high level of protection. The conformity assessment should provide a high level of confidence. (5) Member States should as a general rule prescribe legal metrological control. Where legal metrological control is prescribed, only measuring instruments complying with common performance requirements should be used. (6) The principle of optionality introduced by this Directive, whereby Member States may exercise their right to decide whether or not to regulate any of the instruments covered by this Directive, should be applicable only to the extent that this will not cause unfair competition. (7) The responsibilities of the manufacturer for compliance with the requirements of this Directive should be specifically stated. (8) The performance of measuring instruments is particularly sensitive to the environment, particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference forms an integral part of this Directive and the immunity requirements of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility(6) should therefore not apply. (9) Community legislation should specify essential requirements that do not impede technical progress, preferably performance requirements. Provisions to remove technical barriers to trade should follow the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards. (10) In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, essential requirements may give rise to the establishment of environmental or accuracy classes. (11) In order to ease the task of proving conformity with the essential requirements and to enable conformity to be assessed, it is desirable to have harmonised standards. Such harmonised standards are drawn up by private-law bodies and should retain their status as non-mandatory texts. To this end, the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines on cooperation between the Commission and the European Standardisation bodies signed on 13 November 1984. (12) The technical and performance specifications of internationally agreed normative documents may also comply, in part or in full, with the essential requirements laid down by this Directive. In those cases the use of these internationally agreed normative documents can be an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity. (13) Conformity with the essential requirements laid down by this Directive can also be provided by specifications that are not supplied by a European technical standard or an internationally agreed normative document. The use of European technical standards or internationally agreed normative documents should therefore be optional. (14) The conformity assessment of sub-assemblies should respect the provisions of this Directive. If sub-assemblies are traded separately and independently of an instrument, the exercise of conformity assessment should be undertaken independently of the instrument concerned. (15) The state of the art in measurement technology is subject to constant evolution which may lead to changes in the needs for conformity assessments. Therefore, for each category of measurement and, where appropriate, sub-assemblies, there must be an appropriate procedure or a choice between different procedures of equivalent stringency. The procedures adopted are as required by 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" marking, which are intended to be used in the technical harmonisation Directives(7). However, derogations may have to be made for these modules in order to reflect specific aspects of metrological control. Provision should be made for the "CE" marking to be affixed during the fabrication process. (16) Continued development in measurement technology as well as concerns expressed by stakeholders about certification, stress the need to ensure consistent conformity assessment procedures for industrial products, as requested by the Council Resolution adopted on 10 November 2003(8). (17) Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the "CE" marking and supplementary metrology marking in accordance with the provisions of this Directive. (18) Member States should take appropriate action to prevent non-complying measuring instruments from being placed on the market and/or put into use. Adequate cooperation between the competent authorities of the Member States is therefore necessary to ensure a Community-wide effect of this objective. (19) Manufacturers should be informed of the grounds on which negative decisions in respect of their products were taken, and of the legal remedies available to them. (20) Manufacturers should be offered the possibility to exercise the rights obtained before the entry into force of this Directive, during a reasonable transitional period. (21) National specifications concerning the appropriate national requirements in use should not interfere with the provisions of this Directive on "putting into use". (22) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9). (23) The activity of the Measuring Instruments Commmittee should include proper consultations with representatives of interested parties. (24) Directives 71/318/EEC, 71/319/EEC, 71/348/EEC, 73/362/EEC, 75/33/EEC, as concerns the meters defined in Annex MI-001 of this Directive, 75/410/EEC, 76/891/EEC, 77/95/EEC, 77/313/EEC, 78/1031/EEC and 79/830/EEC should therefore be repealed, Article 1 Scope This Directive applies to the devices and systems with a measuring function defined in the instrument-specific annexes concerning water meters (MI-001), gas meters and volume conversion devices (MI-002), active electrical energy meters (MI-003), heat meters (MI-004), measuring systems for continuous and dynamic measurement of quantities of liquids other then water (MI-005), automatic weighing instruments (MI-006), taximeters (MI-007), material measures (MI-008), dimensional measuring instruments (MI-009) and exhaust gas analysers (MI-010). Article 2 1. Member States may prescribe the use of measuring instruments mentioned in Article 1 for measuring tasks for reasons of public interest, public health, public safety, public order, protection of the environment, protection of consumers, levying of taxes and duties and fair trading, where they consider it justified. 2. Where Member States do not prescribe such use, they shall communicate the reasons therefor to the Commission and the other Member States. Article 3 Object This Directive establishes the requirements that the devices and systems referred to in Article 1 have to satisfy with a view to their being placed on the market and/or put into use for those tasks mentioned in Article 2(1). This Directive is a specific Directive in respect of requirements for electromagnetic immunity in the sense of Article 2(2) of Directive 89/336/EEC. Directive 89/336/EEC continues to apply with regard to emission requirements. Article 4 Definitions For the purposes of this Directive: (a) "measuring instrument" means any device or system with a measurement function that is covered by Articles 1 and 3; (b) "sub-assembly" means a hardware device, mentioned as such in the specific annexes, that functions independently and makes up a measuring instrument together - with other sub-assemblies with which it is compatible, or - with a measuring instrument with which it is compatible; (c) "legal metrological control" means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading; (d) "manufacturer" means a natural or legal person responsible for the conformity of the measuring instrument with this Directive with a view to either placing it on the market under his own name and/or putting it into use for his own purposes; (e) "placing on the market" means making available for the first time in the Community an instrument intended for an end user, whether for reward or free of charge; (f) "putting into use" means the first use of an instrument intended for the end user for the purposes for which it was intended; (g) "authorised representative" means a natural or legal person who is established within the Community and authorised by a manufacturer, in writing, to act on his behalf for specified tasks within the meaning of this Directive; (h) "harmonised standard" means a technical specification adopted by CEN, CENELEC or ETSI or jointly by two or all of these organisations, at the request of the Commission pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(10) and prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations; (i) "normative document" means a document containing technical specifications adopted by the Organisation Internationale de Métrologie Légale (OIML), subject to the procedure stipulated in Article 16(1). Article 5 Applicability to sub-assemblies Where specific annexes exist, laying down the essential requirements for sub-assemblies, the provisions of this Directive shall apply mutatis mutandis to such sub-assemblies. Sub-assemblies and measuring instruments may be assessed independently and separately for the purpose of establishing conformity. Article 6 Essential requirements and assessment of conformity 1. A measuring instrument shall meet the essential requirements laid down in Annex I and in the relevant instrument-specific Annex. Member States may require, if it is needed for correct use of the instrument, the information referred to in Annex I or in the relevant instrument-specific annexes to be provided in the official language(s) of the Member State in which the instrument is placed on the market. 2. The conformity of a measuring instrument with the essential requirements shall be assessed in accordance with Article 9. Article 7 Conformity marking 1. The conformity of a measuring instrument with all the provisions of this Directive shall be indicated by the presence on it of the "CE" marking and the supplementary metrology marking as specified in Article 17. 2. The "CE" marking and supplementary metrology marking shall be affixed by, or under the responsibility of, the manufacturer. These markings may be affixed to the instrument during the fabrication process, if justified. 3. The affixing of markings on a measuring instrument that are likely to deceive third parties as to the meaning and/or form of the "CE" marking and the supplementary metrology marking shall be prohibited. Any other marking may be affixed on a measuring instrument, provided that the visibility and legibility of the "CE" marking and the supplementary metrology marking is not thereby reduced. 4. Where the measuring instrument is subject to measures adopted under other Directives covering other aspects which require the affixing of the "CE" marking, the marking shall indicate that the instrument in question is also presumed to conform to the requirements of those other Directives. In such a case, the publication reference of the said Directives, in the Official Journal of the European Union, must be given in the documents, notices or instructions required by those Directives and accompanying the measuring instrument. Article 8 Placing on the market and putting into use 1. Member States shall not impede for reasons covered by this Directive the placing on the market and/or putting into use of any measuring instrument that carries the "CE" marking and supplementary metrology marking in accordance with Article 7. 2. Member States shall take all appropriate measures to ensure that measuring instruments be placed on the market and/or put into use only if they satisfy the requirements of this Directive. 3. A Member State may require a measuring instrument to satisfy provisions governing its putting into use that are justified by local climatic conditions. In such a case, the Member State shall choose appropriate upper and lower temperature limits from Table 1 of Annex I and, in addition, may specify humidity conditions (condensing or non-condensing) and whether the intended location of use is open or closed. 4. When different accuracy classes are defined for a measuring instrument: (a) the instrument-specific annexes under the heading "Putting into use" may indicate the accuracy classes to be used for specific applications. (b) in all other cases a Member State may determine the accuracy classes to be used for specific applications within the classes defined, subject to allowing the use of all accuracy classes on its territory. In either case falling under (a) or (b), measuring instruments of a better accuracy class may be used if the owner so chooses. 5. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of instruments not in conformity with this Directive, provided that a visible sign clearly indicates their non-conformity and their non-availability for placing on the market and/or putting into use until brought into conformity. Article 9 Conformity assessment Conformity assessment of a measuring instrument with the relevant essential requirements shall be carried out by the application, at the choice of the manufacturer, of one of the conformity assessment procedures listed in the instrument-specific annex. The manufacturer shall provide, where appropriate, technical documentation for specific instruments or groups of instruments as set out in Article 10. The conformity assessment modules making up the procedures are described in Annexes A to H1. Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Member State where the notified body carrying out the Conformity assessment procedures is established, or in a language accepted by that body. Article 10 Technical Documentation 1. The technical documentation shall render the design, manufacture and operation of the measuring instrument intelligible and shall permit an assessment of its conformity with the appropriate requirements of this Directive. 2. The technical documentation shall be sufficiently detailed to ensure: - the definition of the metrological characteristics, - the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and - the integrity of the instrument. 3. The technical documentation shall include insofar as relevant for assessment and identification of the type and/or instrument: (a) a general description of the instrument; (b) conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc; (c) manufacturing procedures to ensure consistent production; (d) if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation; (e) descriptions and explanations necessary for the understanding of paragraphs (b), (c) and (d), including the operation of the instrument; (f) a list of the standards and/or normative documents referred to in Article 13, applied in full or in part; (g) descriptions of the solutions adopted to meet the essential requirements where the standards and/or normative documents referred to in Article 13 have not been applied; (h) results of design calculations, examinations, etc; (i) the appropriate test results, where necessary, to demonstrate that the type and/or instruments comply with: - the requirements of this Directive under declared rated operating conditions and under specified environmental disturbances, - the durability specifications for gas-, water-, heat-meters as well as for liquids other than water. (j) the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design. 4. The manufacturer shall specify where seals and markings have been applied. 5. The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies, where relevant. Article 11 Notification 1. Member States shall notify to the other Member States and the Commission the bodies under their jurisdiction, which they have designated to carry out the tasks pertaining to the conformity assessment modules referred to in Article 9, together with the identification numbers given to them by the Commission in accordance with paragraph 4 of this Article, the kind(s) of measuring instrument for which each body has been designated and in addition, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification. 2. Member States shall apply the criteria set out in Article 12 for the designation of such bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to meet the corresponding criteria. Member States shall publish the references to these national standards. If a Member State has not introduced national legislation for tasks mentioned under Article 2, it shall retain the right to designate and notify a body for tasks relating to that instrument. 3. A Member State that has notified a body shall: - ensure that the body continues to meet the criteria set out in Article 12, - withdraw such notification if it finds that the body no longer meets those criteria. It shall forthwith inform the other Member States and the Commission of any such withdrawal. 4. Each of the bodies to be notified shall be given an identification number by the Commission. The Commission shall publish the list of notified bodies, together with the information in respect of the scope of the notification referred to in paragraph 1, in the Official Journal of the European Union, C series, and shall ensure that the list is kept up to date. Article 12 Criteria to be satisfied by designated bodies Member States shall apply the following criteria for the designation of bodies in accordance with Article 11(1). 1. The body, its director and staff involved in conformity assessment tasks shall not be the designer, manufacturer, supplier, installer or user of the measuring instruments that they inspect, nor the authorised representative of any of them. In addition, they may not be directly involved in the design, manufacture, marketing or maintenance of the instruments, nor represent the parties engaged in these activities. The preceding criterion does not, however, preclude in any way the possibility of exchanges of technical information between the manufacturer and the body for the purposes of conformity assessment. 2. The body, its director and staff involved in conformity assessment tasks shall be free from all pressures and inducements, in particular financial inducements, that might influence their judgement or the results of their conformity assessment, especially from persons or groups of persons with an interest in the results of the assessments. 3. The conformity assessment shall be carried out with the highest degree of professional integrity and requisite competence in the field of metrology. Should the body subcontract specific tasks, it shall first ensure that the subcontractor meets the requirements of this Directive, and in particular of this Article. The body shall keep the relevant documents assessing the subcontractor's qualifications and the work carried out by him under this Directive at the disposal of the notifying authority. 4. The body shall be capable of carrying out all the conformity assessment tasks for which it has been designated, whether those tasks are carried out by the body itself or on its behalf and under its responsibility. It shall have at its disposal the necessary staff and shall have access to the necessary facilities for carrying out in a proper manner the technical and administrative tasks entailed in conformity assessment. 5. The body's staff shall have: - sound technical and vocational training, covering all conformity assessment tasks for which the body was designated; - satisfactory knowledge of the rules governing the tasks which it carries out, and adequate experience of such tasks; - the requisite ability to draw up the certificates, records and reports demonstrating that the tasks have been carried out. 6. The impartiality of the body, its director and staff shall be guaranteed. The remuneration of the body shall not depend on the results of the tasks it carries out. The remuneration of the body's director and staff shall not depend on the number of tasks carried out or on the results of such tasks. 7. The body shall take out civil liability insurance if its civil liability is not covered by the Member State concerned under national law. 8. The body's director and staff shall be bound to observe professional secrecy with regard to all information obtained in the performance of their duties pursuant to this Directive, except vis-à-vis the authority of the Member State which has designated it. Article 13 Harmonised standards and normative documents 1. Member States shall presume conformity with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes in respect of a measuring instrument that complies with the elements of the national standards implementing the European harmonised standard for that measuring instrument that correspond to those elements of this European harmonised standard the references in respect of which have been published in the Official Journal of the European Union, C series. Where a measuring instrument complies only in part with the elements of the national standards referred to in the first subparagraph, Member States shall presume conformity with the essential requirements corresponding to the elements of the national standards with which the instrument complies. Member States shall publish the references to the national standards referred to in the first subparagraph. 2. Member States shall presume conformity with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes in respect of a measuring instrument that complies with the corresponding parts of the normative documents and lists referred to in Article 16(1)(a), the references in respect of which have been published in the Official Journal of the European Union, C series. Where a measuring instrument complies only in part with the normative document referred to in the first subparagraph, Member States shall presume conformity with the essential requirements corresponding to the normative elements with which the instrument complies. Member States shall publish the references of the normative document referred to in the first subparagraph. 3. A manufacturer may choose to use any technical solution that complies with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes (MI-001 to MI-010). In addition, to benefit from the presumption of conformity, the manufacturer must correctly apply solutions mentioned either in the relevant European harmonised standards, or in the corresponding parts of the normative documents and lists as referred to in paragraphs 1 and 2. 4. Member States shall presume compliance with the appropriate tests mentioned in point (i) of Article 10 if the corresponding test programme has been performed in accordance with the relevant documents mentioned in paragraphs 1 to 3 and if the test results ensure compliance with the essential requirements. Article 14 Standing Committee Where a Member State or the Commission considers that a European harmonised standard as referred to in Article 13(1) does not fully meet the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes, the Member State or the Commission shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, giving its reasons for doing so. The Committee shall deliver an opinion without delay. In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw the references to the national standards from the publication referred to in the third subparagraph of Article 13(1). Article 15 Measuring Instruments Committee 1. The Commission shall be assisted by the Measuring Instruments Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 4. The Committee shall adopt its Rules of Procedure. 5. The Commission shall ensure that relevant information about envisaged measures, as referred to in Article 16, is made available to interested parties in due time. Article 16 Functions of the Measuring Instruments Committee 1. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 15(2), may take any appropriate measure to: (a) identify normative documents drawn up by OIML and, in a list, indicate the parts thereof compliance with which gives rise to a presumption of conformity with the corresponding essential requirements of this Directive; (b) publish the references of the normative documents and the list referred to in point (a) in the Official Journal of the European Union, C series. 2. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 15(3), may take any appropriate measure to amend instrument-specific annexes (MI-001 to MI-010) in respect of: - the maximum permissible errors (MPEs) and accuracy classes, - the rated operating conditions, - the critical change values, - disturbances, 3. Where a Member State or the Commission considers that a normative document whose references have been published in the Official Journal of the European Union, C series, in accordance with paragraph 1(b), does not fully meet the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes, that Member State or the Commission shall bring the matter before the Measuring Instruments Committee, giving the reasons for doing so. The Commission, acting in accordance with the procedure referred to in Article 15(2), shall inform the Member States whether or not it is necessary to withdraw the references to the normative document concerned from publication in the Official Journal. 4. Member States may take appropriate measures to consult interested parties at national level about OIML work relating to the scope of this Directive. Article 17 Markings 1. The "CE" marking referred to in Article 7 consists of the symbol "CE" according to the design laid down in paragraph I.B(d) of the Annex to Decision 93/465/EEC. The "CE" marking shall be at least 5 mm high. 2. The supplementary metrology marking consists of the capital letter "M" and the last two digits of the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the "CE" marking. The supplementary metrology marking shall immediately follow the "CE" marking. 3. The identification number of the notified body concerned referred to in Article 11, if prescribed by the conformity assessment procedure, shall follow the "CE" marking and supplementary metrology marking. 4. When a measuring instrument consists of a set of devices, not being sub-assemblies, operating together, the markings shall be affixed on the instrument's main device. When a measuring instrument is too small or too sensitive to carry the "CE" marking and supplementary metrology marking, the markings shall be carried by the packaging, if any, and by the accompanying documents required by this Directive. 5. The "CE" marking and supplementary metrology marking shall be indelible. The identification number of the notified body concerned shall be indelible or self destructive upon removal. All markings shall be clearly visible or easily accessible. Article 18 Market surveillance and administrative cooperation 1. Member States shall take all appropriate measures to ensure that measuring instruments that are subject to legal metrological control but do not comply with applicable provisions of this Directive are neither placed on the market nor put into use. 2. The competent authorities of the Member States shall assist each other in the fulfilment of their obligations to carry out market surveillance. In particular, the competent authorities shall exchange: - information concerning the extent to which instruments they examine comply with the provisions of this Directive, and the results of such examinations; - EC-type examination and design examination certificates and their annexes issued by notified bodies as well as additions, amendments and withdrawals relating to certificates already issued; - quality system approvals issued by notified bodies, as well as information on quality systems refused or withdrawn; - evaluation reports established by notified bodies, when demanded by other authorities. 3. The Member States shall ensure that all necessary information relating to the certificates and quality system approvals is made available to bodies they have notified. 4. Each Member State shall inform the other Member States and the Commission which competent authorities it has designated for such exchange of information. Article 19 Safeguard clause 1. Where a Member State establishes that all or part of the measuring instruments of a particular model that bear the "CE" marking and the supplementary metrology marking do not satisfy the essential requirements relating to metrological performance set out in this Directive, when correctly installed and used in accordance with the manufacturer's instructions, it shall take all appropriate measures to withdraw these instruments from the market, prohibit or restrict their further being placed on the market, or prohibit or restrict their further being used. When deciding on the above measures, the Member State shall take account of the systematic or incidental nature of the non-compliance. Where the Member State has established that the non-compliance is of a systematic nature, it shall immediately inform the Commission of the measures taken, indicating the reasons for its decision. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. (a) Should the Commission find that the measures taken by the Member State concerned are justified, it shall immediately inform that Member State thereof, as well as the other Member States. The competent Member State shall take appropriate action against any person who affixed the markings and shall inform the Commission and the other Member States thereof. If the non-compliance is attributed to shortcomings in the standards or normative documents, the Commission shall, after consulting the parties concerned, bring the matter as soon as possible before the appropriate Committee referred to in Articles 14 or 15. (b) Should the Commission find that the measures taken by the Member State concerned are not justified, it shall immediately inform that Member State thereof, as well as the manufacturer concerned or his authorised representative. The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedure. Article 20 Unduly fixed markings 1. Where a Member State establishes that the "CE" marking and supplementary metrology marking have been affixed unduly, the manufacturer or his authorised representative shall be obliged: - to make the instrument conform as regards those provisions concerning the "CE" marking and supplementary metrology marking not covered by Article 19(1) and - to end the infringement under the conditions imposed by the Member State. 2. Should the infringement described above persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market or prohibit or restrict its further use in accordance with the procedures laid down in Article 19. Article 21 Decisions entailing refusal or restriction Any decision taken pursuant to this Directive entailing the withdrawal from the market of a measuring instrument, or prohibiting or restricting the placing on the market or putting into use of an instrument, shall state the exact grounds on which it is based. The decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the law of the Member State concerned and of the time limits to which such remedies are subject. Article 22 Repeals The following Directives shall be repealed as from 30 October 2006 without prejudice to Article 23: - Council Directive 71/318/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to gas meters(11), - Directive 71/319/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to meters for liquids other than water(12); - Directive 71/348/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to ancillary equipment for meters for liquids other than water(13), - Directive 73/362/EEC of 19 November 1973 on the approximation of the laws of the Member States relating to material measures of length(14), - Directive 75/33/EEC of 17 December 1974 on the approximation of the laws of the Member States relating to cold water meters, as concerns the meters defined in Annex MI-001 of this Directive(15). - Directive 75/410/EEC of 24 June 1975 on the approximation of the laws of the Member States relating to continuous totalising weighing machines(16), - Directive 76/891/EEC of 4 November 1976 on the approximation of the laws of the Member States relating to electrical energy meters(17), - Directive 77/95/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to taximeters(18), - Directive 77/313/EEC of 5 April 1977 on the approximation of the laws of the Member States relating to measuring systems for liquids other than water(19), - Directive 78/1031/EEC of 5 December 1978 on the approximation of the laws of the Member States relating to automatic checkweighing and weight grading machines(20), - Directive 79/830/EEC of 11 September 1979 on the approximation of the laws of the Member States relating to hot-water meters(21). Article 23 Transitional provisions By way of derogation from Article 8(2), Member States shall permit, for measurement tasks for which they have prescribed the use of a legally controlled measuring instrument, the placing on the market and putting into use of measuring instruments that satisfy the rules applicable before 30 October 2006 until the expiry of the validity of the type approval of those measuring instruments or, in the case of a type approval of indefinite validity, for a period of a maximum of ten years from 30 October 2006. Article 24 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 30 April 2006. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Member States shall apply these provisions from 30 October 2006. 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 25 Revision clause The European Parliament and the Council invite the Commission to report, before 30 April 2011, on the implementation of this Directive, inter alia, on the basis of reports provided by the Member States, and, where appropriate, to submit a proposal for amendments. The European Parliament and Council invite the Commission to evaluate whether conformity assessment procedures for industrial products are properly applied and, where appropriate, to propose amendments in order to ensure consistent certification. Article 26 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 27 Addressees This Directive is addressed to the Member States.

32004L0028

2004

Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 and Article 152(4)(b) thereof, Having regard to the proposal of the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure referred to in Article 251 of the Treaty(3), Whereas: (1) Directive 2001/82/EC of the European Parliament and of the Council of 23 October 2001 on the Community code relating to veterinary medicinal products(4) codified and consolidated previous Community legislation on veterinary medicinal products in a single text in the interests of clarity and rationalisation. (2) The Community legislation so far adopted has made a major contribution to the achievement of the objective of free and safe movement of veterinary medicinal products and the elimination of obstacles to trade in such products. However, in the light of the experience gained, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement. (3) It is therefore necessary to align national laws, regulations and administrative provisions that contain differences with regard to the basic principles in order to promote the operation of the internal market without adversely affecting public health. (4) The main purpose of any regulation on the manufacture and distribution of veterinary medicinal products should be to safeguard animal health and welfare as well as public health. The legislation on marketing authorisations for veterinary medicinal products, and the criteria governing the granting of authorisations, are such as to strengthen the protection of public health. That aim should, however, be achieved by means that do not hinder the development of the pharmaceutical industry or trade in veterinary medicinal products within the Community. (5) Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions. (6) In the light of the Commission's report on the experience acquired, it has proved necessary to improve the operation of the marketing authorisation procedures for veterinary medicinal products in the Community. (7) Particularly as a result of scientific and technical progress in the field of animal health, the definitions and scope of Directive 2001/82/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of veterinary medicinal products. In order to take account both of the emergence of new therapies and of the growing number of so-called "borderline" products between the medicinal product sector and other sectors, the definition of "medicinal product" should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a veterinary medicinal product, but could also fall within the definition of other regulated products, it is necessary, in cases of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, feed, feed additives or biocides, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation. (8) The veterinary medicinal products sector has a number of very specific features. Veterinary medicinal products for food-producing animals may be authorised only on conditions that guarantee that the foodstuffs produced will be harmless to consumers as regards any residues of such medicinal products. (9) The costs of research and development to meet increased requirements as regards the quality, safety and efficacy of veterinary medicinal products are leading to a gradual reduction in the range of products authorised for the species and indications representing smaller market sectors. (10) The provisions of Directive 2001/82/EC also need, therefore, to be adapted to the specific features of the sector, particularly to meet the health and welfare needs of food-producing animals on terms that guarantee a high level of consumer protection, and in a context that provides adequate economic interest for the veterinary medicinal products industry. (11) In certain circumstances, particularly where certain types of pets are concerned, the need to obtain a marketing authorisation for a veterinary medicinal product in accordance with Community provisions is clearly disproportionate. Moreover, the absence of authorisation to market an immunological product in the Community should not be an obstacle to international movements of certain live animals for the purpose of which binding health measures have to be taken. The provisions on the authorisation or use of such medicinal products to take account of measures to combat certain infectious animal diseases at Community level also need to be adapted. (12) Evaluation of the operation of market authorisation procedures has revealed the need to revise, in particular, the mutual-recognition procedure in order to improve the opportunities for cooperation between Member States. This cooperation process should be formalised by setting up a coordination group for this procedure and by defining its operation so as to settle disagreements within the framework of a revised decentralised procedure. (13) With regard to referrals, the experience acquired reveals the need for an appropriate procedure, particularly in the case of referrals relating to an entire therapeutic class or to all veterinary medicinal products containing the same active substance. (14) Marketing authorisation for veterinary medicinal products should be limited initially to five years. After this first renewal, the marketing authorisation should normally be valid for an unlimited period. Furthermore, any authorisation not used for three consecutive years, that is to say, one which has not led to the placing on the market of a veterinary medicinal product in the Member States concerned during that period, should be considered invalid, in order, in particular, to avoid the administrative burden of maintaining such authorisations. However, exemptions from this rule should be granted when these are justified on public or animal health grounds. (15) Biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action. When a biological product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both. (16) The criteria of quality, safety and efficacy should enable the risk-benefit balance of all veterinary medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate. In this connection, it is necessary to harmonise and adapt the criteria for refusal, suspension and revocation of marketing authorisations. (17) In the veterinary sector, if no medicinal product has been authorised for a given species or a given disorder, the possibility of using other existing products should be made a straightforward matter, but without prejudicing consumer health in the case of medicinal products intended for administration to food-producing animals. In particular, medicinal products should be used only under conditions that guarantee that the foodstuffs produced will be harmless to consumers as regards any residues of medicinal products. (18) There is also a need to stimulate the interest of the veterinary pharmaceuticals industry in certain market segments in order to encourage the development of new veterinary medicinal products. The period of administrative data-protection vis-a-vis generics should be harmonised. (19) There is also a need to clarify the obligations of, and division of responsibilities between, the applicant for a marketing authorisation, the holder of a marketing authorisation and the competent authorities in charge of monitoring the quality of foodstuffs, particularly through compliance with the provisions on the use of veterinary medicinal products. In addition, in order to facilitate the testing of new medicinal products while guaranteeing a high level of protection for consumers, sufficiently long withdrawal periods should be laid down for foodstuffs that animals involved in tests might produce. (20) Without prejudice to the provisions aimed at guaranteeing consumer protection, the specific characteristics of homeopathic veterinary medicinal products, and particularly their use in organic farming, should be taken into account by establishing a simplified procedure for registration on terms defined in advance. (21) In order to increase the information available to users and to improve consumer protection in the case of food-producing animals, the provisions on the labelling of veterinary medicinal products and the accompanying package leaflet should be strengthened. The requirement that a veterinary medicinal product may only be dispensed after a veterinary prescription has been made out should, as a general principle, be extended to all medicinal products for food-producing animals. However, it should be possible to grant exemptions, where appropriate. The administrative procedures for supplying medicinal products for pets, on the other hand, should be simplified. (22) The quality of veterinary medicinal products manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections. The provisions for the official release of batches of immunological medicinal products should be reviewed in order to take account of the improvement of the general system for monitoring the quality of medicinal products and to reflect technical and scientific progress, and also in order to make mutual recognition fully effective. (23) The environmental impact should be studied and consideration should be given on a case-by-case basis to specific provisions seeking to limit it. (24) Pharmacovigilance and, more generally, market surveillance and sanctions in the event of failure to comply with the provisions should be stepped up. In the field of pharmacovigilance, account should be taken of the facilities offered by new information technologies to improve exchanges between Member States. (25) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(6). (26) Directive 2001/82/EC should be amended accordingly, Article 1 Directive 2001/82/EC shall be amended as follows: 1) Article 1 shall be amended as follows: (a) point 1 shall be deleted; (b) point 2 shall be replaced by the following: "2. Veterinary medicinal product: (a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."; (c) point 3 shall be deleted; (d) points 8, 9 and 10 shall be replaced by the following: "8. Homeopathic veterinary medicinal product: Any veterinary medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in Member States. A homeopathic veterinary medicinal product may contain a number of principles. 9. Withdrawal period: The period necessary between the last administration of the veterinary medicinal product to animals, under normal conditions of use and in accordance with the provisions of this Directive, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to Regulation (EEC) No 2377/90. 10. Adverse reaction: A reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function."; (e) the following point shall be inserted: "17a. Representative of the marketing authorisation holder: The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned."; (f) point 18 shall be replaced by the following: "18. Agency: The European Medicines Agency established by Regulation (EC) No 726/2004(7);"; (g) point 19 shall be replaced by the following: "19. Risks relating to use of the product: - any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health; - any risk of undesirable effects on the environment."; (h) the following points shall be added: "20. Risk/benefit balance: An evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above. 21. Veterinary prescription: Any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law. 22. Name of veterinary medicinal product: The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder. 23. Common name: The international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name. 24. Strength: The content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form. 25. Immediate packaging: The container or any other form of packaging that is in direct contact with the medicinal product. 26. Outer packaging: The packaging into which is placed the immediate packaging. 27. Labelling: Information on the immediate or outer packaging. 28. Package leaflet: The leaflet containing information for the user that accompanies the medicinal product."; 2) Articles 2 and 3 shall be replaced by the following: "Article 2 1. This Directive shall apply to veterinary medicinal products, including pre-mixes for medicated feedingstuffs, intended to be placed on the market in Member States and prepared industrially or by a method involving an industrial process. 2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a 'veterinary medicinal product' and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply. 3. Notwithstanding paragraph 1, this Directive shall also apply to active substances used as starting materials to the extent set out in Articles 50, 50a, 51 and 80 and additionally to certain substances that may be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties to the extent set out in Article 68. Article 3 1. This Directive shall not apply to: (a) medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community(8); (b) inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality; (c) veterinary medicinal products based on radio-active isotopes; (d) any additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(9) where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive; and (e) without prejudice to Article 95, medicinal products for veterinary use intended for research and development trials. However, medicated feedingstuffs referred to in subparagraph (a) may be prepared only from pre-mixes that have been authorised under this Directive. 2. Except for the provisions on the possession, prescription, dispensing and administration of veterinary medicinal products, this Directive shall not apply to: (a) any medicinal product prepared in a pharmacy in accordance with a veterinary prescription for an individual animal or a small group of animals, commonly known as the magistral formula; and (b) any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the end-user, commonly known as the officinal formula."; 3) Article 4(2) shall be replaced by the following: "2. In the case of veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets, Member States may permit exemptions, in their territory, from the provisions in Articles 5 to 8, provided that such products do not contain substances the use of which requires veterinary control and that all possible measures are taken to prevent unauthorised use of the products for other animals."; 4) Articles 5 and 6 shall be replaced by the following: "Article 5 1. No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted by the competent authorities of that Member State in accordance with this Directive or a marketing authorisation has been granted in accordance with Regulation (EC) No 726/2004. When a veterinary medicinal product has been granted an initial authorisation in accordance with the first subparagraph, any additional species, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions, shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 13(1). 2. The marketing authorisation holder shall be responsible for the marketing of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility. Article 6 1. A veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more food-producing species unless the pharmacologically active substances which it contains appear in Annexes I, II or III to Regulation (EEC) No 2377/90. 2. If an amendment to the Annexes to Regulation (EEC) No 2377/90 so warrants, the marketing authorisation holder or, where appropriate, the competent authorities shall take all necessary measures to amend or revoke the marketing authorisation within 60 days of the date on which the amendment to the Annexes to that Regulation was published in the Official Journal of the European Union. 3. By way of derogation from paragraph 1, a veterinary medicinal product containing pharmacologically active substances not included in Annexes I, II or III to Regulation (EEC) No 2377/90 may be authorised for particular animals of the equidae family that have been declared, in accordance with Commission Decision 93/623/EEC of 20 October 1993 establishing the identification document (passport) accompanying registered equidae(10) and Commission Decision 2000/68/EC of 22 December 1999 amending Decision 93/623/EEC and establishing the identification of equidae for breeding and production(11), as not being intended for slaughter for human consumption. Such veterinary medicinal products shall neither include active substances that appear in Annex IV to Regulation (EEC) No 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorised for animals of the equidae family."; 5) Article 8 shall be replaced by the following: "Article 8 In the event of serious epizootic diseases, Member States may provisionally allow the use of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use. The Commission may avail itself of the option set out in the first paragraph when explicit provision is made for that option under Community rules concerning certain serious epizootic diseases. If an animal is being imported from, or exported to, a third country and is thereby subject to specific binding health rules, a Member State may permit the use, for the animal in question, of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the Member State in question but is authorised under the legislation of the third country. Member States shall take all appropriate measures concerning the supervision of the importation and the use of such immunological products."; 6) Articles 10 to 13 shall be replaced by the following: "Article 10 1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a non food-producing species, by way of exception, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animal concerned with: (a) a veterinary medicinal product authorised in the Member State concerned under this Directive or under Regulation (EC) No 726/2004 for use with another animal species, or for another condition in the same species; or (b) if there is no product as referred to in point (a), either: (i) a medicinal product authorised for human use in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council or under Regulation (EC) No 726/2004, or (ii) in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species or in another species for the condition in question or for another condition; or (c) if there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility. 2. By way of derogation from Article 11, the provisions of paragraph 1 of this Article shall also apply to the treatment by a veterinarian of an animal belonging to the equidae family provided that it has been declared, in accordance with Commission Decisions 93/623/EEC and 2000/68/EC, as not being intended for slaughter for human consumption. 3. By way of derogation from Article 11, and in accordance with the procedure referred to in Article 89(2), the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Commission Decisions 93/623/EEC and 2000/68/EC. Article 11 1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing species, by way of exception, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding with: (a) a veterinary medicinal product authorised in the Member State concerned under this Directive or under Regulation (EC) No 726/2004 for use with another animal species, or for another condition in the same species; or (b) if there is no product as referred to in point (a), either: (i) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or (ii) a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species or in another food-producing species for the condition in question or for another condition; or (c) if there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility. 2. Paragraph 1 shall apply provided that pharmacologically active substances included in the medicinal product are listed in Annex I, II or III to Regulation (EEC) No 2377/90, and that the veterinarian specifies an appropriate withdrawal period. Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than: - 7 days for eggs, - 7 days for milk, - 28 days for meat from poultry and mammals including fat and offal, - 500 degree-days for fish meat. However, these specific withdrawal periods may be modified in accordance with the procedure referred to in Article 89(2). 3. With regard to homeopathic veterinary medicinal products in which active principles figure in Annex II to Regulation (EEC) No 2377/90, the withdrawal period referred to in the second subparagraph of paragraph 2 shall be reduced to zero. 4. When a veterinarian has recourse to the provisions of paragraphs 1 and 2 of this Article, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses administered, the duration of treatment and the withdrawal periods recommended, and shall make these records available for inspection by the competent authorities for a period of at least five years. 5. Without prejudice to the other provisions of this Directive, Member States shall take all necessary measures concerning the import, distribution, dispensing of and information on the medicinal products which they permit for administration to food-producing animals in accordance with paragraph 1(b)(ii). Article 12 1. For the purposes of obtaining a marketing authorisation in respect of a veterinary medicinal product, otherwise than under the procedure established by Regulation (EC) No 726/2004, an application shall be lodged with the competent authority of the Member State concerned. In the case of veterinary medicinal products which are intended for one or more food-producing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation. At least six months shall elapse between a valid application for the establishment of maximum residue limits and an application for a marketing authorisation. However, in the case of veterinary medicinal products referred to in Article 6(3), a marketing authorisation may be applied for without a valid application in accordance with Regulation (EEC) No 2377/90. All the scientific documentation necessary for the demonstration of the quality, safety and efficacy of the veterinary medicinal product, as provided for in paragraph 3, shall be submitted. 2. A marketing authorisation may only be granted to an applicant established in the Community. 3. The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question. The file shall be submitted in accordance with Annex I and shall contain, in particular, the following information: (a) name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and, if different, of the manufacturer or manufacturers involved and of the sites of manufacture; (b) name of veterinary medicinal product; (c) qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its international non-proprietary name (INN) recommended by the WHO, where an INN exists, or its chemical name; (d) description of the method of manufacture; (e) therapeutic indications, contra-indications and adverse reactions; (f) dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life; (g) reasons for any precautionary and safety measures to be taken when storing the veterinary medicinal product, administering it to animals and disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human and animal health and to plants; (h) indication of the withdrawal period in the case of medicinal products intended for food-producing species; (i) description of the testing methods employed by the manufacturer; (j) results of: - pharmaceutical (physico-chemical, biological or microbiological) tests, - safety tests and residue tests, - pre-clinical and clinical trials; - tests assessing the potential risks posed by the medicinal product for the environment. This impact shall be studied and consideration shall be given on a case-by-case basis to specific provisions seeking to limit it. (k) a detailed description of the pharmacovigilance system and, where appropriate, the risk management system that the applicant will put in place; (l) a summary in accordance with Article 14 of the product characteristics, a mock-up of the immediate packaging and the outer packaging of the veterinary medicinal product, together with the package leaflet, in accordance with Articles 58 to 61; (m) a document showing that the manufacturer is authorised in his own country to produce veterinary medicinal products; (n) copies of any marketing authorisation obtained in another Member State or in a third country for the relevant veterinary medicinal product, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 14 or approved by the competent authority of the Member State in accordance with Article 25 and copies of the package insert proposed, details of any decision to refuse authorisation, whether in the Community or a third country and the reasons for that decision. All this information shall be updated on a regular basis; (o) proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country; (p) in the case of veterinary medicinal products intended for one or more food-producing species and containing one or more pharmacologically active substances not yet included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with the aforementioned Regulation. The documents and particulars relating to the results of the tests referred to in point (j) of the first subparagraph shall be accompanied by detailed and critical summaries, drawn up as specified in Article 15. Article 13 1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 5 for not less than eight years in a Member State or the Community. A generic veterinary medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subparagraph shall also apply when the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit, within a period of one month, confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. However, the ten-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated in accordance with the procedure referred to in Article 89(2). 2. For the purposes of this Article: (a) 'reference medicinal product' shall mean a product authorised within the meaning of Article 5 in accordance with the provisions of Article 12; (b) 'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information intended to provide proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. 3. In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided. 4. Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided. 5. In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance that has not been authorised in the Community by 30 April 2004 the ten-year period provided for in the second subparagraph of paragraph 1 shall be extended by one year for each extension of the marketing authorisation to another food-producing species, if it is authorised within the five years following the granting of the initial marketing authorisation. This period shall not, however, exceed a total of 13 years, for a marketing authorisation for four or more food-producing species. The extension of the ten-year period to 11, 12, or 13 years for a veterinary medicinal product intended for food-producing species shall be granted only if the marketing authorisation holder also originally applied for determination of the maximum residue limits established for the species covered by the authorisation. 6. Conducting the necessary studies, tests and trials with a view to the application of paragraphs 1 to 5 and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products."; 7) the following Articles shall be inserted: "Article 13a 1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the applicant shall provide appropriate scientific literature. 2. The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with Regulation (EEC) No 2377/90 may be used in an appropriate manner as literature, particularly for the safety tests. 3. If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out. Article 13b In the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with point (j) of the first subparagraph of Article 12(3), but it shall not be necessary to provide scientific references relating to each individual active substance. Article 13c After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Article 13d By way of derogation from point (j) of the first subparagraph of Article 12(3), and in exceptional circumstances with respect to immunological veterinary medicinal products, the applicant shall not be required to provide the results of certain field trials on the target species if these trials cannot be carried out for duly substantiated reasons, in particular on account of other Community provisions."; 8) Articles 14 to 16 shall be replaced by the following: "Article 14 The summary of the product characteristics shall contain, in the order indicated below, the following information: 1) name of the veterinary medicinal product followed by the strength and the pharmaceutical form; 2) qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used; 3) pharmaceutical form; 4) clinical particulars: 4.1. target species, 4.2. indications for use, specifying the target species, 4.3. contra-indications, 4.4. special warnings for each target species, 4.5. special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals, 4.6. adverse reactions (frequency and seriousness), 4.7. use during pregnancy, lactation or lay, 4.8. interaction with other medicinal products and other forms of interaction, 4.9. amounts to be administered and administration route, 4.10. overdose (symptoms, emergency procedures, antidotes), if necessary, 4.11. withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero; 5) pharmacological properties: 5.1. pharmacodynamic properties, 5.2. pharmacokinetic particulars; 6) pharmaceutical particulars: 6.1. list of excipients, 6.2. major incompatibilities, 6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, 6.4. special precautions for storage, 6.5. nature and composition of immediate packaging, 6.6. special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate; 7) marketing authorisation holder; 8) marketing authorisation number(s); 9) date of the first authorisation or date of renewal of the authorisation; 10) date of revision of the text. For authorisation under Article 13, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included. Article 15 1. Applicants shall ensure that the detailed and critical summaries referred to in the second subparagraph of Article 12(3) are drafted and signed by persons with the requisite technical or professional qualifications, set out in a brief curriculum vitae, before being submitted to the competent authorities. 2. Persons with the technical or professional qualifications referred to in paragraph 1 shall justify any use made of the scientific literature referred to in Article 13a(1) in accordance with the conditions set out in Annex I. 3. A brief curriculum vitae of the persons referred to in paragraph 1 shall be appended to the detailed critical summaries. Article 16 1. Member States shall ensure that homeopathic veterinary medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 17, 18 and 19, except where such veterinary medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In the case of homeopathic medicinal products registered in accordance with Article 17, Article 32 and Article 33(1) to (3) shall apply. 2. Member States shall establish a simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17. 3. By way of derogation from Article 10, homeopathic veterinary medicinal products may be administered to non-food producing animals under the responsibility of a veterinarian. 4. By way of derogation from Article 11(1) and (2), Member States shall permit the administration of homeopathic veterinary medicinal products intended for food-producing species the active constituents of which appear in Annex II to Regulation (EEC) No 2377/90 under the responsibility of a veterinarian. Member States shall take appropriate measures to control the use of veterinary homeopathic medicinal products registered or authorised in another Member State in accordance with this Directive for use in the same species."; 9) Article 17 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. Without prejudice to the provisions of Regulation (EEC) No 2377/90 on the establishment of maximum residue limits of pharmacologically active substances intended for food-producing animals, only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure: (a) they are administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in Member States; (b) no specific therapeutic indication appears on the labelling of the veterinary medicinal product or in any information relating thereto; (c) there is a sufficient degree of dilution to guarantee the safety of the medicinal product. In particular, the medicinal product shall not contain more than one part per 10000 of the mother tincture. If it appears justified in the light of new scientific evidence, points (b) and (c) of the first subparagraph may be adapted in accordance with the procedure referred to in Article 89(2). At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product."; (b) paragraph 3 shall be deleted; 10) Article 18 shall be amended as follows: (a) the third indent shall be replaced by the following: "- manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation,"; (b) the sixth indent shall be replaced by the following: "- one or more mock-ups of the outer packaging and immediate packaging of the medicinal products to be registered,"; (c) the following eighth indent shall be added: "- proposed withdrawal period together with all requisite justification."; 11) Article 19 shall be replaced by the following: "Article 19 1. Homeopathic veterinary medicinal products other than those referred to in Article 17(1) shall be authorised in accordance with Articles 12, 13a, 13b, 13c, 13d and 14. 2. A Member State may introduce or retain on its territory specific rules for the safety tests and pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet species and non-food-producing exotic species other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force."; 12) Articles 21, 22 and 23 shall be replaced by the following: "Article 21 1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for a veterinary medicinal product is completed within a maximum of 210 days after the submission of a valid application. Applications for marketing authorisations for the same veterinary medicinal product in two or more Member States, shall be submitted in accordance with Articles 31 to 43. 2. Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 31 to 43 apply. Article 22 Where a Member State is informed, in accordance with point (n) of Article 12(3), that another Member State has authorised a veterinary medicinal product which is the subject of an application for authorisation in the Member State concerned, that Member State shall reject the application unless it was submitted in compliance with Articles 31 to 43. Article 23 In order to examine the application submitted pursuant to Articles 12 to 13d, Member States' competent authorities: 1) shall check that the documentation submitted in support of the application complies with Articles 12 to 13d and ascertain whether the conditions for the issue of the marketing authorisation have been fulfilled; 2) may submit the medicinal product, its starting materials and if necessary intermediate products or other constituent materials for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose, in order to ensure that the testing methods employed by the manufacturer and described in the application documents, in accordance with point (i) of the first subparagraph of Article 12(3), are satisfactory; 3) may similarly check, in particular through consultation of a national or Community reference laboratory, that the analytical method used for detecting residues presented by the applicant for the purposes of Article 12(3)(j), second indent is satisfactory; 4) may, where appropriate, require the applicant to provide further information as regards the items listed in Articles 12, 13a, 13b, 13c and 13d. Where the competent authorities take this course of action, the time-limits specified in Article 21 shall be suspended until the further data required have been provided. Similarly, these time-limits shall be suspended for any period which the applicant may be given to provide oral or written explanations."; 13) Article 25 shall be replaced by the following: "Article 25 1. When granting a marketing authorisation, the competent authority shall inform the holder of the summary of product characteristics that it has approved. 2. The competent authority shall take all necessary measures to ensure that information concerning the veterinary medicinal product, and in particular the labelling and package leaflet, is in conformity with the summary of product characteristics approved when the marketing authorisation was granted or subsequently. 3. The competent authority shall make the marketing authorisation publicly available without delay, together with the summary of product characteristics for each veterinary medicinal product that it has authorised. 4. The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned. The competent authority shall make the assessment report and its reasons for the opinion publicly available without delay, after deleting any information of a commercially confidential nature."; 14) Article 26 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The marketing authorisation may require the holder to indicate on the immediate packaging and/or the outer wrapping and the package leaflet, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Article 12(3)(j) and in Articles 13 to 13d or from experience gained during the use of the veterinary medicinal product once it has been marketed.". (b) paragraph 2 shall be deleted; (c) paragraph 3 shall be replaced by the following: "3. In exceptional circumstances, and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the veterinary medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. Such authorisations may be granted only for objective, verifiable reasons. Continuation of the authorisation shall be linked to the annual reassessment of these conditions."; 15) Article 27 shall be amended as follows: (a) paragraphs 2 and 3 shall be replaced by the following: "2. The competent authority may require the applicant or the marketing authorisation holder to provide sufficient quantities of the substances to enable controls to be made on the identification of the presence of residues of the veterinary medicinal products in question. At the competent authority's request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(12). 3. The authorisation holder shall immediately supply the competent authority with any new information that might entail the amendment of the particulars or documents referred to in Articles 12(3), 13, 13a, 13b and 14 or Annex I. In particular, he shall immediately inform the competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is placed on the market and of any other new information which might influence the assessment of the benefits and risks of the veterinary medicinal product concerned. In order to permit continuous assessment of the risk-benefit balance, the competent authority may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable."; (b) paragraph 4 shall be deleted; (c) paragraph 5 shall be replaced by the following: "5. The marketing authorisation holder shall immediately inform the competent authorities, with a view to authorisation, of any alteration which he proposes to make to the particulars or documents referred to in Articles 12 to 13d."; 16) the following Article shall be inserted: "Article 27a After a marketing authorisation has been granted, the holder of the authorisation shall inform the competent authority of the authorising Member State of the date of the actual placing on the market of the veterinary medicinal product in that Member State, taking into account the various presentations authorised. The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. Upon request by the competent authority, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the veterinary medicinal product, and any data in his possession relating to the volume of prescriptions."; 17) Article 28 shall be replaced by the following: "Article 28 1. Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years. 2. The authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance. To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. The competent authority may require the applicant to submit the listed documents at any time. 3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2. 4. Any authorisation that is not followed within three years of its granting by the actual placing on the market of the authorised veterinary medicinal product in the authorising Member State shall cease to be valid. 5. When an authorised veterinary medicinal product previously placed on the market in the authorising Member State is no longer actually present on the market in that Member State for a period of three consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid. 6. The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant exemptions from paragraphs 4 and 5. Such exemptions shall be duly justified."; 18) Article 30 shall be replaced by the following: "Article 30 The marketing authorisation shall be refused if the file submitted to the competent authorities does not comply with Articles 12 to 13d and Article 15. The authorisation shall also be refused if, after examination of the documents and particulars listed in Articles 12 and 13(1), it is clear that: (a) the risk-benefit balance of the veterinary medicinal product is, under the authorised conditions of use, unfavourable; when the application concerns a veterinary medicinal product for zootechnical use, particular regard shall be had to the benefits for animal health and welfare and to consumer safety; or (b) the product has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated; or (c) its qualitative or quantitative composition is not as stated; or (d) the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated; or (e) the labelling or the package leaflet proposed by the applicant does not comply with this Directive; or (f) the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions. However, when a Community legislative framework is in the course of being adopted, the competent authority may refuse authorisation for a veterinary medicinal product where such action is necessary for the protection of public health, consumer or animal health. The applicant or marketing authorisation holder shall be responsible for the accuracy of documents and data submitted."; 19) the title of Chapter 4 shall be replaced by the following: "CHAPTER 4 Mutual recognition procedure and decentralised procedure"; 20) Articles 31 to 37 shall be replaced by the following: "Article 31 1. A coordination group shall be set up for the examination of any question relating to marketing authorisation of a veterinary medicinal product in two or more Member States in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat of this coordination group. 2. The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Members of the group may arrange to be accompanied by experts. 3. The coordination group shall draw up its own rules of procedure, which shall enter into force after a favourable opinion has been given by the Commission. These rules of procedure shall be made public. Article 32 1. With a view to the granting of a marketing authorisation for a veterinary medicinal product in more than one Member State, the applicant shall submit an application based on an identical dossier in those Member States. The dossier shall contain all the administrative information and scientific and technical documentation described in Articles 12 to 14. The documents submitted shall include a list of Member States concerned by the application. The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with paragraphs 2 or 3. Where appropriate, the assessment report shall contain an evaluation for the purposes of Article 13(5) or Article 13a(3). 2. If the veterinary medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report in respect of the veterinary medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be forwarded to the concerned Member States and the applicant. 3. If the veterinary medicinal product has not received authorisation by the time of application, the applicant shall request the reference Member State to prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet. The reference Member State shall prepare these drafts within 120 days of the receipt of a valid application and shall send them to the concerned Member States and the applicant. 4. Within 90 days after receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly. 5. Each Member State in which an application following paragraph 1 has been submitted shall adopt a decision in conformity with the approved assessment report, summary of product characteristics, labelling and package leaflet within 30 days after acknowledgement of the agreement. Article 33 1. If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant. The points of disagreement shall be referred without delay to the coordination group. If a Member State to which an application has been submitted invokes the reasons referred to in Article 71(1), it shall no longer be regarded as a Member State concerned by this Chapter. 2. The Commission shall adopt guidelines defining a potential serious risk for human or animal health or for the environment. 3. Within the coordination group, all Member States referred to in paragraph 1 shall use their best endeavours to reach agreement on the action to be taken. They shall provide the applicant with the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the reasons for disagreement to the coordination group the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Article 32(5) shall apply. 4. If within the period of 60 days the Member States fail to reach an agreement, the Agency shall be immediately informed with a view to application of the procedure laid down in Articles 36, 37 and 38. The Agency shall be provided with a detailed description of the matters on which agreement could not be reached and the reasons for the disagreement. The applicant shall be provided with a copy of this information. 5. As soon as the applicant has been informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of Article 32(1). 6. In the case referred to in paragraph 4, the Member States that have approved the assessment report, summary of product characteristics, labelling and package leaflet of the reference Member State may, on request by the applicant, grant a marketing authorisation for the veterinary medicinal product without waiting for the outcome of the procedure laid down in Article 36. In that case, the authorisation granted shall be without prejudice to the outcome of that procedure. Article 34 1. If two or more applications submitted in accordance with Articles 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or revocation of authorisation, a Member State, or the Commission, or the marketing-authorisation holder may refer the matter to the Committee for Medicinal Products for Veterinary Use, hereinafter referred to as 'the Committee', for the application of the procedure laid down in Articles 36, 37 and 38. 2. With a view to promoting the harmonisation of veterinary medicinal products authorised in the Community, and to strengthening the efficiency of the provisions of Articles 10 and 11, Member States shall send to the coordination group, no later than 30 April 2005, a list of veterinary medicinal products for which a harmonised summary of product characteristics should be prepared. The coordination group shall agree on a list of medicinal products, on the basis of proposals sent by Member States, and shall forward the list to the Commission. The medicinal products on the list shall be subject to the provisions in paragraph 1 in accordance with a timetable established in cooperation with the Agency. The Commission, acting in collaboration with the Agency, and taking into consideration the views of the interested parties, shall agree the final list and timetable. Article 35 1. Member States or the Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 before a decision is reached on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII. The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder. The Member State and the applicant or the marketing authorisation holder shall forward to the Committee all available information relating to the matter in question. 2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to specific parts of the authorisation. In that case, Article 39 shall apply to those medicinal products only if they are covered by the marketing authorisation procedure referred to in this Chapter. Article 36 1. When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it. However, in cases submitted to the Committee in accordance with Articles 34 and 35, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the marketing authorisation holders concerned. In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline. 2. In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint independent experts to advise it on specific questions. When appointing such experts, the Committee shall define their tasks and specify the time limit for the completion of these tasks. 3. Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit that it will specify. The opinion of the Committee shall include the draft summary of product characteristics and the drafts of the labelling and package leaflet. If it considers appropriate, the Committee may invite any other person to provide information relating to the matter before it. The Committee may suspend the time limit referred to in paragraph 1 to allow the applicant or the marketing authorisation holder to prepare the explanations. 4. The Agency shall forthwith inform the applicant or the marketing authorisation holder when the opinion of the Committee is that: - the application does not satisfy the criteria for authorisation, or - the summary of product characteristics proposed by the applicant or the marketing authorisation holder in accordance with Article 14 should be amended, or - the authorisation should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the veterinary medicinal product including pharmacovigilance, or - a marketing authorisation should be suspended, varied or revoked. Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No 726/2004. The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article. 5. Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to Member States, the Commission and the applicant or the marketing authorisation holder, together with a report describing the assessment of the veterinary medicinal product and the reasons for its conclusions. In the event of an opinion in favour of granting or maintaining a marketing authorisation, the following documents shall be annexed to the opinion: (a) a draft summary of the product characteristics, as referred to in Article 14; where necessary this will reflect the differences in the veterinary conditions in Member States; (b) any conditions affecting the authorisation within the meaning of paragraph 4; (c) details of any recommended conditions or restrictions with regard to the safe and effective use of the veterinary medicinal product; and (d) drafts of the labelling and package leaflet. Article 37 Within 15 days after receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law. In the event of a draft decision that envisages the granting of a marketing authorisation, the documents referred to in the second subparagraph of Article 36(5) shall be annexed. If, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences. The draft decision shall be forwarded to Member States and the applicant or marketing authorisation holder."; 21) Article 38 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 89(3)."; (b) In paragraph 2, the second and third indents shall be replaced by the following: "- Member States shall have 22 days to forward their written observations on the draft decision to the Commission. However, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days, - Member States shall have the option of submitting a written request that the draft decision be discussed in a plenary meeting of the Standing Committee."; (c) paragraph 3 shall be replaced by the following: "3. A decision as referred to in paragraph 1 shall be addressed to all Member States and communicated to the marketing authorisation holder or the applicant for information. The concerned Member States and the reference Member State shall either grant or withdraw marketing authorisation, or vary the terms of a marketing authorisation as necessary to comply with the decision within 30 days of its notification and shall refer to it. They shall inform the Commission and the Agency accordingly."; 22) in Article 39, the third subparagraph of paragraph 1 shall be deleted; 23) in Article 42, paragraph 2 shall be replaced by the following: "2. At least every ten years the Commission shall publish a report on experience gained on the basis of the procedures provided for in this chapter and shall propose any amendments necessary to improve the procedures. The Commission shall submit this report to the European Parliament and the Council."; 24) Article 43 shall be replaced by the following: "Article 43 Articles 33(4), (5) and (6) and 34 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in Article 17. Articles 32 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in Article 19(2)."; 25) in Article 44, the following paragraph shall be added: "4. The Member State shall forward to the Agency a copy of the manufacturing authorisations referred to in paragraph 1. The Agency shall enter that information in the Community database referred to in Article 80(6)."; 26) in Article 50, point (f) shall be replaced by the following: "(f) comply with the principles and the guidelines on good manufacturing practice for medicinal products and use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials."; 27) the following Article shall be inserted: "Article 50a 1. For the purposes of this Directive, manufacturing active substances for use as starting materials shall include the complete or partial manufacture or the import of an active substance used as a starting material, as defined in Part 2, Section C of Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation in a veterinary medicinal product, including repackaging or re-labelling, such as carried out by a starting material distributor. 2. Any amendments which may be necessary to adapt the provisions of this Article to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 89(2)."; 28) in Article 51, the following paragraphs shall be added:"The principles of good manufacturing practice as regards the manufacturing of active substances for use as starting materials as referred to in Article 50(f) shall be adopted in the form of detailed guidelines. The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 44(1), the reports referred to in Article 80(3) and the form and content of the certificate of good manufacturing practice referred to in Article 80(5)."; 29) in Article 53, paragraph 1 shall be replaced by the following: "1. Member States shall ensure that the qualified person referred to in Article 52(1) fulfils the conditions of qualification referred to in paragraphs 2 and 3."; 30) in Article 54, paragraph 1 shall be replaced by the following: "1. A person engaging, in a Member State, in the activities of the person referred to in Article 52(1) on the date on which Directive 81/851/EEC became applicable, without complying with the provisions of Article 53, shall be eligible to continue to engage in those activities within the Community."; 31) in Article 55, paragraph 1(b) shall be replaced by the following: "(b) in the case of veterinary medicinal products coming from third countries, even if manufactured in the Community, each production batch imported has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances, and all the other tests or controls necessary to ensure the quality of veterinary medicinal products in accordance with the requirements of the marketing authorisation."; 32) Article 58 shall be amended as follows: (a) paragraph 1 shall be amended as follows: (i) The introductory wording shall be replaced by the following: "Except in the case of the medicinal products referred to in Article 17(1), the competent authority shall approve the immediate packaging and outer packaging of veterinary medicinal products. Packaging shall bear the following information, which shall conform with the particulars and documents provided pursuant to Articles 12 to 13d and the summary of product characteristics, and shall appear in legible characters:"; (ii) Points (a) and (b) shall be replaced by the following: "(a) the name of the medicinal product, followed by its strength and pharmaceutical form. The common name shall appear if the medicinal product contains only one active substance and its name is an invented name; (b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using the common names;"; (iii) Point (e) shall be replaced by the following: "(e) name or corporate name and permanent address or registered place of business of the marketing authorisation holder and, where appropriate, of the representative designated by the marketing authorisation holder;"; (iv) Point (f) shall be replaced by the following: "(f) the species of animal for which the veterinary medicinal product is intended; the method and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;"; (v) Point (g) shall be replaced by the following: "(g) the withdrawal period for veterinary medicinal products to be administered to food-producing species, for all the species concerned and for the various foodstuffs concerned (meat and offal, eggs, milk, honey), including those for which the withdrawal period is zero;"; (vi) Point (j) shall be replaced by the following: "(j) specific precautions relating to the disposal of unused medicinal products or waste derived from veterinary medicinal products, where appropriate, as well as a reference to any appropriate collection system in place;"; (vii) Point (l) shall be replaced by the following: "(l) the words 'For animal treatment only' or, in the case of the medicinal products referred to in Article 67, the words 'For animal treatment only - to be supplied only on veterinary prescription'."; (b) the following paragraph shall be added: "5. In the case of medicinal products that have been granted a marketing authorisation under Regulation (EC) No 726/2004, Member States may permit or require that the outer packaging bear additional information concerning distribution, possession, sale or any necessary precautions, provided that such information is not in infringement of Community law or the terms of the marketing authorisation, and is not promotional. This additional information shall appear in a box with a blue border to separate it clearly from the information referred to in paragraph 1."; 33) Article 59 shall be amended as follows: (a) the introductory wording of paragraph 1 shall be replaced by the following: "1. As regards ampoules, the particulars listed in the first paragraph of Article 58(1) shall be given on the outer package. On the immediate packaging, however, only the following particulars shall be necessary:"; (b) paragraphs 2 and 3 shall be replaced by the following: "2. As regards small immediate packaging containing a single dose, other than ampoules, on which it is impossible to give the particulars mentioned in paragraph 1, the requirements of Article 58(1), (2) and (3) shall apply only to the outer package. 3. The particulars mentioned in the third and sixth indents of paragraph 1 shall appear on the outer package and on the immediate packaging of the medicinal products in the language or languages of the country in which they are placed on the market."; 34) Article 60 shall be replaced by the following: "Article 60 Where there is no outer package, all the particulars which should feature on such a package pursuant to Articles 58 and 59 shall be shown on the immediate packaging."; 35) Article 61 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The inclusion of a package leaflet in the packaging of veterinary medicinal products shall be obligatory unless all the information required by this Article can be conveyed on the immediate packaging and the outer packaging. Member States shall take all appropriate measures to ensure that the package leaflet relates solely to the veterinary medicinal product with which it is included. The package leaflet shall be written in terms that are comprehensible to the general public and in the official language or languages of the Member State in which the medicinal product is marketed. The first subparagraph shall not prevent the package leaflet from being written in several languages, provided that the information given is identical in all the languages. Competent authorities may exempt labels and package leaflets for specific veterinary medicinal products from the obligation for certain particulars to appear and for the leaflet to be in the official language or languages of the Member State in which the product is placed on the market, when the product is intended to be administered only by a veterinarian."; (b) paragraph 2 shall be amended as follows: (i) The introductory wording shall be replaced by the following: "2. The competent authorities shall approve package leaflets. Leaflets shall contain at least the following information, in the order indicated, which shall conform to the particulars and documents provided pursuant to Articles 12 to 13d and the approved summary of product characteristics:"; (ii) Points (a) and (b) shall be replaced by the following: "(a) name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where appropriate, of the representative of the marketing authorisation holder; (b) name of the veterinary medicinal product followed by its strength and pharmaceutical form. The common name shall appear if the product contains only one active substance and its name is an invented name. Where the medicinal product is authorised according to the procedure provided for in Articles 31 to 43 under different names in the Member States concerned, a list of the names authorised in each Member State;"; (c) paragraph 3 shall be deleted; 36) Article 62 shall be replaced by the following: "Article 62 Where the provisions of this Title are not observed and a formal notice addressed to the person concerned has been ineffectual, Member States' competent authorities may suspend or revoke the marketing authorisation."; 37) Article 64(2) shall be amended as follows: (a) the introductory wording shall be replaced by the following: "2. In addition to the clear mention of the words 'homeopathic veterinary medicinal product without approved therapeutic indications', the labelling and, where appropriate, package leaflet for the homeopathic veterinary medicinal products referred to in Article 17(1) shall bear the following information and no other information:"; (b) the first indent shall be replaced by the following: "- the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used in accordance with point (8) of Article 1. If the homeopathic veterinary medicinal product is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks,"; 38) the title of Title VI shall be replaced by the following: "TITLE VI POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS"; 39) Article 65 shall be amended as follows: (a) the following paragraph shall be inserted: "3a. The holder of a distribution authorisation shall have an emergency plan guaranteeing the effective implementation of any recall operation ordered by the competent authorities or undertaken in cooperation with the manufacturer of the medicinal product in question or the holder of the marketing authorisation."; (b) the following paragraph shall be inserted: "5. Any distributor, not being the marketing authorisation holder, who imports a product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the product will be imported of his intention to import it. In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State."; 40) Article 66 shall be amended as follows: (a) paragraph 2 shall be amended as follows: (i) The introductory wording shall be replaced by the following: "Any person permitted under paragraph 1 to supply veterinary medicinal products shall be required to keep detailed records for veterinary medicinal products that may be supplied only on prescription, the following information being recorded in respect of each incoming or outgoing transaction:"; (ii) The third subparagraph shall be replaced by the following:"These records shall be available for inspection by the competent authorities for a period of five years."; (b) paragraph 3 shall be replaced by the following: "3. Member States may permit the supply on their territory of veterinary medicinal products for food-producing animals for which a veterinary prescription is required by or under the supervision of a person registered for this purpose who provides guarantees with respect to qualifications, record-keeping and reporting in accordance with national law. Member States shall notify the Commission of relevant provisions of national law. This provision shall not apply to the supply of veterinary medicinal products for the oral or parenteral treatment of bacterial infections."; (c) paragraph 4 shall be deleted; 41) Article 67 shall be amended as follows: (a) the first paragraph shall be amended as follows: (i) The introductory wording shall be replaced by the following: "Without prejudice to stricter Community or national rules relating to dispensing veterinary medicinal products and serving to protect human and animal health, a veterinary prescription shall be required for dispensing to the public the following veterinary medicinal products:"; (ii) The following point shall be inserted: "(aa) veterinary medicinal products for food-producing animals. However, Member States may grant exemptions from this requirement according to criteria established in accordance with the procedure referred to in Article 89(2). Member States may continue to apply national provisions until either: (i) the date of application of the decision adopted in accordance with the first subparagraph; or (ii) 1 January 2007, if no such decision has been adopted by 31 December 2006;"; (iii) The third indent of point (b) shall be deleted; (iv) Point (d) shall be replaced by the following: "(d) official formula, within the meaning of Article 3(2)(b), intended for food-producing animals."; (b) the second paragraph shall be replaced by the following:"Member States shall take all necessary measures to ensure that, in the case of medicinal products supplied only on prescription, the quantity prescribed and supplied shall be restricted to the minimum amount required for the treatment or therapy concerned. In addition, a prescription shall be required for new veterinary medicinal products containing an active substance that has been authorised for use in a veterinary medicinal product for fewer than five years."; 42) the first paragraph of Article 69 shall be replaced by the following:"Member States shall ensure that the owners or keepers of food-producing animals can provide proof of purchase, possession and administration of veterinary medicinal products to such animals for five years after their administration, including when the animal is slaughtered during the five-year period."; 43) the introductory wording of Article 70 shall be replaced by the following: "By way of derogation from Article 9 and without prejudice to Article 67, Member States shall ensure that veterinarians providing services in another Member State can take with them and administer to animals small quantities of veterinary medicinal products not exceeding daily requirements other than immunological veterinary medicinal products which are not authorised for use in the Member State in which the services are provided (hereinafter: 'host Member State'), provided that the following conditions are satisfied:"; 44) the following subparagraph shall be added to Article 71(1):"The Member State may also invoke the provisions of the first subparagraph in order to withhold marketing authorisation in accordance with a decentralised procedure as provided for in Articles 31 to 43."; 45) in Article 72, paragraph 2 shall be replaced by the following: "2. Member States may impose specific requirements on veterinary practitioners and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions."; 46) Article 73 shall be amended as follows: (a) the first paragraph shall be replaced by the following:"In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the veterinary medicinal products authorised within the Community, having regard to information obtained about suspected adverse reactions to veterinary medicinal products under normal conditions of use, Member States shall administer a veterinary pharmacovigilance system. This system shall be used to collect information useful in the surveillance of veterinary medicinal products, with particular reference to adverse reactions in animals and in human beings relating to the use of veterinary medicinal products, and to evaluate such information scientifically."; (b) after the second paragraph, the following paragraph shall be inserted:"Member States shall ensure that suitable information collected within this system is communicated to other Member States and the Agency. This information shall be recorded in the database referred to in point (k) of the second subparagraph of Article 57(1) of Regulation (EC) No 726/2004 and shall be permanently accessible to all Member States and without delay to the public."; 47) The following article shall be inserted: "Article 73a The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee their independence." 48) The introductory wording of the second paragraph of Article 74 shall be replaced by the following: "That qualified person shall reside in the Community and shall be responsible for the following:"; 49) Article 75 shall be replaced by the following: "Article 75 1. The marketing authorisation holder shall maintain detailed records of all suspected adverse reactions occurring within the Community or in a third country. Save in exceptional circumstances, these reactions shall be communicated electronically in the form of a report in accordance with the guidelines referred to in Article 77(1). 2. The marketing authorisation holder shall record all suspected serious adverse reactions and human adverse reactions relating to the use of veterinary medicinal products that are brought to his attention, and report them promptly to the competent authority of the Member State on whose territory the incident occurred, and no later than 15 days following receipt of the information. The marketing authorisation holder shall also record all suspected serious adverse reactions and human adverse reactions related to the use of veterinary medicinal products of which he can reasonably be expected to have knowledge, and report them promptly to the competent authority of Member State on whose territory the incident occurred, and no later than 15 days following receipt of the information. 3. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions, human adverse reactions and any suspected transmission via a veterinary medicinal product of any infectious agent occurring on the territory of a third country are reported promptly in accordance with the guidelines referred to in Article 77(1), so that they are available to the Agency and the competent authorities of the Member States in which the veterinary medicinal product is authorised, and no later than 15 days following the receipt of the information. 4. By way of derogation from paragraphs 2 and 3, in the case of veterinary medicinal products which are covered by Directive 87/22/EEC, have benefited from the authorisation procedures under Articles 31 and 32 of this Directive or have been the subject of the procedures provided for in Articles 36, 37 and 38 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions and human adverse reactions occurring in the Community are reported in such a way so as to be accessible to the reference Member State or a competent authority designated as reference Member State. The reference Member State shall assume responsibility for the analysis and follow-up of any such adverse reactions. 5. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently as indicated in the guidelines referred to in Article 77(1), reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product. 6. Amendments to paragraph 5 may be adopted in accordance with the procedure referred to in Article 89(2) in the light of the experience gained from its operation. 7. Following the granting of a marketing authorisation, the holder of such authorisation may request the amendment of the periods referred to in paragraph 5 of this Article in accordance with the procedure laid down by Commission Regulation (EC) No 1084/2003(13). 8. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the competent authority. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties."; 50) Article 76(1) shall be replaced by the following: "1. The Agency, in collaboration with Member States and the Commission, shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding veterinary medicinal products marketed in the Community in order to allow the competent authorities to share the information at the same time."; 51) in Article 77(1), the second subparagraph shall be replaced by the following:"In accordance with those guidelines, the marketing authorisation holder shall use internationally agreed veterinary medical terminology for the transmission of reports on adverse reactions. The Commission shall publish the guidelines, which shall take account of international harmonisation work achieved in the field of pharmacovigilance."; 52) Article 78 shall be amended as follows: (a) paragraph 2 shall be replaced by the following: "2. If urgent action is necessary for protecting human or animal health, the Member State concerned may suspend the marketing authorisation of a veterinary medicinal product, provided that the Agency, the Commission and the other Member States are informed on the following working day at the latest."; (b) the following paragraph shall be added: "3. When the Agency is informed in accordance with paragraphs 1 or 2, it shall give its opinion as soon as possible, according to the urgency of the matter. On the basis of this opinion, the Commission may request all Member States in which the veterinary medicinal is marketed to take temporary measures immediately. Final measures shall be adopted in accordance with the procedure referred to in Article 89(3)."; 53) Article 80 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The competent authority of the Member State concerned shall ensure, by means of repeated inspections and, if necessary, unannounced inspections, and where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to conduct tests on samples, that the legal requirements relating to veterinary medicinal products are complied with. The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and of the premises of the marketing authorisation holder whenever it considers that there are grounds for suspecting non-compliance with the provisions of Article 51. Such inspections may also be carried out at the request of another Member State, the Commission or the Agency. In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardisation body for nomenclatures and quality norms within the meaning of the Convention relating to the elaboration of a European Pharmacopoeia(14) (European Directorate for the Quality of Medicines) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph. The competent authority of the Member State concerned may carry out inspections of starting material manufacturers at the manufacturer's own request. Such inspections shall be carried out by authorised representatives of the competent authority who shall be empowered to: (a) inspect manufacturing or trading establishments and any laboratories entrusted by the holder of the manufacturing authorisation with the task of carrying out control tests pursuant to Article 24; (b) take samples including with a view to an independent analysis by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by a Member State; (c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 9 October 1981 placing restrictions on these powers with regard to the description of the manufacturing method; (d) inspect the premises, records and documents of marketing authorisation holders or any firms performing the activities described in Title VII, and in particular Articles 74 and 75 thereof, on behalf of a marketing authorisation holder."; (b) paragraph 3 shall be replaced by the following: "3. The authorised representatives of the competent authority shall report after each of the inspections mentioned in paragraph 1 on whether the principles and guidelines on good manufacturing practice referred to in Article 51 or, where appropriate, the requirements set out in Title VII, are being complied with. The inspected manufacturer or market authorisation holder shall be informed of the content of such reports."; (c) the following paragraphs shall be added: "4. Without prejudice to any arrangements which may have been concluded between the Community and a third country, a Member State, the Commission or the Agency may require a manufacturer established in a third country to undergo an inspection as referred to in paragraph 1. 5. Within 90 days after an inspection as referred to in paragraph 1, a certificate of good manufacturing practice shall be issued to the manufacturer if the inspection established that the manufacturer in question is complying with the principles and guidelines on good manufacturing practice as provided for by Community law. In the event of an inspection carried out at the request of the European Pharmacopoeia, a certificate of compliance with the monograph shall be issued, if appropriate. 6. Member States shall enter the certificates of good manufacturing practice which they issue in a Community database managed by the Agency on behalf of the Community. 7. If the outcome of the inspection as referred to in paragraph 1 is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice as provided for by Community legislation, the information shall be entered in the Community database as referred to in paragraph 6."; 54) Article 82 shall be replaced by the following: "Article 82 1. Where it considers it necessary for reasons of human or animal health, a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the bulk product and/or veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation. 2. On request by the competent authorities, the marketing authorisation holder shall promptly supply the samples referred to in paragraph 1, together with the reports of the control referred to in Article 81(2). The competent authority shall inform all the other Member States in which the veterinary medicinal product is authorised as well as the European Directorate for the Quality of Medicines of its intention to control batches or the batch in question. In such cases, the competent authorities of another Member State shall not apply the provisions of paragraph 1. 3. After studying the control reports referred to in Article 81(2), the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished product, in accordance with the relevant provisions shown in the dossier for marketing authorisation. The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all Member States concerned, and if appropriate the European Directorate for the Quality of Medicines, agree to this. For immunological veterinary medicinal products authorised under Regulation (EC) No 726/2004, the list of tests to be repeated by the control laboratory may be reduced only after agreement by the Agency. 4. All Member States concerned shall recognise the results of the tests. 5. Unless the Commission is informed that a longer period is necessary to conduct the tests, Member States shall ensure that this control is completed within 60 days of receipt of the samples. The competent authority shall notify the other Member States concerned, the European Directorate for the Quality of Medicines, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time. If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take all the necessary measures vis-a-vis the marketing authorisation holder and the manufacturer, where appropriate, and shall inform accordingly the other Member States in which the veterinary medicinal product is authorised."; 55) Article 83 shall be amended as follows: (a) paragraph 1 shall be amended as follows: (i) The introductory words shall be replaced by the following: "Member States' competent authorities shall suspend, revoke, withdraw or vary marketing authorisations when it is clear that:"; (ii) Point (a) shall be replaced by the following: "(a) the risk-benefit assessment of the veterinary medicinal product is, under the authorised conditions of use, unfavourable, particular regard being had to the benefits for animal health and welfare and to consumer safety, when the authorisation concerns a veterinary medicinal product for zootechnical use;"; (iii) The second subparagraph of point (e) shall be deleted; (iv) Point (f) shall be replaced by the following: "(f) information given in the application documents pursuant to Articles 12 to 13d and 27 is incorrect;"; (v) Point (h) shall be deleted; (vi) The following second subparagraph shall be added:"However, when a Community legislative framework is in the course of being adopted, the competent authority may refuse authorisation for a veterinary medicinal product where such action is necessary for the protection of public health, consumer and animal health."; (b) paragraph 2 shall be amended as follows: (i) The introductory words shall be replaced by the following: "Marketing authorisations may be suspended, revoked, withdrawn or varied when it is established that:"; (ii) Point (a) shall be replaced by the following: "(a) the particulars supporting the application, as provided for in Articles 12 to 13d, have not been amended in accordance with Article 27(1) and (5);"; 56) in Article 84, point (a) of paragraph 1 shall be replaced by the following: "(a) it is clear that the risk-benefit assessment of the veterinary medicinal product is, under the authorised conditions of use, unfavourable, particular regard being had to the benefits for animal health and welfare and to the safety and health benefits for the consumer, when the authorisation concerns a veterinary medicinal product for zootechnical use."; 57) in Article 85, the following paragraph shall be added: "3. Member States shall prohibit the advertising to the general public of veterinary medicinal products that: (a) in accordance with Article 67, are available on veterinary prescription only; or (b) contain psychotropic drugs or narcotics, such as those covered by the United Nations Conventions of 1961 and 1971."; 58) in Article 89, paragraphs 2 and 3 shall be replaced by the following: "2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 4. The Standing Committee shall adopt its rules of procedure. These rules of procedure shall be made public."; 59) Article 90 shall be replaced by the following: "Article 90 Member States shall take all necessary measures to ensure that the competent authorities concerned communicate the appropriate information to each other, particularly regarding compliance with the requirements adopted for the authorisations referred to in Article 44, for the certificates referred to in Article 80(5) or for authorisation to place products on the market. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 80(3) to the competent authorities of another Member State. The conclusions reached following an inspection as referred to in Article 80(1) carried out by the inspectors of the Member State concerned shall be valid for the Community. However, by way of exception, if a Member State has not been able, for serious reasons of human or animal health, to accept the conclusions of an inspection as referred to in Article 80(1), that Member State shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned. When the Commission is informed of such serious reasons, it may, after consulting the Member States concerned, ask the inspector of the competent supervisory authority to carry out a new inspection; the inspector may be accompanied by two other inspectors from Member States that are not parties to the disagreement."; 60) in Article 94, the third subparagraph shall be replaced by the following:"Decisions to grant or revoke a marketing authorisation shall be made publicly available."; 61) Article 95 shall be replaced by the following: "Article 95 Member States shall not permit foodstuffs for human consumption to be taken from test animals unless the competent authorities have established an appropriate withdrawal period. The withdrawal period shall either: (a) be at least as laid down in Article 11(2), including, where appropriate, a safety factor reflecting the nature of the substance being tested; or (b) if maximum residue limits have been established by the Community in accordance with Regulation (EEC) No 2377/90, ensure that this maximum limit will not be exceeded in foodstuffs."; 62) the following articles shall be inserted: "Article 95a Member States shall ensure that appropriate collection systems are in place for veterinary medicinal products that are unused or expired. Article 95b When a veterinary medicinal product is to be authorised in accordance with Regulation (EC) No 726/2004 and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the veterinary medicinal product as provided for in Article 34(4)(d) of that Regulation, a decision addressed to Member States shall be adopted in accordance with the procedure laid down in Articles 37 and 38 of this Directive, for the implementation of those conditions or restrictions." Article 2 The periods of protection provided for in Article 1, point 6, which amends Article 13 of Directive 2001/82/EC, shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date of transposition referred to in Article 3 first paragraph. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 October 2005 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 on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0017

2004

Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors Having regard to the Treaty establishing the European Community, and in particular Article 47(2) and Article 55 and Article 95 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 251 of the Treaty(4), in the light of the joint text approved by the Conciliation Committee on 9 December 2003, Whereas: (1) On the occasion of new amendments being made to Council Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(5), which are necessary to meet requests for simplification and modernisation made by contracting entities and economic operators alike in their responses to the Green Paper adopted by the Commission on 27 November 1996, the Directive should, in the interests of clarity, be recast. This Directive is based on Court of Justice case-law, in particular case-law on award criteria, which clarifies the possibilities for the contracting entities to meet the needs of the public concerned, including in the environmental and/or social area, provided that such criteria are linked to the subject-matter of the contract, do not confer an unrestricted freedom of choice on the contracting entity, are expressly mentioned and comply with the fundamental principles mentioned in recital 9. (2) One major reason for the introduction of rules coordinating procedures for the award of contracts in these sectors is the variety of ways in which national authorities can influence the behaviour of these entities, including participation in their capital and representation in the entities' administrative, managerial or supervisory bodies. (3) Another main reason why it is necessary to coordinate procurement procedures applied by the entities operating in these sectors is the closed nature of the markets in which they operate, due to the existence of special or exclusive rights granted by the Member States concerning the supply to, provision or operation of networks for providing the service concerned. (4) Community legislation, and in particular Council Regulation (EEC) No 3975/87 of 14 December 1987 laying down the procedure for the application of the rules on competition to undertakings in the air transport sector(6) and Regulation (EEC) No 3976/87 of 14 December 1987 on the application of Article 85(3) of the Treaty to certain categories of agreements and concerted practices in the air transport sector(7), is designed to introduce more competition between carriers providing air transport services to the public. It is therefore not appropriate to include such entities in the scope of this Directive. In view of the competitive position of Community shipping, it would also be inappropriate to make the contracts awarded in this sector subject to the rules of this Directive. (5) The scope of Directive 98/38/EEC covers, at present, certain contracts awarded by contracting entities operating in the telecommunications sector. A legislative framework, as mentioned in the Fourth report on the implementation of the telecommunications regulations of 25 November 1998, has been adopted to open this sector. One of its consequences has been the introduction of effective competition, both de jure and de facto, in this sector. For information purposes, and in the light of this situation, the Commission has published a list of telecommunications services(8) which may already be excluded from the scope of that Directive by virtue of Article 8 thereof. Further progress has been confirmed in the Seventh report on the implementation of telecommunications regulations of 26 November 2001. It is therefore no longer necessary to regulate purchases by entities operating in this sector. (6) It is therefore no longer appropriate to maintain the Advisory Committee on Telecommunications Procurement set up by Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy transport and telecommunications sectors(9). (7) Nevertheless, it is appropriate to continue to monitor developments in the telecommunications sector and to reconsider the situation if it is established that there is no longer effective competition in that sector. (8) Directive 93/38/EEC excludes from its scope purchases of voice telephony, telex, mobile telephone, paging and satellite services. Those exclusions were introduced to take account of the fact that the services in question could frequently be provided only by one service provider in a given geographical area because of the absence of effective competition and the existence of special or exclusive rights. The introduction of effective competition in the telecommunications sector removes the justification for these exclusions. It is therefore necessary to include the procurement of such telecommunications services in the scope of this Directive. (9) In order to guarantee the opening up to competition of public procurement contracts awarded by entities operating in the water, energy, transport and postal services sectors, it is advisable to draw up provisions for Community coordination of contracts above a certain value. Such coordination is based on the requirements inferable from Articles 14, 28 and 49 of the EC Treaty and from Article 97 of the Euratom Treaty, namely the principle of equal treatment, of which the principle of non-discrimination is no more than a specific expression, the principle of mutual recognition, the principle of proportionality, as well as the principle of transparency. In view of the nature of the sectors affected by such coordination, the latter should, while safeguarding the application of those principles, establish a framework for sound commercial practice and should allow maximum flexibility. For public contracts the value of which is lower than that triggering the application of provisions of Community coordination, it is advisable to recall the case-law developed by the Court of Justice according to which the rules and principles of the Treaties referred to above apply. (10) To ensure a real opening up of the market and a fair balance in the application of procurement rules in the water, energy, transport and postal services sectors it is necessary for the entities covered to be identified on a basis other than their legal status. It should be ensured, therefore, that the equal treatment of contracting entities operating in the public sector and those operating in the private sector is not prejudiced. It is also necessary to ensure, in keeping with Article 295 of the Treaty, that the rules governing the system of property ownership in Member States are not prejudiced. (11) Member States should ensure that the participation of a body governed by public law as a tenderer in a procedure for the award of a contract does not cause any distortion of competition in relation to private tenderers. (12) Under Article 6 of the Treaty, environmental protection requirements are to be integrated into the definition and implementation of the Community policies and activities referred to in Article 3 of the Treaty, in particular with a view to promoting sustainable development. This Directive therefore clarifies how the contracting entities may contribute to the protection of the environment and the promotion of sustainable development, whilst ensuring the possibility of obtaining the best value for money for their contracts. (13) Nothing in this Directive should prevent the imposition or enforcement of measures necessary to protect public morality, public policy, public security, health, human and animal life or the preservation of plant life, in particular with a view to sustainable development, provided that these measures are in conformity with the Treaty. (14) Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the Agreements reached in the Uruguay Round multilateral negotiations (1986 to 1994)(10), approved in particular the WTO Agreement on Government Procurement (hereinafter referred to as the "Agreement"), the aim of which is to establish a multilateral framework of balanced rights and obligations relating to public contracts with the aim of achieving the liberalisation and expansion of world trade. In view of the international rights and commitments devolving on the Community as a result of the acceptance of the Agreement, the arrangements to be applied to tenderers and products from signatory third countries are those defined by the Agreement. The Agreement does not have direct effect. The contracting entities covered by the Agreement which comply with this Directive and which apply the latter to economic operators of third countries which are signatories to the Agreement should therefore be in conformity with the Agreement. It is also appropriate that this Directive should guarantee for Community economic operators conditions for participation in public procurement which are just as favourable as those reserved for economic operators of third countries which are signatories to the Agreement. (15) Before launching a procurement procedure, contracting entities may, using a technical dialogue, seek or accept advice which may be used in the preparation of the specifications, provided, however, that such advice does not have the effect of precluding competition. (16) In view of the diversity of works contracts, contracting entities should be able to make provision for contracts for the design and execution of work to be awarded either separately or jointly. It is not the intention of this Directive to prescribe either joint or separate contract awards. The decision to award contracts separately or jointly should be determined by qualitative and economic criteria, which may be defined by national law. A contract may be considered to be a works contract only if its subject-matter specifically covers the execution of activities listed in Annex XII, even if the contract covers the provision of other services necessary for the execution of such activities. Service contracts, in particular in the sphere of property management services, may in certain circumstances include works. However, insofar as such works are incidental to the principal subject-matter of the contract, and are a possible consequence thereof or a complement thereto, the fact that such works are included in the contract does not justify the qualification of the contract as a works contract. For the purpose of calculating the estimated value of a works contract it is appropriate to take as a basis the value of the works themselves as well as the estimated value of supplies and services, if any, that the contracting entities place at the disposal of contractors, insofar as these services or supplies are necessary for the execution of the works in question. It should be understood that, for the purposes of this paragraph, the services concerned are those rendered by the contracting entities through their own personnel. On the other hand, calculation of the value of services contracts, whether or not to be placed at the disposal of a contractor for the subsequent execution of works, follows the rules applicable to service contracts. (17) The field of services is best delineated, for the purpose of applying the procedural rules of this Directive and for monitoring purposes, by subdividing it into categories corresponding to particular headings of a common classification and by bringing them together in two Annexes, XVII A and XVII B, according to the regime to which they are subject. As regards services in Annex XVII B, the relevant provisions of this Directive should be without prejudice to the application of Community rules specific to the services in question. (18) As regards service contracts, full application of this Directive should be limited, for a transitional period, to contracts where its provisions will permit the full potential for increased cross-frontier trade to be realised. Contracts for other services need to be monitored during this transitional period before a decision is taken on the full application of this Directive. In this respect, the mechanism for such monitoring needs to be defined. This mechanism should, at the same time, enable interested parties to have access to the relevant information. (19) Obstacles to the free provision of services should be avoided. Therefore, service providers may be either natural or legal persons. This Directive should not, however, prejudice the application, at national level, of rules concerning the conditions for the pursuit of an activity or a profession, provided that they are compatible with Community law. (20) Certain new electronic purchasing techniques are continually being developed. Such techniques help to increase competition and streamline public purchasing, particularly in terms of the savings in time and money which their use will allow. Contracting entities may make use of electronic purchasing techniques, provided that such use complies with the rules of this Directive and the principles of equal treatment, non-discrimination and transparency. To that extent, a tender submitted by a tenderer, in particular under a framework agreement or where a dynamic purchasing system is being used, may take the form of that tenderer's electronic catalogue if the latter uses the means of communication chosen by the contracting entity in accordance with Article 48. (21) In view of the rapid expansion of electronic purchasing systems, appropriate rules should now be introduced to enable contracting entities to take full advantage of the possibilities afforded by these systems. Against this background, it is necessary to define a completely electronic dynamic purchasing system for commonly used purchases and to lay down specific rules for setting up and operating such a system in order to ensure the fair treatment of any economic operator who wishes to join. Any economic operator which submits an indicative tender in accordance with the specification and meets the selection criteria should be allowed to join such a system. This purchasing technique allows the contracting entity, through the establishment of a list of tenderers already selected and the opportunity given to new tenderers to join, to have a particularly broad range of tenders, as a result of the electronic facilities available, and hence to ensure optimum use of funds through broad competition. (22) Since use of the technique of electronic auctions is likely to increase, such auctions should be given a Community definition and be governed by specific rules in order to ensure that they operate fully in accordance with the principles of equal treatment, non-discrimination and transparency. To that end, provision should be made for such electronic auctions to deal only with contracts for works, supplies or services for which the specifications can be determined with precision. Such may in particular be the case for recurring supplies, works and service contracts. With the same objective, it should also be possible to establish the respective ranking of the tenderers at any stage of the electronic auction. Recourse to electronic auctions enables contracting entities to ask tenderers to submit new prices, revised downwards, and, when the contract is awarded to the most economically advantageous tender, also to improve elements of the tenders other than prices. In order to guarantee compliance with the principle of transparency, only the elements suitable for automatic evaluation by electronic means, without any intervention and/or appreciation by the contracting entity, may be the object of electronic auctions, that is, only the elements which are quantifiable so that they can be expressed in figures or percentages. On the other hand, those aspects of tenders which imply an appreciation of non-quantifiable elements should not be the object of electronic auctions. Consequently, certain works contracts and certain service contracts having as their subject-matter intellectual performances, such as the design of works, should not be the object of electronic auctions. (23) Certain centralised purchasing techniques have been developed in Member States. Several contracting authorities are responsible for making acquisitions or awarding contracts/framework agreements for contracting entities. In view of the large volumes purchased, those techniques help increase competition and streamline public purchasing. Provision should therefore be made for a Community definition of central purchasing bodies used by contracting entities. A definition should also be given of the conditions under which, in accordance with the principles of non-discrimination and equal treatment, contracting entities purchasing works, supplies and/or services through a central purchasing body may be deemed to have complied with this Directive. (24) In order to take account of the different circumstances obtaining in Member States, Member States should be allowed to choose whether contracting entities may use central purchasing bodies, dynamic purchasing systems or electronic auctions, as defined and regulated by this Directive. (25) There has to be an appropriate definition of the concept of special or exclusive rights. The consequence of the definition is that the fact that, for the purpose of constructing networks or port or airport facilities, an entity may take advantage of a procedure for the expropriation or use of property or may place network equipment on, under or over the public highway will not in itself constitute exclusive or special rights within the meaning of this Directive. Nor does the fact that an entity supplies drinking water, electricity, gas or heat to a network which is itself operated by an entity enjoying special or exclusive rights granted by a competent authority of the Member State concerned in itself constitute an exclusive or special right within the meaning of this Directive. Nor may rights granted by a Member State in any form, including by way of acts of concession, to a limited number of undertakings on the basis of objective, proportionate and non-discriminatory criteria that allow any interested party fulfilling those criteria to enjoy those rights be considered special or exclusive rights. (26) It is appropriate for the contracting entities to apply common procurement procedures in respect of their activities relating to water and for such rules also to apply where contracting authorities within the meaning of this Directive award contracts in respect of their projects in the field of hydraulic engineering, irrigation, land drainage or the disposal and treatment of sewage. However, procurement rules of the type proposed for supplies of goods are inappropriate for purchases of water, given the need to procure water from sources near the area in which it will be used. (27) Certain entities providing bus transport services to the public were already excluded from the scope of Directive 93/38/EEC. Such entities should also be excluded from the scope of this Directive. In order to forestall the existence of a multitude of specific arrangements applying to certain sectors only, the general procedure that permits the effects of opening up to competition to be taken into account should also apply to all entities providing bus transport services that are not excluded from the scope of Directive 93/38/EEC pursuant to Article 2(4) thereof. (28) Taking into account the further opening up of Community postal services to competition and the fact that such services are provided through a network by contracting authorities, public undertakings and other undertakings, contracts awarded by contracting entities providing postal services should be subject to the rules of this Directive, including those in Article 30, which, safeguarding the application of the principles referred to in recital 9, create a framework for sound commercial practice and allow greater flexibility than is offered by Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts(11). For a definition of the activities in question, it is necessary to take into account the definitions of Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service(12). Whatever their legal status, entities providing postal services are not currently subject to the rules set out in Directive 93/38/EEC. The adjustment of contract award procedures to this Directive could therefore take longer to implement for such entities than for entities already subject to those rules which will merely have to adapt their procedures to the amendments made by this Directive. It should therefore be permissible to defer application of this Directive to accommodate the additional time required for this adjustment. Given the varying situations of such entities, Member States should have the option of providing for a transitional period for the application of this Directive to contracting entities operating in the postal services sector. (29) Contracts may be awarded for the purpose of meeting the requirements of several activities, possibly subject to different legal regimes. It should be clarified that the legal regime applicable to a single contract intended to cover several activities should be subject to the rules applicable to the activity for which it is principally intended. Determination of the activity for which the contract is principally intended may be based on an analysis of the requirements which the specific contract must meet, carried out by the contracting entity for the purposes of estimating the contract value and drawing up the tender documents. In certain cases, such as the purchase of a single piece of equipment for the pursuit of activities for which information allowing an estimation of the respective rates of use would be unavailable, it might be objectively impossible to determine for which activity the contract is principally intended. The rules applicable to such cases should be indicated. (30) Without prejudice to the international commitments of the Community, it is necessary to simplify the implementation of this Directive, particularly by simplifying the thresholds and by rendering applicable to all contracting entities, regardless of the sector in which they operate, the provisions regarding the information to be given to participants concerning decisions taken in relation to contract award procedures and the results thereof. Furthermore, in the context of Monetary Union, such thresholds should be established in euro in such a way as to simplify the application of these provisions while at the same time ensuring compliance with the thresholds laid down in the Agreement, which are expressed in Special Drawing Rights (SDR). In this context, provision should also be made for periodic reviews of the thresholds expressed in euro so as to adjust them, where necessary, in line with possible variations in the value of the euro in relation to the SDR. In addition, the thresholds applicable to design contests should be identical to those applicable to service contracts. (31) Provision should be made for cases in which it is possible to refrain from applying the measures for coordinating procedures on grounds relating to State security or secrecy, or because specific rules on the awarding of contracts which derive from international agreements, relating to the stationing of troops, or which are specific to international organisations are applicable. (32) It is appropriate to exclude certain service, supply and works contracts awarded to an affiliated undertaking having as its principal activity the provision of such services, supply or works to the group of which it is part, rather than offering them on the market. It is also appropriate to exclude certain service, supply and works contracts awarded by a contracting entity to a joint venture which is formed by a number of contracting entities for the purpose of carrying out activities covered by this Directive and of which that entity is part. However, it is appropriate to ensure that this exclusion does not give rise to distortions of competition to the benefit of the undertakings or joint ventures that are affiliated with the contracting entities; it is appropriate to provide a suitable set of rules, in particular as regards the maximum limits within which the undertakings may obtain a part of their turnover from the market and above which they would lose the possibility of being awarded contracts without calls for competition, the composition of joint ventures and the stability of links between these joint ventures and the contracting entities of which they are composed. (33) In the context of services, contracts for the acquisition or rental of immovable property or rights to such property have particular characteristics which make the application of procurement rules inappropriate. (34) Arbitration and conciliation services are usually provided by bodies or individuals designated or selected in a manner which cannot be governed by procurement rules. (35) In accordance with the Agreement, the financial services covered by this Directive do not include contracts relating to the issue, purchase, sale or transfer of securities or other financial instruments; in particular, transactions by the contracting entities to raise money or capital are not covered. (36) This Directive should cover the provision of services only where based on contracts. (37) Pursuant to Article 163 of the Treaty, the encouragement of research and technological development is a means of strengthening the scientific and technological basis of Community industry, and the opening up of service contracts contributes to this end. This Directive should not cover the cofinancing of research and development programmes: research and development contracts other than those where the benefits accrue exclusively to the contracting entity for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting entity, are therefore not covered by this Directive. (38) To forestall the proliferation of specific arrangements applicable to certain sectors only, the current special arrangements created by Article 3 of Directive 93/38/EEC and Article 12 of Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons(13) governing entities exploiting a geographical area for the purpose of exploring for or extracting oil, gas, coal or other solid fuels should be replaced by the general procedure allowing for exemption of sectors directly exposed to competition. It has to be ensured, however, that this will be without prejudice to Commission Decision 93/676/EEC of 10 December 1993 establishing that the exploitation of geographical areas for the purpose of exploring for or extracting oil or gas does not constitute in the Netherlands an activity defined by Article 2(2)(b)(i) of Council Directive 90/531/EEC and that entities carrying on such an activity are not to be considered in the Netherlands as operating under special or exclusive rights within the meaning of Article 2(3)(b) of the Directive(14), Commission Decision 97/367/EC of 30 May 1997 establishing that the exploitation of geographical areas for the purpose of exploring for or extracting oil or gas does not constitute in the United Kingdom an activity defined by Article 2(2)(b)(i) of Council Directive 93/38/EEC and that entities carrying on such an activity are not to be considered in the United Kingdom as operating under special or exclusive rights within the meaning of Article 2(3)(b) of the Directive(15), Commission Decision 2002/205/EC of 4 March 2002 following a request by Austria applying for the special regime provided for in Article 3 of Directive 93/38/EEC(16) and Commission Decision 2004/73/EC on a request from Germany to apply the special procedure laid down in Article 3 of Directive 93/38/EEC(17). (39) Employment and occupation are key elements in guaranteeing equal opportunities for all and contribute to integration in society. In this context, sheltered workshops and sheltered employment programmes contribute efficiently towards the integration or reintegration of people with disabilities in the labour market. However, such workshops might not be able to obtain contracts under normal conditions of competition. Consequently, it is appropriate to provide that Member States may reserve the right to participate in award procedures for contracts to such workshops or reserve performance of contracts to the context of sheltered employment programmes. (40) This Directive should apply neither to contracts intended to permit the performance of an activity referred to in Articles 3 to 7 nor to design contests organised for the pursuit of such an activity if, in the Member State in which this activity is carried out, it is directly exposed to competition on markets to which access is not limited. It is therefore appropriate to introduce a procedure, applicable to all sectors covered by this Directive, that will enable the effects of current or future opening up to competition to be taken into account. Such a procedure should provide legal certainty for the entities concerned, as well as an appropriate decision-making process, ensuring, within short time limits, uniform application of Community law in this area. (41) Direct exposure to competition should be assessed on the basis of objective criteria, taking account of the specific characteristics of the sector concerned. The implementation and application of appropriate Community legislation opening a given sector, or a part of it, will be considered to provide sufficient grounds for assuming there is free access to the market in question. Such appropriate legislation should be identified in an annex which can be updated by the Commission. When updating, the Commission takes in particular into account the possible adoption of measures entailing a genuine opening up to competition of sectors other than those for which a legislation is already mentioned in Annex XI, such as that of railway transports. Where free access to a given market does not result from the implementation of appropriate Community legislation, it should be demonstrated that, de jure and de facto, such access is free. For this purpose, application by a Member State of a Directive, such as Directive 94/22/EC opening up a given sector to competition, to another sector, such as the coal sector, is a circumstance to be taken into account for the purposes of Article 30. (42) The technical specifications drawn up by purchasers should allow public procurement to be opened up to competition. To this end, it should be possible to submit tenders which reflect the diversity of technical solutions. Accordingly, it should be possible to draw up the technical specifications in terms of functional performance and requirements and, where reference is made to the European standard or, in the absence thereof, to the national standard, tenders based on other equivalent arrangements which meet the requirements of the contracting entities and are equivalent in terms of safety should be considered by the contracting entities. To demonstrate equivalence, tenderers should be permitted to use any form of evidence. Contracting entities should be able to provide a reason for any decision that equivalence does not exist in a given case. Contracting entities that wish to define environmental requirements for the technical specifications of a given contract may lay down the environmental characteristics, such as a given production method, and/or specific environmental effects of product groups or services. They may use, but are not obliged to use appropriate specifications that are defined in eco-labels, such as the European Eco-label, (multi-) national eco-labels or any other eco-label provided that the requirements for the label are drawn up and adopted on the basis of scientific information using a procedure in which stakeholders, such as government bodies, consumers, manufacturers, distributors and environmental organisations can participate, and provided that the label is accessible and available to all interested parties. Contracting entities should, whenever possible, lay down technical specifications so as to take into account accessibility criteria for people with disabilities or design for all users. The technical specifications should be clearly indicated, so that all tenderers know what the requirements established by the contracting entity cover. (43) In order to encourage the involvement of small and medium-sized undertakings in the public contracts procurement market, it is advisable to include provisions on subcontracting. (44) Contract performance conditions are compatible with the Directive provided that they are not directly or indirectly discriminatory and are indicated in the notice used to make the call for competition, or in the specifications. They may in particular be intended to encourage on-site vocational training, the employment of people experiencing particular difficulty in integration, the fight against unemployment or the protection of the environment. For example, mention may be made of the requirements - applicable during the performance of the contract - to recruit long-term job-seekers or to implement training measures for the unemployed or for young persons, to comply in substance with the provisions of the basic International Labour Organisation (ILO) Conventions, assuming that such provisions have not been implemented in national law, and to recruit more handicapped persons than are required under national legislation. (45) The laws, regulations and collective agreements, at both national and Community level, which are in force in the areas of employment conditions and safety at work apply during the performance of a contract, provided that such rules, and their application, comply with Community law. In cross-border situations where workers from one Member State provide services in another Member State for the purpose of performing a contract, Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services(18) lays down the minimum conditions which must be observed by the host country in respect of such posted workers. If national law contains provisions to this effect, non-compliance with those obligations may be considered to be grave misconduct or an offence concerning the professional conduct of the economic operator concerned, liable to lead to the exclusion of that economic operator from the procedure for the award of a contract. (46) In view of new developments in information and telecommunications technology, and the simplifications these can bring in terms of publicising contracts and the efficiency and transparency of procurement procedures, electronic means should be put on a par with traditional means of communication and information exchange. As far as possible, the means and technology chosen should be compatible with the technologies used in the other Member States. (47) The use of electronic means leads to savings in time. As a result, provision should be made for reducing the minimum periods where electronic means are used, subject, however, to the condition that they are compatible with the specific mode of transmission envisaged at Community level. However, it is necessary to ensure that the cumulative effect of reductions of time limits does not lead to excessively short time limits. (48) Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures(19) and Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the internal market ("Directive on electronic commerce")(20) should, in the context of this Directive, apply to the transmission of information by electronic means. The public procurement procedures and the rules applicable to service contests require a level of security and confidentiality higher than that required by these Directives. Accordingly, the devices for the electronic receipt of offers, requests to participate and plans and projects should comply with specific additional requirements. To this end, use of electronic signatures, in particular advanced electronic signatures, should, as far as possible, be encouraged. Moreover, the existence of voluntary accreditation schemes could constitute a favourable framework for enhancing the level of certification service provision for these devices. (49) It is appropriate that the participants in an award procedure are informed of decisions to conclude a framework agreement or to award a contract or to abandon the procedure within time limits that are sufficiently short so as not to render the lodging of requests for review impossible; this information should therefore be given as soon as possible and in general within 15 days following the decision. (50) It should be clarified that contracting entities which establish selection criteria in an open procedure should do so in accordance with objective rules and criteria, just as the selection criteria in restricted and negotiated procedures should be objective. These objective rules and criteria, just as the selection criteria, do not necessarily imply weightings. (51) It is important to take into account Court of Justice case-law in cases where an economic operator claims the economic, financial or technical capabilities of other entities, whatever the legal nature of the link between itself and those entities, in order to meet the selection criteria or, in the context of qualification systems, in support of its application for qualification. In the latter case, it is for the economic operator to prove that those resources will actually be available to it throughout the period of validity of the qualification. For the purposes of that qualification, a contracting entity may therefore determine the level of requirements to be met and in particular, for example where the operator lays claim to the financial standing of another entity, it may require that that entity be held liable, if necessary jointly and severally. Qualification systems should be operated in accordance with objective rules and criteria, which, at the contracting entities' choice, may concern the capacities of the economic operators and/or the characteristics of the works, supplies or services covered by the system. For the purposes of qualification, contracting entities may conduct their own tests in order to evaluate the characteristics of the works, supplies or services concerned, in particular in terms of compatibility and safety. (52) The relevant Community rules on mutual recognition of diplomas, certificates or other evidence of formal qualifications apply when evidence of a particular qualification is required for participation in a procurement procedure or a design contest. (53) In appropriate cases, in which the nature of the works and/or services justifies applying environmental management measures or schemes during the performance of a contract, the application of such measures or schemes may be required. Environmental management schemes, whether or not they are registered under Community instruments such as Regulation (EC) No 761/2001 (EMAS)(21), can demonstrate that the economic operator has the technical capability to perform the contract. Moreover, a description of the measures implemented by the economic operator to ensure the same level of environmental protection should be accepted as an alternative to environmental management registration schemes as a form of evidence. (54) The award of public contracts to economic operators who have participated in a criminal organisation or who have been found guilty of corruption or of fraud to the detriment of the financial interests of the European Communities or of money laundering should be avoided. Given that contracting entities, which are not contracting authorities, might not have access to indisputable proof on the matter, it is appropriate to leave the choice of whether or not to apply the exclusion criteria listed in Article 45(1) of Directive 2004/18/EC to these contracting entities. The obligation to apply Article 45(1) should therefore be limited only to contracting entities that are contracting authorities. Where appropriate, the contracting entities should ask applicants for qualification, candidates or tenderers to supply relevant documents and, where they have doubts concerning the personal situation of these economic operators, they may seek the cooperation of the competent authorities of the Member State concerned. The exclusion of such economic operators should take place as soon as the contracting authority has knowledge of a judgment concerning such offences rendered in accordance with national law that has the force of res judicata. If national law contains provisions to this effect, non-compliance with environmental legislation or legislation on unlawful agreements in contracts which has been the subject of a final judgment or a decision having equivalent effect may be considered an offence concerning the professional conduct of the economic operator concerned or grave misconduct. Non-observance of national provisions implementing the Council Directives 2000/78/EC(22) and 76/207/EEC(23) concerning equal treatment of workers, which has been the subject of a final judgment or a decision having equivalent effect may be considered an offence concerning the professional conduct of the economic operator concerned or grave misconduct. (55) Contracts must be awarded on the basis of objective criteria which ensure compliance with the principles of transparency, non-discrimination and equal treatment and which guarantee that tenders are assessed in conditions of effective competition. As a result, it is appropriate to allow the application of two award criteria only: "the lowest price" and "the most economically advantageous tender". To ensure compliance with the principle of equal treatment in the award of contracts, it is appropriate to lay down an obligation - established by case-law - to ensure the necessary transparency to enable all tenderers to be reasonably informed of the criteria and arrangements which will be applied to identify the most economically advantageous tender. It is therefore the responsibility of contracting entities to indicate the criteria for the award of the contract and the relative weighting given to each of those criteria in sufficient time for tenderers to be aware of them when preparing their tenders. Contracting entities may derogate from indicating the weighting of the criteria for the award of the contract in duly justified cases for which they must be able to give reasons, where the weighting cannot be established in advance, in particular on account of the complexity of the contract. In such cases, they must indicate the descending order of importance of the criteria. Where contracting entities choose to award a contract to the most economically advantageous tender, they should assess the tenders in order to determine which one offers the best value for money. In order to do this, they should determine the economic and quality criteria which, taken as a whole, must make it possible to determine the most economically advantageous tender for the contracting entity. The determination of these criteria depends on the object of the contract since they must allow the level of performance offered by each tender to be assessed in the light of the object of the contract, as defined in the technical specifications, and the value for money of each tender to be measured. In order to guarantee equal treatment, the criteria for the award of the contract must enable tenders to be compared and assessed objectively. If these conditions are fulfilled, economic and qualitative criteria for the award of the contract, such as meeting environmental requirements, may enable the contracting entity to meet the needs of the public concerned, as expressed in the specifications of the contract. Under the same conditions, a contracting entity may use criteria aiming to meet social requirements, in particular in response to the needs - defined in the specifications of the contract - of particularly disadvantaged groups of people to which those receiving/using the works, supplies or services which are the object of the contract belong. (56) The award criteria must not affect the application of national provisions on the remuneration of certain services, such as the services provided by architects, engineers or lawyers. (57) Council Regulation (EEC, Euratom) No 1182/71 of 3 June 1971 determining the rules applicable to periods, dates and time limits(24) should apply to the calculation of the time limits contained in this Directive. (58) This Directive should be without prejudice to the existing international obligations of the Community or of the Member States and should not prejudice the application of the provisions of the Treaty, in particular Articles 81 and 86 thereof. (59) This Directive should not prejudice the time-limits set out in Annex XXV, within which Member States are required to transpose and apply Directive 93/38/EEC. (60) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission,(25). CONTENTS >TABLE> TITLE I GENERAL PROVISIONS APPLICABLE TO CONTRACTS AND DESIGN CONTESTS CHAPTER I Basic terms Article 1 Definitions 1. For the purposes of this Directive, the definitions set out in this Article shall apply. 2. (a) "Supply, works and service contracts" are contracts for pecuniary interest concluded in writing between one or more of the contracting entities referred to in Article 2(2), and one or more contractors, suppliers, or service providers. (b) "Works contracts" are contracts having as their object either the execution, or both the design and execution, of works related to one of the activities within the meaning of Annex XII or a work, or the realisation by whatever means of a work corresponding to the requirements specified by the contracting entity. A "work" means the outcome of building or civil engineering works taken as a whole which is sufficient of itself to fulfil an economic or technical function. (c) "Supply contracts" are contracts other than those referred to in (b) having as their object the purchase, lease, rental or hire-purchase, with or without the option to buy, of products. A contract having as its object the supply of products, which also covers, as an incidental matter, siting and installation operations shall be considered to be a "supply contract"; (d) "Service contracts" are contracts other than works or supply contracts having as their object the provision of services referred to in Annex XVII. A contract having as its object both products and services within the meaning of Annex XVII shall be considered to be a "service contract" if the value of the services in question exceeds that of the products covered by the contract. A contract having as its object services within the meaning of Annex XVII and including activities within the meaning of Annex XII that are only incidental to the principal object of the contract shall be considered to be a service contract. 3. (a) A "works concession" is a contract of the same type as a works contract except for the fact that the consideration for the works to be carried out consists either solely in the right to exploit the work or in that right together with payment; (b) A "service concession" is a contract of the same type as a service contract except for the fact that the consideration for the provision of services consists either solely in the right to exploit the service or in that right together with payment. 4. A "framework agreement" is an agreement between one or more contracting entities referred to in Article 2(2) and one or more economic operators, the purpose of which is to establish the terms governing contracts to be awarded during a given period, in particular with regard to price and, where appropriate, the quantities envisaged. 5. A "dynamic purchasing system" is a completely electronic process for making commonly used purchases, the characteristics of which, as generally available on the market, meet the requirements of the contracting entity, which is limited in duration and open throughout its validity to any economic operator which satisfies the selection criteria and has submitted an indicative tender that complies with the specification. 6. An "electronic auction" is a repetitive process involving an electronic device for the presentation of new prices, revised downwards, and/or new values concerning certain elements of tenders, which occurs after an initial full evaluation of the tenders, enabling them to be ranked using automatic evaluation methods. Consequently, certain service contracts and certain works contracts having as their subject-matter intellectual performances, such as the design of works, may not be the object of electronic auctions. 7. The terms "contractor", "supplier" or "service provider" mean either a natural or a legal person, or a contracting entity within the meaning of Article 2(2)(a) or (b), or a group of such persons and/or entities which offers on the market, respectively, the execution of works and/or a work, products or services. The terms "economic operator" shall cover equally the concepts of contractor, supplier and service provider. It is used merely in the interests of simplification. A "tenderer" is an economic operator who submits a tender, and "candidate" means one who has sought an invitation to take part in a restricted or negotiated procedure. 8. A "central purchasing body" is a contracting authority within the meaning of Article 2(1)(a) or a contracting authority within the meaning of Article 1(9) of Directive 2004/18/EC which: - acquires supplies and/or services intended for contracting entities or - awards public contracts or concludes framework agreements for works, supplies or services intended for contracting entities. 9. "Open, restricted and negotiated procedures" are the procurement procedures applied by contracting entities, whereby: (a) in the case of open procedures, any interested economic operator may submit a tender; (b) in the case of restricted procedures, any economic operator may request to participate and only candidates invited by the contracting entity may submit a tender; (c) in the case of negotiated procedures, the contracting entity consults the economic operators of its choice and negotiates the terms of the contract with one or more of these. 10. "Design contests" are those procedures which enable the contracting entity to acquire, mainly in the fields of town and country planning, architecture, engineering or data processing, a plan or design selected by a jury after having been put out to competition with or without the award of prizes. 11. "Written" or "in writing" means any expression consisting of words or figures that can be read, reproduced and subsequently communicated. It may include information transmitted and stored by electronic means. 12. "Electronic means" means using electronic equipment for the processing (including digital compression) and storage of data which is transmitted, conveyed and received by wire, by radio, by optical means or by other electromagnetic means. 13. "Common Procurement Vocabulary (CPV)" means the reference nomenclature applicable to public contracts as adopted by Regulation (EC) No 2195/2002 of 5 November 2002 of the European Parliament and of the Council on the Common Procurement Vocabulary (CVP)(26) while ensuring equivalence with the other existing nomenclatures. In the event of varying interpretations of the scope of this Directive, owing to possible differences between the CPV and NACE nomenclatures listed in Annex XII or between the CPV and CPC (provisional version) nomenclatures listed in Annex XVII, the NACE or the CPC nomenclature respectively shall take precedence. CHAPTER II Definition of the activities and entities covered Section 1 Entities Article 2 Contracting entities 1. For the purposes of this Directive, (a) "Contracting authorities" are State, regional or local authorities, bodies governed by public law, associations formed by one or several such authorities or one or several of such bodies governed by public law. "A body governed by public law" means any body: - established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character, - having legal personality and - financed, for the most part, by the State, regional or local authorities, or other bodies governed by public law; or subject to management supervision by those bodies; or having an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law; (b) a "public undertaking" is any undertaking over which the contracting authorities may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the contracting authorities shall be presumed when these authorities, directly or indirectly, in relation to an undertaking: - hold the majority of the undertaking's subscribed capital, or - control the majority of the votes attaching to shares issued by the undertaking, or - can appoint more than half of the undertaking's administrative, management or supervisory body. 2. This Directive shall apply to contracting entities: (a) which are contracting authorities or public undertakings and which pursue one of the activities referred to in Articles 3 to 7; (b) which, when they are not contracting authorities or public undertakings, have as one of their activities any of the activities referred to in Articles 3 to 7, or any combination thereof and operate on the basis of special or exclusive rights granted by a competent authority of a Member State. 3. For the purposes of this Directive, "special or exclusive rights" mean rights granted by a competent authority of a Member State by way of any legislative, regulatory or administrative provision the effect of which is to limit the exercise of activities defined in Articles 3 to 7 to one or more entities, and which substantially affects the ability of other entities to carry out such activity. Section 2 Activities Article 3 Gas, heat and electricity 1. As far as gas and heat are concerned, this Directive shall apply to the following activities: (a) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of gas or heat; or (b) the supply of gas or heat to such networks. 2. The supply of gas or heat to networks which provide a service to the public by a contracting entity other than a contracting authority shall not be considered a relevant activity within the meaning of paragraph 1 where: (a) the production of gas or heat by the entity concerned is the unavoidable consequence of carrying out an activity other than those referred to in paragraphs 1 or 3 of this Article or in Articles 4 to 7; and (b) supply to the public network is aimed only at the economic exploitation of such production and amounts to not more than 20 % of the entity's turnover having regard to the average for the preceding three years, including the current year. 3. As far as electricity is concerned, this Directive shall apply to the following activities: (a) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of electricity; or (b) the supply of electricity to such networks. 4. The supply of electricity to networks which provide a service to the public by a contracting entity other than a contracting authority shall not be considered a relevant activity within the meaning of paragraph 3 where: (a) the production of electricity by the entity concerned takes place because its consumption is necessary for carrying out an activity other than those referred to in paragraphs 1 or 3 of this Article or in Articles 4 to 7; and (b) supply to the public network depends only on the entity's own consumption and has not exceeded 30% of the entity's total production of energy, having regard to the average for the preceding three years, including the current year. Article 4 Water 1. This Directive shall apply to the following activities: (a) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of drinking water; or (b) the supply of drinking water to such networks. 2. This Directive shall also apply to contracts or design contests awarded or organised by entities which pursue an activity referred to in paragraph 1 and which: (a) are connected with hydraulic engineering projects, irrigation or land drainage, provided that the volume of water to be used for the supply of drinking water represents more than 20 % of the total volume of water made available by such projects or irrigation or drainage installations, or (b) are connected with the disposal or treatment of sewage. 3. The supply of drinking water to networks which provide a service to the public by a contracting entity other than a contracting authority shall not be considered a relevant activity within the meaning of paragraph 1 where: (a) the production of drinking water by the entity concerned takes place because its consumption is necessary for carrying out an activity other than those referred to in Articles 3 to 7; and (b) supply to the public network depends only on the entity's own consumption and has not exceeded 30 % of the entity's total production of drinking water, having regard to the average for the preceding three years, including the current year. Article 5 Transport services 1. This Directive shall apply to activities relating to the provision or operation of networks providing a service to the public in the field of transport by railway, automated systems, tramway, trolley bus, bus or cable. As regards transport services, a network shall be considered to exist where the service is provided under operating conditions laid down by a competent authority of a Member State, such as conditions on the routes to be served, the capacity to be made available or the frequency of the service. 2. This Directive shall not apply to entities providing bus transport services to the public which were excluded from the scope of Directive 93/38/EEC pursuant to Article 2(4) thereof. Article 6 Postal services 1. This Directive shall apply to activities relating to the provision of postal services or, on the conditions set out in paragraph 2(c), other services than postal services. 2. For the purpose of this Directive and without prejudice to Directive 97/67/EC: (a) "postal item": means an item addressed in the final form in which it is to be carried, irrespective of weight. In addition to items of correspondence, such items also include for instance books, catalogues, newspapers, periodicals and postal packages containing merchandise with or without commercial value, irrespective of weight; (b) "postal services": means services consisting of the clearance, sorting, routing and delivery of postal items. These services comprise: - "reserved postal services": postal services which are or may be reserved on the basis of Article 7 of Directive 97/67/EC, - "other postal services": postal services which may not be reserved on the basis of Article 7 of Directive 97/67/EC; and (c) "other services than postal services": means services provided in the following areas: - mail service management services (services both preceding and subsequent to despatch, such as "mailroom management services"), - added-value services linked to and provided entirely by electronic means (including the secure transmission of coded documents by electronic means, address management services and transmission of registered electronic mail), - services concerning postal items not included in point (a), such as direct mail bearing no address, - financial services, as defined in category 6 of Annex XVII A and in Article 24(c) and including in particular postal money orders and postal giro transfers, - philatelic services, and - logistics services (services combining physical delivery and/or warehousing with other non-postal functions), on condition that such services are provided by an entity which also provides postal services within the meaning of point (b), first or second indent, and provided that the conditions set out in Article 30(1) are not satisfied in respect of the services falling within those indents. Article 7 Exploration for, or extraction of, oil, gas, coal or other solid fuels, as well as ports and airports This Directive shall apply to activities relating to the exploitation of a geographical area for the purpose of: (a) exploring for or extracting oil, gas, coal or other solid fuels, or (b) the provision of airports and maritime or inland ports or other terminal facilities to carriers by air, sea or inland waterway. Article 8 Lists of contracting entities The non-exhaustive lists of contracting entities within the meaning of this Directive are contained in Annexes I to X. Member States shall notify the Commission periodically of any changes to their lists. Article 9 Contracts covering several activities 1. A contract which is intended to cover several activities shall be subject to the rules applicable to the activity for which it is principally intended. However, the choice between awarding a single contract and awarding a number of separate contracts may not be made with the objective of excluding it from the scope of this Directive or, where applicable, Directive 2004/18/EC. 2. If one of the activities for which the contract is intended is subject to this Directive and the other to the abovementioned Directive 2004/18/EC and if it is objectively impossible to determine for which activity the contract is principally intended, the contract shall be awarded in accordance with the abovementioned Directive 2004/18/EC. 3. If one of the activities for which the contract is intended is subject to this Directive and the other is not subject to either this Directive or the abovementioned Directive 2004/18/EC, and if it is objectively impossible to determine for which activity the contract is principally intended, the contract shall be awarded in accordance with this Directive. CHAPTER III General principles Article 10 Principles of awarding contracts Contracting entities shall treat economic operators equally and non-discriminatorily and shall act in a transparent way. TITLE II RULES APPLICABLE TO CONTRACTS CHAPTER I General provisions Article 11 Economic operators 1. Candidates or tenderers who, under the law of the Member State in which they are established, are entitled to provide the relevant service, shall not be rejected solely on the ground that, under the law of the Member State in which the contract is awarded, they would be required to be either natural or legal persons. However, in the case of service and works contracts as well as supply contracts covering in addition services and/or siting and installation operations, legal persons may be required to indicate, in the tender or the request to participate, the names and relevant professional qualifications of the staff to be responsible for the performance of the contract in question. 2. Groups of economic operators may submit tenders or put themselves forward as candidates. In order to submit a tender or a request to participate, these groups may not be required by the contracting entities to assume a specific legal form; however, the group selected may be required to do so when it has been awarded the contract, to the extent to which this change is necessary for the satisfactory performance of the contract. Article 12 Conditions relating to agreements concluded within the World Trade Organisation For the purposes of the award of contracts by contracting entities, Member States shall apply in their relations conditions as favourable as those which they grant to economic operators of third countries in implementation of the Agreement. Member States shall, to this end, consult one another within the Advisory Committee for Public Contracts on the measures to be taken pursuant to the Agreement. Article 13 Confidentiality 1. In the context of provision of technical specifications to interested economic operators, of qualification and selection of economic operators and of award of contracts, contracting entities may impose requirements with a view to protecting the confidential nature of information which they make available. 2. Without prejudice to the provisions of this Directive, in particular those concerning the obligations relating to the advertising of awarded contracts and to the information to candidates and tenderers set out in Articles 43 and 49, and in accordance with the national law to which the contracting entity is subject, the contracting authority shall not disclose information forwarded to it by economic operators which they have designated as confidential; such information includes, in particular, technical or trade secrets and the confidential aspects of tenders. Article 14 Framework agreements 1. Contracting entities may regard a framework agreement as a contract within the meaning of Article 1(2) and award it in accordance with this Directive. 2. Where contracting entities have awarded a framework agreement in accordance with this Directive, they may avail themselves of Article 40(3)(i) when awarding contracts based on that framework agreement. 3. Where a framework agreement has not been awarded in accordance with this Directive, contracting entities may not avail themselves of Article 40(3)(i). 4. Contracting entities may not misuse framework agreements in order to hinder, limit or distort competition. Article 15 Dynamic purchasing systems 1. Member States may provide that contracting entities may use dynamic purchasing systems. 2. In order to set up a dynamic purchasing system, contracting entities shall follow the rules of the open procedure in all its phases up to the award of the contracts to be concluded under this system. All tenderers who satisfy the selection criteria and have submitted an indicative tender which complies with the specification and any possible additional documents shall be admitted to the system; indicative tenders may be improved at any time provided that they continue to comply with the specification. With a view to setting up the system and to the award of contracts under that system, contracting entities shall use solely electronic means in accordance with Article 48(2) to (5). 3. For the purposes of setting up the dynamic purchasing system, contracting entities shall: (a) publish a contract notice making it clear that a dynamic purchasing system is involved; (b) indicate in the specification, amongst other matters, the nature of the purchases envisaged under that system, as well as all the necessary information concerning the purchasing system, the electronic equipment used and the technical connection arrangements and specifications; (c) offer by electronic means, on publication of the notice and until the system expires, unrestricted, direct and full access to the specification and to any additional documents and shall indicate in the notice the internet address at which such documents may be consulted. 4. Contracting entities shall give any economic operator, throughout the entire period of the dynamic purchasing system, the possibility of submitting an indicative tender and of being admitted to the system under the conditions referred to in paragraph 2. They shall complete evaluation within a maximum of 15 days from the date of submission of the indicative tender. However, they may extend the evaluation period provided that no invitation to tender is issued in the meantime. Contracting entities shall inform the tenderer referred to in the first subparagraph at the earliest possible opportunity of its admittance to the dynamic purchasing system or of the rejection of its indicative tender. 5. Each specific contract shall be the subject of an invitation to tender. Before issuing the invitation to tender, contracting entities shall publish a simplified contract notice inviting all interested economic operators to submit an indicative tender, in accordance with paragraph 4, within a time limit that may not be less than 15 days from the date on which the simplified notice was sent. Contracting entities may not proceed with tendering until they have completed evaluation of all the indicative tenders received within that time limit. 6. Contracting entities shall invite all tenderers admitted to the system to submit a tender for each specific contract to be awarded under the system. To that end, they shall set a time limit for the submission of tenders. They shall award the contract to the tenderer which submitted the best tender on the basis of the award criteria set out in the contract notice for the establishment of the dynamic purchasing system. Those criteria may, if appropriate, be formulated more precisely in the invitation referred to in the first subparagraph. 7. A dynamic purchasing system may not last for more than four years, except in duly justified exceptional cases. Contracting entities may not resort to this system to prevent, restrict or distort competition. No charges may be billed to the interested economic operators or to parties to the system. CHAPTER II Thresholds and exclusion provisions Section 1 Thresholds Article 16 Contract thresholds Save where they are ruled out by the exclusions in Articles 19 to 26 or pursuant to Article 30, concerning the pursuit of the activity in question, this Directive shall apply to contracts which have a value excluding value-added tax (VAT) estimated to be no less than the following thresholds: (a) EUR 499000 in the case of supply and service contracts; (b) EUR 6242000 in the case of works contracts. Article 17 Methods of calculating the estimated value of contracts, framework agreements and dynamic purchasing systems 1. The calculation of the estimated value of a contract shall be based on the total amount payable, net of VAT, as estimated by the contracting entity. This calculation shall take account of the estimated total amount, including any form of option and any renewals of the contract. Where the contracting entity provides for prizes or payments to candidates or tenderers it shall take them into account when calculating the estimated value of the contract. 2. Contracting entities may not circumvent this Directive by splitting works projects or proposed purchases of a certain quantity of supplies and/or services or by using special methods for calculating the estimated value of contracts. 3. With regard to framework agreements and dynamic purchasing systems, the estimated value to be taken into consideration shall be the maximum estimated value net of VAT of all the contracts envisaged for the total term of the agreement or system. 4. For the purposes of Article 16, contracting entities shall include in the estimated value of a works contract both the cost of the works and the value of any supplies or services necessary for the execution of the works, which they make available to the contractor. 5. The value of supplies or services which are not necessary for the performance of a particular works contract may not be added to the value of the works contract when to do so would result in removing the procurement of those supplies or services from the scope of this Directive. 6. (a) Where a proposed work or purchase of services may result in contracts being awarded at the same time in the form of separate lots, account shall be taken of the total estimated value of all such lots. Where the aggregate value of the lots is equal to or exceeds the threshold laid down in Article 16, this Directive shall apply to the awarding of each lot. However, the contracting entities may waive such application in respect of lots the estimated value of which, net of VAT, is less than EUR 80000 for services or EUR 1 million for works, provided that the aggregate value of those lots does not exceed 20 % of the aggregate value of the lots as a whole. (b) Where a proposal for the acquisition of similar supplies may result in contracts being awarded at the same time in the form of separate lots, account shall be taken of the total estimated value of all such lots when applying Article 16. Where the aggregate value of the lots is equal to or exceeds the threshold laid down in Article 16, this Directive shall apply to the awarding of each lot. However, the contracting entities may waive such application in respect of lots, the estimated value of which, net of VAT, is less than EUR 80000, provided that the aggregate cost of those lots does not exceed 20 % of the aggregate value of the lots as a whole. 7. In the case of supply or service contracts which are regular in nature or which are intended to be renewed within a given period, the calculation of the estimated contract value shall be based on the following: (a) either the total actual value of the successive contracts of the same type awarded during the preceding twelve months or financial year adjusted, if possible, to take account of the changes in quantity or value which would occur in the course of the 12 months following the initial contract; (b) or the total estimated value of the successive contracts awarded during the 12 months following the first delivery, or during the financial year if that is longer than 12 months. 8. The basis for calculating the estimated value of a contract including both supplies and services shall be the total value of the supplies and services, regardless of their respective shares. The calculation shall include the value of the siting and installation operations. 9. With regard to supply contracts relating to the leasing, hire, rental or hire purchase of products, the value to be taken as a basis for calculating the estimated contract value shall be as follows: (a) in the case of fixed-term contracts, if that term is less than or equal to 12 months, the total estimated value for the term of the contract or, if the term of the contract is greater than 12 months, the total value including the estimated residual value; (b) in the case of contracts without a fixed term or the term of which cannot be defined, the monthly value multiplied by 48. 10. For the purposes of calculating the estimated contract value of service contracts, the following amounts shall, where appropriate, be taken into account: (a) the premium payable, and other forms of remuneration, in the case of insurance services; (b) fees, commissions, interest and other modes of remuneration, in the case of banking and other financial services; (c) fees, commissions payable and other forms of remuneration, in the case of contracts involving design tasks. 11. In the case of service contracts which do not indicate a total price, the value to be used as the basis for calculating the estimated contract value shall be: (a) in the case of fixed-term contracts, if that term is less than or equal to 48 months: the total value for their full term; (b) in the case of contracts without a fixed term or with a term greater than 48 months: the monthly value multiplied by 48. Section 2 Contracts and concessions and contracts subject to special arrangements SUBSECTION 1 Article 18 Works and service concessions This Directive shall not apply to works and service concessions which are awarded by contracting entities carrying out one or more of the activities referred to in Articles 3 to 7, where those concessions are awarded for carrying out those activities. SUBSECTION 2 Exclusions applicable to all contracting entities and to all types of contract Article 19 Contracts awarded for purposes of resale or lease to third parties 1. This Directive shall not apply to contracts awarded for purposes of resale or lease to third parties, provided that the contracting entity enjoys no special or exclusive right to sell or lease the subject of such contracts, and other entities are free to sell or lease it under the same conditions as the contracting entity. 2. The contracting entities shall notify the Commission at its request of all the categories of products or activities which they regard as excluded under paragraph 1. The Commission may periodically publish in the Official Journal of the European Union, for information purposes, lists of the categories of products and activities which it considers to be covered by this exclusion. In so doing, the Commission shall respect any sensitive commercial aspects that the contracting entities may point out when forwarding information. Article 20 Contracts awarded for purposes other than the pursuit of an activity covered or for the pursuit of such an activity in a third country 1. This Directive shall not apply to contracts which the contracting entities award for purposes other than the pursuit of their activities as described in Articles 3 to 7 or for the pursuit of such activities in a third country, in conditions not involving the physical use of a network or geographical area within the Community. 2. The contracting entities shall notify the Commission at its request of any activities which they regard as excluded under paragraph 1. The Commission may periodically publish in the Official Journal of the European Union for information purposes, lists of the categories of activities which it considers to be covered by this exclusion. In so doing, the Commission shall respect any sensitive commercial aspects that the contracting entities may point out when forwarding this information. Article 21 Contracts which are secret or require special security measures This Directive shall not apply to contracts when they are declared to be secret by a Member State, when their performance must be accompanied by special security measures in accordance with the laws, regulations or administrative provisions in force in the Member State concerned, or when the protection of the basic security interests of that Member State so requires. Article 22 Contracts awarded pursuant to international rules This Directive shall not apply to contracts governed by different procedural rules and awarded: (a) pursuant to an international agreement concluded in accordance with the Treaty between a Member State and one or more third countries and covering supplies, works, services or design contests intended for the joint implementation or exploitation of a project by the signatory States; all agreements shall be communicated to the Commission, which may consult the Advisory Committee for Public Contracts referred to in Article 68; (b) pursuant to a concluded international agreement relating to the stationing of troops and concerning the undertakings of a Member State or a third country; (c) pursuant to the particular procedure of an international organisation. Article 23 Contracts awarded to an affiliated undertaking, to a joint venture or to a contracting entity forming part of a joint venture 1. For the purposes of this Article, "affiliated undertaking" means any undertaking the annual accounts of which are consolidated with those of the contracting entity in accordance with the requirements of the Seventh Council Directive 83/349/EEC of 13 June 1983 based on the Article 44(2)(g) of the Treaty on consolidated accounts(27)(28), or, in the case of entities not subject to that Directive, any undertaking over which the contracting entity may exercise, directly or indirectly, a dominant influence within the meaning of Article 2(1)(b) hereof or which may exercise a dominant influence over the contracting entity or which, in common with the contracting entity, is subject to the dominant influence of another undertaking by virtue of ownership, financial participation, or the rules which govern it. 2. Provided that the conditions in paragraph 3 are met, this Directive shall not apply to contracts awarded: (a) by a contracting entity to an affiliated undertaking, or (b) by a joint venture, formed exclusively by a number of contracting entities for the purpose of carrying out activities within the meaning of Articles 3 to 7, to an undertaking which is affiliated with one of these contracting entities. 3. Paragraph 2 shall apply: (a) to service contracts provided that at least 80 % of the average turnover of the affiliated undertaking with respect to services for the preceding three years derives from the provision of such services to undertakings with which it is affiliated; (b) to supplies contracts provided that at least 80 % of the average turnover of the affiliated undertaking with respect to supplies for the preceding three years derives from the provision of such supplies to undertakings with which it is affiliated; (c) to works contracts provided that at least 80 % of the average turnover of the affiliated undertaking with respect to works for the preceding three years derives from the provision of such works to undertakings with which it is affiliated. When, because of the date on which an affiliated undertaking was created or commenced activities, the turnover is not available for the preceding three years, it will be sufficient for that undertaking to show that the turnover referred to in points (a), (b) or (c) is credible, particularly by means of business projections. Where more than one undertaking affiliated with the contracting entity provides the same or similar services, supplies or works, the above percentages shall be calculated taking into account the total turnover deriving respectively from the provision of services, supplies or works by those affiliated undertakings. 4. This Directive shall not apply to contracts awarded: (a) by a joint venture, formed exclusively by a number of contracting entities for the purpose of carrying out activities within the meaning of Articles 3 to 7, to one of these contracting entities, or (b) by a contracting entity to such a joint venture of which it forms part, provided that the joint venture has been set up in order to carry out the activity concerned over a period of at least three years and that the instrument setting up the joint venture stipulates that the contracting entities, which form it, will be part thereof for at least the same period. 5. Contracting entities shall notify to the Commission, at its request, the following information regarding the application of paragraphs 2, 3 and 4: (a) the names of the undertakings or joint ventures concerned, (b) the nature and value of the contracts involved, (c) such proof as may be deemed necessary by the Commission that the relationship between the undertaking or joint venture to which the contracts are awarded and the contracting entity complies with the requirements of this Article. SUBSECTION 3 Exclusions applicable to all contracting entities, but to service contracts only Article 24 Contracts relating to certain services excluded from the scope of this Directive This Directive shall not apply to service contracts for: (a) the acquisition or rental, by whatever financial means, of land, existing buildings or other immovable property or concerning rights thereon; nevertheless, financial service contracts concluded at the same time as, before or after the contract of acquisition or rental, in whatever form, shall be subject to this Directive; (b) arbitration and conciliation services; (c) financial services in connection with the issue, sale, purchase or transfer of securities or other financial instruments, in particular transactions by the contracting entities to raise money or capital; (d) employment contracts; (e) research and development services other than those where the benefits accrue exclusively to the contracting entity for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting entity. Article 25 Service contracts awarded on the basis of an exclusive right This Directive shall not apply to service contracts awarded to an entity which is itself a contracting authority within the meaning of Article 2(1)(a) or to an association of contracting authorities on the basis of an exclusive right which they enjoy pursuant to a published law, regulation or administrative provision which is compatible with the Treaty. SUBSECTION 4 Exclusions applicable to certain contracting entities only Article 26 Contracts awarded by certain contracting entities for the purchase of water and for the supply of energy or of fuels for the production of energy This Directive shall not apply: (a) to contracts for the purchase of water if awarded by contracting entities engaged in one or both of the activities referred to in Article 4(1). (b) to contracts for the supply of energy or of fuels for the production of energy, if awarded by contracting entities engaged in an activity referred to in Article 3(1), Article 3(3) or Article 7(a). SUBSECTION 5 Contracts subject to special arrangements, provisions concerning central purchasing bodies and the general procedure in case of direct exposure to competition Article 27 Contracts subject to special arrangements Without prejudice to Article 30 the Kingdom of the Netherlands, the United Kingdom, the Republic of Austria and the Federal Republic of Germany shall ensure, by way of the conditions of authorisation or other appropriate measures, that any entity operating in the sectors mentioned in Decisions 93/676/EEC, 97/367/EEC, 2002/205/EC and 2004/73/EC: (a) observes the principles of non-discrimination and competitive procurement in respect of the award of supplies, works and service contracts, in particular as regards the information which the entity makes available to economic operators concerning its procurement intentions; (b) communicates to the Commission, under the conditions defined in Commission Decision 93/327/EEC defining the conditions under which contracting entities exploiting geographical areas for the purpose of exploring for or extracting oil, gas, coal or other solid fuels must communicate to the Commission information relating to the contracts they award(29). Article 28 Reserved contracts Member States may reserve the right to participate in contract award procedures to sheltered workshops or provide for such contracts to be performed in the context of sheltered employment programmes where most of the employees concerned are handicapped persons who, by reason of the nature or the seriousness of their disabilities, cannot carry on occupations under normal conditions. The notice used to make the call for competition shall make reference to this Article. Article 29 Contracts and framework agreements awarded by central purchasing bodies 1. Member States may prescribe that contracting entities may purchase works, supplies and/or services from or through a central purchasing body. 2. Contracting entities which purchase works, supplies and/or services from or through a central purchasing body in the cases set out in Article 1(8) shall be deemed to have complied with this Directive insofar as the central purchasing body has complied with it or, where appropriate, with Directive 2004/18/EC. Article 30 Procedure for establishing whether a given activity is directly exposed to competition 1. Contracts intended to enable an activity mentioned in Articles 3 to 7 to be carried out shall not be subject to this Directive if, in the Member State in which it is performed, the activity is directly exposed to competition on markets to which access is not restricted. 2. For the purposes of paragraph 1, the question of whether an activity is directly exposed to competition shall be decided on the basis of criteria that are in conformity with the Treaty provisions on competition, such as the characteristics of the goods or services concerned, the existence of alternative goods or services, the prices and the actual or potential presence of more than one supplier of the goods or services in question. 3. For the purposes of paragraph 1, access to a market shall be deemed not to be restricted if the Member State has implemented and applied the provisions of Community legislation mentioned in Annex XI. If free access to a given market cannot be presumed on the basis of the first subparagraph, it must be demonstrated that access to the market in question is free de facto and de jure. 4. When a Member State considers that, in compliance with paragraphs 2 and 3, paragraph 1 is applicable to a given activity, it shall notify the Commission and inform it of all relevant facts, and in particular of any law, regulation, administrative provision or agreement concerning compliance with the conditions set out in paragraph 1, where appropriate together with the position adopted by an independent national authority that is competent in relation to the activity concerned. Contracts intended to enable the activity concerned to be carried out shall no longer be subject to this Directive if the Commission: - has adopted a Decision establishing the applicability of paragraph 1 in accordance with paragraph 6 and within the period it provides for, or - has not adopted a Decision concerning such applicability within that period. However, where free access to a given market is presumed on the basis of the first subparagraph of paragraph 3, and where an independent national authority that is competent in the activity concerned has established the applicability of paragraph 1, contracts intended to enable the activity concerned to be carried out shall no longer be subject to this Directive if the Commission has not established the inapplicability of paragraph 1 by a Decision adopted in conformity with paragraph 6 and within the period it provides for. 5. When the legislation of the Member State concerned provides for it, the contracting entities may ask the Commission to establish the applicability of paragraph 1 to a given activity by a Decision in conformity with paragraph 6. In such a case, the Commission shall immediately inform the Member State concerned. That Member State shall, taking account of paragraphs 2 and 3, inform the Commission of all relevant facts, and in particular of any law, regulation, administrative provision or agreement concerning compliance with the conditions set out in paragraph 1, where appropriate together with the position adopted by an independent national authority that is competent in the activity concerned. The Commission may also begin the procedure for adoption of a Decision establishing the applicability of paragraph 1 to a given activity on its own initiative. In such a case, the Commission shall immediately inform the Member State concerned. If, at the end of the period laid down in paragraph 6, the Commission has not adopted a Decision concerning the applicability of paragraph 1 to a given activity, paragraph 1 shall be deemed to be applicable. 6. For the adoption of a Decision under this Article, in accordance with the procedure under Article 68(2), the Commission shall be allowed a period of three months commencing on the first working day following the date on which it receives the notification or the request. However, this period may be extended once by a maximum of three months in duly justified cases, in particular if the information contained in the notification or the request or in the documents annexed thereto is incomplete or inexact or if the facts as reported undergo any substantive changes. This extension shall be limited to one month where an independent national authority that is competent in the activity concerned has established the applicability of paragraph 1 in the cases provided for under the third subparagraph of paragraph 4. When an activity in a given Member State is already the subject of a procedure under this Article, further requests concerning the same activity in the same Member State before the expiry of the period opened in respect of the first request shall not be considered as new procedures and shall be treated in the context of the first request. The Commission shall adopt detailed rules for applying paragraphs 4, 5 and 6 in accordance with the procedure under Article 68(2). These rules shall include at least: (a) the publication in the Official Journal, for information, of the date on which the three-month period referred to in the first subparagraph begins, and, in case this period is prolonged, the date of prolongation and the period by which it is prolonged; (b) publication of the possible applicability of paragraph 1 in accordance with the second or third subparagraph of paragraph 4 or in accordance with the fourth subparagraph of paragraph 5; and (c) the arrangements for forwarding positions adopted by an independent authority that is competent in the activity concerned, regarding questions relevant to paragraphs 1 and 2. CHAPTER III Rules applicable to service contracts Article 31 Service contracts listed in Annex XVII A Contracts which have as their object services listed in Annex XVII A shall be awarded in accordance with Articles 34 to 59. Article 32 Service contracts listed in Annex XVII B Contracts which have as their object services listed in Annex XVII B shall be governed solely by Articles 34 and 43. Article 33 Mixed service contracts including services listed in Annexes XVII A and services listed in Annex XVII B Contracts which have as their subject-matter services listed both in Annex XVII A and in Annex XVII B shall be awarded in accordance with Articles 34 to 59 where the value of the services listed in Annex XVII A is greater than the value of the services listed in Annex XVII B. In other cases, contracts shall be awarded in accordance with Articles 34 and 43. CHAPTER IV Specific rules governing specifications and contract documents Article 34 Technical specifications 1. Technical specifications as defined in point 1 of Annex XXI shall be set out in the contract documentation, such as contract notices, contract documents or additional documents. Whenever possible these technical specifications should be defined so as to take into account accessibility criteria for people with disabilities or design for all users. 2. Technical specifications shall afford equal access for tenderers and not have the effect of creating unjustified obstacles to the opening up of public procurement to competition. 3. Without prejudice to legally binding national technical rules, to the extent that they are compatible with Community law, the technical specifications shall be formulated: (a) either by reference to technical specifications defined in Annex XXI and, in order of preference, to national standards transposing European standards, European technical approvals, common technical specifications, international standards, other technical reference systems established by the European standardisation bodies or - when these do not exist - national standards, national technical approvals or national technical specifications relating to the design, calculation and execution of the works and use of the products. Each reference shall be accompanied by the words "or equivalent"; (b) or in terms of performance or functional requirements; the latter may include environmental characteristics. However, such parameters must be sufficiently precise to allow tenderers to determine the subject-matter of the contract and to allow contracting entities to award the contract; (c) or in terms of performance or functional requirements as mentioned in subparagraph (b), with reference to the specifications mentioned in subparagraph (a) as a means of presuming conformity with such performance or functional requirements; (d) or by referring to the specifications mentioned in subparagraph (a) for certain characteristics, and by referring to the performance or functional requirements mentioned in subparagraph (b) for other characteristics. 4. Where a contracting entity makes use of the option of referring to the specifications mentioned in paragraph 3(a), it cannot reject a tender on the ground that the products and services tendered for do not comply with the specifications to which it has referred, once the tenderer proves in his tender to the satisfaction of the contracting entity, by whatever appropriate means, that the solutions which he proposes satisfy in an equivalent manner the requirements defined by the technical specifications. An appropriate means might be constituted by a technical dossier from the manufacturer or a test report from a recognised body. 5. Where a contracting entity uses the option provided for in paragraph 3 of laying down performance or functional requirements, it may not reject a tender for products, services or works which comply with a national standard transposing a European standard, with a European technical approval, a common technical specification, an international standard, or a technical reference system established by a European standardisation body, if these specifications address the performance or functional requirements which it has laid down. In his tender, the tenderer shall prove to the satisfaction of the contracting entity and by any appropriate means that the product, service or work in compliance with the standard meets the performance or functional requirements of the contracting entity. An appropriate means might be constituted by a technical dossier from the manufacturer or a test report from a recognised body. 6. Where contracting entities lay down environmental characteristics in terms of performance or functional requirements as referred to in paragraph 3(b) they may use the detailed specifications, or, if necessary, parts thereof, as defined by European or (multi-) national eco-labels, or by any other eco-label, provided that: - those specifications are appropriate to define the characteristics of the supplies or services that are the object of the contract, - the requirements for the label are drawn up on the basis of scientific information, - the eco-labels are adopted using a procedure in which all stakeholders, such as government bodies, consumers, manufacturers, distributors and environmental organisations can participate, and - they are accessible to all interested parties. Contracting entities may indicate that the products and services bearing the eco-label are presumed to comply with the technical specifications laid down in the contract documents; they must accept any other appropriate means of proof, such as a technical dossier from the manufacturer or a test report from a recognised body. 7. "Recognised bodies", within the meaning of this Article, are test and calibration laboratories, and certification and inspection bodies which comply with applicable European standards. Contracting entities shall accept certificates from recognised bodies established in other Member States. 8. Unless justified by the subject-matter of the contract, technical specifications shall not refer to a specific make or source, or to a particular process, or to trade marks, patents, types or a specific origin or production with the effect of favouring or eliminating certain undertakings or certain products. Such reference shall be permitted, on an exceptional basis, where a sufficiently precise and intelligible description of the subject-matter of the contract pursuant to paragraphs 3 and 4 is not possible; such reference shall be accompanied by the words "or equivalent". Article 35 Communication of technical specifications 1. Contracting entities shall make available on request to economic operators interested in obtaining a contract the technical specifications regularly referred to in their supply, works or service contracts, or the technical specifications which they intend to apply to contracts covered by periodic indicative notices within the meaning of Article 41(1). 2. Where the technical specifications are based on documents available to interested economic operators, the inclusion of a reference to those documents shall be sufficient. Article 36 Variants 1. Where the criterion for the award of the contract is that of the most economically advantageous tender, contracting entities may take account of variants which are submitted by a tenderer and meet the minimum requirements specified by the contracting entities. Contracting entities shall indicate in the specifications whether or not they authorise variants and, if so, the minimum requirements to be met by the variants and any specific requirements for their presentation. 2. In procedures for awarding supply or service contracts, contracting entities which have authorised variants pursuant to paragraph 1 may not reject a variant on the sole ground that it would, if successful, lead either to a service contract rather than a supply contract or to a supply contract rather than a service contract. Article 37 Subcontracting In the contract documents, the contracting entity may ask, or may be required by a Member State to ask, the tenderer to indicate in his tender any share of the contract he intends to subcontract to third parties and any proposed subcontractors. This indication shall be without prejudice to the question of the principal economic operator's liability. Article 38 Conditions for performance of contracts Contracting entities may lay down special conditions relating to the performance of a contract, provided that these are compatible with Community law and are indicated in the notice used as a means of calling for competition or in the specifications. The conditions governing the performance of a contract may, in particular, concern social and environmental considerations. Article 39 Obligations relating to taxes, environmental protection, employment protection provisions and working conditions 1. A contracting entity may state in the contract documents, or be required by a Member State so to state, the body or bodies from which a candidate or tenderer may obtain the appropriate information on the obligations relating to taxes, to environmental protection, to protection provisions and to the working conditions which are in force in the Member State, region or locality in which the services are to be provided and which shall be applicable to the works carried out on site or to the services provided during the performance of the contract. 2. A contracting entity which supplies the information referred to in paragraph 1 shall request the tenderers or candidates in the contract award procedure to indicate that they have taken account, when drawing up their tender, of the obligations relating to employment protection provisions and the working conditions which are in force in the place where the service is to be provided. The first subparagraph shall be without prejudice to the application of Article 57. CHAPTER V Procedures Article 40 Use of open, restricted and negotiated procedures 1. When awarding supply, works or service contracts, contracting entities shall apply the procedures adjusted for the purposes of this Directive. 2. Contracting entities may choose any of the procedures described in Article 1(9)(a), (b) or (c), provided that, subject to paragraph 3, a call for competition has been made in accordance with Article 42. 3. Contracting entities may use a procedure without prior call for competition in the following cases: (a) when no tenders or no suitable tenders or no applications have been submitted in response to a procedure with a prior call for competition, provided that the initial conditions of contract are not substantially altered; (b) where a contract is purely for the purpose of research, experiment, study or development, and not for the purpose of securing a profit or of recovering research and development costs, and insofar as the award of such contract does not prejudice the competitive award of subsequent contracts which do seek, in particular, those ends; (c) when, for technical or artistic reasons, or for reasons connected with the protection of exclusive rights, the contract may be executed only by a particular economic operator; (d) insofar as is strictly necessary when, for reasons of extreme urgency brought about by events unforeseeable by the contracting entities, the time limits laid down for open procedures, restricted procedures and negotiated procedures with a prior call for competition cannot be adhered to; (e) in the case of supply contracts for additional deliveries by the original supplier which are intended either as a partial replacement of normal supplies or installations or as the extension of existing supplies or installations, where a change of supplier would oblige the contracting entity to acquire material having different technical characteristics which would result in incompatibility or disproportionate technical difficulties in operation and maintenance; (f) for additional works or services which were not included in the project initially awarded or in the contract first concluded but have, through unforeseen circumstances, become necessary to the performance of the contract, on condition that the award is made to the contractor or service provider executing the original contract: - when such additional works or services cannot be technically or economically separated from the main contract without great inconvenience to the contracting entities, or - when such additional works or services, although separable from the performance of the original contract, are strictly necessary to its later stages; (g) in the case of works contracts, for new works consisting in the repetition of similar works assigned to the contractor to which the same contracting entities awarded an earlier contract, provided that such works conform to a basic project for which a first contract was awarded after a call for competition; as soon as the first project is put up for tender, notice shall be given that this procedure might be adopted and the total estimated cost of subsequent works shall be taken into consideration by the contracting entities when they apply the provisions of Articles 16 and 17; (h) for supplies quoted and purchased on a commodity market; (i) for contracts to be awarded on the basis of a framework agreement, provided that the condition referred to in Article 14(2) is fulfilled; (j) for bargain purchases, where it is possible to procure supplies by taking advantage of a particularly advantageous opportunity available for a very short time at a price considerably lower than normal market prices; (k) for purchases of supplies under particularly advantageous conditions from either a supplier definitively winding up his business activities or the receivers or liquidators of a bankruptcy, an arrangement with creditors or a similar procedure under national laws or regulations; (l) when the service contract concerned is part of the follow-up to a design contest organised in accordance with the provisions of this Directive and shall, in accordance with the relevant rules, be awarded to the winner or to one of the winners of that contest; in the latter case, all the winners shall be invited to participate in the negotiations. CHAPTER VI Rules on publication and transparency Section 1 Publication of notices Article 41 Periodic indicative notices and notices on the existence of a system of qualification 1. Contracting entities shall make known, at least once a year, by means of a periodic indicative notice as referred to in Annex XV A, published by the Commission or by themselves on their "buyer profile", as described in point 2(b) of Annex XX: (a) where supplies are concerned, the estimated total value of the contracts or the framework agreements by product area which they intend to award over the following 12 months, where the total estimated value, taking into account the provisions of Articles 16 and 17, is equal to or greater than EUR 750000. The product area shall be established by the contracting entities by reference to the CPV nomenclature: (b) where services are concerned, the estimated total value of the contracts or the framework agreements in each of the categories of services listed in Annex XVII A which they intend to award over the following 12 months, where such estimated total value, taking into account the provisions of Articles 16 and 17, is equal to or greater than EUR 750000; (c) where works are concerned, the essential characteristics of the works contracts or the framework agreements which they intend to award over the following 12 months, whose estimated value is equal to or greater than the threshold specified in Article 16, taking into account the provisions of Article 17. The notices referred to in subparagraphs (a) and (b) shall be sent to the Commission or published on the buyer profile as soon as possible after the beginning of the budgetary year. The notice referred to in subparagraph (c) shall be sent to the Commission or published on the buyer profile as soon as possible after the decision approving the planning of the works contracts or the framework agreements that the contracting entities intend to award. Contracting entities which publish a periodic indicative notice on their buyer profiles shall transmit to the Commission, electronically, a notice of the publication of the periodic indicative notice on a buyer profile, in accordance with the format and procedures for the electronic transmission of notices indicated in point 3 of Annex XX. The publication of the notices referred to in subparagraphs (a), (b) and (c) shall be compulsory only where the contracting entities take the option of reducing the time limits for the receipt of tenders as laid down in Article 45(4). This paragraph shall not apply to procedures without prior call for competition. 2. Contracting entities may, in particular, publish or arrange for the Commission to publish periodic indicative notices relating to major projects without repeating information previously included in a periodic indicative notice, provided that it is clearly pointed out that these notices are additional ones. 3. Where contracting entities choose to set up a qualification system in accordance with Article 53, the system shall be the subject of a notice as referred to in Annex XIV, indicating the purpose of the qualification system and how to have access to the rules concerning its operation. Where the system is of a duration greater than three years, the notice shall be published annually. Where the system is of a shorter duration, an initial notice shall suffice. Article 42 Notices used as a means of calling for competition 1. In the case of supply, works or service contracts, the call for competition may be made: (a) by means of a periodic indicative notice as referred to in Annex XV A; or (b) by means of a notice on the existence of a qualification system as referred to in Annex XIV; or (c) by means of a contract notice as referred to in Annex XIII A, B or C. 2. In the case of dynamic purchasing systems, the system's call for competition shall be by contract notice as referred to in paragraph 1(c), whereas calls for competition for contracts based on such systems shall be by simplified contract notice as referred to in Annex XIII D. 3. When a call for competition is made by means of a periodic indicative notice, the notice shall: (a) refer specifically to the supplies, works or services which will be the subject of the contract to be awarded; (b) indicate that the contract will be awarded by restricted or negotiated procedure without further publication of a notice of a call for competition and invite interested economic operators to express their interest in writing; and (c) have been published in accordance with Annex XX not more than 12 months prior to the date on which the invitation referred to in Article 47(5) is sent. Moreover, the contracting entity shall meet the time limits laid down in Article 45. Article 43 Contract award notices 1. Contracting entities which have awarded a contract or a framework agreement shall, within two months of the award of the contract or framework agreement, send a contract award notice as referred to in Annex XVI under conditions to be laid down by the Commission in accordance with the procedure referred to in Article 68(2). In the case of contracts awarded under a framework agreement within the meaning of Article 14(2), the contracting entities shall not be bound to send a notice of the results of the award procedure for each contract based on that agreement. Contracting entities shall send a contract award notice based on a dynamic purchasing system within two months after the award of each contract. They may, however, group such notices on a quarterly basis. In that case, they shall send the grouped notices within two months of the end of each quarter. 2. The information provided in accordance with Annex XVI and intended for publication shall be published in accordance with Annex XX. In this connection, the Commission shall respect any sensitive commercial aspects which the contracting entities may point out when forwarding this information, concerning the number of tenders received, the identity of economic operators, or prices. 3. Where contracting entities award a research-and-development service contract ("R& D contract") by way of a procedure without a call for competition in accordance with Article 40(3)(b), they may limit to the reference "research and development services" the information to be provided in accordance with Annex XVI concerning the nature and quantity of the services provided. Where contracting entities award an R& D contract which cannot be awarded by way of a procedure without a call for competition in accordance with Article 40(3)(b), they may, on grounds of commercial confidentiality, limit the information to be provided in accordance with Annex XVI concerning the nature and quantity of the services supplied. In such cases, contracting entities shall ensure that any information published under this paragraph is no less detailed than that contained in the notice of the call for competition published in accordance with Article 42(1). If they use a qualification system, contracting entities shall ensure in such cases that such information is no less detailed than the category referred to in the list of qualified service providers drawn up in accordance with Article 53(7). 4. In the case of contracts awarded for services listed in Annex XVII B, the contracting entities shall indicate in the notice whether they agree to publication. 5. Information provided in accordance with Annex XVI and marked as not being intended for publication shall be published only in simplified form and in accordance with Annex XX for statistical purposes. Article 44 Form and manner of publication of notices 1. Notices shall include the information mentioned in Annexes XIII, XIV, XV A, XV B and XVI and, where appropriate, any other information deemed useful by the contracting entity in the format of standard forms adopted by the Commission in accordance with the procedure referred to in Article 68(2). 2. Notices sent by contracting entities to the Commission shall be sent either by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex XX, or by other means. The notices referred to in Articles 41, 42 and 43 shall be published in accordance with the technical characteristics for publication set out in point 1(a) and (b) of Annex XX. 3. Notices drawn up and transmitted by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex XX, shall be published no later than five days after they are sent. Notices which are not transmitted by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex XX shall be published not later than 12 days after they are transmitted. However, in exceptional cases, the contract notices referred to in Article 42(1)(c) shall be published within five days in response to a request by the contracting entity, provided that the notice has been sent by fax. 4. Contract notices shall be published in full in an official language of the Community as chosen by the contracting entity, this original language version constituting the sole authentic text. A summary of the important elements of each notice shall be published in the other official languages. The costs of publication of notices by the Commission shall be borne by the Community. 5. Notices and their contents may not be published at national level before the date on which they are sent to the Commission. Notices published at national level shall not contain information other than that contained in the notices dispatched to the Commission or published on a buyer profile in accordance with the first subparagraph of Article 41(1), but shall mention the date of dispatch of the notice to the Commission or its publication on the buyer profile. Periodic indicative notices may not be published on a buyer profile before the dispatch to the Commission of the notice of their publication in that form; they shall mention the date of that dispatch. 6. Contracting entities shall ensure that they are able to supply proof of the dates on which notices are dispatched. 7. The Commission shall give the contracting entity confirmation of the publication of the information sent, mentioning the date of that publication. Such confirmation shall constitute proof of publication. 8. Contracting entities may publish in accordance with paragraphs 1 to 7 contract notices which are not subject to the publication requirements laid down in this Directive. Section 2 Time limits Article 45 Time limits for the receipt of requests to participate and for the receipt of tenders 1. When fixing the time limits for requests to participate and the receipt of tenders, contracting entities shall take particular account of the complexity of the contract and the time required for drawing up tenders, without prejudice to the minimum time limits set by this Article. 2. In the case of open procedures, the minimum time limit for the receipt of tenders shall be 52 days from the date on which the contract notice was sent. 3. In restricted procedures and in negotiated procedures with a prior call for competition, the following arrangements shall apply: (a) the time limit for the receipt of requests to participate, in response to a notice published under Article 42(1)(c), or in response to an invitation by the contracting entities under Article 47(5), shall, as a general rule, be fixed at no less than 37 days from the date on which the notice or invitation was sent and may in no case be less than 22 days if the notice is sent for publication by means other than electronic means or fax, and at no less than 15 days if the notice is transmitted by such means; (b) the time limit for the receipt of tenders may be set by mutual agreement between the contracting entity and the selected candidates, provided that all candidates have the same time to prepare and submit their tenders; (c) where it is not possible to reach agreement on the time limit for the receipt of tenders, the contracting entity shall fix a time limit which shall, as a general rule, be at least 24 days and shall in no case be less than 10 days from the date of the invitation to tender. 4. If the contracting entities have published a periodic indicative notice as referred to in Article 41(1) in accordance with Annex XX, the minimum time limit for the receipt of tenders in open procedures shall, as a general rule, not be less than 36 days, but shall in no case be less than 22 days from the date on which the notice was sent. These reduced time limits are permitted, provided that the periodic indicative notice has included, in addition to the information required by Annex XV A, part I, all the information required by Annex XV A, part II, insofar as the latter information is available at the time the notice is published, and that the notice has been sent for publication between 52 days and 12 months before the date on which the contract notice referred to in Article 42(1)(c) is sent. 5. Where notices are drawn up and transmitted by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex XX the time-limits for the receipt of requests to participate in restricted and negotiated procedures, and for receipt of tenders in open procedures, may be reduced by seven days. 6. Except in the case of a time limit set by mutual agreement in accordance with paragraph 3(b), time limits for the receipt of tenders in open, restricted and negotiated procedures may be further reduced by five days where the contracting entity offers unrestricted and full direct access to the contract documents and any supplementary documents by electronic means from the date on which the notice used as a means of calling for competition is published, in accordance with Annex XX. The notice should specify the internet address at which this documentation is accessible. 7. In open procedures, the cumulative effect of the reductions provided for in paragraphs 4, 5 and 6 may in no case result in a time limit for the receipt of tenders of less than 15 days from the date on which the contract notice is sent. However, if the contract notice is not transmitted by fax or electronic means, the cumulative effect of the reductions provided for in paragraphs 4, 5 and 6 may in no case result in a time limit for receipt of tenders in an open procedure of less than 22 days from the date on which the contract notice is transmitted. 8. The cumulative effect of the reductions provided for in paragraphs 4, 5 and 6 may in no case result in a time limit for receipt of requests to participate, in response to a notice published under Article 42(1)(c), or in response to an invitation by the contracting entities under Article 47(5), of less than 15 days from the date on which the contract notice or invitation is sent. In restricted and negotiated procedures, the cumulative effect of the reductions provided for in paragraphs 4, 5 and 6 may in no case, except that of a time limit set by mutual agreement in accordance with paragraph 3(b), result in a time limit for the receipt of tenders of less than 10 days from the date of the invitation to tender. 9. If, for whatever reason, the contract documents and the supporting documents or additional information, although requested in good time, have not been supplied within the time limits set in Articles 46 and 47, or where tenders can be made only after a visit to the site or after on-the-spot inspection of the documents supporting the contract documents, the time limits for the receipt of tenders shall be extended accordingly, except in the case of a time-limit set by mutual agreement in accordance with paragraph 3(b), so that all economic operators concerned may be aware of all the information needed for the preparation of a tender. 10. A summary table of the time limits laid down in this Article is given in Annex XXII. Article 46 Open procedures: specifications, additional documents and information 1. In open procedures, where contracting entities do not offer unrestricted and full direct access by electronic means in accordance with Article 45(6) to the specifications and any supporting documents, the specifications and supporting documents shall be sent to economic operators within six days of receipt of the request, provided that the request was made in good time before the time limit for the submission of tenders. 2. Provided that it has been requested in good time, additional information relating to the specifications shall be supplied by the contracting entities or competent departments not later than six days before the time limit fixed for the receipt of tenders. Article 47 Invitations to submit a tender or to negotiate 1. In restricted procedures and negotiated procedures, contracting entities shall simultaneously and in writing invite the selected candidates to submit their tenders or to negotiate. The invitation to the candidates shall include either: - a copy of the specifications and any supporting documents, or - a reference to accessing the specifications and the supporting documents indicated in the first indent, when they are made directly available by electronic means in accordance with Article 45(6). 2. Where the specifications and/or any supporting documents are held by an entity other than the contracting entity responsible for the award procedure, the invitation shall state the address from which those specifications and documents may be requested and, if appropriate, the closing date for requesting such documents, the sum payable for obtaining them and any payment procedures. The competent department shall send that documentation to the economic operator immediately upon receipt of the request. 3. The additional information on the specifications or the supporting documents shall be sent by the contracting entity or the competent department not less than six days before the final date fixed for the receipt of tenders, provided that it is requested in good time. 4. In addition, the invitation shall include at least the following: (a) where appropriate, the time limit for requesting additional documents, as well as the amount and terms of payment of any sum to be paid for such documents; (b) the final date for receipt of tenders, the address to which they are to be sent, and the language or languages in which they are to be drawn up; (c) a reference to any published contract notice; (d) an indication of any documents to be attached; (e) the criteria for the award of the contract, where they are not indicated in the notice on the existence of a qualification system used as a means of calling for competition; (f) the relative weighting of the contract award criteria or, where appropriate, the order of importance of such criteria, if this information is not given in the contract notice, the notice on the existence of a qualification system or the specifications. 5. When a call for competition is made by means of a periodic indicative notice, contracting entities shall subsequently invite all candidates to confirm their interest on the basis of detailed information on the contract concerned before beginning the selection of tenderers or participants in negotiations. This invitation shall include at least the following information: (a) nature and quantity, including all options concerning complementary contracts and, if possible, the estimated time available for exercising these options for renewable contracts, the nature and quantity and, if possible, the estimated publication dates of future notices of competition for works, supplies or services to be put out to tender; (b) type of procedure: restricted or negotiated; (c) where appropriate, the date on which the delivery of supplies or the execution of works or services is to commence or terminate; (d) the address and closing date for the submission of requests for tender documents and the language or languages in which they are to be drawn up; (e) the address of the entity which is to award the contract and the information necessary for obtaining the specifications and other documents; (f) economic and technical conditions, financial guarantees and information required from economic operators; (g) the amount and payment procedures for any sum payable for obtaining tender documents; (h) the form of the contract which is the subject of the invitation to tender: purchase, lease, hire or hire-purchase, or any combination of these; and (i) the contract award criteria and their weighting or, where appropriate, the order of importance of such criteria, if this information is not given in the indicative notice or the specifications or in the invitation to tender or to negotiate. Section 3 Communication and information Article 48 Rules applicable to communication 1. All communication and information exchange referred to in this Title may be carried out by post, by fax, by electronic means in accordance with paragraphs 4 and 5, by telephone in the cases and circumstances referred to in paragraph 6, or by a combination of those means, according to the choice of the contracting entity. 2. The means of communication chosen shall be generally available and thus not restrict economic operators' access to the tendering procedure. 3. Communication and the exchange and storage of information shall be carried out in such a way as to ensure that the integrity of data and the confidentiality of tenders and requests to participate are preserved, and that the contracting entities examine the content of tenders and requests to participate only after the time limit set for submitting them has expired. 4. The tools to be used for communicating by electronic means, as well as their technical characteristics, shall be non-discriminatory, generally available and interoperable with the information and communication technology products in general use. 5. The following rules are applicable to devices for the electronic transmission and receipt of tenders and to devices for the electronic receipt of requests to participate: (a) information regarding the specifications necessary for the electronic submission of tenders and requests to participate, including encryption, shall be available to interested parties. Moreover, the devices for the electronic receipt of tenders and requests to participate shall conform to the requirements of Annex XXIV; (b) Member States may, in compliance with Article 5 of Directive 1999/93/EC, require that electronic tenders be accompanied by an advanced electronic signature in conformity with paragraph 1 thereof; (c) Member States may introduce or maintain voluntary accreditation schemes aiming at enhanced levels of certification service provision for these devices; (d) tenderers or candidates shall undertake to submit, before expiry of the time limit laid down for the submission of tenders or requests to participate, the documents, certificates and declarations mentioned in Articles 52(2), 52(3), 53 and 54 if they do not exist in electronic format. 6. The following rules shall apply to the transmission of requests to participate: (a) requests to participate in procedures for the award of contracts may be made in writing or by telephone; (b) where requests to participate are made by telephone, a written confirmation must be sent before expiry of the time limit set for their receipt; (c) contracting entities may require that requests for participation made by fax should be confirmed by post or by electronic means, where this is necessary for the purposes of legal proof. Any such requirement, together with the time limit for sending confirmation by post or electronic means, should be stated by the contracting entity in the notice used as a means of calling for competition or in the invitation referred to in Article 47(5). Article 49 Information to applicants for qualification, candidates and tenderers 1. Contracting entities shall as soon as possible inform the economic operators involved of decisions reached concerning the conclusion of a framework agreement, the award of the contract, or admission to a dynamic purchasing system, including the grounds for any decision not to conclude a framework agreement or award a contract for which there has been a call for competition or to recommence the procedure, or not to implement a dynamic purchasing system; this information shall be provided in writing if the contracting entities are requested to do so. 2. On request from the party concerned, contracting entities shall, as soon as possible, inform: - any unsuccessful candidate of the reasons for the rejection of his application, - any unsuccessful tenderer of the reasons for the rejection of his tender, including, for the cases referred to in Article 34(4) and (5), the reasons for their decision of non-equivalence or their decision that the works, supplies or services do not meet the performance or functional requirements, - any tenderer who has made an admissible tender of the characteristics and relative advantages of the tender selected, as well as the name of the successful tenderer or the parties to the framework agreement. The time taken to do so may under no circumstances exceed 15 days from receipt of the written enquiry. However, contracting entities may decide that certain information on the contract award or the conclusion of the framework agreement or on admission to a dynamic purchasing system, referred to in the paragraph 1, is to be withheld where release of such information would impede law enforcement or otherwise be contrary to the public interest or would prejudice the legitimate commercial interests of a particular economic operator, public or private, including the interests of the economic operator to whom the contract has been awarded, or might prejudice fair competition between economic operators. 3. Contracting entities which establish and operate a system of qualification shall inform applicants of their decision as to qualification within a period of six months. If the decision will take longer than four months from the presentation of an application, the contracting entity shall inform the applicant, within two months of the application, of the reasons justifying the longer period and of the date by which his application will be accepted or refused. 4. Applicants whose qualification is refused shall be informed of this decision and the reasons for refusal as soon as possible and under no circumstances more than 15 days later than the date of the decision. The reasons shall be based on the criteria for qualification referred to in Article 53(2). 5. Contracting entities which establish and operate a system of qualification may bring the qualification of an economic operator to an end only for reasons based on the criteria for qualification referred to in Article 53(2). Any intention to bring qualification to an end shall be notified in writing to the economic operator beforehand, at least 15 days before the date on which qualification is due to end, together with the reason or reasons justifying the proposed action. Article 50 Information to be stored concerning awards 1. Contracting entities shall keep appropriate information on each contract which shall be sufficient to permit them at a later date to justify decisions taken in connection with: (a) the qualification and selection of economic operators and the award of contracts; (b) the use of procedures without a prior call for competition by virtue of Article 40(3); (c) the non-application of Chapters III to VI of this Title by virtue of the derogations provided for in Chapter II of Title I and in Chapter II of this Title. Contracting entities shall take appropriate steps to document the progress of award procedures conducted by electronic means. 2. The information shall be kept for at least four years from the date of award of the contract so that the contracting entity will be able, during that period, to provide the necessary information to the Commission if the latter so requests. CHAPTER VII Conduct of the procedure Article 51 General provisions 1. For the purpose of selecting participants in their award procedures: (a) contracting entities having provided rules and criteria for the exclusion of tenderers or candidates in accordance with Article 54(1), (2) or (4) shall exclude economic operators which comply with such rules and meet such criteria; (b) they shall select tenderers and candidates in accordance with the objective rules and criteria laid down pursuant to Article 54; (c) in restricted procedures and in negotiated procedures with a call for competition, they shall where appropriate reduce in accordance with Article 54 the number of candidates selected pursuant to subparagraphs (a) and (b). 2. When a call for competition is made by means of a notice on the existence of a qualification system and for the purpose of selecting participants in award procedures for the specific contracts which are the subject of the call for competition, contracting entities shall: (a) qualify economic operators in accordance with the provisions of Article 53; (b) apply to such qualified economic operators those provisions of paragraph 1 that are relevant to restricted or negotiated procedures. 3. Contracting entities shall verify that the tenders submitted by the selected tenderers comply with the rules and requirements applicable to tenders and award the contract on the basis of the criteria laid down in Articles 55 and 57. Section 1 Qualification and qualitative selection Article 52 Mutual recognition concerning administrative, technical or financial conditions, and certificates, tests and evidence 1. When selecting participants for a restricted or negotiated procedure, in reaching their decision as to qualification or when the criteria and rules are being updated, contracting entities shall not: (a) impose administrative, technical or financial conditions on certain economic operators which would not be imposed on others; (b) require tests or evidence which would duplicate objective evidence already available. 2. Where they request the production of certificates drawn up by independent bodies attesting the compliance of the economic operator with certain quality assurance standards, contracting entities shall refer to quality assurance systems based on the relevant European standards series certified by bodies conforming to the European standards series concerning certification. Contracting entities shall recognise equivalent certificates from bodies established in other Member States. They shall also accept other evidence of equivalent quality assurance measures from economic operators. 3. For works and service contracts, and only in appropriate cases, the contracting entities may require, in order to verify the economic operator's technical abilities, an indication of the environmental management measures which the economic operator will be able to apply when carrying out the contract. In such cases, should the contracting entities require the production of certificates drawn up by independent bodies attesting the compliance of the economic operator with certain environmental management standards, they shall refer to the EMAS or to environmental management standards based on the relevant European or international standards certified by bodies conforming to Community law or the relevant European or international standards concerning certification. Contracting entities shall recognise equivalent certificates from bodies established in other Member States. They shall also accept other evidence of equivalent environmental management measures from economic operators. Article 53 Qualification systems 1. Contracting entities which so wish may establish and operate a system of qualification of economic operators. Contracting entities which establish or operate a system of qualification shall ensure that economic operators are at all times able to request qualification. 2. The system under paragraph 1 may involve different qualification stages. It shall be operated on the basis of objective criteria and rules for qualification to be established by the contracting entity. Where those criteria and rules include technical specifications, the provisions of Article 34 shall apply. The criteria and rules may be updated as required. 3. The criteria and rules for qualification referred to in paragraph 2 may include the exclusion criteria listed in Article 45 of Directive 2004/18/EC on the terms and conditions set out therein. Where the contracting entity is a contracting authority within the meaning of Article 2(1)(a), those criteria and rules shall include the exclusion criteria listed in Article 45(1) of Directive 2004/18/EC. 4. Where the criteria and rules for qualification referred to in paragraph 2 include requirements relating to the economic and financial capacity of the economic operator, the latter may where necessary rely on the capacity of other entities, whatever the legal nature of the link between itself and those entities. In this case the economic operator must prove to the contracting entity that these resources will be available to it throughout the period of the validity of the qualification system, for example by producing an undertaking by those entities to that effect. Under the same conditions, a group of economic operators as referred to in Article 11 may rely on the capacity of participants in the group or of other entities. 5. Where the criteria and rules for qualification referred to in paragraph 2 include requirements relating to the technical and/or professional abilities of the economic operator, the latter may where necessary rely on the capacity of other entities, whatever the legal nature of the link between itself and those entities. In this case the economic operator must prove to the contracting entity that those resources will be available to it throughout the period of the validity of the qualification system, for example by producing an undertaking by those entities to make the necessary resources available to the economic operator. Under the same conditions, a group of economic operators referred to in Article 11 may rely on the abilities of participants in the group or of other entities. 6. The criteria and rules for qualification referred to in paragraph 2 shall be made available to economic operators on request. The updating of these criteria and rules shall be communicated to interested economic operators. Where a contracting entity considers that the qualification system of certain other entities or bodies meets its requirements, it shall communicate to interested economic operators the names of such other entities or bodies. 7. A written record of qualified economic operators shall be kept; it may be divided into categories according to the type of contract for which the qualification is valid. 8. When establishing or operating a qualification system, contracting entities shall in particular observe the provisions of Article 41(3) concerning notices on the existence of a system of qualification, of Article 49(3), (4) and (5) concerning the information to be delivered to economic operators having applied for qualification, of Article 51(2) concerning the selection of participants when a call for competition is made by means of a notice on the existence of a qualification system as well as the provisions of Article 52 on mutual recognition concerning administrative, technical or financial conditions, certificates, tests and evidence. 9. When a call for competition is made by means of a notice on the existence of a qualification system, tenderers in a restricted procedure or participants in a negotiated procedure shall be selected from the qualified candidates in accordance with such a system. Article 54 Criteria for qualitative selection 1. Contracting entities which establish selection criteria in an open procedure shall do so in accordance with objective rules and criteria which are available to interested economic operators. 2. Contracting entities which select candidates for restricted or negotiated procedures shall do so according to objective rules and criteria which they have established and which are available to interested economic operators. 3. In restricted or negotiated procedures, the criteria may be based on the objective need of the contracting entity to reduce the number of candidates to a level which is justified by the need to balance the particular characteristics of the procurement procedure with the resources required to conduct it. The number of candidates selected shall, however, take account of the need to ensure adequate competition. 4. The criteria set out in paragraphs 1 and 2 may include the exclusion criteria listed in Article 45 of Directive 2004/18/EC on the terms and conditions set out therein. Where the contracting entity is a contracting authority within the meaning of Article 2(1)(a), the criteria and rules referred to in paragraphs 1 and 2 of this Article shall include the exclusion criteria listed in Article 45(1) of Directive 2004/18/EC. 5. Where the criteria referred to in paragraphs 1 and 2 include requirements relating to the economic and financial capacity of the economic operator, the latter may where necessary and for a particular contract rely on the capacity of other entities, whatever the legal nature of the link between itself and those entities. In this case the economic operator shall prove to the contracting entity that the necessary resources will be available to it, for example by delivering an undertaking by those entities to that effect. Under the same conditions, a group of economic operators as referred to in Article 11 may rely on the capacities of participants in the group or of other entities. 6. Where the criteria referred to in paragraphs 1 and 2 include requirements relating to the technical and/or professional abilities of the economic operator, the latter may where necessary and for a particular contract rely on the abilities of other entities, whatever the legal nature of the link between itself and those entities. In this case the economic operator must prove to the contracting entity that for the performance of the contract those resources will be available to it, for example by delivering an undertaking by those entities to make the necessary resources available to the economic operator. Under the same conditions, a group of economic operators as referred to in Article 11 may rely on the abilities of participants in the group or of other entities. Section 2 Award of the contract Article 55 Contract award criteria 1. Without prejudice to national laws, regulations or administrative provisions on the remuneration of certain services, the criteria on which the contracting entities shall base the award of contracts shall: (a) where the contract is awarded on the basis of the most economically advantageous tender from the point of view of the contracting entity, be various criteria linked to the subject-matter of the contract in question, such as delivery or completion date, running costs, cost-effectiveness, quality, aesthetic and functional characteristics, environmental characteristics, technical merit, after-sales service and technical assistance, commitments with regard to parts, security of supply, and price or otherwise (b) the lowest price only. 2. Without prejudice to the provisions of the third subparagraph, in the case referred to in paragraph 1(a), the contracting entity shall specify the relative weighting which it gives to each of the criteria chosen to determine the most economically advantageous tender. Those weightings can be expressed by providing for a range with an appropriate maximum spread. Where, in the opinion of the contracting entity, weighting is not possible for demonstrable reasons, the contracting entity shall indicate the criteria in descending order of importance. The relative weighting or order of importance shall be specified, as appropriate, in the notice used as a means of calling for competition, in the invitation to confirm the interest referred to in Article 47(5), in the invitation to tender or to negotiate, or in the specifications. Article 56 Use of electronic auctions 1. Member States may provide that contracting entities may use electronic auctions. 2. In open, restricted or negotiated procedures with a prior call for competition, the contracting entities may decide that the award of a contract shall be preceded by an electronic auction when the contract specifications can be established with precision. In the same circumstances, an electronic auction may be held on the opening for competition of contracts to be awarded under the dynamic purchasing system referred to in Article 15. The electronic auction shall be based: (a) either solely on prices when the contract is awarded to the lowest price, (b) or on prices and/or on the new values of the features of the tenders indicated in the specification, when the contract is awarded to the most economically advantageous tender. 3. Contracting entities which decide to hold an electronic auction shall state that fact in the notice used as a means of calling for competition. The specifications shall include, inter alia, the following details: (a) the features whose values will be the subject of electronic auction, provided that such features are quantifiable and can be expressed in figures or percentages; (b) any limits on the values which may be submitted, as they result from the specifications relating to the subject of the contract; (c) the information which will be made available to tenderers in the course of the electronic auction and, where appropriate, when it will be made available to them; (d) the relevant information concerning the electronic auction process; (e) the conditions under which the tenderers will be able to bid and, in particular, the minimum differences which will, where appropriate, be required when bidding; (f) the relevant information concerning the electronic equipment used and the arrangements and technical specifications for connection. 4. Before proceeding with the electronic auction, contracting entities shall make a full initial evaluation of the tenders in accordance with the award criterion/criteria set and with the weighting fixed for them. All tenderers who have submitted admissible tenders shall be invited simultaneously by electronic means to submit new prices and/or new values; the invitation shall contain all relevant information concerning individual connection to the electronic equipment being used and shall state the date and time of the start of the electronic auction. The electronic auction may take place in a number of successive phases. The electronic auction may not start sooner than two working days after the date on which invitations are sent out. 5. When the contract is to be awarded on the basis of the most economically advantageous tender, the invitation shall be accompanied by the outcome of a full evaluation of the relevant tender carried out in accordance with the weighting provided for in the first subparagraph of Article 55(2). The invitation shall also state the mathematical formula to be used in the electronic auction to determine automatic rerankings on the basis of the new prices and/or new values submitted. That formula shall incorporate the weighting of all the criteria established to determine the most economically advantageous tender, as indicated in the notice used as a means of calling for competition or in the specifications; for that purpose, any ranges shall, however, be reduced beforehand to a specified value. Where variants are authorised, a separate formula shall be provided for each variant. 6. Throughout each phase of an electronic auction the contracting entities shall instantaneously communicate to all tenderers sufficient information to enable them to ascertain their relative rankings at any moment. They may also communicate other information concerning other prices or values submitted, provided that that is stated in the specifications. They may also at any time announce the number of participants in that phase of the auction. In no case, however, may they disclose the identities of the tenderers during any phase of an electronic auction. 7. Contracting entities shall close an electronic auction in one or more of the following manners: (a) in the invitation to take part in the auction they shall indicate the date and time fixed in advance; (b) when they receive no more new prices or new values which meet the requirements concerning minimum differences. In that event, the contracting entities shall state in the invitation to take part in the auction the time which they will allow to elapse after receiving the last submission before they close the electronic auction; (c) when the number of phases in the auction, fixed in the invitation to take part in the auction, has been completed. When the contracting entities have decided to close an electronic auction in accordance with subparagraph (c), possibly in combination with the arrangements laid down in subparagraph (b), the invitation to take part in the auction shall indicate the timetable for each phase of the auction. 8. After closing an electronic auction the contracting entities shall award the contract in accordance with Article 55 on the basis of the results of the electronic auction. 9. Contracting entities may not have improper recourse to electronic auctions nor may they use them in such a way as to prevent, restrict or distort competition or to change the subject-matter of the contract, as defined in the notice used as a means of calling for competition and in the specification. Article 57 Abnormally low tenders 1. If, for a given contract, tenders appear to be abnormally low in relation to the goods, works or services, the contracting entity shall, before it may reject those tenders, request in writing details of the constituent elements of the tender which it considers relevant. Those details may relate in particular to: (a) the economics of the manufacturing process, of the services provided and of the construction method; (b) the technical solutions chosen and/or any exceptionally favourable conditions available to the tenderer for the supply of the goods or services or for the execution of the work; (c) the originality of the supplies, services or work proposed by the tenderer; (d) compliance with the provisions relating to employment protection and working conditions in force at the place where the work, service or supply is to be performed; (e) the possibility of the tenderer obtaining State aid. 2. The contracting entity shall verify those constituent elements by consulting the tenderer, taking account of the evidence supplied. 3. Where a contracting entity establishes that a tender is abnormally low because the tenderer has obtained State aid, the tender can be rejected on that ground alone only after consultation with the tenderer where the latter is unable to prove, within a sufficient time limit fixed by the contracting entity, that the aid in question was granted legally. Where the contracting entity rejects a tender in these circumstances, it shall inform the Commission of that fact. Section 3 Tenders comprising products originating in third countries and relations with those countries Article 58 Tenders comprising products originating in third countries 1. This Article shall apply to tenders covering products originating in third countries with which the Community has not concluded, whether multilaterally or bilaterally, an agreement ensuring comparable and effective access for Community undertakings to the markets of those third countries. It shall be without prejudice to the obligations of the Community or its Member States in respect of third countries. 2. Any tender submitted for the award of a supply contract may be rejected where the proportion of the products originating in third countries, as determined in accordance with Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(30), exceeds 50 % of the total value of the products constituting the tender. For the purposes of this Article, software used in telecommunications network equipment shall be regarded as products. 3. Subject to the second subparagraph, where two or more tenders are equivalent in the light of the contract award criteria defined in Article 55, preference shall be given to those tenders which may not be rejected pursuant to paragraph 2. The prices of those tenders shall be considered equivalent for the purposes of this Article, if the price difference does not exceed 3 %. However, a tender shall not be preferred to another pursuant to the first subparagraph where its acceptance would oblige the contracting entity to acquire equipment having technical characteristics different from those of existing equipment, resulting in incompatibility, technical difficulties in operation and maintenance, or disproportionate costs. 4. For the purposes of this Article, those third countries to which the benefit of the provisions of this Directive has been extended by a Council Decision in accordance with paragraph 1 shall not be taken into account for determining the proportion, referred to in paragraph 2, of products originating in third countries. 5. The Commission shall submit an annual report to the Council, commencing in the second half of the first year following the entry into force of this Directive, on progress made in multilateral or bilateral negotiations regarding access for Community undertakings to the markets of third countries in the fields covered by this Directive, on any result which such negotiations may have achieved, and on the implementation in practice of all the agreements which have been concluded. The Council, acting by a qualified majority on a proposal from the Commission, may amend the provisions of this Article in the light of such developments. Article 59 Relations with third countries as regards works, supplies and service contracts 1. Member States shall inform the Commission of any general difficulties, in law or in fact, encountered and reported by their undertakings in securing the award of service contracts in third countries. 2. The Commission shall report to the Council before 31 December 2005, and periodically thereafter, on the opening up of service contracts in third countries and on progress in negotiations with these countries on this subject, particularly within the framework of the WTO. 3. The Commission shall endeavour, by approaching the third country concerned, to remedy any situation whereby it finds, on the basis either of the reports referred to in paragraph 2 or of other information, that, in the context of the award of service contracts, a third country: (a) does not grant Community undertakings effective access comparable to that granted by the Community to undertakings from that country; or (b) does not grant Community undertakings national treatment or the same competitive opportunities as are available to national undertakings; or (c) grants undertakings from other third countries more favourable treatment than Community undertakings. 4. Member States shall inform the Commission of any difficulties, in law or in fact, encountered and reported by their undertakings and which are due to the non-observance of the international labour law provisions listed in Annex XXIII when these undertakings have tried to secure the award of contracts in third countries. 5. In the circumstances referred to in paragraphs 3 and 4, the Commission may at any time propose that the Council decide to suspend or restrict, over a period to be laid down in the decision, the award of service contracts to: (a) undertakings governed by the law of the third country in question; (b) undertakings affiliated to the undertakings specified in point (a) and having their registered office in the Community but having no direct and effective link with the economy of a Member State; (c) undertakings submitting tenders which have as their subject-matter services originating in the third country in question. The Council shall act, by qualified majority, as soon as possible. The Commission may propose these measures on its own initiative or at the request of a Member State. 6. This Article shall be without prejudice to the commitments of the Community in relation to third countries ensuing from international agreements on public procurement, particularly within the framework of the WTO. TITLE III RULES GOVERNING SERVICE DESIGN CONTESTS Article 60 General provision 1. The rules for the organisation of a design contest shall be in conformity with paragraph 2 of this Article and with Articles 61 and 63 to 66 and shall be made available to those interested in participating in the contest. 2. The admission of participants to design contests shall not be limited: (a) by reference to the territory or part of the territory of a Member State; (b) on the ground that, under the law of the Member State in which the contest is organised, they would have been required to be either natural or legal persons. Article 61 Thresholds 1. This Title shall apply to design contests organised as part of a procurement procedure for services whose estimated value, net of VAT, is equal to or greater than EUR 499000. For the purposes of this paragraph, "threshold" means the estimated value net of VAT of the service contract, including any possible prizes and/or payments to participants. 2. This Title shall apply to all design contests where the total amount of contest prizes and payments to participants is equal to or greater than EUR 499000. For the purposes of this paragraph, "threshold" means the total amount of the prizes and payments, including the estimated value net of VAT of the service contract which might subsequently be concluded under Article 40(3) if the contracting entity does not exclude such an award in the contest notice. Article 62 Design contests excluded This Title shall not apply to: (1) contests which are organised in the same cases as referred to in Articles 20, 21 and 22 for service contracts; (2) design contests organised for the pursuit, in the Member State concerned, of an activity to which the applicability of paragraph 1 of Article 30 has been established by a Commission decision or has been deemed applicable pursuant to paragraph 4, second or third subparagraph, or to paragraph 5, fourth subparagraph, of that Article. Article 63 Rules on advertising and transparency 1. Contracting entities which wish to organise a design contest shall call for competition by means of a contest notice. Contracting entities which have held a design contest shall make the results known by means of a notice. The call for competition shall contain the information referred to in Annex XVIII and the notice of the results of a design contest shall contain the information referred to in Annex XIX in accordance with the format of standard forms adopted by the Commission in accordance with the procedure in Article 68(2). The notice of the results of a design contest shall be forwarded to the Commission within two months of the closure of the design contest and under conditions to be laid down by the Commission in accordance with the procedure referred to in Article 68(2). In this connection, the Commission shall respect any sensitive commercial aspects which the contracting entities may point out when forwarding this information, concerning the number of projects or plans received, the identity of the economic operators and the prices tendered. 2. Article 44(2) to (8) shall also apply to notices relating to design contests. Article 64 Means of communication 1. Article 48(1), (2) and (4) shall apply to all communications relating to contests. 2. Communications, exchanges and the storage of information shall be such as to ensure that the integrity and the confidentiality of all information communicated by the participants in a contest are preserved and that the jury ascertains the contents of plans and projects only after the expiry of the time-limit for their submission. 3. The following rules shall apply to the devices for the electronic receipt of plans and projects: (a) the information relating to the specifications which is necessary for the presentation of plans and projects by electronic means, including encryption, shall be available to the parties concerned. In addition, the devices for the electronic receipt of plans and projects shall comply with the requirements of Annex XXIV; (b) Member States may introduce or maintain voluntary accreditation schemes aiming at enhanced levels of certification service provision for such devices. Article 65 Rules on the organisation of design contests, the selection of participants and the jury 1. When organising design contests, contracting entities shall apply procedures which are adapted to the provisions of this Directive. 2. Where design contests are restricted to a limited number of participants, contracting entities shall establish clear and non-discriminatory selection criteria. In any event, the number of candidates invited to participate shall be sufficient to ensure genuine competition. 3. The jury shall be composed exclusively of natural persons who are independent of participants in the contest. Where a particular professional qualification is required of participants in a contest, at least a third of the jury members shall have the same qualification or an equivalent qualification. Article 66 Decisions of the jury 1. The jury shall be autonomous in its decisions or opinions. 2. It shall examine the plans and projects submitted by the candidates anonymously and solely on the basis of the criteria indicated in the contest notice. 3. It shall record its ranking of projects in a report, signed by its members, made according to the merits of each project, together with its remarks and any points which may need clarification. 4. Anonymity must be observed until the jury has reached its opinion or decision. 5. Candidates may be invited, if need be, to answer questions which the jury has recorded in the minutes to clarify any aspects of the projects. 6. Complete minutes shall be drawn up of the dialogue between jury members and candidates. TITLE IV STATISTICAL OBLIGATIONS, EXECUTORY POWERS AND FINAL PROVISIONS Article 67 Statistical obligations 1. Member States shall ensure, in accordance with the arrangements to be laid down under the procedure provided for in Article 68(2), that the Commission receives every year a statistical report concerning the total value, broken down by Member State and by category of activity to which Annexes I to X refer, of the contracts awarded below the thresholds set out in Article 16 but which would be covered by this Directive were it not for those thresholds. 2. As regards the categories of activity to which Annexes II, III, V, IX and X refer, Member States shall ensure that the Commission receives a statistical report on contracts awarded no later than 31 October 2004 for the previous year, and before 31 October of each year thereafter, in accordance with arrangements to be laid down under the procedure provided for in Article 68(2). The statistical report shall contain the information required to verify the proper application of the Agreement. The information required under the first subparagraph shall not include information concerning contracts for the R & D services listed in category 8 of Annex XVII A, for telecommunications services listed in category 5 of Annex XVII A whose CPV positions are equivalent to the CPC reference numbers 7524, 7525 and 7526, or for the services listed in Annex XVII B. 3. The arrangements under paragraphs 1 and 2 shall be laid down in such a way as to ensure that: (a) in the interests of administrative simplification, contracts of lesser value may be excluded, provided that the usefulness of the statistics is not jeopardised; (b) the confidential nature of the information provided is respected. Article 68 Committee procedure 1. The Commission shall be assisted by the Advisory Committee for Public Contracts instituted by Article 1 of Council Decision 71/306/EEC(31) (hereinafter referred to as "the Committee"). 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. The Committee shall adopt its rules of procedure. Article 69 Revision of the thresholds 1. The Commission shall verify the thresholds established in Article 16 every two years from 30 April 2004, and shall, if necessary with regard to the second subparagraph, revise them in accordance with the procedure provided for in Article 68(2). The calculation of the value of these thresholds shall be based on the average daily value of the euro, expressed in SDR, over the 24 months terminating on the last day of August preceding the revision with effect from 1 January. The value of the thresholds thus revised shall, where necessary, be rounded down to the nearest thousand euro so as to ensure that the thresholds in force provided for by the Agreement, expressed in SDR, are observed. 2. At the same time as performing the revision under paragraph 1, the Commission shall, in accordance with the procedure provided for in Article 68(2), align the thresholds laid down in Article 61 (design contests) with the revised threshold applicable to service contracts. The values of the thresholds laid down in accordance with paragraph 1 in the national currencies of Member States not participating in Monetary Union shall, in principle, be revised every two years from 1 January 2004. The calculation of such values shall be based on the average daily values of those currencies, expressed in euro, over the 24 months terminating on the last day of August preceding the revision with effect from 1 January. 3. The revised thresholds referred to in paragraph 1, their values in national currencies and the aligned thresholds referred to in paragraph 2 shall be published by the Commission in the Official Journal of the European Union at the beginning of the month of November following their revision. Article 70 Amendments The Commission may amend, in accordance with the procedure provided for in Article 68(2): (a) the list of contracting entities in Annexes I to X so that they fulfil the criteria set out in Articles 2 to 7; (b) the procedures for the drawing-up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 41, 42, 43 and 63; (c) the procedures for specific references to particular positions in the CPV nomenclature in the notices; (d) the reference numbers in the nomenclature set out in Annex XVII, in so far as this does not change the material scope of the Directive, and the procedures for reference in the notices to particular positions in this nomenclature within the categories of services listed in the Annex; (e) the reference numbers in the nomenclature set out in Annex XII, insofar as this does not change the material scope of the Directive, and the procedures for reference to particular positions of this nomenclature in the notices; (f) Annex XI; (g) the procedure for sending and publishing data referred to in Annex XX, on grounds of technical progress or for administrative reasons; (h) the technical details and characteristics of the devices for electronic receipt referred to in points (a), (f) and (g) of Annex XXIV; (i) in the interests of administrative simplification as provided for in Article 67(3), the procedures for the use, drawing-up, transmission, receipt, translation, collection and distribution of the statistical reports referred to in Article 67(1) and (2); (j) the technical procedures for the calculation methods set out in Article 69(1) and (2), second subparagraph. Article 71 Implementation of the Directive 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 January 2006 at the latest. They shall forthwith inform the Commission thereof. Member States may avail themselves of an additional period of up to 35 months after expiry of the time limit provided for in the first subparagraph for the application of the provisions necessary to comply with Article 6 of this Directive. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such references shall be laid down by Member States. The provisions of Article 30 are applicable from 30 April 2004. 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 72 Monitoring mechanisms In conformity with Council Directive 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(32), Member States shall ensure implementation of this Directive by effective, available and transparent mechanisms. For this purpose they may, among other things, appoint or establish an independent body. Article 73 Repeal Directive 93/38/EEC is hereby repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition into national law set out in Annex XXV. References to the repealed Directive shall be construed as being made to this Directive and shall be read in accordance with the correlation table in Annex XXVI. Article 74 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 75 Addressees This Directive is addressed to the Member States.

32004L0027

2004

Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal by the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4), codified and consolidated in a single text the texts of Community legislation on medicinal products for human use, in the interests of clarity and rationalisation. (2) The Community legislation so far adopted has made a major contribution to the achievement of the objective of the free and safe movement of medicinal products for human use and the elimination of obstacles to trade in such products. However, in the light of the experience acquired, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement. (3) It is therefore necessary to align the national laws, regulations and administrative provisions which contain differences with regard to the basic principles in order to promote the operation of the internal market while realising a high level of human health protection. (4) The main purpose of any regulation on the manufacture and distribution of medicinal products for human use should be to safeguard public health. However, this objective should be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products in the Community. (5) Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions. (6) In the light of the Commission's report on the experience acquired, it has proved necessary to improve the operation of the marketing authorisation procedures for medicinal products in the Community. (7) Particularly as a result of scientific and technical progress, the definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products for human use. In order to take account both of the emergence of new therapies and of the growing number of so-called "borderline" products between the medicinal product sector and other sectors, the definition of "medicinal product" should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. This definition should specify the type of action that the medicinal product may exert on physiological functions. This enumeration of actions will also make it possible to cover medicinal products such as gene therapy, radiopharmaceutical products as well as certain medicinal products for topical use. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a medicinal product but could also fall within the definition of other regulated products, it is necessary, in case of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation. (8) Wherever it is proposed to change the scope of the centralised procedure, it should no longer be possible to opt for the mutual-recognition procedure or the decentralised procedure in respect of orphan medicinal products and medicinal products which contain new active substances and for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes. Four years after the date of entry into force of Regulation (EC) No 726/2004(6), it should no longer be possible to opt for the mutual-recognition procedure or the decentralised procedure in respect of medicinal products which contain new active substances and for which the therapeutic indication is the treatment of auto-immune diseases and other immune dysfunctions and viral diseases. (9) On the other hand, in the case of generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual-recognition or decentralised procedure should be available as an option for medicinal products which represent a therapeutic innovation or which are of benefit to society or to patients. (10) In order to increase availability of medicinal products, in particular on smaller markets, it should, in cases where an applicant does not apply for an authorisation for a medicinal product in the context of the mutual-recognition procedure in a given Member State, be possible for that Member State, for justified public health reasons, to authorise the placing on the market of the medicinal product. (11) Evaluation of the operation of marketing authorisation procedures has revealed the need to revise, in particular, the mutual-recognition procedure in order to improve the opportunities for cooperation between Member States. This cooperation process should be formalised by setting up a coordination group for this procedure and by defining its operation so as to settle disagreements within the framework of a revised decentralised procedure. (12) With regard to referrals, the experience acquired reveals the need for an appropriate procedure, particularly in the case of referrals relating to an entire therapeutic class or to all medicinal products containing the same active substance. (13) There is a need to provide for the ethical requirements of Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(7) to apply to all medicinal products authorised within the Community. In particular, with respect to clinical trials conducted outside the Community on medicinal products destined to be authorised within the Community, it should be verified, at the time of the evaluation of the application for authorisation, that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of that Directive. (14) Since generic medicines account for a major part of the market in medicinal products, their access to the Community market should be facilitated in the light of the experience acquired. Furthermore, the period for protection of data relating to pre-clinical tests and clinical trials should be harmonised. (15) Biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action. When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both. (16) The criteria of quality, safety and efficacy should enable the risk-benefit balance of all medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate. In this connection, it is necessary to harmonise and adapt the criteria for refusal, suspension and revocation of marketing authorisations. (17) A marketing authorisation should be renewed once five years after the granting of the marketing authorisation. Thereafter, the marketing authorisation should normally be of unlimited validity. Furthermore, any authorisation not used for three consecutive years, that is to say one which has not led to the placing on the market of a medicinal product in the Member States concerned during that period, should be considered invalid, in order, in particular, to avoid the administrative burden of maintaining such authorisations. However, exemptions from this rule should be granted when these are justified on public health grounds. (18) The environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit it should be envisaged. In any event this impact should not constitute a criterion for refusal of a marketing authorisation. (19) The quality of medicinal products for human use manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections. (20) Pharmacovigilance and, more generally, market surveillance and sanctions in the event of failure to comply with the provisions should be stepped up. In the field of pharmacovigilance, account should be taken of the facilities offered by new information technologies to improve exchanges between Member States. (21) As part of the proper use of medicinal products, the rules on packaging should be adapted to take account of the experience acquired. (22) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8). (23) Directive 2001/83/EC should be amended accordingly, Article 1 Directive 2001/83/EC is hereby amended as follows: 1) Article 1 shall be amended as follows: (a) point 1 shall be deleted; (b) point 2 shall be replaced by the following: "2. Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis." (c) point 5 shall be replaced by the following: "5. Homeopathic medicinal product: Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles."; (d) the Title of point 8 shall be replaced by "Kit"; (e) the following point shall be inserted: "18a Representative of the marketing authorisation holder: The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned". (f) point 20 shall be replaced by the following: "20. Name of the medicinal product: The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder."; (g) the heading of point 26 shall be replaced by the following: (only concerns the Portuguese version); (h) point 27 shall be replaced by the following: "27. Agency: The European Medicines Agency established by Regulation (EC) No 726/2004(9);"; (i) point 28 shall be replaced by the following points: "28. Risks related to use of the medicinal product: - any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health; - any risk of undesirable effects on the environment; 28a. Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28, first indent."; 2) Article 2 shall be replaced by the following: "Article 2 1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process. 2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a 'medicinal product' and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply. 3. Notwithstanding paragraph 1 and Article 3(4), Title IV of this Directive shall apply to medicinal products intended only for export and to intermediate products."; 3) Article 3 shall be amended as follows: (a) point 2 shall be replaced by the following: "2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula)." (b) point 3 shall be replaced by the following: "3. Medicinal products intended for research and development trials, but without prejudice to the provisions of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(10)."; (c) point 6 shall be replaced by the following: "6. Whole blood, plasma or blood cells of human origin, except for plasma which is prepared by a method involving an industrial process."; 4) Article 5 shall be replaced by the following: "Article 5 1. A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility. 2. Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. 3. Without prejudice to paragraph 1, Member States shall lay down provisions in order to ensure that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised indications or from the use of an unauthorised medicinal product, when such use is recommended or required by a competent authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not national or Community authorisation has been granted. 4. Liability for defective products, as provided for by Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States, concerning liability for defective products(11), shall not be affected by paragraph 3."; 5) Article 6 shall be amended as follows: (a) in paragraph 1, the following subparagraph shall be added:"When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1)."; (b) the following paragraph shall be inserted: "1a The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility."; (c) in paragraph 2, "radionuclide kits" shall be replaced by "kits"; 6) in Article 7, "radionuclide kits" shall be replaced by "kits"; 7) Article 8(3) shall be amended as follows: (a) points (b) and (c) shall be replaced by the following: "(b) Name of the medicinal product. (c) Qualitative and quantitative particulars of all the constituents of the medicinal product, including the reference to its international non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or a reference to the relevant chemical name;"; (b) the following point shall be inserted: "(ca) Evaluation of the potential environmental risks posed by the medicinal product. This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it shall be envisaged."; (c) points (g), (h), (i) and (j) shall be replaced by the following points: "(g) Reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment. (h) Description of the control methods employed by the manufacturer. (i) Results of: - pharmaceutical (physico-chemical, biological or microbiological) tests, - pre-clinical (toxicological and pharmacological) tests, - clinical trials. (ia) A detailed description of the pharmacovigilance and, where appropriate, of the risk-management system which the applicant will introduce. (ib) A statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC. (j) A summary, in accordance with Article 11, of the product characteristics, a mock-up of the outer packaging, containing the details provided for in Article 54, and of the immediate packaging of the medicinal product, containing the details provided for in Article 55, together with a package leaflet in accordance with Article 59."; (d) the following points shall be added: "(m) A copy of any designation of the medicinal product as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products(12), accompanied by a copy of the relevant Agency opinion. (n) Proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country."; (e) the following subparagraph shall be added:"The documents and information concerning the results of the pharmaceutical and pre-clinical tests and the clinical trials referred to in point (i) of the first subparagraph shall be accompanied by detailed summaries in accordance with Article 12."; 8) Article 10 shall be replaced by the following: "Article 10 1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. 2. For the purposes of this Article: (a) 'reference medicinal product' shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8; (b) 'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. 3. In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided. 4. Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided. 5. In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication. 6. Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products."; 9) the following Articles shall be inserted: "Article 10a By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature. Article 10b In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance. Article 10c Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form."; 10) Article 11 shall be replaced by the following: "Article 11 The summary of the product characteristics shall contain, in the order indicated below, the following information: 1. name of the medicinal product followed by the strength and the pharmaceutical form. 2. qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used. 3. pharmaceutical form. 4. clinical particulars: 4.1. therapeutic indications, 4.2. posology and method of administration for adults and, where necessary for children, 4.3. contra-indications, 4.4. special warnings and precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient, 4.5. interaction with other medicinal products and other forms of interactions, 4.6. use during pregnancy and lactation, 4.7. effects on ability to drive and to use machines, 4.8. undesirable effects, 4.9. overdose (symptoms, emergency procedures, antidotes). 5. pharmacological properties: 5.1. pharmacodynamic properties, 5.2. pharmacokinetic properties, 5.3. preclinical safety data. 6. pharmaceutical particulars: 6.1. list of excipients, 6.2. major incompatibilities, 6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, 6.4. special precautions for storage, 6.5. nature and contents of container, 6.6. special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product, if appropriate. 7. marketing authorisation holder. 8. marketing authorisation number(s). 9. date of the first authorisation or renewal of the authorisation. 10. date of revision of the text. 11. for radiopharmaceuticals, full details of internal radiation dosimetry. 12. for radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications. For authorisations under Article 10, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included."; 11) Article 12 shall be replaced by the following: "Article 12 1. The applicant shall ensure that, before the detailed summaries referred to in the last subparagraph of Article 8(3) are submitted to the competent authorities, they have been drawn up and signed by experts with the necessary technical or professional qualifications, which shall be set out in a brief curriculum vitae. 2. Persons having the technical and professional qualifications referred to in paragraph 1 shall justify any use made of scientific literature under Article 10a in accordance with the conditions set out in Annex I. 3. The detailed summaries shall form part of the file which the applicant submits to the competent authorities."; 12) Article 13 shall be replaced by the following: "Article 13 1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply. 2. Member States shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in Article 14."; 13) Article 14 shall be amended as follows: (a) in paragraph 1, the following second subparagraph shall be inserted: "If new scientific evidence so warrants, the Commission may amend the third indent of the first subparagraph by the procedure referred to in Article 121(2)."; (b) paragraph 3 shall be deleted; 14) Article 15 shall be amended as follows: (a) the second indent shall be replaced by the following: "- dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic use, on the basis of an adequate bibliography,"; (b) the sixth indent shall be replaced by the following: "- one or more mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered,"; 15) Article 16 shall be amended as follows: (a) in paragraph 1, "Articles 8, 10 and 11" shall be replaced by "Articles 8, 10, 10a, 10b, 10c and 11". (b) in paragraph 2, "toxicological and pharmacological tests" shall be replaced by "pre-clinical tests"; 16) Articles 17 and 18 shall be replaced by the following: "Article 17 1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days after the submission of a valid application. Applications for marketing authorisations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with Articles 27 to 39. 2. Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 27 to 39 apply. Article 18 Where a Member State is informed in accordance with Article 8(3)(1) that another Member State has authorised a medicinal product which is the subject of a marketing authorisation application in the Member State concerned, it shall reject the application unless it was submitted in compliance with Articles 27 to 39."; 17) Article 19 shall be amended as follows: (a) in the introductory sentence, "Articles 8 and 10(1)" shall be replaced by "Articles 8, 10, 10a, 10b and 10c"; (b) in point 1, "Articles 8 and 10(1)" shall be replaced by "Articles 8, 10, 10a, 10b and 10c"; (c) in point 2, "a State laboratory or a laboratory designated for that purpose" shall be replaced by "an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose"; (d) in point 3, "Articles 8(3) and 10(1)" shall be replaced by "Articles 8(3), 10, 10a, 10b and 10c"; 18) in point (b) of Article 20, "in exceptional and justifiable cases" shall be replaced by "in justifiable cases"; 19) in Article 21, paragraphs 3 and 4 shall be replaced by the following: "3. The competent authorities shall make publicly available without delay the marketing authorisation together with the summary of the product characteristics for each medicinal product which they have authorised. 4. The competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned. The competent authorities shall make publicly accessible without delay the assessment report, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each indication applied for."; 20) Article 22 shall be replaced by the following: "Article 22 In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to meet certain conditions, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only for objective, verifiable reasons and must be based on one of the grounds set out in Annex I. Continuation of the authorisation shall be linked to the annual reassessment of these conditions. The list of these conditions shall be made publicly accessible without delay, together with deadlines and dates of fulfilment."; 21) in Article 23, the following paragraphs shall be added:"The authorisation holder shall forthwith supply to the competent authority any new information which might entail the amendment of the particulars or documents referred to in Articles 8(3), 10, 10a, 10b and 11, or 32(5), or Annex I. In particular, he shall forthwith inform the competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product for human use concerned. In order that the risk-benefit balance may be continuously assessed, the competent authority may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk-benefit balance remains favourable."; 22) the following Article shall be inserted: "Article 23a After a marketing authorisation has been granted, the holder of the authorisation shall inform the competent authority of the authorising Member State of the date of actual marketing of the medicinal product for human use in that Member State, taking into account the various presentations authorised. The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product. Upon request by the competent authority, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, and any data in his possession relating to the volume of prescriptions."; 23) Article 24 shall be replaced by the following: "Article 24 1. Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years. 2. The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the competent authority of the authorising Member State. To this end, the marketing authorisation holder shall provide the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. 3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2. 4. Any authorisation which within three years of its granting is not followed by the actual placing on the market of the authorised product in the authorising Member State shall cease to be valid. 5. When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid. 6. The competent authority may, in exceptional circumstances and on public health grounds grant exemptions from paragraphs 4 and 5. Such exemptions must be duly justified."; 24) Article 26 shall be replaced by the following: "Article 26 1. The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8, 10, 10a, 10b and 10c, it is clear that: (a) the risk-benefit balance is not considered to be favourable; or (b) its therapeutic efficacy is insufficiently substantiated by the applicant; or (c) its qualitative and quantitative composition is not as declared. 2. Authorisation shall likewise be refused if any particulars or documents submitted in support of the application do not comply with Articles 8, 10, 10a, 10b and 10c. 3. The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and the data submitted."; 25) the heading of Chapter 4 of Title III shall be replaced by the following: "CHAPTER 4 Mutual recognition procedure and decentralised procedure"; 26) Articles 27 to 32 shall be replaced by the following: "Article 27 1. A coordination group shall be set up for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat of this coordination group. 2. The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts. 3. The coordination group shall draw up its own Rules of Procedure, which shall enter into force after a favourable opinion has been given by the Commission. These Rules of Procedure shall be made public. Article 28 1. With a view to the granting of a marketing authorisation for a medicinal product in more than one Member State, an applicant shall submit an application based on an identical dossier in these Member States. The dossier shall contain the information and documents referred to in Articles 8, 10, 10a, 10b, 10c and 11. The documents submitted shall include a list of Member States concerned by the application. The applicant shall request one Member State to act as 'reference Member State' and to prepare an assessment report on the medicinal product in accordance with paragraphs 2 or 3. 2. Where the medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be sent to the concerned Member States and to the applicant. 3. In cases where the medicinal product has not received a marketing authorisation at the time of application, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. The reference Member State shall prepare these draft documents within 120 days after receipt of a valid application and shall send them to the concerned Member States and to the applicant. 4. Within 90 days of receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly. 5. Each Member State in which an application has been submitted in accordance with paragraph 1 shall adopt a decision in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet as approved, within 30 days after acknowledgement of the agreement. Article 29 1. If, within the period laid down in Article 28(4), a Member State cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the coordination group. 2. Guidelines to be adopted by the Commission shall define a potential serious risk to public health. 3. Within the coordination group, all Member States referred to in paragraph 1 shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the points of disagreement, the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Article 28(5) shall apply. 4. If the Member States fail to reach an agreement within the 60-day period laid down in paragraph 3, the Agency shall be immediately informed, with a view to the application of the procedure under Articles 32, 33 and 34. The Agency shall be provided with a detailed statement of the matters on which the Member States have been unable to reach agreement and the reasons for their disagreement. A copy shall be forwarded to the applicant. 5. As soon as the applicant is informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of Article 28(1). 6. In the circumstances referred to in paragraph 4, Member States that have approved the assessment report, the draft summary of product characteristics and the labelling and package leaflet of the reference Member State may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the procedure laid down in Article 32. In that event, the authorisation granted shall be without prejudice to the outcome of that procedure. Article 30 1. If two or more applications submitted in accordance with Articles 8, 10, 10a, 10b, 10c and 11 have been made for marketing authorisation for a particular medicinal product, and if Member States have adopted divergent decisions concerning the authorisation of the medicinal product or its suspension or revocation, a Member State, the Commission or the applicant or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use, hereinafter referred to as 'the Committee', for the application of the procedure laid down in Articles 32, 33 and 34. 2. In order to promote harmonisation of authorisations for medicinal products authorised in the Community, Member States shall, each year, forward to the coordination group a list of medicinal products for which a harmonised summary of product characteristics should be drawn up. The coordination group shall lay down a list taking into account the proposals from all Member States and shall forward this list to the Commission. The Commission or a Member State, in agreement with the Agency and taking into account the views of interested parties, may refer these products to the Committee in accordance with paragraph 1. Article 31 1. The Member States or the Commission or the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 before any decision is reached on a request for a marketing authorisation or on the suspension or revocation of an authorisation, or on any other variation to the terms of a marketing authorisation which appears necessary, in particular to take account of the information collected in accordance with Title IX. The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder. The Member States and the applicant or the marketing authorisation holder shall supply the Committee with all available information relating to the matter in question. 2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation. In that event, Article 35 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in this Chapter. Article 32 1. When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it. However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the applicants or the marketing authorisation holders concerned. In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline. 2. In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks. 3. Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit which it shall specify. The opinion of the Committee shall be accompanied by a draft summary of product characteristics for the product and a draft text of the labelling and package leaflet. If necessary, the Committee may call upon any other person to provide information relating to the matter before it. The Committee may suspend the time-limits referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder to prepare explanations. 4. The Agency shall forthwith inform the applicant or the marketing authorisation holder where the opinion of the Committee is that: (a) the application does not satisfy the criteria for authorisation; or (b) the summary of the product characteristics proposed by the applicant or the marketing authorisation holder in accordance with Article 11 should be amended; or (c) the authorisation should be granted subject to certain conditions, in view of conditions considered essential for the safe and effective use of the medicinal product including pharmacovigilance; or (d) a marketing authorisation should be suspended, varied or revoked. Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No 726/2004. The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article. 5. Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to the Member States, to the Commission and to the applicant or the marketing authorisation holder, together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions. In the event of an opinion in favour of granting or maintaining an authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion: (a) a draft summary of the product characteristics, as referred to in Article 11; (b) any conditions affecting the authorisation within the meaning of paragraph 4(c); (c) details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product; (d) the proposed text of the labelling and leaflet." 27) Article 33 shall be amended as follows: (a) in the first paragraph, "30 days" shall be replaced by "15 days"; (b) in the second paragraph, "Article 32(5)(a) and (b)" shall be replaced by "Article 32(5), second subparagraph"; (c) in the fourth paragraph, the words "or the marketing authorisation holder" shall be added after the word "applicant"; 28) Article 34 shall be replaced by the following: "Article 34 1. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 121(3). 2. The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it under this Chapter. Those adjustments shall entail the following provisions: (a) except in cases referred to in the third paragraph of Article 33, the opinion of the Standing Committee shall be given in writing; (b) Member States shall have 22 days to forward their written observations on the draft decision to the Commission. However, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days; (c) Member States shall have the option of submitting a written request that the draft Decision be discussed in a plenary meeting of the Standing Committee. Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion delivered by the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration. The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2). 3. The decision as referred to in paragraph 1 shall be addressed to all Member States and reported for information to the marketing authorisation holder or applicant. The concerned Member States and the reference Member State shall either grant or revoke the marketing authorisation, or vary its terms as necessary to comply with the decision within 30 days following its notification, and they shall refer to it. They shall inform the Commission and the Agency accordingly."; 29) the third subparagraph of Article 35(1) shall be deleted; 30) in Article 38, paragraph 2 shall be replaced by the following: "2. At least every ten years the Commission shall publish a report on the experience acquired on the basis of the procedures described in this Chapter and shall propose any amendments which may be necessary to improve those procedures. The Commission shall submit this report to the European Parliament and to the Council."; 31) Article 39 shall be replaced by the following: "Article 39 Article 29(4), (5) and (6) and Articles 30 to 34 shall not apply to the homeopathic medicinal products referred to in Article 14. Articles 28 to 34 shall not apply to the homeopathic medicinal products referred to in Article 16(2)."; 32) the following paragraph shall be added to Article 40: "4. The Member States shall forward to the Agency a copy of the authorisation referred to in paragraph 1. The Agency shall enter that information on the Community database referred to in Article 111(6)."; 33) in Article 46, point (f) shall be replaced by the following: "(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. This point shall also be applicable to certain excipients, the list of which as well as the specific conditions of application shall be established by a Directive adopted by the Commission in accordance with the procedure referred to in Article 121(2)."; 34) the following Article shall be inserted: "Article 46a 1. For the purposes of this Directive, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials. 2. Any amendments necessary to adapt paragraph 1 to new scientific and technical developments shall be laid down in accordance with the procedure referred to in Article 121(2)."; 35) in Article 47, the following paragraphs shall be added:"The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines. The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 40(1), on the reports referred to in Article 111(3) and on the form and content of the certificate of good manufacturing practice referred to in Article 111(5)."; 36) in Article 49(1), "minimum" shall be deleted; 37) in Article 49(2), fourth subparagraph, first indent "Applied physics" shall be replaced by "Experimental physics"; 38) in Article 50(1), "in the State concerned" shall be replaced by "within the Community"; 39) in Article 51(1), point (b) shall be replaced by the following: "(b) in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation."; 40) Article 54 shall be amended as follows: (a) point (a) shall be replaced by the following: "(a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;"; (b) in point (d), "guidelines" shall be replaced by "detailed guidance"; (c) Point (e) shall be replaced by the following: "(e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated."; (d) point (f) shall be replaced by the following: "(f) a special warning that the medicinal product must be stored out of the reach and sight of children;"; (e) Point (j) shall be replaced by the following: "(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;"; (f) point (k) shall be replaced by the following: "(k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;"; (g) point (n) shall be replaced by the following: "(n) in the case of non-prescription medicinal products, instructions for use"; 41) Article 55 shall be amended as follows: (a) in paragraph 1, "in Articles 54 and 62" shall be replaced by "in Article 54"; (b) the first indent of paragraph 2 shall be replaced by the following: "- the name of the medicinal product as laid down in point (a) of Article 54,"; (c) the first indent of paragraph 3 shall be replaced by the following: "- the name of the medicinal product as laid down in point (a) of Article 54 and, if necessary, the route of administration,"; 42) the following Article shall be inserted: "Article 56a The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted." 43) in Article 57, the following paragraph shall be added:"For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive."; 44) Article 59 shall be replaced by the following: "Article 59 1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order: (a) for the identification of the medicinal product: (i) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name; (ii) the pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient; (b) the therapeutic indications; (c) a list of information which is necessary before the medicinal product is taken: (i) contra-indications; (ii) appropriate precautions for use; (iii) forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product; (iv) special warnings; (d) the necessary and usual instructions for proper use, and in particular: (i) the dosage, (ii) the method and, if necessary, route of administration; (iii) the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered; and, as appropriate, depending on the nature of the product: (iv) the duration of treatment, where it should be limited; (v) the action to be taken in case of an overdose (such as symptoms, emergency procedures); (vi) what to do when one or more doses have not been taken; (vii) indication, if necessary, of the risk of withdrawal effects; (viii) a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product; (e) a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist; (f) a reference to the expiry date indicated on the label, with: (i) a warning against using the product after that date; (ii) where appropriate, special storage precautions; (iii) if necessary, a warning concerning certain visible signs of deterioration; (iv) the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product; (v) for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage; (vi) the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States; (vii) the name and address of the manufacturer; (g) where the medicinal product is authorised in accordance with Articles 28 to 39 under different names in the Member States concerned, a list of the names authorised in each Member State; (h) the date on which the package leaflet was last revised. 2. The list set out in point (c) of paragraph 1 shall: (a) take into account the particular condition of certain categories of users (children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions); (b) mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; (c) list those excipients knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65. 3. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use."; 45) Article 61(1) shall be replaced by the following: "1. One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorising marketing when the marketing authorisation is requested. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority."; 46) in Article 61(4), "or as appropriate" shall be replaced by "and"; 47) in Article 62, "for health education" shall be replaced by "for the patient"; 48) Article 63 shall be amended as follows: (a) the following subparagraph shall be added to paragraph 1:"In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Community."; (b) paragraphs 2 and 3 shall be replaced by the following: "2. The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in the official language or languages of the Member State in which the medicinal product is placed on the market. The first subparagraph shall not prevent the package leaflet from being printed in several languages, provided that the same information is given in all the languages used. 3. When the product is not intended to be delivered directly to the patient, the competent authorities may grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet and that the leaflet must be in the official language or languages of the Member State in which the product is placed on the market."; 49) Article 65 shall be replaced by the following: "Article 65 In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular: (a) the wording of certain special warnings for certain categories of medicinal products; (b) the particular information needs relating to non-prescription medicinal products; (c) the legibility of particulars on the labelling and package leaflet; (d) the methods for the identification and authentication of medicinal products; (e) the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated; (f) harmonised provisions for the implementation of Article 57."; 50) Article 66(3), fourth indent shall be replaced by: "- the name and address of the manufacturer,"; 51) Article 69(1) shall be amended as follows: (a) the first indent shall be replaced by the following: "- the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5); if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name"; (b) the last indent shall be replaced by the following: "- a warning advising the user to consult a doctor if the symptoms persist"; 52) Article 70(2) shall be amended as follows: (a) point (a) shall be replaced by the following: "(a) medicinal products on medical prescription for renewable or non-renewable delivery;"; (b) point (c) shall be replaced by the following: "(c) medicinal products on 'restricted' medical prescription, reserved for use in certain specialised areas."; 53) Article 74 shall be replaced by the following: "Article 74 When new facts are brought to their attention, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product by applying the criteria listed in Article 71."; 54) the following Article shall be inserted: "Article 74a Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised."; 55) Article 76 shall be amended as follows: (a) the existing text shall become paragraph 1; (b) the following paragraphs shall be added: "2. In the case of wholesale distribution and storage, medicinal products shall be covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive. 3. Any distributor, not being the marketing authorisation holder, who imports a product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the product will be imported of his intention to import it. In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State."; 56) the second indent of point (e) of Article 80 shall be replaced by the following: "- name of the medicinal product,"; 57) Article 81 shall be replaced by the following: "Article 81 With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities. The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition."; 58) in Article 82, the second indent of the first paragraph shall be replaced by the following: "- the name and pharmaceutical form of the medicinal product,"; 59) Article 84 shall be replaced by the following: "Article 84 The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC(13)."; 60) Article 85 shall be replaced by the following: "Article 85 This Title shall apply to homeopathic medicinal products."; 61) the fourth indent of Article 86(2) shall be replaced by the following: "- information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products"; 62) Article 88 shall be replaced by the following: "Article 88 1. Member States shall prohibit the advertising to the general public of medicinal products which: (a) are available on medical prescription only, in accordance with Title VI; (b) contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971. 2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. 3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed. 4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States. 5. The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC. 6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes."; 63) the following text is inserted after Article 88: "TITLE VIIIa INFORMATION AND ADVERTISING Article 88a Within three years of the entry into force of Directive 2004/726/EC, the Commission shall, following consultations with patients' and consumers' organisations, doctors' and pharmacists' organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision - particularly on the Internet - and its risks and benefits for patients. Following analysis of the above data, the Commission shall, if appropriate, put forward proposals setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products and other treatments and shall address the question of the information source's liability."; 64) Article 89 shall be amended as follows: (a) the first indent of point (b) of paragraph 1 shall be replaced by the following: (does not affect the English version); (b) paragraph 2 shall be replaced by the following: "2. Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product or its international non-proprietary name, where this exists, or the trademark if it is intended solely as a reminder."; 65) in Article 90, point (l) shall be deleted; 66) in Article 91, paragraph 2 shall be replaced by the following: "2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark, if it is intended solely as a reminder."; 67) Article 94(2) shall be replaced by the following: "2. Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than health-care professionals."; 68) Article 95 shall be replaced by the following: "Article 95 The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals."; 69) point (d) of Article 96(1) shall be replaced by the following: "(d) each sample shall be no larger than the smallest presentation on the market;"; 70) in Article 98, the following paragraph shall be added: "3. The Member States shall not prohibit the co-promotion of a medicinal product by the holder of the marketing authorisation and one or more companies nominated by him."; 71) Article 100 shall be replaced by the following: "Article 100 Advertising of the homeopathic medicinal products referred to in Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1). However, only the information specified in Article 69(1) may be used in the advertising of such medicinal products."; 72) in Article 101, the second paragraph shall be replaced by the following:"The Member States may impose specific requirements on doctors and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions."; 73) Article 102 shall be replaced by the following: "Article 102 In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the medicinal products authorised within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall operate a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically. Member States shall ensure that suitable information collected within this system is communicated to the other Member States and the Agency. The information shall be recorded in the database referred to in point (l) of the second subparagraph of Article 57(1) of Regulation (EC) No 726/2004 and shall be permanently accessible to all Member States and without delay to the public. This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks."; 74) the following Article shall be inserted: "Article 102a The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee their independence."; 75) in Article 103, the introductory phrase of the second paragraph shall be replaced by the following: "That qualified person shall reside in the Community and shall be responsible for the following:"; 76) Articles 104 to 107 shall be replaced by the following: "Article 104 1. The marketing authorisation holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. Save in exceptional circumstances, these reactions shall be communicated electronically in the form of a report in accordance with the guidelines referred to in Article 106(1). 2. The marketing authorisation holder shall be required to record all suspected serious adverse reactions which are brought to his attention by a health-care professional and to report them promptly to the competent authority of the Member State on whose territory the incident occurred, and no later than 15 days following the receipt of the information. 3. The marketing authorisation holder shall be required to record and report all other suspected serious adverse reactions which meet the notification criteria in accordance with the guidelines referred to in Article 106(1), of which he can reasonably be expected to have knowledge, promptly to the competent authority of the Member State in whose territory the incident occurred, and no later than 15 days following the receipt of the information. 4. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly in accordance with the guidelines referred to in Article 106(1), so that the Agency and the competent authorities of the Member States in which the medicinal product is authorised are informed of them, and no later than 15 days following the receipt of the information. 5. By way of derogation from paragraphs 2, 3 and 4, in the case of medicinal products which are covered by Directive 87/22/EEC or which have qualified for the procedures laid down in Articles 28 and 29 of this Directive or which have been the subject of the procedures under Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall also ensure that all suspected serious adverse reactions occurring in the Community are reported in such a way as to be accessible to the reference Member State or to any competent authority acting as reference Member State. The reference Member State shall assume the responsibility of analysing and monitoring such adverse reactions. 6. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation, or subsequently as indicated in the guidelines referred to in Article 106(1), reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, immediately upon request or at least every six months after authorisation and until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the medicinal product. 7. The Commission may lay down provisions to amend paragraph 6 in view of experience gained through its operation. The Commission shall adopt the provisions in accordance with the procedure referred to in Article 121(2). 8. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in paragraph 6 in accordance with the procedure laid down by Commission Regulation (EC) No 1084/2003(14). 9. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the competent authority. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties. Article 105 1. The Agency, in collaboration with the Member States and the Commission, shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community in order to allow all competent authorities to share the information at the same time. 2. Making use of the network referred to in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are promptly made available to the Agency and the other Member States, and in any case within 15 days after their notification at the latest. 3. The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are promptly made available to the marketing authorisation holder, and in any case within 15 days after their notification at the latest. Article 106 1. In order to facilitate the exchange of information on pharmacovigilance within the Community, the Commission, after consulting the Agency, the Member States and interested parties, shall draw up guidelines on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats, and shall publish a reference to an internationally agreed medical terminology. Acting in accordance with the guidelines, marketing authorisation holders shall use internationally agreed medical terminology for the reporting of adverse reactions. These guidelines shall be published in Volume 9 of The Rules governing Medicinal Products in the European Community and shall take account of international harmonisation work carried out in the field of pharmacovigilance. 2. For the interpretation of the definitions referred to in points (11) to (16) of Article 1 and of the principles outlined in this Title, the marketing authorisation holder and the competent authorities shall follow the guidelines referred to in paragraph 1. Article 107 1. Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, revoked or varied in accordance with the guidelines referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder. 2. Where urgent action to protect public health is necessary, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided that the Agency, the Commission and the other Member States are informed no later than the following working day. When the Agency is informed in accordance with paragraph 1 in relation to suspensions and revocation, or the first subparagraph of this paragraph, the Committee shall prepare an opinion within a time-frame to be determined depending on the urgency of the matter. In relation to variations, the Committee may upon request from a Member State prepare an opinion. Acting on the basis of this opinion, the Commission may request all Member States in which the product is being marketed to take temporary measures immediately. The final measures shall be adopted in accordance with the procedure referred to in Article 121(3)."; 77) Article 111 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The competent authority of the Member State concerned shall ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples, that the legal requirements governing medicinal products are complied with. The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47. These inspections may also be carried out at the request of a Member State, the Commission or the Agency. In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardisation body of the nomenclatures and the quality norms within the meaning of the Convention relating to the elaboration of the European Pharmacopoeia(15) (European Directorate for the quality of Medicinal Products) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph. The competent authority of the Member State concerned may carry out inspections of starting material manufacturers at the specific request of the manufacturer himself. Such inspections shall be carried out by officials representing the competent authority who shall be empowered to: (a) inspect the manufacturing or commercial establishments of manufacturers of medicinal products or of active substances used as starting materials, and any laboratories employed by the holder of the manufacturing authorisation to carry out checks pursuant to Article 20; (b) take samples including with a view to independent tests being carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by a Member State; (c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 placing restrictions on these powers with regard to the description of the manufacturing method; (d) inspect the premises, records and documents of marketing authorisation holders or any firms employed by the marketing authorisation holder to perform the activities described in Title IX, and in particular Articles 103 and 104."; (b) paragraph 3 shall be replaced by the following: "3. After every inspection as referred to in paragraph 1, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down in Article 47 or, where appropriate, with the requirements laid down in Articles 101 to 108. The content of such reports shall be communicated to the manufacturer or marketing authorisation holder who has undergone the inspection."; (c) the following paragraphs shall be added: "4. Without prejudice to any arrangements which may have been concluded between the Community and third countries, a Member State, the Commission or the Agency may require a manufacturer established in a third country to submit to an inspection as referred to in paragraph 1. 5. Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice shall be issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice as provided for by Community legislation. If inspections are performed as part of the certification procedure for the monographs of the European Pharmacopoeia, a certificate shall be drawn up. 6. Member States shall enter the certificates of good manufacturing practice which they issue in a Community database managed by the Agency on behalf of the Community. 7. If the outcome of the inspection as referred to in paragraph 1 is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice as provided for by Community legislation, the information shall be entered in the Community database as referred to in paragraph 6."; 78) in Article 114(1) and (2), the terms "by a State laboratory or a laboratory designated for that purpose" shall be replaced by the terms "by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose"; 79) Article 116 shall be replaced by the following: "Article 116 The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken that the product is harmful under normal conditions of use, or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive under the normal conditions of use, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product. An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in Article 8 or Articles 10, 10a, 10b, 10c and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out."; 80) Article 117(1) shall be replaced by the following: "1. Without prejudice to the measures provided for in Article 116, Member States shall take all appropriate steps to ensure that the supply of the medicinal product is prohibited and the medicinal product withdrawn from the market, if the view is taken that: (a) the medicinal product is harmful under normal conditions of use; or (b) it lacks therapeutic efficacy; or (c) the risk-benefit balance is not favourable under the authorised conditions of use; or (d) its qualitative and quantitative composition is not as declared; or (e) the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled."; 81) Article 119 shall be replaced by the following: "Article 119 The provisions of this Title shall apply to homeopathic medicinal products."; 82) Articles 121 and 122 shall be replaced by the following: "Article 121 1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, hereinafter called 'the Standing Committee', in the task of adapting to technical progress the directives on the removal of technical barriers to trade in the medicinal products sector. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 4. The Standing Committee shall adopt its own rules of procedure which shall be made public. Article 122 1. Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements placed on the authorisations referred to in Articles 40 and 77, on the certificates referred to in Article 111(5) or on the marketing authorisations are fulfilled. 2. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 111(3) to the competent authorities of another Member State. 3. The conclusions reached in accordance with Article 111(1) shall be valid throughout the Community. However, in exceptional cases, if a Member State is unable, for reasons relating to public health, to accept the conclusions reached following an inspection under Article 111(1), that Member State shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned. When the Commission is informed of these divergences of opinion, it may, after consulting the Member States concerned, ask the inspector who performed the original inspection to perform a new inspection; the inspector may be accompanied by two other inspectors from Member States which are not parties to the disagreement."; 83) in Article 125, the third subparagraph shall be replaced by the following:"Decisions to grant or revoke a marketing authorisation shall be made publicly available."; 84) the following Article shall be inserted: "Article 126a 1. In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product. 2. When a Member State avails itself of this possibility, it shall adopt the necessary measures in order to ensure that the requirements of this Directive are complied with, in particular those referred to in Titles V, VI, VIII, IX and XI. 3. Before granting such an authorisation a Member State shall: (a) notify the marketing authorisation holder, in the Member State in which the medicinal product concerned is authorised, of the proposal to grant an authorisation under this Article in respect of the product concerned; and (b) request the competent authority in that State to furnish a copy of the assessment report referred to in Article 21(4) and of the marketing authorisation in force in respect of the said medicinal product. 4. The Commission shall set up a publicly accessible register of medicinal products authorised under paragraph 1. Member States shall notify the Commission if any medicinal product is authorised, or ceases to be authorised, under paragraph 1, including the name or corporate name and permanent address of the authorisation holder. The Commission shall amend the register of medicinal products accordingly and make this register available on their website. 5. No later than 30 April 2008, the Commission shall present a report to the European Parliament and the Council concerning the application of this provision with a view to proposing any necessary amendments."; 85) the following Article 126b is inserted: "Article 126b In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry which could affect their impartiality. These persons shall make an annual declaration of their financial interests. In addition, the Member States shall ensure that the competent authority makes publicly accessible its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions."; 86) the following Article shall be inserted: "Article 127a When a medicinal product is to be authorised in accordance with Regulation (EC) No 726/2004 and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the medicinal product as provided for in Article 9(4)(c) of that Regulation, a decision addressed to the Member States shall be adopted in accordance with the procedure provided for in Articles 33 and 34 of this Directive, for the implementation of those conditions or restrictions."; 87) the following Article shall be inserted: "Article 127b Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired." Article 2 The periods of protection provided for in Article 1, point 8, which amends Article 10(1) of Directive 2001/83/EC, shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date of transposition referred to in Article 3 first paragraph. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 October 2005. 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 a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0018

2004

DIRECTIVE 2004/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts Having regard to the Treaty establishing the European Community, and in particular Article 47(2) and Article 55 and Article 95 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 251 of the Treaty (4), in the light of the joint text approved by the Conciliation Committee on 9 December 2003, Whereas: (1) On the occasion of new amendments being made to Council Directives 92/50/EEC of 18 June 1992 relating to the coordination of procedures for the award of public service contracts (5), 93/36/EEC of 14 June 1993 coordinating procedures for the award of public supply contracts (6) and 93/37/EEC of 14 June 1993 concerning the coordination of procedures for the award of public works contracts (7), which are necessary to meet requests for simplification and modernisation made by contracting authorities and economic operators alike in their responses to the Green Paper adopted by the Commission on 27 November 1996, the Directives should, in the interests of clarity, be recast. This Directive is based on Court of Justice case-law, in particular case-law on award criteria, which clarifies the possibilities for the contracting authorities to meet the needs of the public concerned, including in the environmental and/or social area, provided that such criteria are linked to the subject-matter of the contract, do not confer an unrestricted freedom of choice on the contracting authority, are expressly mentioned and comply with the fundamental principles mentioned in recital 2. (2) The award of contracts concluded in the Member States on behalf of the State, regional or local authorities and other bodies governed by public law entities, is subject to the respect of the principles of the Treaty and in particular to the principle of freedom of movement of goods, the principle of freedom of establishment and the principle of freedom to provide services and to the principles deriving therefrom, such as the principle of equal treatment, the principle of non-discrimination, the principle of mutual recognition, the principle of proportionality and the principle of transparency. However, for public contracts above a certain value, it is advisable to draw up provisions of Community coordination of national procedures for the award of such contracts which are based on these principles so as to ensure the effects of them and to guarantee the opening-up of public procurement to competition. These coordinating provisions should therefore be interpreted in accordance with both the aforementioned rules and principles and other rules of the Treaty. (3) Such coordinating provisions should comply as far as possible with current procedures and practices in each of the Member States. (4) Member States should ensure that the participation of a body governed by public law as a tenderer in a procedure for the award of a public contract does not cause any distortion of competition in relation to private tenderers. (5) Under Article 6 of the Treaty, environmental protection requirements are to be integrated into the definition and implementation of the Community policies and activities referred to in Article 3 of that Treaty, in particular with a view to promoting sustainable development. This Directive therefore clarifies how the contracting authorities may contribute to the protection of the environment and the promotion of sustainable development, whilst ensuring the possibility of obtaining the best value for money for their contracts. (6) Nothing in this Directive should prevent the imposition or enforcement of measures necessary to protect public policy, public morality, public security, health, human and animal life or the preservation of plant life, in particular with a view to sustainable development, provided that these measures are in conformity with the Treaty. (7) Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the Agreements reached in the Uruguay Round multilateral negotiations (1986 to 1994) (8), approved in particular the WTO Agreement on Government Procurement, hereinafter referred to as the ‘Agreement’, the aim of which is to establish a multilateral framework of balanced rights and obligations relating to public contracts with a view to achieving the liberalisation and expansion of world trade. In view of the international rights and commitments devolving on the Community as a result of the acceptance of the Agreement, the arrangements to be applied to tenderers and products from signatory third countries are those defined by the Agreement. This Agreement does not have direct effect. The contracting authorities covered by the Agreement which comply with this Directive and which apply the latter to economic operators of third countries which are signatories to the Agreement should therefore be in conformity with the Agreement. It is also appropriate that those coordinating provisions should guarantee for Community economic operators conditions for participation in public procurement which are just as favourable as those reserved for economic operators of third countries which are signatories to the Agreement. (8) Before launching a procedure for the award of a contract, contracting authorities may, using a technical dialogue, seek or accept advice which may be used in the preparation of the specifications provided, however, that such advice does not have the effect of precluding competition. (9) In view of the diversity of public works contracts, contracting authorities should be able to make provision for contracts for the design and execution of work to be awarded either separately or jointly. It is not the intention of this Directive to prescribe either joint or separate contract awards. The decision to award contracts separately or jointly must be determined by qualitative and economic criteria, which may be defined by national law. (10) A contract shall be deemed to be a public works contract only if its subject matter specifically covers the execution of activities listed in Annex I, even if the contract covers the provision of other services necessary for the execution of such activities. Public service contracts, in particular in the sphere of property management services, may, in certain circumstances, include works. However, insofar as such works are incidental to the principal subject-matter of the contract, and are a possible consequence thereof or a complement thereto, the fact that such works are included in the contract does not justify the qualification of the contract as a public works contract. (11) A Community definition of framework agreements, together with specific rules on framework agreements concluded for contracts falling within the scope of this Directive, should be provided. Under these rules, when a contracting authority enters into a framework agreement in accordance with the provisions of this Directive relating, in particular, to advertising, time limits and conditions for the submission of tenders, it may enter into contracts based on such a framework agreement during its term of validity either by applying the terms set forth in the framework agreement or, if all terms have not been fixed in advance in the framework agreement, by reopening competition between the parties to the framework agreement in relation to those terms. The reopening of competition should comply with certain rules the aim of which is to guarantee the required flexibility and to guarantee respect for the general principles, in particular the principle of equal treatment. For the same reasons, the term of the framework agreements should not exceed four years, except in cases duly justified by the contracting authorities. (12) Certain new electronic purchasing techniques are continually being developed. Such techniques help to increase competition and streamline public purchasing, particularly in terms of the savings in time and money which their use will allow. Contracting authorities may make use of electronic purchasing techniques, providing such use complies with the rules drawn up under this Directive and the principles of equal treatment, non-discrimination and transparency. To that extent, a tender submitted by a tenderer, in particular where competition has been reopened under a framework agreement or where a dynamic purchasing system is being used, may take the form of that tenderer's electronic catalogue if the latter uses the means of communication chosen by the contracting authority in accordance with Article 42. (13) In view of the rapid expansion of electronic purchasing systems, appropriate rules should now be introduced to enable contracting authorities to take full advantage of the possibilities afforded by these systems. Against this background, it is necessary to define a completely electronic dynamic purchasing system for commonly used purchases, and lay down specific rules for setting up and operating such a system in order to ensure the fair treatment of any economic operator who wishes to take part therein. Any economic operator which submits an indicative tender in accordance with the specification and meets the selection criteria should be allowed to join such a system. This purchasing technique allows the contracting authority, through the establishment of a list of tenderers already selected and the opportunity given to new tenderers to take part, to have a particularly broad range of tenders as a result of the electronic facilities available, and hence to ensure optimum use of public funds through broad competition. (14) Since use of the technique of electronic auctions is likely to increase, such auctions should be given a Community definition and governed by specific rules in order to ensure that they operate in full accordance with the principles of equal treatment, non-discrimination and transparency. To that end, provision should be made for such electronic auctions to deal only with contracts for works, supplies or services for which the specifications can be determined with precision. Such may in particular be the case for recurring supplies, works and service contracts. With the same objective, it must also to be possible to establish the respective ranking of the tenderers at any stage of the electronic auction. Recourse to electronic auctions enables contracting authorities to ask tenderers to submit new prices, revised downwards, and when the contract is awarded to the most economically advantageous tender, also to improve elements of the tenders other than prices. In order to guarantee compliance with the principle of transparency, only the elements suitable for automatic evaluation by electronic means, without any intervention and/or appreciation by the contracting authority, may be the object of electronic auctions, that is, only the elements which are quantifiable so that they can be expressed in figures or percentages. On the other hand, those aspects of the tenders which imply an appreciation of non-quantifiable elements should not be the object of electronic auctions. Consequently, certain works contracts and certain service contracts having as their subject-matter intellectual performances, such as the design of works, should not be the object of electronic auctions. (15) Certain centralised purchasing techniques have been developed in Member States. Several contracting authorities are responsible for making acquisitions or awarding public contracts/framework agreements for other contracting authorities. In view of the large volumes purchased, those techniques help increase competition and streamline public purchasing. Provision should therefore be made for a Community definition of central purchasing bodies dedicated to contracting authorities. A definition should also be given of the conditions under which, in accordance with the principles of non-discrimination and equal treatment, contracting authorities purchasing works, supplies and/or services through a central purchasing body may be deemed to have complied with this Directive. (16) In order to take account of the different circumstances obtaining in Member States, Member States should be allowed to choose whether contracting authorities may use framework agreements, central purchasing bodies, dynamic purchasing systems, electronic auctions or the competitive dialogue procedure, as defined and regulated by this Directive. (17) Multiplying the number of thresholds for applying the coordinating provisions complicates matters for contracting authorities. Furthermore, in the context of monetary union such thresholds should be established in euro. Accordingly, thresholds should be set, in euro, in such a way as to simplify the application of such provisions, while at the same time ensuring compliance with the thresholds provided for by the Agreement which are expressed in special drawing rights. In this context, provision should also be made for periodic reviews of the thresholds expressed in euro so as to adjust them, where necessary, in line with possible variations in the value of the euro in relation to the special drawing right. (18) The field of services is best delineated, for the purpose of applying the procedural rules of this Directive and for monitoring purposes, by subdividing it into categories corresponding to particular headings of a common classification and by bringing them together in two Annexes, II A and II B, according to the regime to which they are subject. As regards services in Annex II B, the relevant provisions of this Directive should be without prejudice to the application of Community rules specific to the services in question. (19) As regards public service contracts, full application of this Directive should be limited, for a transitional period, to contracts where its provisions will permit the full potential for increased cross-frontier trade to be realised. Contracts for other services need to be monitored during this transitional period before a decision is taken on the full application of this Directive. In this respect, the mechanism for such monitoring needs to be defined. This mechanism should, at the same time, enable interested parties to have access to the relevant information. (20) Public contracts which are awarded by the contracting authorities operating in the water, energy, transport and postal services sectors and which fall within the scope of those activities are covered by Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (9). However, contracts awarded by the contracting authorities in the context of their service activities for maritime, coastal or river transport must fall within the scope of this Directive. (21) In view of the situation of effective market competition in the telecommunications sector following the implementation of the Community rules aimed at liberalising that sector, public contracts in that area should be excluded from the scope of this Directive insofar as they are intended primarily to allow the contracting authorities to exercise certain activities in the telecommunications sector. Those activities are defined in accordance with the definitions used in Articles 1, 2 and 8 of Council Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sector (10), such that this Directive does not apply to contracts which have been excluded from the scope of Directive 93/38/EEC pursuant to Article 8 thereof. (22) Provision should be made for cases in which it is possible to refrain from applying the measures for coordinating procedures on grounds relating to State security or secrecy, or because specific rules on the awarding of contracts which derive from international agreements, relating to the stationing of troops, or which are specific to international organisations are applicable. (23) Pursuant to Article 163 of the Treaty, the encouragement of research and technological development is a means of strengthening the scientific and technological basis of Community industry, and the opening-up of public service contracts contributes to this end. This Directive should not cover the cofinancing of research and development programmes: research and development contracts other than those where the benefits accrue exclusively to the contracting authority for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting authority, are not therefore covered by this Directive. (24) In the context of services, contracts for the acquisition or rental of immovable property or rights to such property have particular characteristics which make the application of public procurement rules inappropriate. (25) The awarding of public contracts for certain audiovisual services in the field of broadcasting should allow aspects of cultural or social significance to be taken into account which render application of procurement rules inappropriate. For these reasons, an exception must therefore be made for public service contracts for the purchase, development, production or co-production of off-the-shelf programmes and other preparatory services, such as those relating to scripts or artistic performances necessary for the production of the programme and contracts concerning broadcasting times. However, this exclusion should not apply to the supply of technical equipment necessary for the production, co-production and broadcasting of such programmes. A broadcast should be defined as transmission and distribution using any form of electronic network. (26) Arbitration and conciliation services are usually provided by bodies or individuals designated or selected in a manner which cannot be governed by procurement rules. (27) In accordance with the Agreement, the financial services covered by this Directive do not include instruments of monetary policy, exchange rates, public debt, reserve management or other policies involving transactions in securities or other financial instruments, in particular transactions by the contracting authorities to raise money or capital. Accordingly, contracts relating to the issue, purchase, sale or transfer of securities or other financial instruments are not covered. Central bank services are also excluded. (28) Employment and occupation are key elements in guaranteeing equal opportunities for all and contribute to integration in society. In this context, sheltered workshops and sheltered employment programmes contribute efficiently towards the integration or reintegration of people with disabilities in the labour market. However, such workshops might not be able to obtain contracts under normal conditions of competition. Consequently, it is appropriate to provide that Member States may reserve the right to participate in award procedures for public contracts to such workshops or reserve performance of contracts to the context of sheltered employment programmes. (29) The technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition. To this end, it must be possible to submit tenders which reflect the diversity of technical solutions. Accordingly, it must be possible to draw up the technical specifications in terms of functional performance and requirements, and, where reference is made to the European standard or, in the absence thereof, to the national standard, tenders based on equivalent arrangements must be considered by contracting authorities. To demonstrate equivalence, tenderers should be permitted to use any form of evidence. Contracting authorities must be able to provide a reason for any decision that equivalence does not exist in a given case. Contracting authorities that wish to define environmental requirements for the technical specifications of a given contract may lay down the environmental characteristics, such as a given production method, and/or specific environmental effects of product groups or services. They can use, but are not obliged to use appropriate specifications that are defined in eco-labels, such as the European Eco-label, (multi-)national eco-labels or any other eco-label providing the requirements for the label are drawn up and adopted on the basis of scientific information using a procedure in which stakeholders, such as government bodies, consumers, manufacturers, distributors and environmental organisations can participate, and providing the label is accessible and available to all interested parties. Contracting authorities should, whenever possible, lay down technical specifications so as to take into account accessibility criteria for people with disabilities or design for all users. The technical specifications should be clearly indicated, so that all tenderers know what the requirements established by the contracting authority cover. (30) Additional information concerning contracts must, as is customary in Member States, be given in the contract documents for each contract or else in an equivalent document. (31) Contracting authorities which carry out particularly complex projects may, without this being due to any fault on their part, find it objectively impossible to define the means of satisfying their needs or of assessing what the market can offer in the way of technical solutions and/or financial/legal solutions. This situation may arise in particular with the implementation of important integrated transport infrastructure projects, large computer networks or projects involving complex and structured financing the financial and legal make-up of which cannot be defined in advance. To the extent that use of open or restricted procedures does not allow the award of such contracts, a flexible procedure should be provided which preserves not only competition between economic operators but also the need for the contracting authorities to discuss all aspects of the contract with each candidate. However, this procedure must not be used in such a way as to restrict or distort competition, particularly by altering any fundamental aspects of the offers, or by imposing substantial new requirements on the successful tenderer, or by involving any tenderer other than the one selected as the most economically advantageous. (32) In order to encourage the involvement of small and medium-sized undertakings in the public contracts procurement market, it is advisable to include provisions on subcontracting. (33) Contract performance conditions are compatible with this Directive provided that they are not directly or indirectly discriminatory and are indicated in the contract notice or in the contract documents. They may, in particular, be intended to favour on-site vocational training, the employment of people experiencing particular difficulty in achieving integration, the fight against unemployment or the protection of the environment. For instance, mention may be made, amongst other things, of the requirements — applicable during performance of the contract — to recruit long-term job-seekers or to implement training measures for the unemployed or young persons, to comply in substance with the provisions of the basic International Labour Organisation (ILO) Conventions, assuming that such provisions have not been implemented in national law, and to recruit more handicapped persons than are required under national legislation. (34) The laws, regulations and collective agreements, at both national and Community level, which are in force in the areas of employment conditions and safety at work apply during performance of a public contract, providing that such rules, and their application, comply with Community law. In cross-border situations, where workers from one Member State provide services in another Member State for the purpose of performing a public contract, Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (11) lays down the minimum conditions which must be observed by the host country in respect of such posted workers. If national law contains provisions to this effect, non-compliance with those obligations may be considered to be grave misconduct or an offence concerning the professional conduct of the economic operator concerned, liable to lead to the exclusion of that economic operator from the procedure for the award of a public contract. (35) In view of new developments in information and communications technology, and the simplifications these can bring in terms of publicising contracts and the efficiency and transparency of procurement processes, electronic means should be put on a par with traditional means of communication and information exchange. As far as possible, the means and technology chosen should be compatible with the technologies used in other Member States. (36) To ensure development of effective competition in the field of public contracts, it is necessary that contract notices drawn up by the contracting authorities of Member States be advertised throughout the Community. The information contained in these notices must enable economic operators in the Community to determine whether the proposed contracts are of interest to them. For this purpose, it is appropriate to give them adequate information on the object of the contract and the conditions attached thereto. Improved visibility should therefore be ensured for public notices by means of appropriate instruments, such as standard contract notice forms and the Common Procurement Vocabulary (CPV) provided for in Regulation (EC) No 2195/2002 of the European Parliament and of the Council (12) as the reference nomenclature for public contracts. In restricted procedures, advertisement is, more particularly, intended to enable contractors of Member States to express their interest in contracts by seeking from the contracting authorities invitations to tender under the required conditions. (37) Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (13) and Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the internal market (‘Directive on electronic commerce’) (14) should, in the context of this Directive, apply to the transmission of information by electronic means. The public procurement procedures and the rules applicable to service contests require a level of security and confidentiality higher than that required by these Directives. Accordingly, the devices for the electronic receipt of offers, requests to participate and plans and projects should comply with specific additional requirements. To this end, use of electronic signatures, in particular advanced electronic signatures, should, as far as possible, be encouraged. Moreover, the existence of voluntary accreditation schemes could constitute a favourable framework for enhancing the level of certification service provision for these devices. (38) The use of electronic means leads to savings in time. As a result, provision should be made for reducing the minimum periods where electronic means are used, subject, however, to the condition that they are compatible with the specific mode of transmission envisaged at Community level. (39) Verification of the suitability of tenderers, in open procedures, and of candidates, in restricted and negotiated procedures with publication of a contract notice and in the competitive dialogue, and the selection thereof, should be carried out in transparent conditions. For this purpose, non-discriminatory criteria should be indicated which the contracting authorities may use when selecting competitors and the means which economic operators may use to prove they have satisfied those criteria. In the same spirit of transparency, the contracting authority should be required, as soon as a contract is put out to competition, to indicate the selection criteria it will use and the level of specific competence it may or may not demand of the economic operators before admitting them to the procurement procedure. (40) A contracting authority may limit the number of candidates in the restricted and negotiated procedures with publication of a contract notice, and in the competitive dialogue. Such a reduction of candidates should be performed on the basis of objective criteria indicated in the contract notice. These objective criteria do not necessarily imply weightings. For criteria relating to the personal situation of economic operators, a general reference in the contract notice to the situations set out in Article 45 may suffice. (41) In the competitive dialogue and negotiated procedures with publication of a contract notice, in view of the flexibility which may be required and the high level of costs associated with such methods of procurement, contracting authorities should be entitled to make provision for the procedure to be conducted in successive stages in order gradually to reduce, on the basis of previously indicated contract award criteria, the number of tenders which they will go on to discuss or negotiate. This reduction should, insofar as the number of appropriate solutions or candidates allows, ensure that there is genuine competition. (42) The relevant Community rules on mutual recognition of diplomas, certificates or other evidence of formal qualifications apply when evidence of a particular qualification is required for participation in a procurement procedure or a design contest. (43) The award of public contracts to economic operators who have participated in a criminal organisation or who have been found guilty of corruption or of fraud to the detriment of the financial interests of the European Communities or of money laundering should be avoided. Where appropriate, the contracting authorities should ask candidates or tenderers to supply relevant documents and, where they have doubts concerning the personal situation of a candidate or tenderer, they may seek the cooperation of the competent authorities of the Member State concerned. The exclusion of such economic operators should take place as soon as the contracting authority has knowledge of a judgment concerning such offences rendered in accordance with national law that has the force of res judicata. If national law contains provisions to this effect, non-compliance with environmental legislation or legislation on unlawful agreements in public contracts which has been the subject of a final judgment or a decision having equivalent effect may be considered an offence concerning the professional conduct of the economic operator concerned or grave misconduct. Non-observance of national provisions implementing the Council Directives 2000/78/EC (15) and 76/207/EEC (16) concerning equal treatment of workers, which has been the subject of a final judgment or a decision having equivalent effect may be considered an offence concerning the professional conduct of the economic operator concerned or grave misconduct. (44) In appropriate cases, in which the nature of the works and/or services justifies applying environmental management measures or schemes during the performance of a public contract, the application of such measures or schemes may be required. Environmental management schemes, whether or not they are registered under Community instruments such as Regulation (EC) No 761/2001 (17) (EMAS), can demonstrate that the economic operator has the technical capability to perform the contract. Moreover, a description of the measures implemented by the economic operator to ensure the same level of environmental protection should be accepted as an alternative to environmental management registration schemes as a form of evidence. (45) This Directive allows Member States to establish official lists of contractors, suppliers or service providers or a system of certification by public or private bodies, and makes provision for the effects of such registration or such certification in a contract award procedure in another Member State. As regards official lists of approved economic operators, it is important to take into account Court of Justice case-law in cases where an economic operator belonging to a group claims the economic, financial or technical capabilities of other companies in the group in support of its application for registration. In this case, it is for the economic operator to prove that those resources will actually be available to it throughout the period of validity of the registration. For the purposes of that registration, a Member State may therefore determine the level of requirements to be met and in particular, for example where the operator lays claim to the financial standing of another company in the group, it may require that that company be held liable, if necessary jointly and severally. (46) Contracts should be awarded on the basis of objective criteria which ensure compliance with the principles of transparency, non-discrimination and equal treatment and which guarantee that tenders are assessed in conditions of effective competition. As a result, it is appropriate to allow the application of two award criteria only: ‘the lowest price’ and ‘the most economically advantageous tender’. To ensure compliance with the principle of equal treatment in the award of contracts, it is appropriate to lay down an obligation — established by case-law — to ensure the necessary transparency to enable all tenderers to be reasonably informed of the criteria and arrangements which will be applied to identify the most economically advantageous tender. It is therefore the responsibility of contracting authorities to indicate the criteria for the award of the contract and the relative weighting given to each of those criteria in sufficient time for tenderers to be aware of them when preparing their tenders. Contracting authorities may derogate from indicating the weighting of the criteria for the award in duly justified cases for which they must be able to give reasons, where the weighting cannot be established in advance, in particular on account of the complexity of the contract. In such cases, they must indicate the descending order of importance of the criteria. Where the contracting authorities choose to award a contract to the most economically advantageous tender, they shall assess the tenders in order to determine which one offers the best value for money. In order to do this, they shall determine the economic and quality criteria which, taken as a whole, must make it possible to determine the most economically advantageous tender for the contracting authority. The determination of these criteria depends on the object of the contract since they must allow the level of performance offered by each tender to be assessed in the light of the object of the contract, as defined in the technical specifications, and the value for money of each tender to be measured. In order to guarantee equal treatment, the criteria for the award of the contract should enable tenders to be compared and assessed objectively. If these conditions are fulfilled, economic and qualitative criteria for the award of the contract, such as meeting environmental requirements, may enable the contracting authority to meet the needs of the public concerned, as expressed in the specifications of the contract. Under the same conditions, a contracting authority may use criteria aiming to meet social requirements, in response in particular to the needs — defined in the specifications of the contract — of particularly disadvantaged groups of people to which those receiving/using the works, supplies or services which are the object of the contract belong. (47) In the case of public service contracts, the award criteria must not affect the application of national provisions on the remuneration of certain services, such as, for example, the services performed by architects, engineers or lawyers and, where public supply contracts are concerned, the application of national provisions setting out fixed prices for school books. (48) Certain technical conditions, and in particular those concerning notices and statistical reports, as well as the nomenclature used and the conditions of reference to that nomenclature, will need to be adopted and amended in the light of changing technical requirements. The lists of contracting authorities in the Annexes will also need to be updated. It is therefore appropriate to put in place a flexible and rapid adoption procedure for this purpose. (49) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (18). (50) It is appropriate that Council Regulation (EEC, Euratom) No 1182/71 of 3 June 1971 determining the rules applicable to periods, dates and time limits (19) should apply to the calculation of the time limits contained in this Directive. (51) This Directive should not prejudice the time limits set out in Annex XI, within which Member States are required to transpose and apply Directives 92/50/EEC, 93/36/EEC and 93/37/EEC, TABLE OF CONTENTS TITLE I Definitions and general principles Article 1 — Definitions Article 2 — Principles of awarding contracts Article 3 — Granting of special or exclusive rights: non-discrimination clause TITLE II Rules on public contracts CHAPTER I General provisions Article 4 — Economic operators Article 5 — Conditions relating to agreements concluded within the World Trade Organisation Article 6 — Confidentiality CHAPTER II Scope Section 1 — Thresholds Article 7 — Threshold amounts for public contracts Article 8 — Contracts subsidised by more than 50 % by contracting authorities Article 9 — Methods for calculating the estimated value of public contracts, framework agreements and dynamic purchasing systems Section 2 — Specific situations Article 10 — Defence procurement Article 11 — Public contracts and framework agreements awarded by central purchasing bodies Section 3 — Excluded contracts Article 12 — Contracts in the water, energy, transport and postal services sectors Article 13 — Specific exclusions in the field of telecommunications Article 14 — Secret contracts and contracts requiring special security measures Article 15 — Contracts awarded pursuant to international rules Article 16 — Specific exclusions Article 17 — Service concessions Article 18 — Service contracts awarded on the basis of an exclusive right Section 4 — Special arrangement Article 19 — Reserved contracts CHAPTER III Arrangements for public service contracts Article 20 — Service contracts listed in Annex II A Article 21 — Service contracts listed in Annex II B Article 22 — Mixed contracts including services listed in Annex II A and services listed in Annex II B CHAPTER IV Specific rules governing specifications and contract documents Article 23 — Technical specifications Article 24 — Variants Article 25 — Subcontracting Article 26 — Conditions for performance of contracts Article 27 — Obligations relating to taxes, environmental protection, employment protection provisions and working conditions CHAPTER V Procedures Article 28 — Use of open, restricted and negotiated procedures and of competitive dialogue Article 29 — Competitive dialogue Article 30 — Cases justifying use of the negotiated procedure with prior publication of a contract notice Article 31 — Cases justifying use of the negotiated procedure without publication of a contract notice Article 32 — Framework agreements Article 33 — Dynamic purchasing systems Article 34 — Public works contracts: particular rules on subsidised housing schemes CHAPTER VI Rules on advertising and transparency Section 1 — Publication of notices Article 35 — Notices Article 36 — Form and manner of publication of notices Article 37 — Non-mandatory publication Section 2 — Time limits Article 38 — Time limits for receipt of requests to participate and for receipt of tenders Article 39 — Open procedures: Specifications, additional documents and information Section 3 — Information content and means of transmission Article 40 — Invitations to submit a tender, participate in the dialogue or negotiate Article 41 — Informing candidates and tenderers Section 4 — Communication Article 42 — Rules applicable to communication Section 5 — Reports Article 43 — Content of reports CHAPTER VII Conduct of the procedure Section 1 — General provisions Article 44 — Verification of the suitability and choice of participants and award of contracts Section 2 — Criteria for qualitative selection Article 45 — Personal situation of the candidate or tenderer Article 46 — Suitability to pursue the professional activity Article 47 — Economic and financial standing Article 48 — Technical and/or professional ability Article 49 — Quality assurance standards Article 50 — Environmental management standards Article 51 — Additional documentation and information Article 52 — Official lists of approved economic operators and certification by bodies established under public or private law Section 3 — Award of the contract Article 53 — Contract award criteria Article 54 — Use of electronic auctions Article 55 — Abnormally low tenders TITLE III Rules on public works concessions CHAPTER I Rules governing public works concessions Article 56 — Scope Article 57 — Exclusions from the scope Article 58 — Publication of the notice concerning public works concessions Article 59 — Time limit Article 60 — Subcontracting Article 61 — Awarding of additional works to the concessionaire CHAPTER II Rules on contracts awarded by concessionaires which are contracting authorities Article 62 — Applicable rules CHAPTER III Rules applicable to contracts awarded by concessionaires which are not contracting authorities Article 63 — Advertising rules: threshold and exceptions Article 64 — Publication of the notice Article 65 — Time limit for the receipt of requests to participate and receipt of tenders TITLE IV Rules governing design contests Article 66 — General provisions Article 67 — Scope Article 68 — Exclusions from the scope Article 69 — Notices Article 70 — Form and manner of publication of notices of contests Article 71 — Means of communication Article 72 — Selection of competitors Article 73 — Composition of the jury Article 74 — Decisions of the jury TITLE V Statistical obligations, executory powers and final provisions Article 75 — Statistical obligations Article 76 — Content of statistical report Article 77 — Advisory Committee Article 78 — Revision of the thresholds Article 79 — Amendments Article 80 — Implementation Article 81 — Monitoring mechanisms Article 82 — Repeals Article 83 — Entry into force Article 84 — Addressees ANNEXES Annex I — List of the activities referred to in Article 1(2)(b) Annex II — Services referred to in Article 1(2)(d) Annex II A Annex II B Annex III — List of bodies and categories of bodies governed by public law referred to in the second subparagraph of Article 1(9) Annex IV — Central Government authorities Annex V — List of products referred to in Article 7 with regard to contracts awarded by contracting authorities in the field of defence Annex VI — Definition of certain technical specifications Annex VII — Information to be included in notices Annex VII A — Information to be included in public contract notices Annex VII B — Information which must appear in public works concession notices Annex VII C — Information which must appear in works contracts notices of concessionaires who are not contracting authorities Annex VII D — Information which must appear in design contest notices Annex VIII — Features concerning publication Annex IX — Registers Annex IX A — Public works contracts Annex IX B — Public supply contracts Annex IX C — Public service contracts Annex X — Requirements relating to equipment for the electronic receipt of tenders, requests to participate and plans and projects in design contests Annex XI — Deadlines for transportation and application (Article 80) Annex XII — Correlation table TITLE I DEFINITIONS AND GENERAL PRINCIPLES Article 1 Definitions 1. For the purposes of this Directive, the definitions set out in paragraphs 2 to 15 shall apply. 2. (a) ‘Public contracts’ are contracts for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of works, the supply of products or the provision of services within the meaning of this Directive. (b) ‘Public works contracts’ are public contracts having as their object either the execution, or both the design and execution, of works related to one of the activities within the meaning of Annex I or a work, or the realisation, by whatever means, of a work corresponding to the requirements specified by the contracting authority. A ‘work’ means the outcome of building or civil engineering works taken as a whole which is sufficient of itself to fulfil an economic or technical function. (c) ‘Public supply contracts’ are public contracts other than those referred to in (b) having as their object the purchase, lease, rental or hire purchase, with or without option to buy, of products. A public contract having as its object the supply of products and which also covers, as an incidental matter, siting and installation operations shall be considered to be a ‘public supply contract’. (d) ‘Public service contracts’ are public contracts other than public works or supply contracts having as their object the provision of services referred to in Annex II. A public contract having as its object both products and services within the meaning of Annex II shall be considered to be a ‘public service contract’ if the value of the services in question exceeds that of the products covered by the contract. A public contract having as its object services within the meaning of Annex II and including activities within the meaning of Annex I that are only incidental to the principal object of the contract shall be considered to be a public service contract. 3. ‘Public works concession’ is a contract of the same type as a public works contract except for the fact that the consideration for the works to be carried out consists either solely in the right to exploit the work or in this right together with payment. 4. ‘Service concession’ is a contract of the same type as a public service contract except for the fact that the consideration for the provision of services consists either solely in the right to exploit the service or in this right together with payment. 5. A ‘framework agreement’ is an agreement between one or more contracting authorities and one or more economic operators, the purpose of which is to establish the terms governing contracts to be awarded during a given period, in particular with regard to price and, where appropriate, the quantity envisaged. 6. A ‘dynamic purchasing system’ is a completely electronic process for making commonly used purchases, the characteristics of which, as generally available on the market, meet the requirements of the contracting authority, which is limited in duration and open throughout its validity to any economic operator which satisfies the selection criteria and has submitted an indicative tender that complies with the specification. 7. An ‘electronic auction’ is a repetitive process involving an electronic device for the presentation of new prices, revised downwards, and/or new values concerning certain elements of tenders, which occurs after an initial full evaluation of the tenders, enabling them to be ranked using automatic evaluation methods. Consequently, certain service contracts and certain works contracts having as their subject-matter intellectual performances, such as the design of works, may not be the object of electronic auctions. 8. The terms ‘contractor’, ‘supplier’ and ‘service provider’ mean any natural or legal person or public entity or group of such persons and/or bodies which offers on the market, respectively, the execution of works and/or a work, products or services. The term ‘economic operator’ shall cover equally the concepts of contractor, supplier and service provider. It is used merely in the interest of simplification. An economic operator who has submitted a tender shall be designated a ‘tenderer’. One which has sought an invitation to take part in a restricted or negotiated procedure or a competitive dialogue shall be designated a ‘candidate’. 9. ‘Contracting authorities’ means the State, regional or local authorities, bodies governed by public law, associations formed by one or several of such authorities or one or several of such bodies governed by public law. A ‘body governed by public law’ means any body: (a) established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character; (b) having legal personality; and (c) financed, for the most part, by the State, regional or local authorities, or other bodies governed by public law; or subject to management supervision by those bodies; or having an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law. Non-exhaustive lists of bodies and categories of bodies governed by public law which fulfil the criteria referred to in (a), (b) and (c) of the second subparagraph are set out in Annex III. Member States shall periodically notify the Commission of any changes to their lists of bodies and categories of bodies. 10. A ‘central purchasing body’ is a contracting authority which: — acquires supplies and/or services intended for contracting authorities, or — awards public contracts or concludes framework agreements for works, supplies or services intended for contracting authorities. 11. (a) ‘Open procedures’ means those procedures whereby any interested economic operator may submit a tender. (b) ‘Restricted procedures’ means those procedures in which any economic operator may request to participate and whereby only those economic operators invited by the contracting authority may submit a tender. (c) ‘Competitive dialogue’ is a procedure in which any economic operator may request to participate and whereby the contracting authority conducts a dialogue with the candidates admitted to that procedure, with the aim of developing one or more suitable alternatives capable of meeting its requirements, and on the basis of which the candidates chosen are invited to tender. For the purpose of recourse to the procedure mentioned in the first subparagraph, a public contract is considered to be ‘particularly complex’ where the contracting authorities: — are not objectively able to define the technical means in accordance with Article 23(3)(b), (c) or (d), capable of satisfying their needs or objectives, and/or — are not objectively able to specify the legal and/or financial make-up of a project. (d) ‘Negotiated procedures’ means those procedures whereby the contracting authorities consult the economic operators of their choice and negotiate the terms of contract with one or more of these. (e) ‘Design contests’ means those procedures which enable the contracting authority to acquire, mainly in the fields of town and country planning, architecture and engineering or data processing, a plan or design selected by a jury after being put out to competition with or without the award of prizes. 12. ‘Written’ or ‘in writing’ means any expression consisting of words or figures which can be read, reproduced and subsequently communicated. It may include information which is transmitted and stored by electronic means. 13. ‘Electronic means’ means using electronic equipment for the processing (including digital compression) and storage of data which is transmitted, conveyed and received by wire, by radio, by optical means or by other electromagnetic means. 14. The ‘Common Procurement Vocabulary (CPV)’ shall designate the reference nomenclature applicable to public contracts as adopted by Regulation (EC) No 2195/2002, while ensuring equivalence with the other existing nomenclatures. In the event of varying interpretations of the scope of this Directive, owing to possible differences between the CPV and NACE nomenclatures listed in Annex I, or between the CPV and CPC (provisional version) nomenclatures listed in Annex II, the NACE or the CPC nomenclature respectively shall take precedence. 15. For the purposes of Article 13, Article 57(a) and Article 68(b), the following phrases shall have the following meanings: (a) ‘public telecommunications network’ means the public telecommunications infrastructure which enables signals to be conveyed between defined network termination points by wire, by microwave, by optical means or by other electromagnetic means; (b) a ‘network termination point’ means all physical connections and their technical access specifications which form part of the public telecommunications network and are necessary for access to, and efficient communication through, that public network; (c) ‘public telecommunications services’ means telecommunications services the provision of which the Member States have specifically assigned, in particular, to one or more telecommunications entities; (d) ‘telecommunications services’ means services the provision of which consists wholly or partly in the transmission and routing of signals on the public telecommunications network by means of telecommunications processes, with the exception of broadcasting and television. Article 2 Principles of awarding contracts Contracting authorities shall treat economic operators equally and non-discriminatorily and shall act in a transparent way. Article 3 Granting of special or exclusive rights: non-discrimination clause Where a contracting authority grants special or exclusive rights to carry out a public service activity to an entity other than such a contracting authority, the act by which that right is granted shall provide that, in respect of the supply contracts which it awards to third parties as part of its activities, the entity concerned must comply with the principle of non-discrimination on the basis of nationality. TITLE II RULES ON PUBLIC CONTRACTS CHAPTER I General provisions Article 4 Economic operators 1. Candidates or tenderers who, under the law of the Member State in which they are established, are entitled to provide the relevant service, shall not be rejected solely on the ground that, under the law of the Member State in which the contract is awarded, they would be required to be either natural or legal persons. However, in the case of public service and public works contracts as well as public supply contracts covering in addition services and/or siting and installation operations, legal persons may be required to indicate in the tender or the request to participate, the names and relevant professional qualifications of the staff to be responsible for the performance of the contract in question. 2. Groups of economic operators may submit tenders or put themselves forward as candidates. In order to submit a tender or a request to participate, these groups may not be required by the contracting authorities to assume a specific legal form; however, the group selected may be required to do so when it has been awarded the contract, to the extent that this change is necessary for the satisfactory performance of the contract. Article 5 Conditions relating to agreements concluded within the World Trade Organisation For the purposes of the award of contracts by contracting authorities, Member States shall apply in their relations conditions as favourable as those which they grant to economic operators of third countries in implementation of the Agreement on Government Procurement (hereinafter referred to as ‘the Agreement’), concluded in the framework of the Uruguay Round multilateral negotiations. Member States shall, to this end, consult one another within the Advisory Committee for Public Contracts referred to in Article 77 on the measures to be taken pursuant to the Agreement. Article 6 Confidentiality Without prejudice to the provisions of this Directive, in particular those concerning the obligations relating to the advertising of awarded contracts and to the information to candidates and tenderers set out in Articles 35(4) and 41, and in accordance with the national law to which the contracting authority is subject, the contracting authority shall not disclose information forwarded to it by economic operators which they have designated as confidential; such information includes, in particular, technical or trade secrets and the confidential aspects of tenders. CHAPTER II Scope Section 1 Thresholds Article 7 Threshold amounts for public contracts This Directive shall apply to public contracts which are not excluded in accordance with the exceptions provided for in Articles 10 and 11 and Articles 12 to 18 and which have a value exclusive of value-added tax (VAT) estimated to be equal to or greater than the following thresholds: (a) EUR 162 000 for public supply and service contracts others than those covered by point (b), third indent, awarded by contracting authorities which are listed as central government authorities in Annex IV; in the case of public supply contracts awarded by contracting authorities operating in the field of defence, this shall apply only to contracts involving products covered by Annex V; (b) EUR 249 000 — for public supply and service contracts awarded by contracting authorities other than those listed in Annex IV, — for public supply contracts awarded by contracting authorities which are listed in Annex IV and operate in the field of defence, where these contracts involve products not covered by Annex V, — for public service contracts awarded by any contracting authority in respect of the services listed in Category 8 of Annex IIA, Category 5 telecommunications services the positions of which in the CPV are equivalent to CPC reference Nos 7524, 7525 and 7526 and/or the services listed in Annex II B; (c) EUR 6 242 000 for public works contracts. Article 8 Contracts subsidised by more than 50 % by contracting authorities This Directive shall apply to the awarding of: (a) contracts which are subsidised directly by contracting authorities by more than 50 % and the estimated value of which, net of VAT, is equal to or greater than EUR 6 242 000, — where those contracts involve civil engineering activities within the meaning of Annex I, — where those contracts involve building work for hospitals, facilities intended for sports, recreation and leisure, school and university buildings and buildings used for administrative purposes; (b) service contracts which are subsidised directly by contracting authorities by more than 50 % and the estimated value of which, net of VAT, is equal to or greater than EUR 249 000 and which are connected with a works contract within the meaning of point (a). Member States shall take the necessary measures to ensure that the contracting authorities awarding such subsidies ensure compliance with this Directive where that contract is awarded by one or more entities other than themselves or comply with this Directive where they themselves award that contract for and on behalf of those other entities. Article 9 Methods for calculating the estimated value of public contracts, framework agreements and dynamic purchasing systems 1. The calculation of the estimated value of a public contract shall be based on the total amount payable, net of VAT, as estimated by the contracting authority. This calculation shall take account of the estimated total amount, including any form of option and any renewals of the contract. Where the contracting authority provides for prizes or payments to candidates or tenderers it shall take them into account when calculating the estimated value of the contract. 2. This estimate must be valid at the moment at which the contract notice is sent, as provided for in Article 35(2), or, in cases where such notice is not required, at the moment at which the contracting authority commences the contract awarding procedure. 3. No works project or proposed purchase of a certain quantity of supplies and/or services may be subdivided to prevent its coming within the scope of this Directive. 4. With regard to public works contracts, calculation of the estimated value shall take account of both the cost of the works and the total estimated value of the supplies necessary for executing the works and placed at the contractor's disposal by the contracting authorities. 5. (a) Where a proposed work or purchase of services may result in contracts being awarded at the same time in the form of separate lots, account shall be taken of the total estimated value of all such lots. Where the aggregate value of the lots is equal to or exceeds the threshold laid down in Article 7, this Directive shall apply to the awarding of each lot. However, the contracting authorities may waive such application in respect of lots the estimated value of which net of VAT is less than EUR 80 000 for services or EUR 1 million for works, provided that the aggregate value of those lots does not exceed 20 % of the aggregate value of the lots as a whole. (b) Where a proposal for the acquisition of similar supplies may result in contracts being awarded at the same time in the form of separate lots, account shall be taken of the total estimated value of all such lots when applying Article 7(a) and (b). Where the aggregate value of the lots is equal to or exceeds the threshold laid down in Article 7, this Directive shall apply to the awarding of each lot. However, the contracting authorities may waive such application in respect of lots, the estimated value of which, net of VAT, is less than EUR 80 000, provided that the aggregate cost of those lots does not exceed 20 % of the aggregate value of the lots as a whole. 6. With regard to public supply contracts relating to the leasing, hire, rental or hire purchase of products, the value to be taken as a basis for calculating the estimated contract value shall be as follows: (a) in the case of fixed-term public contracts, if that term is less than or equal to 12 months, the total estimated value for the term of the contract or, if the term of the contract is greater than 12 months, the total value including the estimated residual value; (b) in the case of public contracts without a fixed term or the term of which cannot be defined, the monthly value multiplied by 48. 7. In the case of public supply or service contracts which are regular in nature or which are intended to be renewed within a given period, the calculation of the estimated contract value shall be based on the following: (a) either the total actual value of the successive contracts of the same type awarded during the preceding 12 months or financial year adjusted, if possible, to take account of the changes in quantity or value which would occur in the course of the 12 months following the initial contract; (b) or the total estimated value of the successive contracts awarded during the 12 months following the first delivery, or during the financial year if that is longer than 12 months. The choice of method used to calculate the estimated value of a public contract may not be made with the intention of excluding it from the scope of this Directive. 8. With regard to public service contracts, the value to be taken as a basis for calculating the estimated contract value shall, where appropriate, be the following: (a) for the following types of services: (i) insurance services: the premium payable and other forms of remuneration; (ii) banking and other financial services: the fees, commissions, interest and other forms of remuneration; (iii) design contracts: fees, commission payable and other forms of remuneration; (b) for service contracts which do not indicate a total price: (i) in the case of fixed-term contracts, if that term is less than or equal to 48 months: the total value for their full term; (ii) in the case of contracts without a fixed term or with a term greater than 48 months: the monthly value multiplied by 48. 9. With regard to framework agreements and dynamic purchasing systems, the value to be taken into consideration shall be the maximum estimated value net of VAT of all the contracts envisaged for the total term of the framework agreement or the dynamic purchasing system. Section 2 Specific situations Article 10 Defence procurement This Directive shall apply to public contracts awarded by contracting authorities in the field of defence, subject to Article 296 of the Treaty. Article 11 Public contracts and framework agreements awarded by central purchasing bodies 1. Member States may stipulate that contracting authorities may purchase works, supplies and/or services from or through a central purchasing body. 2. Contracting authorities which purchase works, supplies and/or services from or through a central purchasing body in the cases set out in Article 1(10) shall be deemed to have complied with this Directive insofar as the central purchasing body has complied with it. Section 3 Excluded contracts Article 12 Contracts in the water, energy, transport and postal services sectors This Directive shall not apply to public contracts which, under Directive 2004/17/EC, are awarded by contracting authorities exercising one or more of the activities referred to in Articles 3 to 7 of that Directive and are awarded for the pursuit of those activities, or to public contracts excluded from the scope of that Directive under Article 5(2) and Articles 19, 26 and 30 thereof. However, this Directive shall continue to apply to public contracts awarded by contracting authorities carrying out one or more of the activities referred to in Article 6 of Directive 2004/17/EC and awarded for those activities, insofar as the Member State concerned takes advantage of the option referred to in the second subparagraph of Article 71 thereof to defer its application. Article 13 Specific exclusions in the field of telecommunications This Directive shall not apply to public contracts for the principal purpose of permitting the contracting authorities to provide or exploit public telecommunications networks or to provide to the public one or more telecommunications services. Article 14 Secret contracts and contracts requiring special security measures This Directive shall not apply to public contracts when they are declared to be secret, when their performance must be accompanied by special security measures in accordance with the laws, regulations or administrative provisions in force in the Member State concerned, or when the protection of the essential interests of that Member State so requires. Article 15 Contracts awarded pursuant to international rules This Directive shall not apply to public contracts governed by different procedural rules and awarded: (a) pursuant to an international agreement concluded in conformity with the Treaty between a Member State and one or more third countries and covering supplies or works intended for the joint implementation or exploitation of a work by the signatory States or services intended for the joint implementation or exploitation of a project by the signatory States; all agreements shall be communicated to the Commission, which may consult the Advisory Committee for Public Contracts referred to in Article 77; (b) pursuant to a concluded international agreement relating to the stationing of troops and concerning the undertakings of a Member State or a third country; (c) pursuant to the particular procedure of an international organisation. Article 16 Specific exclusions This Directive shall not apply to public service contracts for: (a) the acquisition or rental, by whatever financial means, of land, existing buildings or other immovable property or concerning rights thereon; nevertheless, financial service contracts concluded at the same time as, before or after the contract of acquisition or rental, in whatever form, shall be subject to this Directive; (b) the acquisition, development, production or co-production of programme material intended for broadcasting by broadcasters and contracts for broadcasting time; (c) arbitration and conciliation services; (d) financial services in connection with the issue, sale, purchase or transfer of securities or other financial instruments, in particular transactions by the contracting authorities to raise money or capital, and central bank services; (e) employment contracts; (f) research and development services other than those where the benefits accrue exclusively to the contracting authority for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting authority. Article 17 Service concessions Without prejudice to the application of Article 3, this Directive shall not apply to service concessions as defined in Article 1(4). Article 18 Service contracts awarded on the basis of an exclusive right This Directive shall not apply to public service contracts awarded by a contracting authority to another contracting authority or to an association of contracting authorities on the basis of an exclusive right which they enjoy pursuant to a published law, regulation or administrative provision which is compatible with the Treaty. Section 4 Special arrangement Article 19 Reserved contracts Member States may reserve the right to participate in public contract award procedures to sheltered workshops or provide for such contracts to be performed in the context of sheltered employment programmes where most of the employees concerned are handicapped persons who, by reason of the nature or the seriousness of their disabilities, cannot carry on occupations under normal conditions. The contract notice shall make reference to this provision. CHAPTER III Arrangements for public service contracts Article 20 Service contracts listed in Annex II A Contracts which have as their object services listed in Annex II A shall be awarded in accordance with Articles 23 to 55. Article 21 Service contracts listed in Annex II B Contracts which have as their object services listed in Annex II B shall be subject solely to Article 23 and Article 35(4). Article 22 Mixed contracts including services listed in Annex II A and services listed in Annex II B Contracts which have as their object services listed both in Annex II A and in Annex II B shall be awarded in accordance with Articles 23 to 55 where the value of the services listed in Annex II A is greater than the value of the services listed in Annex II B. In other cases, contracts shall be awarded in accordance with Article 23 and Article 35(4). CHAPTER IV Specific rules governing specifications and contract documents Article 23 Technical specifications 1. The technical specifications as defined in point 1 of Annex VI shall be set out in the contract documentation, such as contract notices, contract documents or additional documents. Whenever possible these technical specifications should be defined so as to take into account accessibility criteria for people with disabilities or design for all users. 2. Technical specifications shall afford equal access for tenderers and not have the effect of creating unjustified obstacles to the opening up of public procurement to competition. 3. Without prejudice to mandatory national technical rules, to the extent that they are compatible with Community law, the technical specifications shall be formulated: (a) either by reference to technical specifications defined in Annex VI and, in order of preference, to national standards transposing European standards, European technical approvals, common technical specifications, international standards, other technical reference systems established by the European standardisation bodies or — when these do not exist — to national standards, national technical approvals or national technical specifications relating to the design, calculation and execution of the works and use of the products. Each reference shall be accompanied by the words ‘or equivalent’; (b) or in terms of performance or functional requirements; the latter may include environmental characteristics. However, such parameters must be sufficiently precise to allow tenderers to determine the subject-matter of the contract and to allow contracting authorities to award the contract; (c) or in terms of performance or functional requirements as mentioned in subparagraph (b), with reference to the specifications mentioned in subparagraph (a) as a means of presuming conformity with such performance or functional requirements; (d) or by referring to the specifications mentioned in subparagraph (a) for certain characteristics, and by referring to the performance or functional requirements mentioned in subparagraph (b) for other characteristics. 4. Where a contracting authority makes use of the option of referring to the specifications mentioned in paragraph 3(a), it cannot reject a tender on the grounds that the products and services tendered for do not comply with the specifications to which it has referred, once the tenderer proves in his tender to the satisfaction of the contracting authority, by whatever appropriate means, that the solutions which he proposes satisfy in an equivalent manner the requirements defined by the technical specifications. An appropriate means might be constituted by a technical dossier of the manufacturer or a test report from a recognised body. 5. Where a contracting authority uses the option laid down in paragraph 3 to prescribe in terms of performance or functional requirements, it may not reject a tender for works, products or services which comply with a national standard transposing a European standard, with a European technical approval, a common technical specification, an international standard or a technical reference system established by a European standardisation body, if these specifications address the performance or functional requirements which it has laid down. In his tender, the tenderer must prove to the satisfaction of the contracting authority and by any appropriate means that the work, product or service in compliance with the standard meets the performance or functional requirements of the contracting authority. An appropriate means might be constituted by a technical dossier of the manufacturer or a test report from a recognised body. 6. Where contracting authorities lay down environmental characteristics in terms of performance or functional requirements as referred to in paragraph 3(b) they may use the detailed specifications, or, if necessary, parts thereof, as defined by European or (multi-) national eco-labels, or by and any other eco-label, provided that: — those specifications are appropriate to define the characteristics of the supplies or services that are the object of the contract, — the requirements for the label are drawn up on the basis of scientific information, — the eco-labels are adopted using a procedure in which all stakeholders, such as government bodies, consumers, manufacturers, distributors and environmental organisations can participate, and — they are accessible to all interested parties. Contracting authorities may indicate that the products and services bearing the eco-label are presumed to comply with the technical specifications laid down in the contract documents; they must accept any other appropriate means of proof, such as a technical dossier of the manufacturer or a test report from a recognised body. 7. ‘Recognised bodies’, within the meaning of this Article, are test and calibration laboratories and certification and inspection bodies which comply with applicable European standards. Contracting authorities shall accept certificates from recognised bodies established in other Member States. 8. Unless justified by the subject-matter of the contract, technical specifications shall not refer to a specific make or source, or a particular process, or to trade marks, patents, types or a specific origin or production with the effect of favouring or eliminating certain undertakings or certain products. Such reference shall be permitted on an exceptional basis, where a sufficiently precise and intelligible description of the subject-matter of the contract pursuant to paragraphs 3 and 4 is not possible; such reference shall be accompanied by the words ‘or equivalent’. Article 24 Variants 1. Where the criterion for award is that of the most economically advantageous tender, contracting authorities may authorise tenderers to submit variants. 2. Contracting authorities shall indicate in the contract notice whether or not they authorise variants: variants shall not be authorised without this indication. 3. Contracting authorities authorising variants shall state in the contract documents the minimum requirements to be met by the variants and any specific requirements for their presentation. 4. Only variants meeting the minimum requirements laid down by these contracting authorities shall be taken into consideration. In procedures for awarding public supply or service contracts, contracting authorities which have authorised variants may not reject a variant on the sole ground that it would, if successful, lead to either a service contract rather than a public supply contract or a supply contract rather than a public service contract. Article 25 Subcontracting In the contract documents, the contracting authority may ask or may be required by a Member State to ask the tenderer to indicate in his tender any share of the contract he may intend to subcontract to third parties and any proposed subcontractors. This indication shall be without prejudice to the question of the principal economic operator's liability. Article 26 Conditions for performance of contracts Contracting authorities may lay down special conditions relating to the performance of a contract, provided that these are compatible with Community law and are indicated in the contract notice or in the specifications. The conditions governing the performance of a contract may, in particular, concern social and environmental considerations. Article 27 Obligations relating to taxes, environmental protection, employment protection provisions and working conditions 1. A contracting authority may state in the contract documents, or be obliged by a Member State so to state, the body or bodies from which a candidate or tenderer may obtain the appropriate information on the obligations relating to taxes, to environmental protection, to the employment protection provisions and to the working conditions which are in force in the Member State, region or locality in which the works are to be carried out or services are to be provided and which shall be applicable to the works carried out on site or to the services provided during the performance of the contract. 2. A contracting authority which supplies the information referred to in paragraph 1 shall request the tenderers or candidates in the contract award procedure to indicate that they have taken account, when drawing up their tender, of the obligations relating to employment protection provisions and the working conditions which are in force in the place where the works are to be carried out or the service is to be provided. The first subparagraph shall be without prejudice to the application of the provisions of Article 55 concerning the examination of abnormally low tenders. CHAPTER V Procedures Article 28 Use of open, restricted and negotiated procedures and of competitive dialogue In awarding their public contracts, contracting authorities shall apply the national procedures adjusted for the purposes of this Directive. They shall award these public contracts by applying the open or restricted procedure. In the specific circumstances expressly provided for in Article 29, contracting authorities may award their public contracts by means of the competitive dialogue. In the specific cases and circumstances referred to expressly in Articles 30 and 31, they may apply a negotiated procedure, with or without publication of the contract notice. Article 29 Competitive dialogue 1. In the case of particularly complex contracts, Member States may provide that where contracting authorities consider that the use of the open or restricted procedure will not allow the award of the contract, the latter may make use of the competitive dialogue in accordance with this Article. A public contract shall be awarded on the sole basis of the award criterion for the most economically advantageous tender. 2. Contracting authorities shall publish a contract notice setting out their needs and requirements, which they shall define in that notice and/or in a descriptive document. 3. Contracting authorities shall open, with the candidates selected in accordance with the relevant provisions of Articles 44 to 52, a dialogue the aim of which shall be to identify and define the means best suited to satisfying their needs. They may discuss all aspects of the contract with the chosen candidates during this dialogue. During the dialogue, contracting authorities shall ensure equality of treatment among all tenderers. In particular, they shall not provide information in a discriminatory manner which may give some tenderers an advantage over others. Contracting authorities may not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without his/her agreement. 4. Contracting authorities may provide for the procedure to take place in successive stages in order to reduce the number of solutions to be discussed during the dialogue stage by applying the award criteria in the contract notice or the descriptive document. The contract notice or the descriptive document shall indicate that recourse may be had to this option. 5. The contracting authority shall continue such dialogue until it can identify the solution or solutions, if necessary after comparing them, which are capable of meeting its needs. 6. Having declared that the dialogue is concluded and having so informed the participants, contracting authorities shall ask them to submit their final tenders on the basis of the solution or solutions presented and specified during the dialogue. These tenders shall contain all the elements required and necessary for the performance of the project. These tenders may be clarified, specified and fine-tuned at the request of the contracting authority. However, such clarification, specification, fine-tuning or additional information may not involve changes to the basic features of the tender or the call for tender, variations in which are likely to distort competition or have a discriminatory effect. 7. Contracting authorities shall assess the tenders received on the basis of the award criteria laid down in the contract notice or the descriptive document and shall choose the most economically advantageous tender in accordance with Article 53. At the request of the contracting authority, the tenderer identified as having submitted the most economically advantageous tender may be asked to clarify aspects of the tender or confirm commitments contained in the tender provided this does not have the effect of modifying substantial aspects of the tender or of the call for tender and does not risk distorting competition or causing discrimination. 8. The contracting authorities may specify prices or payments to the participants in the dialogue. Article 30 Cases justifying use of the negotiated procedure with prior publication of a contract notice 1. Contracting authorities may award their public contracts by negotiated procedure, after publication of a contract notice, in the following cases: (a) in the event of irregular tenders or the submission of tenders which are unacceptable under national provisions compatible with Articles 4, 24, 25, 27 and Chapter VII, in response to an open or restricted procedure or a competitive dialogue insofar as the original terms of the contract are not substantially altered. Contracting authorities need not publish a contract notice where they include in the negotiated procedure all of, and only, the tenderers which satisfy the criteria of Articles 45 to 52 and which, during the prior open or restricted procedure or competitive dialogue, have submitted tenders in accordance with the formal requirements of the tendering procedure; (b) in exceptional cases, when the nature of the works, supplies, or services or the risks attaching thereto do not permit prior overall pricing; (c) in the case of services, inter alia services within category 6 of Annex II A, and intellectual services such as services involving the design of works, insofar as the nature of the services to be provided is such that contract specifications cannot be established with sufficient precision to permit the award of the contract by selection of the best tender according to the rules governing open or restricted procedures; (d) in respect of public works contracts, for works which are performed solely for purposes of research, testing or development and not with the aim of ensuring profitability or recovering research and development costs. 2. In the cases referred to in paragraph 1, contracting authorities shall negotiate with tenderers the tenders submitted by them in order to adapt them to the requirements which they have set in the contract notice, the specifications and additional documents, if any, and to seek out the best tender in accordance with Article 53(1). 3. During the negotiations, contracting authorities shall ensure the equal treatment of all tenderers. In particular, they shall not provide information in a discriminatory manner which may give some tenderers an advantage over others. 4. Contracting authorities may provide for the negotiated procedure to take place in successive stages in order to reduce the number of tenders to be negotiated by applying the award criteria in the contract notice or the specifications. The contract notice or the specifications shall indicate whether recourse has been had to this option. Article 31 Cases justifying use of the negotiated procedure without publication of a contract notice Contracting authorities may award public contracts by a negotiated procedure without prior publication of a contract notice in the following cases: (1) for public works contracts, public supply contracts and public service contracts: (a) when no tenders or no suitable tenders or no applications have been submitted in response to an open procedure or a restricted procedure, provided that the initial conditions of contract are not substantially altered and on condition that a report is sent to the Commission if it so requests; (b) when, for technical or artistic reasons, or for reasons connected with the protection of exclusive rights, the contract may be awarded only to a particular economic operator; (c) insofar as is strictly necessary when, for reasons of extreme urgency brought about by events unforeseeable by the contracting authorities in question, the time limit for the open, restricted or negotiated procedures with publication of a contract notice as referred to in Article 30 cannot be complied with. The circumstances invoked to justify extreme urgency must not in any event be attributable to the contracting authority; (2) for public supply contracts: (a) when the products involved are manufactured purely for the purpose of research, experimentation, study or development; this provision does not extend to quantity production to establish commercial viability or to recover research and development costs; (b) for additional deliveries by the original supplier which are intended either as a partial replacement of normal supplies or installations or as the extension of existing supplies or installations where a change of supplier would oblige the contracting authority to acquire material having different technical characteristics which would result in incompatibility or disproportionate technical difficulties in operation and maintenance; the length of such contracts as well as that of recurrent contracts may not, as a general rule, exceed three years; (c) for supplies quoted and purchased on a commodity market; (d) for the purchase of supplies on particularly advantageous terms, from either a supplier which is definitively winding up its business activities, or the receivers or liquidators of a bankruptcy, an arrangement with creditors, or a similar procedure under national laws or regulations; (3) for public service contracts, when the contract concerned follows a design contest and must, under the applicable rules, be awarded to the successful candidate or to one of the successful candidates, in the latter case, all successful candidates must be invited to participate in the negotiations; (4) for public works contracts and public service contracts: (a) for additional works or services not included in the project initially considered or in the original contract but which have, through unforeseen circumstances, become necessary for the performance of the works or services described therein, on condition that the award is made to the economic operator performing such works or services: — when such additional works or services cannot be technically or economically separated from the original contract without major inconvenience to the contracting authorities, or — when such works or services, although separable from the performance of the original contract, are strictly necessary for its completion. However, the aggregate value of contracts awarded for additional works or services may not exceed 50 % of the amount of the original contract; (b) for new works or services consisting in the repetition of similar works or services entrusted to the economic operator to whom the same contracting authorities awarded an original contract, provided that such works or services are in conformity with a basic project for which the original contract was awarded according to the open or restricted procedure. As soon as the first project is put up for tender, the possible use of this procedure shall be disclosed and the total estimated cost of subsequent works or services shall be taken into consideration by the contracting authorities when they apply the provisions of Article 7. This procedure may be used only during the three years following the conclusion of the original contract. Article 32 Framework agreements 1. Member States may provide that contracting authorities may conclude framework agreements. 2. For the purpose of concluding a framework agreement, contracting authorities shall follow the rules of procedure referred to in this Directive for all phases up to the award of contracts based on that framework agreement. The parties to the framework agreement shall be chosen by applying the award criteria set in accordance with Article 53. Contracts based on a framework agreement shall be awarded in accordance with the procedures laid down in paragraphs 3 and 4. Those procedures may be applied only between the contracting authorities and the economic operators originally party to the framework agreement. When awarding contracts based on a framework agreement, the parties may under no circumstances make substantial amendments to the terms laid down in that framework agreement, in particular in the case referred to in paragraph 3. The term of a framework agreement may not exceed four years, save in exceptional cases duly justified, in particular by the subject of the framework agreement. Contracting authorities may not use framework agreements improperly or in such a way as to prevent, restrict or distort competition. 3. Where a framework agreement is concluded with a single economic operator, contracts based on that agreement shall be awarded within the limits of the terms laid down in the framework agreement. For the award of those contracts, contracting authorities may consult the operator party to the framework agreement in writing, requesting it to supplement its tender as necessary. 4. Where a framework agreement is concluded with several economic operators, the latter must be at least three in number, insofar as there is a sufficient number of economic operators to satisfy the selection criteria and/or of admissible tenders which meet the award criteria. Contracts based on framework agreements concluded with several economic operators may be awarded either: — by application of the terms laid down in the framework agreement without reopening competition, or — where not all the terms are laid down in the framework agreement, when the parties are again in competition on the basis of the same and, if necessary, more precisely formulated terms, and, where appropriate, other terms referred to in the specifications of the framework agreement, in accordance with the following procedure: (a) for every contract to be awarded, contracting authorities shall consult in writing the economic operators capable of performing the contract; (b) contracting authorities shall fix a time limit which is sufficiently long to allow tenders for each specific contract to be submitted, taking into account factors such as the complexity of the subject-matter of the contract and the time needed to send in tenders; (c) tenders shall be submitted in writing, and their content shall remain confidential until the stipulated time limit for reply has expired; (d) contracting authorities shall award each contract to the tenderer who has submitted the best tender on the basis of the award criteria set out in the specifications of the framework agreement. Article 33 Dynamic purchasing systems 1. Member States may provide that contracting authorities may use dynamic purchasing systems. 2. In order to set up a dynamic purchasing system, contracting authorities shall follow the rules of the open procedure in all its phases up to the award of the contracts to be concluded under this system. All the tenderers satisfying the selection criteria and having submitted an indicative tender which complies with the specification and any possible additional documents shall be admitted to the system; indicative tenders may be improved at any time provided that they continue to comply with the specification. With a view to setting up the system and to the award of contracts under that system, contracting authorities shall use solely electronic means in accordance with Article 42(2) to (5). 3. For the purposes of setting up the dynamic purchasing system, contracting authorities shall: (a) publish a contract notice making it clear that a dynamic purchasing system is involved; (b) indicate in the specification, amongst other matters, the nature of the purchases envisaged under that system, as well as all the necessary information concerning the purchasing system, the electronic equipment used and the technical connection arrangements and specifications; (c) offer by electronic means, on publication of the notice and up to the expiry of the system, unrestricted, direct and full access to the specification and to any additional documents and shall indicate in the notice the internet address at which such documents may be consulted. 4. Contracting authorities shall give any economic operator, throughout the entire period of the dynamic purchasing system, the possibility of submitting an indicative tender and of being admitted to the system under the conditions referred to in paragraph 2. They shall complete evaluation within a maximum of 15 days from the date of submission of the indicative tender. However, they may extend the evaluation period provided that no invitation to tender is issued in the meantime. The contracting authority shall inform the tenderer referred to in the first subparagraph at the earliest possible opportunity of its admittance to the dynamic purchasing system or of the rejection of its indicative tender. 5. Each specific contract must be the subject of an invitation to tender. Before issuing the invitation to tender, contracting authorities shall publish a simplified contract notice inviting all interested economic operators to submit an indicative tender, in accordance with paragraph 4, within a time limit that may not be less than 15 days from the date on which the simplified notice was sent. Contracting authorities may not proceed with tendering until they have completed evaluation of all the indicative tenders received by that deadline. 6. Contracting authorities shall invite all tenderers admitted to the system to submit a tender for each specific contract to be awarded under the system. To that end they shall set a time limit for the submission of tenders. They shall award the contract to the tenderer which submitted the best tender on the basis of the award criteria set out in the contract notice for the establishment of the dynamic purchasing system. Those criteria may, if appropriate, be formulated more precisely in the invitation referred to in the first subparagraph. 7. A dynamic purchasing system may not last for more than four years, except in duly justified exceptional cases. Contracting authorities may not resort to this system to prevent, restrict or distort competition. No charges may be billed to the interested economic operators or to parties to the system. Article 34 Public works contracts: particular rules on subsidised housing schemes In the case of public contracts relating to the design and construction of a subsidised housing scheme the size and complexity of which, and the estimated duration of the work involved require that planning be based from the outset on close collaboration within a team comprising representatives of the contracting authorities, experts and the contractor to be responsible for carrying out the works, a special award procedure may be adopted for selecting the contractor most suitable for integration into the team. In particular, contracting authorities shall include in the contract notice as accurate as possible a description of the works to be carried out so as to enable interested contractors to form a valid idea of the project. Furthermore, contracting authorities shall, in accordance with the qualitative selection criteria referred to in Articles 45 to 52, set out in such a contract notice the personal, technical, economic and financial conditions to be fulfilled by candidates. Where such a procedure is adopted, contracting authorities shall apply Articles 2, 35, 36, 38, 39, 41, 42, 43 and 45 to 52. CHAPTER VI Rules on advertising and transparency Section 1 Publication of notices Article 35 Notices 1. Contracting authorities shall make known, by means of a prior information notice published by the Commission or by themselves on their ‘buyer profile’, as described in point 2(b) of Annex VIII: (a) where supplies are concerned, the estimated total value of the contracts or the framework agreements by product area which they intend to award over the following 12 months, where the total estimated value, taking into account Articles 7 and 9, is equal to or greater than EUR 750 000. The product area shall be established by the contracting authorities by reference to the CPV nomenclature; (b) where services are concerned, the estimated total value of the contracts or the framework agreements in each of the categories of services listed in Annex II A which they intend to award over the following 12 months, where such estimated total value, taking into account the provisions of Articles 7 and 9, is equal to or greater than EUR 750 000; (c) where works are concerned, the essential characteristics of the contracts or the framework agreements which they intend to award, the estimated value of which is equal to or greater than the threshold specified in Article 7, taking into account Article 9. The notices referred to in subparagraphs (a) and (b) shall be sent to the Commission or published on the buyer profile as soon as possible after the beginning of the budgetary year. The notice referred to in subparagraph (c) shall be sent to the Commission or published on the buyer profile as soon as possible after the decision approving the planning of the works contracts or the framework agreements that the contracting authorities intend to award. Contracting authorities who publish a prior information notice on their buyer profiles shall send the Commission, electronically, a notice of the publication of the prior information notice on a buyer profile, in accordance with the format and detailed procedures for sending notices indicated in point 3 of Annex VIII. Publication of the notices referred to in subparagraphs (a), (b) and (c) shall be compulsory only where the contracting authorities take the option of shortening the time limits for the receipt of tenders as laid down in Article 38(4). This paragraph shall not apply to negotiated procedures without the prior publication of a contract notice. 2. Contracting authorities which wish to award a public contract or a framework agreement by open, restricted or, under the conditions laid down in Article 30, negotiated procedure with the publication of a contract notice or, under the conditions laid down in Article 29, a competitive dialogue, shall make known their intention by means of a contract notice. 3. Contracting authorities which wish to set up a dynamic purchasing system shall make known their intention by means of a contract notice. Contracting authorities which wish to award a contract based on a dynamic purchasing system shall make known their intention by means of a simplified contract notice. 4. Contracting authorities which have awarded a public contract or concluded a framework agreement shall send a notice of the results of the award procedure no later than 48 days after the award of the contract or the conclusion of the framework agreement. In the case of framework agreements concluded in accordance with Article 32 the contracting authorities are not bound to send a notice of the results of the award procedure for each contract based on that agreement. Contracting authorities shall send a notice of the result of the award of contracts based on a dynamic purchasing system within 48 days of the award of each contract. They may, however, group such notices on a quarterly basis. In that case, they shall send the grouped notices within 48 days of the end of each quarter. In the case of public contracts for services listed in Annex II B, the contracting authorities shall indicate in the notice whether they agree to its publication. For such services contracts the Commission shall draw up the rules for establishing statistical reports on the basis of such notices and for the publication of such reports in accordance with the procedure laid down in Article 77(2). Certain information on the contract award or the conclusion of the framework agreement may be withheld from publication where release of such information would impede law enforcement or otherwise be contrary to the public interest, would harm the legitimate commercial interests of economic operators, public or private, or might prejudice fair competition between them. Article 36 Form and manner of publication of notices 1. Notices shall include the information mentioned in Annex VII A and, where appropriate, any other information deemed useful by the contracting authority in the format of standard forms adopted by the Commission in accordance with the procedure referred to in Article 77(2). 2. Notices sent by contracting authorities to the Commission shall be sent either by electronic means in accordance with the format and procedures for transmission indicated in Annex VIII, paragraph 3, or by other means. In the event of recourse to the accelerated procedure set out in Article 38(8), notices must be sent either by telefax or by electronic means, in accordance with the format and procedures for transmission indicated in point 3 of Annex VIII. Notices shall be published in accordance with the technical characteristics for publication set out in point 1(a) and (b) of Annex VIII. 3. Notices drawn up and transmitted by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex VIII, shall be published no later than five days after they are sent. Notices which are not transmitted by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex VIII, shall be published not later than 12 days after they are sent, or in the case of accelerated procedure referred to in Article 38(8), not later than five days after they are sent. 4. Contract notices shall be published in full in an official language of the Community as chosen by the contracting authority, this original language version constituting the sole authentic text. A summary of the important elements of each notice shall be published in the other official languages. The costs of publication of such notices by the Commission shall be borne by the Community. 5. Notices and their contents may not be published at national level before the date on which they are sent to the Commission. Notices published at national level shall not contain information other than that contained in the notices dispatched to the Commission or published on a buyer profile in accordance with the first subparagraph of Article 35(1), but shall mention the date of dispatch of the notice to the Commission or its publication on the buyer profile. Prior information notices may not be published on a buyer profile before the dispatch to the Commission of the notice of their publication in that form; they shall mention the date of that dispatch. 6. The content of notices not sent by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex VIII, shall be limited to approximately 650 words. 7. Contracting authorities must be able to supply proof of the dates on which notices are dispatched. 8. The Commission shall give the contracting authority confirmation of the publication of the information sent, mentioning the date of that publication. Such confirmation shall constitute proof of publication. Article 37 Non-mandatory publication Contracting authorities may publish in accordance with Article 36 notices of public contracts which are not subject to the publication requirement laid down in this Directive. Section 2 Time limits Article 38 Time limits for receipt of requests to participate and for receipt of tenders 1. When fixing the time limits for the receipt of tenders and requests to participate, contracting authorities shall take account in particular of the complexity of the contract and the time required for drawing up tenders, without prejudice to the minimum time limits set by this Article. 2. In the case of open procedures, the minimum time limit for the receipt of tenders shall be 52 days from the date on which the contract notice was sent. 3. In the case of restricted procedures, negotiated procedures with publication of a contract notice referred to in Article 30 and the competitive dialogue: (a) the minimum time limit for receipt of requests to participate shall be 37 days from the date on which the contract notice is sent; (b) in the case of restricted procedures, the minimum time limit for the receipt of tenders shall be 40 days from the date on which the invitation is sent. 4. When contracting authorities have published a prior information notice, the minimum time limit for the receipt of tenders under paragraphs 2 and 3(b) may, as a general rule, be shortened to 36 days, but under no circumstances to less than 22 days. The time limit shall run from the date on which the contract notice was sent in open procedures, and from the date on which the invitation to tender was sent in restricted procedures. The shortened time limits referred to in the first subparagraph shall be permitted, provided that the prior information notice has included all the information required for the contract notice in Annex VII A, insofar as that information is available at the time the notice is published and that the prior information notice was sent for publication between 52 days and 12 months before the date on which the contract notice was sent. 5. Where notices are drawn up and transmitted by electronic means in accordance with the format and procedures for transmission indicated in point 3 of Annex VIII, the time limits for the receipt of tenders referred to in paragraphs 2 and 4 in open procedures, and the time limit for the receipt of the requests to participate referred to in paragraph 3(a), in restricted and negotiated procedures and the competitive dialogue, may be shortened by seven days. 6. The time limits for receipt of tenders referred to in paragraphs 2 and 3(b) may be reduced by five days where the contracting authority offers unrestricted and full direct access by electronic means to the contract documents and any supplementary documents from the date of publication of the notice in accordance with Annex VIII, specifying in the text of the notice the internet address at which this documentation is accessible. This reduction may be added to that referred to in paragraph 5. 7. If, for whatever reason, the specifications and the supporting documents or additional information, although requested in good time, are not supplied within the time limits set in Articles 39 and 40, or where tenders can be made only after a visit to the site or after on-the-spot inspection of the documents supporting the contract documents, the time limits for the receipt of tenders shall be extended so that all economic operators concerned may be aware of all the information needed to produce tenders. 8. In the case of restricted procedures and negotiated procedures with publication of a contract notice referred to in Article 30, where urgency renders impracticable the time limits laid down in this Article, contracting authorities may fix: (a) a time limit for the receipt of requests to participate which may not be less than 15 days from the date on which the contract notice was sent, or less than 10 days if the notice was sent by electronic means, in accordance with the format and procedure for sending notices indicated in point 3 of Annex VIII; (b) and, in the case of restricted procedures, a time limit for the receipt of tenders which shall be not less than 10 days from the date of the invitation to tender. Article 39 Open procedures: Specifications, additional documents and information 1. In open procedures, where contracting authorities do not offer unrestricted and full direct access by electronic means in accordance with Article 38(6) to the specifications and any supporting documents, the specifications and supplementary documents shall be sent to economic operators within six days of receipt of the request to participate, provided that the request was made in good time before the deadline for the submission of tenders. 2. Provided that it has been requested in good time, additional information relating to the specifications and any supporting documents shall be supplied by the contracting authorities or competent departments not later than six days before the deadline fixed for the receipt of tenders. Section 3 Information content and means of transmission Article 40 Invitations to submit a tender, participate in the dialogue or negotiate 1. In restricted procedures, competitive dialogue procedures and negotiated procedures with publication of a contract notice within the meaning of Article 30, contracting authorities shall simultaneously and in writing invite the selected candidates to submit their tenders or to negotiate or, in the case of a competitive dialogue, to take part in the dialogue. 2. The invitation to the candidates shall include either: — a copy of the specifications or of the descriptive document and any supporting documents, or — a reference to accessing the specifications and the other documents indicated in the first indent, when they are made directly available by electronic means in accordance with Article 38(6). 3. Where an entity other than the contracting authority responsible for the award procedure has the specifications, the descriptive document and/or any supporting documents, the invitation shall state the address from which those specifications, that descriptive document and those documents may be requested and, if appropriate, the deadline for requesting such documents, and the sum payable for obtaining them and any payment procedures. The competent department shall send that documentation to the economic operator without delay upon receipt of a request. 4. The additional information on the specifications, the descriptive document or the supporting documents shall be sent by the contracting authority or the competent department not less than six days before the deadline fixed for the receipt of tenders, provided that it is requested in good time. In the event of a restricted or an accelerated procedure, that period shall be four days. 5. In addition, the invitation to submit a tender, to participate in the dialogue or to negotiate must contain at least: (a) a reference to the contract notice published; (b) the deadline for the receipt of the tenders, the address to which the tenders must be sent and the language or languages in which the tenders must be drawn up; (c) in the case of competitive dialogue the date and the address set for the start of consultation and the language or languages used; (d) a reference to any possible adjoining documents to be submitted, either in support of verifiable declarations by the tenderer in accordance with Article 44, or to supplement the information referred to in that Article, and under the conditions laid down in Articles 47 and 48; (e) the relative weighting of criteria for the award of the contract or, where appropriate, the descending order of importance for such criteria, if they are not given in the contract notice, the specifications or the descriptive document. However, in the case of contracts awarded in accordance with the rules laid down in Article 29, the information referred to in (b) above shall not appear in the invitation to participate in the dialogue but it shall appear in the invitation to submit a tender. Article 41 Informing candidates and tenderers 1. Contracting authorities shall as soon as possible inform candidates and tenderers of decisions reached concerning the conclusion of a framework agreement, the award of the contract or admittance to a dynamic purchasing system, including the grounds for any decision not to conclude a framework agreement or award a contract for which there has been a call for competition or to recommence the procedure or implement a dynamic purchasing system; that information shall be given in writing upon request to the contracting authorities. 2. On request from the party concerned, the contracting authority shall as quickly as possible inform: — any unsuccessful candidate of the reasons for the rejection of his application, — any unsuccessful tenderer of the reasons for the rejection of his tender, including, for the cases referred to in Article 23, paragraphs 4 and 5, the reasons for its decision of non-equivalence or its decision that the works, supplies or services do not meet the performance or functional requirements, — any tenderer who has made an admissible tender of the characteristics and relative advantages of the tender selected as well as the name of the successful tenderer or the parties to the framework agreement. The time taken may in no circumstances exceed 15 days from receipt of the written request. 3. However, contracting authorities may decide to withhold certain information referred to in paragraph 1, regarding the contract award, the conclusion of framework agreements or admittance to a dynamic purchasing system where the release of such information would impede law enforcement, would otherwise be contrary to the public interest, would prejudice the legitimate commercial interests of economic operators, whether public or private, or might prejudice fair competition between them. Section 4 Communication Article 42 Rules applicable to communication 1. All communication and information exchange referred to in this Title may be by post, by fax, by electronic means in accordance with paragraphs 4 and 5, by telephone in the cases and circumstances referred to in paragraph 6, or by a combination of those means, according to the choice of the contracting authority. 2. The means of communication chosen must be generally available and thus not restrict economic operators' access to the tendering procedure. 3. Communication and the exchange and storage of information shall be carried out in such a way as to ensure that the integrity of data and the confidentiality of tenders and requests to participate are preserved, and that the contracting authorities examine the content of tenders and requests to participate only after the time limit set for submitting them has expired. 4. The tools to be used for communicating by electronic means, as well as their technical characteristics, must be non-discriminatory, generally available and interoperable with the information and communication technology products in general use. 5. The following rules are applicable to devices for the electronic transmission and receipt of tenders and to devices for the electronic receipt of requests to participate: (a) information regarding the specifications necessary for the electronic submission of tenders and requests to participate, including encryption, shall be available to interested parties. Moreover, the devices for the electronic receipt of tenders and requests to participate shall conform to the requirements of Annex X; (b) Member States may, in compliance with Article 5 of Directive 1999/93/EC, require that electronic tenders be accompanied by an advanced electronic signature in conformity with paragraph 1 thereof; (c) Member States may introduce or maintain voluntary accreditation schemes aiming at enhanced levels of certification service provision for these devices; (d) tenderers or candidates shall undertake to submit, before expiry of the time limit laid down for submission of tenders or requests to participate, the documents, certificates and declarations referred to in Articles 45 to 50 and Article 52 if they do not exist in electronic format. 6. The following rules shall apply to the transmission of requests to participate: (a) requests to participate in procedures for the award of public contracts may be made in writing or by telephone; (b) where requests to participate are made by telephone, a written confirmation must be sent before expiry of the time limit set for their receipt; (c) contracting authorities may require that requests for participation made by fax must be confirmed by post or by electronic means, where this is necessary for the purposes of legal proof. Any such requirement, together with the time limit for sending confirmation by post or electronic means, must be stated by the contracting authority in the contract notice. Section 5 Reports Article 43 Content of reports For every contract, framework agreement, and every establishment of a dynamic purchasing system, the contracting authorities shall draw up a written report which shall include at least the following: (a) the name and address of the contracting authority, the subject-matter and value of the contract, framework agreement or dynamic purchasing system; (b) the names of the successful candidates or tenderers and the reasons for their selection; (c) the names of the candidates or tenderers rejected and the reasons for their rejection; (d) the reasons for the rejection of tenders found to be abnormally low; (e) the name of the successful tenderer and the reasons why his tender was selected and, if known, the share of the contract or framework agreement which the successful tenderer intends to subcontract to third parties; (f) for negotiated procedures, the circumstances referred to in Articles 30 and 31 which justify the use of these procedures; (g) as far as the competitive dialogue is concerned, the circumstances as laid down in Article 29 justifying the use of this procedure; (h) if necessary, the reasons why the contracting authority has decided not to award a contract or framework agreement or to establish a dynamic purchasing system. The contracting authorities shall take appropriate steps to document the progress of award procedures conducted by electronic means. The report, or the main features of it, shall be communicated to the Commission if it so requests. CHAPTER VII Conduct of the procedure Section 1 General provisions Article 44 Verification of the suitability and choice of participants and award of contracts 1. Contracts shall be awarded on the basis of the criteria laid down in Articles 53 and 55, taking into account Article 24, after the suitability of the economic operators not excluded under Articles 45 and 46 has been checked by contracting authorities in accordance with the criteria of economic and financial standing, of professional and technical knowledge or ability referred to in Articles 47 to 52, and, where appropriate, with the non-discriminatory rules and criteria referred to in paragraph 3. 2. The contracting authorities may require candidates and tenderers to meet minimum capacity levels in accordance with Articles 47 and 48. The extent of the information referred to in Articles 47 and 48 and the minimum levels of ability required for a specific contract must be related and proportionate to the subject-matter of the contract. These minimum levels shall be indicated in the contract notice. 3. In restricted procedures, negotiated procedures with publication of a contract notice and in the competitive dialogue procedure, contracting authorities may limit the number of suitable candidates they will invite to tender, to negotiate or to conduct a dialogue with, provided a sufficient number of suitable candidates is available. The contracting authorities shall indicate in the contract notice the objective and non-discriminatory criteria or rules they intend to apply, the minimum number of candidates they intend to invite and, where appropriate, the maximum number. In the restricted procedure the minimum shall be five. In the negotiated procedure with publication of a contract notice and the competitive dialogue procedure the minimum shall be three. In any event the number of candidates invited shall be sufficient to ensure genuine competition. The contracting authorities shall invite a number of candidates at least equal to the minimum number set in advance. Where the number of candidates meeting the selection criteria and the minimum levels of ability is below the minimum number, the contracting authority may continue the procedure by inviting the candidate(s) with the required capabilities. In the context of this same procedure, the contracting authority may not include other economic operators who did not request to participate, or candidates who do not have the required capabilities. 4. Where the contracting authorities exercise the option of reducing the number of solutions to be discussed or of tenders to be negotiated, as provided for in Articles 29(4) and 30(4), they shall do so by applying the award criteria stated in the contract notice, in the specifications or in the descriptive document. In the final stage, the number arrived at shall make for genuine competition insofar as there are enough solutions or suitable candidates. Section 2 Criteria for qualitative selection Article 45 Personal situation of the candidate or tenderer 1. Any candidate or tenderer who has been the subject of a conviction by final judgment of which the contracting authority is aware for one or more of the reasons listed below shall be excluded from participation in a public contract: (a) participation in a criminal organisation, as defined in Article 2(1) of Council Joint Action 98/733/JHA (20); (b) corruption, as defined in Article 3 of the Council Act of 26 May 1997 (21) and Article 3(1) of Council Joint Action 98/742/JHA (22) respectively; (c) fraud within the meaning of Article 1 of the Convention relating to the protection of the financial interests of the European Communities (23); (d) money laundering, as defined in Article 1 of Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (24). Member States shall specify, in accordance with their national law and having regard for Community law, the implementing conditions for this paragraph. They may provide for a derogation from the requirement referred to in the first subparagraph for overriding requirements in the general interest. For the purposes of this paragraph, the contracting authorities shall, where appropriate, ask candidates or tenderers to supply the documents referred to in paragraph 3 and may, where they have doubts concerning the personal situation of such candidates or tenderers, also apply to the competent authorities to obtain any information they consider necessary on the personal situation of the candidates or tenderers concerned. Where the information concerns a candidate or tenderer established in a State other than that of the contracting authority, the contracting authority may seek the cooperation of the competent authorities. Having regard for the national laws of the Member State where the candidates or tenderers are established, such requests shall relate to legal and/or natural persons, including, if appropriate, company directors and any person having powers of representation, decision or control in respect of the candidate or tenderer. 2. Any economic operator may be excluded from participation in a contract where that economic operator: (a) is bankrupt or is being wound up, where his affairs are being administered by the court, where he has entered into an arrangement with creditors, where he has suspended business activities or is in any analogous situation arising from a similar procedure under national laws and regulations; (b) is the subject of proceedings for a declaration of bankruptcy, for an order for compulsory winding up or administration by the court or of an arrangement with creditors or of any other similar proceedings under national laws and regulations; (c) has been convicted by a judgment which has the force of res judicata in accordance with the legal provisions of the country of any offence concerning his professional conduct; (d) has been guilty of grave professional misconduct proven by any means which the contracting authorities can demonstrate; (e) has not fulfilled obligations relating to the payment of social security contributions in accordance with the legal provisions of the country in which he is established or with those of the country of the contracting authority; (f) has not fulfilled obligations relating to the payment of taxes in accordance with the legal provisions of the country in which he is established or with those of the country of the contracting authority; (g) is guilty of serious misrepresentation in supplying the information required under this Section or has not supplied such information. Member States shall specify, in accordance with their national law and having regard for Community law, the implementing conditions for this paragraph. 3. Contracting authorities shall accept the following as sufficient evidence that none of the cases specified in paragraphs 1 or 2(a), (b), (c), (e) or (f) applies to the economic operator: (a) as regards paragraphs 1 and 2(a), (b) and (c), the production of an extract from the ‘judicial record’ or, failing that, of an equivalent document issued by a competent judicial or administrative authority in the country of origin or the country whence that person comes showing that these requirements have been met; (b) as regards paragraph 2(e) and (f), a certificate issued by the competent authority in the Member State concerned. Where the country in question does not issue such documents or certificates, or where these do not cover all the cases specified in paragraphs 1 and 2(a), (b) and (c), they may be replaced by a declaration on oath or, in Member States where there is no provision for declarations on oath, by a solemn declaration made by the person concerned before a competent judicial or administrative authority, a notary or a competent professional or trade body, in the country of origin or in the country whence that person comes. 4. Member States shall designate the authorities and bodies competent to issue the documents, certificates or declarations referred to in paragraph 3 and shall inform the Commission thereof. Such notification shall be without prejudice to data protection law. Article 46 Suitability to pursue the professional activity Any economic operator wishing to take part in a public contract may be requested to prove its enrolment, as prescribed in his Member State of establishment, on one of the professional or trade registers or to provide a declaration on oath or a certificate as described in Annex IX A for public works contracts, in Annex IX B for public supply contracts and in Annex IX C for public service contracts. In procedures for the award of public service contracts, insofar as candidates or tenderers have to possess a particular authorisation or to be members of a particular organisation in order to be able to perform in their country of origin the service concerned, the contracting authority may require them to prove that they hold such authorisation or membership. Article 47 Economic and financial standing 1. Proof of the economic operator's economic and financial standing may, as a general rule, be furnished by one or more of the following references: (a) appropriate statements from banks or, where appropriate, evidence of relevant professional risk indemnity insurance; (b) the presentation of balance-sheets or extracts from the balance-sheets, where publication of the balance-sheet is required under the law of the country in which the economic operator is established; (c) a statement of the undertaking's overall turnover and, where appropriate, of turnover in the area covered by the contract for a maximum of the last three financial years available, depending on the date on which the undertaking was set up or the economic operator started trading, as far as the information on these turnovers is available. 2. An economic operator may, where appropriate and for a particular contract, rely on the capacities of other entities, regardless of the legal nature of the links which it has with them. It must in that case prove to the contracting authority that it will have at its disposal the resources necessary, for example, by producing an undertaking by those entities to that effect. 3. Under the same conditions, a group of economic operators as referred to in Article 4 may rely on the capacities of participants in the group or of other entities. 4. Contracting authorities shall specify, in the contract notice or in the invitation to tender, which reference or references mentioned in paragraph 1 they have chosen and which other references must be provided. 5. If, for any valid reason, the economic operator is unable to provide the references requested by the contracting authority, he may prove his economic and financial standing by any other document which the contracting authority considers appropriate. Article 48 Technical and/or professional ability 1. The technical and/or professional abilities of the economic operators shall be assessed and examined in accordance with paragraphs 2 and 3. 2. Evidence of the economic operators' technical abilities may be furnished by one or more of the following means according to the nature, quantity or importance, and use of the works, supplies or services: (a) (i) a list of the works carried out over the past five years, accompanied by certificates of satisfactory execution for the most important works. These certificates shall indicate the value, date and site of the works and shall specify whether they were carried out according to the rules of the trade and properly completed. Where appropriate, the competent authority shall submit these certificates to the contracting authority direct; (ii) a list of the principal deliveries effected or the main services provided in the past three years, with the sums, dates and recipients, whether public or private, involved. Evidence of delivery and services provided shall be given: — where the recipient was a contracting authority, in the form of certificates issued or countersigned by the competent authority, — where the recipient was a private purchaser, by the purchaser's certification or, failing this, simply by a declaration by the economic operator; (b) an indication of the technicians or technical bodies involved, whether or not belonging directly to the economic operator's undertaking, especially those responsible for quality control and, in the case of public works contracts, those upon whom the contractor can call in order to carry out the work; (c) a description of the technical facilities and measures used by the supplier or service provider for ensuring quality and the undertaking's study and research facilities; (d) where the products or services to be supplied are complex or, exceptionally, are required for a special purpose, a check carried out by the contracting authorities or on their behalf by a competent official body of the country in which the supplier or service provider is established, subject to that body's agreement, on the production capacities of the supplier or the technical capacity of the service provider and, if necessary, on the means of study and research which are available to it and the quality control measures it will operate; (e) the educational and professional qualifications of the service provider or contractor and/or those of the undertaking's managerial staff and, in particular, those of the person or persons responsible for providing the services or managing the work; (f) for public works contracts and public services contracts, and only in appropriate cases, an indication of the environmental management measures that the economic operator will be able to apply when performing the contract; (g) a statement of the average annual manpower of the service provider or contractor and the number of managerial staff for the last three years; (h) a statement of the tools, plant or technical equipment available to the service provider or contractor for carrying out the contract; (i) an indication of the proportion of the contract which the services provider intends possibly to subcontract; (j) with regard to the products to be supplied: (i) samples, descriptions and/or photographs, the authenticity of which must be certified if the contracting authority so requests; (ii) certificates drawn up by official quality control institutes or agencies of recognised competence attesting the conformity of products clearly identified by references to specifications or standards. 3. An economic operator may, where appropriate and for a particular contract, rely on the capacities of other entities, regardless of the legal nature of the links which it has with them. It must in that case prove to the contracting authority that it will have at its disposal the resources necessary for the execution of the contract, for example, by producing an undertaking by those entities to place the necessary resources at the disposal of the economic operator. 4. Under the same conditions a group of economic operators as referred to Article 4 may rely on the abilities of participants in the group or in other entities. 5. In procedures for awarding public contracts having as their object supplies requiring siting or installation work, the provision of services and/or the execution of works, the ability of economic operators to provide the service or to execute the installation or the work may be evaluated in particular with regard to their skills, efficiency, experience and reliability. 6. The contracting authority shall specify, in the notice or in the invitation to tender, which references under paragraph 2 it wishes to receive. Article 49 Quality assurance standards Should they require the production of certificates drawn up by independent bodies attesting the compliance of the economic operator with certain quality assurance standards, contracting authorities shall refer to quality assurance systems based on the relevant European standards series certified by bodies conforming to the European standards series concerning certification. They shall recognise equivalent certificates from bodies established in other Member States. They shall also accept other evidence of equivalent quality assurance measures from economic operators. Article 50 Environmental management standards Should contracting authorities, in the cases referred to in Article 48(2)(f), require the production of certificates drawn up by independent bodies attesting the compliance of the economic operator with certain environmental management standards, they shall refer to the Community Eco-Management and Audit Scheme (EMAS) or to environmental management standards based on the relevant European or international standards certified by bodies conforming to Community law or the relevant European or international standards concerning certification. They shall recognise equivalent certificates from bodies established in other Member States. They shall also accept other evidence of equivalent environmental management measures from economic operators. Article 51 Additional documentation and information The contracting authority may invite economic operators to supplement or clarify the certificates and documents submitted pursuant to Articles 45 to 50. Article 52 Official lists of approved economic operators and certification by bodies established under public or private law 1. Member States may introduce either official lists of approved contractors, suppliers or service providers or certification by certification bodies established in public or private law. Member States shall adapt the conditions for registration on these lists and for the issue of certificates by certification bodies to the provisions of Article 45(1), Article 45(2)(a) to (d) and (g), Articles 46, Article 47(1), (4) and (5), Article 48(1), (2), (5) and (6), Article 49 and, where appropriate, Article 50. Member States shall also adapt them to Article 47(2) and Article 48(3) as regards applications for registration submitted by economic operators belonging to a group and claiming resources made available to them by the other companies in the group. In such case, these operators must prove to the authority establishing the official list that they will have these resources at their disposal throughout the period of validity of the certificate attesting to their being registered in the official list and that throughout the same period these companies continue to fulfil the qualitative selection requirements laid down in the Articles referred to in the second subparagraph on which operators rely for their registration. 2. Economic operators registered on the official lists or having a certificate may, for each contract, submit to the contracting authority a certificate of registration issued by the competent authority or the certificate issued by the competent certification body. The certificates shall state the references which enabled them to be registered in the list/to obtain certification and the classification given in that list. 3. Certified registration on official lists by the competent bodies or a certificate issued by the certification body shall not, for the purposes of the contracting authorities of other Member States, constitute a presumption of suitability except as regards Articles 45(1) and (2)(a) to (d) and (g), Article 46, Article 47(1)(b) and (c), and Article 48(2)(a)(i), (b), (e), (g) and (h) in the case of contractors, (2)(a)(ii), (b), (c), (d) and (j) in the case of suppliers and 2(a)(ii) and (c) to (i) in the case of service providers. 4. Information which can be deduced from registration on official lists or certification may not be questioned without justification. With regard to the payment of social security contributions and taxes, an additional certificate may be required of any registered economic operator whenever a contract is offered. The contracting authorities of other Member States shall apply paragraph 3 and the first subparagraph of this paragraph only in favour of economic operators established in the Member State holding the official list. 5. For any registration of economic operators of other Member States in an official list or for their certification by the bodies referred to in paragraph 1, no further proof or statements can be required other than those requested of national economic operators and, in any event, only those provided for under Articles 45 to 49 and, where appropriate, Article 50. However, economic operators from other Member States may not be obliged to undergo such registration or certification in order to participate in a public contract. The contracting authorities shall recognise equivalent certificates from bodies established in other Member States. They shall also accept other equivalent means of proof. 6. Economic operators may ask at any time to be registered in an official list or for a certificate to be issued. They must be informed within a reasonably short period of time of the decision of the authority drawing up the list or of the competent certification body. 7. The certification bodies referred to in paragraph 1 shall be bodies complying with European certification standards. 8. Member States which have official lists or certification bodies as referred to in paragraph 1 shall be obliged to inform the Commission and the other Member States of the address of the body to which applications should be sent. Section 3 Award of the contract Article 53 Contract award criteria 1. Without prejudice to national laws, regulations or administrative provisions concerning the remuneration of certain services, the criteria on which the contracting authorities shall base the award of public contracts shall be either: (a) when the award is made to the tender most economically advantageous from the point of view of the contracting authority, various criteria linked to the subject-matter of the public contract in question, for example, quality, price, technical merit, aesthetic and functional characteristics, environmental characteristics, running costs, cost-effectiveness, after-sales service and technical assistance, delivery date and delivery period or period of completion, or (b) the lowest price only. 2. Without prejudice to the provisions of the third subparagraph, in the case referred to in paragraph 1(a) the contracting authority shall specify in the contract notice or in the contract documents or, in the case of a competitive dialogue, in the descriptive document, the relative weighting which it gives to each of the criteria chosen to determine the most economically advantageous tender. Those weightings can be expressed by providing for a range with an appropriate maximum spread. Where, in the opinion of the contracting authority, weighting is not possible for demonstrable reasons, the contracting authority shall indicate in the contract notice or contract documents or, in the case of a competitive dialogue, in the descriptive document, the criteria in descending order of importance. Article 54 Use of electronic auctions 1. Member States may provide that contracting authorities may use electronic auctions. 2. In open, restricted or negotiated procedures in the case referred to in Article 30(1)(a), the contracting authorities may decide that the award of a public contract shall be preceded by an electronic auction when the contract specifications can be established with precision. In the same circumstances, an electronic auction may be held on the reopening of competition among the parties to a framework agreement as provided for in the second indent of the second subparagraph of Article 32(4) and on the opening for competition of contracts to be awarded under the dynamic purchasing system referred to in Article 33. The electronic auction shall be based: — either solely on prices when the contract is awarded to the lowest price, — or on prices and/or on the new values of the features of the tenders indicated in the specification when the contract is awarded to the most economically advantageous tender. 3. Contracting authorities which decide to hold an electronic auction shall state that fact in the contract notice. The specifications shall include, inter alia, the following details: (a) the features, the values for which will be the subject of electronic auction, provided that such features are quantifiable and can be expressed in figures or percentages; (b) any limits on the values which may be submitted, as they result from the specifications relating to the subject of the contract; (c) the information which will be made available to tenderers in the course of the electronic auction and, where appropriate, when it will be made available to them; (d) the relevant information concerning the electronic auction process; (e) the conditions under which the tenderers will be able to bid and, in particular, the minimum differences which will, where appropriate, be required when bidding; (f) the relevant information concerning the electronic equipment used and the arrangements and technical specifications for connection. 4. Before proceeding with an electronic auction, contracting authorities shall make a full initial evaluation of the tenders in accordance with the award criterion/criteria set and with the weighting fixed for them. All tenderers who have submitted admissible tenders shall be invited simultaneously by electronic means to submit new prices and/or new values; the invitation shall contain all relevant information concerning individual connection to the electronic equipment being used and shall state the date and time of the start of the electronic auction. The electronic auction may take place in a number of successive phases. The electronic auction may not start sooner than two working days after the date on which invitations are sent out. 5. When the contract is to be awarded on the basis of the most economically advantageous tender, the invitation shall be accompanied by the outcome of a full evaluation of the relevant tenderer, carried out in accordance with the weighting provided for in the first subparagraph of Article 53(2). The invitation shall also state the mathematical formula to be used in the electronic auction to determine automatic rerankings on the basis of the new prices and/or new values submitted. That formula shall incorporate the weighting of all the criteria fixed to determine the most economically advantageous tender, as indicated in the contract notice or in the specifications; for that purpose, any ranges shall, however, be reduced beforehand to a specified value. Where variants are authorised, a separate formula shall be provided for each variant. 6. Throughout each phase of an electronic auction the contracting authorities shall instantaneously communicate to all tenderers at least sufficient information to enable them to ascertain their relative rankings at any moment. They may also communicate other information concerning other prices or values submitted, provided that that is stated in the specifications. They may also at any time announce the number of participants in that phase of the auction. In no case, however, may they disclose the identities of the tenderers during any phase of an electronic auction. 7. Contracting authorities shall close an electronic auction in one or more of the following manners: (a) in the invitation to take part in the auction they shall indicate the date and time fixed in advance; (b) when they receive no more new prices or new values which meet the requirements concerning minimum differences. In that event, the contracting authorities shall state in the invitation to take part in the auction the time which they will allow to elapse after receiving the last submission before they close the electronic auction; (c) when the number of phases in the auction, fixed in the invitation to take part in the auction, has been completed. When the contracting authorities have decided to close an electronic auction in accordance with subparagraph (c), possibly in combination with the arrangements laid down in subparagraph (b), the invitation to take part in the auction shall indicate the timetable for each phase of the auction. 8. After closing an electronic auction contracting authorities shall award the contract in accordance with Article 53 on the basis of the results of the electronic auction. Contracting authorities may not have improper recourse to electronic auctions nor may they use them in such a way as to prevent, restrict or distort competition or to change the subject-matter of the contract, as put up for tender in the published contract notice and defined in the specification. Article 55 Abnormally low tenders 1. If, for a given contract, tenders appear to be abnormally low in relation to the goods, works or services, the contracting authority shall, before it may reject those tenders, request in writing details of the constituent elements of the tender which it considers relevant. Those details may relate in particular to: (a) the economics of the construction method, the manufacturing process or the services provided; (b) the technical solutions chosen and/or any exceptionally favourable conditions available to the tenderer for the execution of the work, for the supply of the goods or services; (c) the originality of the work, supplies or services proposed by the tenderer; (d) compliance with the provisions relating to employment protection and working conditions in force at the place where the work, service or supply is to be performed; (e) the possibility of the tenderer obtaining State aid. 2. The contracting authority shall verify those constituent elements by consulting the tenderer, taking account of the evidence supplied. 3. Where a contracting authority establishes that a tender is abnormally low because the tenderer has obtained State aid, the tender can be rejected on that ground alone only after consultation with the tenderer where the latter is unable to prove, within a sufficient time limit fixed by the contracting authority, that the aid in question was granted legally. Where the contracting authority rejects a tender in these circumstances, it shall inform the Commission of that fact. TITLE III RULES ON PUBLIC WORKS CONCESSIONS CHAPTER I Rules governing public works concessions Article 56 Scope This Chapter shall apply to all public works concession contracts concluded by the contracting authorities where the value of the contracts is equal to or greater than EUR 6 242 000. The value shall be calculated in accordance with the rules applicable to public works contracts defined in Article 9. Article 57 Exclusions from the scope This Title shall not apply to public works concessions which are awarded: (a) in the cases referred to in Articles 13, 14 and 15 of this Directive in respect of public works contracts; (b) by contracting authorities exercising one or more of the activities referred to in Articles 3 to 7 of Directive 2004/17/EC where those concessions are awarded for carrying out those activities. However, this Directive shall continue to apply to public works concessions awarded by contracting authorities carrying out one or more of the activities referred to in Article 6 of Directive 2004/17/EC and awarded for those activities, insofar as the Member State concerned takes advantage of the option referred to in the second subparagraph of Article 71 thereof to defer its application. Article 58 Publication of the notice concerning public works concessions 1. Contracting authorities which wish to award a public works concession contract shall make known their intention by means of a notice. 2. Notices of public works concessions shall contain the information referred to in Annex VII C and, where appropriate, any other information deemed useful by the contracting authority, in accordance with the standard forms adopted by the Commission pursuant to the procedure in Article 77(2). 3. Notices shall be published in accordance with Article 36(2) to (8). 4. Article 37 on the publication of notices shall also apply to public works concessions. Article 59 Time limit When contracting authorities resort to a public works concession, the time limit for the presentation of applications for the concession shall be not less than 52 days from the date of dispatch of the notice, except where Article 38(5) applies. Article 38(7) shall apply. Article 60 Subcontracting The contracting authority may either: (a) require the concessionaire to award contracts representing a minimum of 30 % of the total value of the work for which the concession contract is to be awarded, to third parties, at the same time providing the option for candidates to increase this percentage, this minimum percentage being specified in the concession contract, or (b) request the candidates for concession contracts to specify in their tenders the percentage, if any, of the total value of the work for which the concession contract is to be awarded which they intend to assign to third parties. Article 61 Awarding of additional works to the concessionaire This Directive shall not apply to additional works not included in the concession project initially considered or in the initial contract but which have, through unforeseen circumstances, become necessary for the performance of the work described therein, which the contracting authority has awarded to the concessionaire, on condition that the award is made to the economic operator performing such work: — when such additional works cannot be technically or economically separated from the initial contract without major inconvenience to the contracting authorities, or — when such works, although separable from the performance of the initial contract, are strictly necessary for its completion. However, the aggregate value of contracts awarded for additional works may not exceed 50 % of the amount of the original works concession contract. CHAPTER II Rules on contracts awarded by concessionaires which are contracting authorities Article 62 Applicable rules Where the concessionaire is a contracting authority as referred to in Article 1(9), it shall comply with the provisions laid down by this Directive for public works contracts in the case of works to be carried out by third parties. CHAPTER III Rules applicable to contracts awarded by concessionaires which are not contracting authorities Article 63 Advertising rules: threshold and exceptions 1. The Member States shall take the necessary measures to ensure that public works concessionaires which are not contracting authorities apply the advertising rules defined in Article 64 when awarding works contracts to third parties where the value of such contracts is equal to or greater than EUR 6 242 000. Advertising shall not, however, be required where a works contract satisfies the conditions listed in Article 31. The values of contracts shall be calculated in accordance with the rules applicable to public works contracts laid down in Article 9. 2. Groups of undertakings which have been formed to obtain the concession or undertakings related to them shall not be considered third parties. ‘Related undertaking’ shall mean any undertaking over which the concessionaire can exert a dominant influence, whether directly or indirectly, or any undertaking which can exert a dominant influence on the concessionaire or which, as the concessionaire, is subject to the dominant influence of another undertaking as a result of ownership, financial participation or the rules which govern it. A dominant influence on the part of an undertaking is presumed when, directly or indirectly in relation to another undertaking, it: (a) holds a majority of the undertaking's subscribed capital; (b) controls a majority of the votes attached to the shares issued by the undertaking; or (c) can appoint more than half of the undertaking's administrative, management or supervisory body. The exhaustive list of such undertakings shall be included in the application for the concession. That list shall be brought up to date following any subsequent changes in the relationship between the undertakings. Article 64 Publication of the notice 1. Works concessionaires which are not contracting authorities and which wish to award works contracts to a third party shall make known their intention by way of a notice. 2. Notices shall contain the information referred to in Annex VII C and, where appropriate, any other information deemed useful by the works concessionaire, in accordance with the standard form adopted by the Commission in accordance with the procedure in Article 77(2). 3. The notice shall be published in accordance with Article 36(2) to (8). 4. Article 37 on the voluntary publication of notices shall also apply. Article 65 Time limit for the receipt of requests to participate and receipt of tenders In works contracts awarded by a works concessionaire which is not a contracting authority, the time limit for the receipt of requests to participate, fixed by the concessionaire, shall be not less than 37 days from the date on which the contract notice was dispatched and the time limit for the receipt of tenders not less than 40 days from the date on which the contract notice or the invitation to tender was dispatched. Article 38(5), (6) and (7) shall apply. TITLE IV RULES GOVERNING DESIGN CONTESTS Article 66 General provisions 1. The rules for the organisation of design contests shall be in conformity with Articles 66 to 74 and shall be communicated to those interested in participating in the contest. 2. The admission of participants to design contests shall not be limited: (a) by reference to the territory or part of the territory of a Member State; (b) on the grounds that, under the law of the Member State in which the contest is organised, they would be required to be either natural or legal persons. Article 67 Scope 1. In accordance with this Title, design contests shall be organised by: (a) contracting authorities which are listed as central government authorities in Annex IV, starting from a threshold equal to or greater than EUR 162 000; (b) contracting authorities not listed in Annex IV, starting from a threshold equal to or greater than EUR 249 000; (c) by all the contracting authorities, starting from a threshold equal to or greater than EUR 249 000 where contests concern services in category 8 of Annex II A, category 5 telecommunications services, the positions of which in the CPV are equivalent to reference Nos CPC 7524, 7525 and 7526 and/or services listed in Annex II B. 2. This Title shall apply to: (a) design contests organised as part of a procedure leading to the award of a public service contract; (b) design contests with prizes and/or payments to participants. In the cases referred to in (a) the threshold refers to the estimated value net of VAT of the public services contract, including any possible prizes and/or payments to participants. In the cases referred to in (b), the threshold refers to the total amount of the prizes and payments, including the estimated value net of VAT of the public services contract which might subsequently be concluded under Article 31(3) if the contracting authority does not exclude such an award in the contest notice. Article 68 Exclusions from the scope This Title shall not apply to: (a) design contests within the meaning of Directive 2004/17/EC which are organised by contracting authorities exercising one or more of the activities referred to in Articles 3 to 7 of that Directive and are organised for the pursuit of such activities; nor shall it apply to contests excluded from the scope of this Directive. However, this Directive shall continue to apply to design contests awarded by contracting authorities carrying out one or more of the activities referred to in Article 6 of Directive 2004/17/EC and awarded for those activities, insofar as the Member State concerned takes advantage of the option referred to in the second subparagraph of Article 71 thereof to defer its application; (b) contests which are organised in the same cases as those referred to in Articles 13, 14 and 15 of this Directive for public service contracts. Article 69 Notices 1. Contracting authorities which wish to carry out a design contest shall make known their intention by means of a contest notice. 2. Contracting authorities which have held a design contest shall send a notice of the results of the contest in accordance with Article 36 and must be able to prove the date of dispatch. Where the release of information on the outcome of the contest would impede law enforcement, be contrary to the public interest, prejudice the legitimate commercial interests of a particular enterprise, whether public or private, or might prejudice fair competition between service providers, such information need not be published. 3. Article 37 concerning publication of notices shall also apply to contests. Article 70 Form and manner of publication of notices of contests 1. The notices referred to in Article 69 shall contain the information referred to in Annex VII D in accordance with the standard model notices adopted by the Commission in accordance with the procedure in Article 77(2). 2. The notices shall be published in accordance with Article 36(2) to (8). Article 71 Means of communication 1. Article 42(1), (2) and (4) shall apply to all communications relating to contests. 2. Communications, exchanges and the storage of information shall be such as to ensure that the integrity and the confidentiality of all information communicated by the participants in a contest are preserved and that the jury ascertains the contents of plans and projects only after the expiry of the time limit for their submission. 3. The following rules shall apply to devices for the electronic receipt of plans and projects: (a) the information relating to the specifications which is necessary for the presentation of plans and projects by electronic means, including encryption, shall be available to the parties concerned. In addition, the devices for the electronic receipt of plans and projects shall comply with the requirements of Annex X; (b) the Member States may introduce or maintain voluntary arrangements for accreditation intended to improve the level of the certification service provided for such devices. Article 72 Selection of competitors Where design contests are restricted to a limited number of participants, the contracting authorities shall lay down clear and non-discriminatory selection criteria. In any event, the number of candidates invited to participate shall be sufficient to ensure genuine competition. Article 73 Composition of the jury The jury shall be composed exclusively of natural persons who are independent of participants in the contest. Where a particular professional qualification is required from participants in a contest, at least a third of the members of the jury shall have that qualification or an equivalent qualification. Article 74 Decisions of the jury 1. The jury shall be autonomous in its decisions or opinions. 2. It shall examine the plans and projects submitted by the candidates anonymously and solely on the basis of the criteria indicated in the contest notice. 3. It shall record its ranking of projects in a report, signed by its members, made according to the merits of each project, together with its remarks and any points which may need clarification. 4. Anonymity must be observed until the jury has reached its opinion or decision. 5. Candidates may be invited, if need be, to answer questions which the jury has recorded in the minutes to clarify any aspects of the projects. 6. Complete minutes shall be drawn up of the dialogue between jury members and candidates. TITLE V STATISTICAL OBLIGATIONS, EXECUTORY POWERS AND FINAL PROVISIONS Article 75 Statistical obligations In order to permit assessment of the results of applying this Directive, Member States shall forward to the Commission a statistical report, prepared in accordance with Article 76, separately addressing public supply, services and works contracts awarded by contracting authorities during the preceding year, by no later than 31 October of each year. Article 76 Content of statistical report 1. For each contracting authority listed in Annex IV, the statistical report shall detail at least: (a) the number and value of awarded contracts covered by this Directive; (b) the number and total value of contracts awarded pursuant to derogations to the Agreement. As far as possible, the data referred to in point (a) of the first subparagraph shall be broken down by: (a) the contract award procedures used; and (b) for each of these procedures, works as given in Annex I and products and services as given in Annex II identified by category of the CPV nomenclature; (c) the nationality of the economic operator to which the contract was awarded. Where the contracts have been concluded according to the negotiated procedure, the data referred to in point (a) of the first subparagraph shall also be broken down according to the circumstances referred to in Articles 30 and 31 and shall specify the number and value of contracts awarded, by Member State and third country of the successful contractor. 2. For each category of contracting authority which is not given in Annex IV, the statistical report shall detail at least: (a) the number and value of the contracts awarded, broken down in accordance with the second subparagraph of paragraph 1; (b) the total value of contracts awarded pursuant to derogations to the Agreement. 3. The statistical report shall set out any other statistical information which is required under the Agreement. The information referred to in the first subparagraph shall be determined pursuant to the procedure under Article 77(2). Article 77 Advisory Committee 1. The Commission shall be assisted by the Advisory Committee for Public Contracts set up by Article 1 of Decision 71/306/EEC (25) (hereinafter referred to as ‘the Committee’). 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, in compliance with Article 8 thereof. 3. The Committee shall adopt its rules of procedure. Article 78 Revision of the thresholds 1. The Commission shall verify the thresholds established in Article 7 every two years from the entry into force of this Directive and shall, if necessary, revise them in accordance with the procedure laid down in Article 77(2). The calculation of the value of these thresholds shall be based on the average daily value of the euro, expressed in SDRs, over the 24 months terminating on the last day of August preceding the revision with effect from 1 January. The value of the thresholds thus revised shall, where necessary, be rounded down to the nearest thousand euro so as to ensure that the thresholds in force provided for by the Agreement, expressed in SDRs, are observed. 2. At the same time as the revision under paragraph 1, the Commission, in accordance with the procedure under Article 77(2), shall align: (a) the thresholds established in (a) of the first subparagraph of Article 8, in Article 56 and in the first subparagraph of Article 63(1) on the revised threshold applying to public works contracts; (b) the thresholds established in (b) of the first subparagraph of Article 8, and in Article 67(1)(a) on the revised threshold applying to public service contracts concluded by the contracting authorities referred to in Annex IV; (c) the threshold established in Article 67(1)(b) and (c) on the revised threshold applying to public service contracts awarded by the contracting authorities not included in Annex IV. 3. The value of the thresholds set pursuant to paragraph 1 in the national currencies of the Member States which are not participating in monetary union is normally to be adjusted every two years from 1 January 2004 onwards. The calculation of such value shall be based on the average daily values of those currencies expressed in euro over the 24 months terminating on the last day of August preceding the revision with effect from 1 January. 4. The revised thresholds referred to in paragraph 1 and their corresponding values in the national currencies referred to in paragraph 3 shall be published by the Commission in the Official Journal of the European Union at the beginning of the month of November following their revision. Article 79 Amendments 1. In accordance with the procedure referred to in Article 77(2), the Commission may amend: (a) the technical procedures for the calculation methods set out in the second subparagraph of Article 78(1) and in Article 78(3); (b) the procedures for the drawing-up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 35, 58, 64 and 69 and the statistical reports provided for in the fourth subparagraph of Article 35(4), and in Articles 75 and 76; (c) the procedures for specific reference to specific positions in the CPV nomenclature in the notices; (d) the lists of bodies and categories of bodies governed by public law in Annex III, when, on the basis of the notifications from the Member States, these prove necessary; (e) the lists of central government authorities in Annex IV, following the adaptations necessary to give effect to the Agreement; (f) the reference numbers in the nomenclature set out in Annex I, insofar as this does not change the material scope of this Directive, and the procedures for reference to particular positions of this nomenclature in the notices; (g) the reference numbers in the nomenclature set out in Annex II, insofar as this does not change the material scope of this Directive, and the procedures for reference in the notices to particular positions in this nomenclature within the categories of services listed in the Annex; (h) the procedure for sending and publishing data referred to in Annex VIII, on grounds of technical progress or for administrative reasons; (i) the technical details and characteristics of the devices for electronic receipt referred to in points (a), (f) and (g) of Annex X. Article 80 Implementation 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 January 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods 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 covered by this Directive. Article 81 Monitoring mechanisms In conformity with Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts (26), Member States shall ensure implementation of this Directive by effective, available and transparent mechanisms. For this purpose they may, among other things, appoint or establish an independent body. Article 82 Repeals Directive 92/50/EEC, except for Article 41 thereof, and Directives 93/36/EEC and 93/37/EEC shall be repealed with effect from the date shown in Article 80, without prejudice to the obligations of the Member States concerning the deadlines for transposition and application set out in Annex XI. References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XII. Article 83 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 84 Addressees This Directive is addressed to the Member States.

32004L0023

2004

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Following consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The transplantation of human tissues and cells is a strongly expanding field of medicine offering great opportunities for the treatment of as yet incurable diseases. The quality and safety of these substances should be ensured, particularly in order to prevent the transmission of diseases. (2) The availability of human tissues and cells used for therapeutic purposes is dependent on Community citizens who are prepared to donate them. In order to safeguard public health and to prevent the transmission of infectious diseases by these tissues and cells, all safety measures need to be taken during their donation, procurement, testing, processing, preservation, storage, distribution and use. (3) It is necessary to promote information and awareness campaigns at national and European level on the donation of tissues, cells and organs based on the theme "we are all potential donors". The aim of these campaigns should be to help European citizens decide to become donors during their lifetime and let their families or legal representatives know their wishes. As there is a need to ensure the availability of tissues and cells for medical treatments, Member States should promote the donation of tissues and cells, including haematopoietic progenitors, of high quality and safety, thereby also increasing self-sufficiency in the Community. (4) There is an urgent need for a unified framework in order to ensure high standards of quality and safety with respect to the procurement, testing, processing, storage and distribution of tissues and cells across the Community and to facilitate exchanges thereof for patients receiving this type of therapy each year. It is essential, therefore, that Community provisions ensure that human tissues and cells, whatever their intended use, are of comparable quality and safety. The establishment of such standards, therefore, will help to reassure the public that human tissues and cells that are procured in another Member State, nonetheless carry the same guarantees as those in their own country. (5) As tissue and cell therapy is a field in which an intensive worldwide exchange is taking place, it is desirable to have worldwide standards. The Community should therefore endeavour to promote the highest possible level of protection to safeguard public health regarding quality and safety of tissues and cells. The Commission should include in its report to the European Parliament and to the Council information on the progress made in this respect. (6) Tissues and cells intended to be used for industrially manufactured products, including medical devices, should be covered by this Directive only as far as donation, procurement and testing are concerned, where the processing, preservation, storage and distribution are regulated by other Community legislation. The further manufacturing steps are covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4). (7) This Directive should apply to tissues and cells including haematopoietic peripheral blood, umbilical-cord (blood) and bone-marrow stem cells, reproductive cells (eggs, sperm), foetal tissues and cells and adult and embryonic stem cells. (8) This Directive excludes blood and blood products (other than haematopoietic progenitor cells) and human organs, as well as organs, tissues, or cells of animal origin. Blood and blood products are currently regulated by Directives 2001/83/EC and 2000/70/EC(5), Recommendation 98/463/EC(6) and Directive 2002/98/EC(7). Tissues and cells used as an autologous graft (tissues removed and transplanted back to the same individual), within the same surgical procedure and without being subjected to any banking process, are also excluded from this Directive. The quality and safety considerations associated with this process are completely different. (9) The use of organs to some extent raises the same issues as the use of tissues and cells, though there are serious differences, and the two subjects should therefore not be covered by one directive. (10) This Directive covers tissues and cells intended for human applications, including human tissues and cells used for the preparation of cosmetic products. However, in view of the risk of transmission of communicable diseases, the use of human cells, tissues and products in cosmetic products is prohibited by 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(8). (11) This Directive does not cover research using human tissues and cells, such as when used for purposes other than application to the human body, e.g. in vitro research or in animal models. Only those cells and tissues that in clinical trials are applied to the human body should comply with the quality and safety standards laid down in this Directive. (12) This Directive should not interfere with decisions made by Member States concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells. If, however, any particular use of such cells is authorised in a Member State, this Directive will require the application of all provisions necessary to protect public health, given the specific risks of these cells based on the scientific knowledge and their particular nature, and guarantee respect for fundamental rights. Moreover, this Directive should not interfere with provisions of Member States defining the legal term "person" or "individual". (13) The donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications should comply with high standards of quality and safety in order to ensure a high level of health protection in the Community. This Directive should establish standards for each one of the steps in the human tissues and cells application process. (14) The clinical use of tissues and cells of human origin for human application may be constrained by limited availability. Therefore it would be desirable that the criteria for access to such tissues and cells are defined in a transparent manner, on the basis of an objective evaluation of medical needs. (15) It is necessary to increase confidence among the Member States in the quality and safety of donated tissues and cells, in the health protection of living donors and respect for deceased donors and in the safety of the application process. (16) Tissues and cells used for allogeneic therapeutic purposes can be procured from both living and deceased donors. In order to ensure that the health status of a living donor is not affected by the donation, a prior medical examination should be required. The dignity of the deceased donor should be respected, notably through the reconstruction of the donor's body, so that it is as similar as possible to its original anatomical shape. (17) The use of tissues and cells for application in the human body can cause diseases and unwanted effects. Most of these can be prevented by careful donor evaluation and the testing of each donation in accordance with rules established and updated according to the best available scientific advice. (18) As a matter of principle, tissue and cell application programmes should be founded on the philosophy of voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient. Member States are urged to take steps to encourage a strong public and non-profit sector involvement in the provision of tissue and cell application services and the related research and development. (19) Voluntary and unpaid tissue and cell donations are a factor which may contribute to high safety standards for tissues and cells and therefore to the protection of human health. (20) Any establishment may also be accredited as a tissue and cell establishment, provided it complies with the standards. (21) With due regard to the principle of transparency, all tissue establishments accredited, designated, authorised or licensed under the provisions of this Directive, including those manufacturing products from human tissues and cells, whether subject or not to other Community legislation, should have access to relevant tissues and cells procured in accordance with the provisions of this Directive, without prejudice to the provisions in force in Member States on the use of tissues and cells. (22) This Directive respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union(9) and takes into account as appropriate the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Neither the Charter nor the Convention makes express provision for harmonisation or prevents Member States from introducing more stringent requirements in their legislation. (23) All necessary measures need to be taken in order to provide prospective donors of tissues and cells with assurances regarding the confidentiality of any health-related information provided to the authorised personnel, the results of tests on their donations, as well as any future traceability of their donation. (24) 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 the free movement of such data(10) applies to personal data processed in application of this Directive. Article 8 of that directive prohibits in principle the processing of data concerning health. Limited exemptions to this prohibition principle are laid down. Directive 95/46/EC also provides for the controller to implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access and against all other unlawful forms of processing. (25) An accreditation system for tissue establishments and a system for notification of adverse events and reactions linked to the procurement, testing, processing, preservation, storage and distribution of human tissues and cells should be established in the Member States. (26) Member States should organise inspections and control measures, to be carried out by officials representing the competent authority, to ensure that tissue establishments comply with the provisions of this Directive. Member States should ensure that the officials involved in inspections and control measures are appropriately qualified and receive adequate training. (27) Personnel directly involved in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells should be appropriately qualified and provided with timely and relevant training. The provisions laid down in this Directive as regards training should be applicable without prejudice to existing Community legislation on the recognition of professional qualifications. (28) An adequate system to ensure the traceability of human tissues and cells should be established. This would also make it possible to verify compliance with quality and safety standards. Traceability should be enforced through accurate substance, donor, recipient, tissue establishment and laboratory identification procedures as well as record maintenance and an appropriate labelling system. (29) As a general principle, the identity of the recipient(s) should not be disclosed to the donor or his/her family and vice versa, without prejudice to legislation in force in Member States on the conditions of disclosure, which could authorise in exceptional cases, notably in the case of gametes donation, the lifting of donor anonymity. (30) In order to increase the effective implementation of the provisions adopted in accordance with this Directive, it is appropriate to provide for penalties to be applied by Member States. (31) Since the objective of this Directive, namely to set high standards of quality and safety for human tissues and cells throughout the Community, cannot be sufficiently achieved by the Member States and can therefore, by reason of scale and effects, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (32) It is necessary that the best possible scientific advice is available to the Community in relation to the safety of tissues and cells; in particular in order to assist the Commission in adapting the provisions of this Directive to scientific and technical progress in the light of the rapid advance in biotechnology knowledge and practice in the field of human tissues and cells. (33) The opinions of the Scientific Committee for Medicinal Products and Medical Devices and that of the European Group on Ethics in Science and New Technologies have been taken into account, as well as international experience in this field, and will be sought in the future whenever necessary. (34) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11), CHAPTER I GENERAL PROVISIONS Article 1 Objective This Directive lays down standards of quality and safety for human tissues and cells intended for human applications, in order to ensure a high level of protection of human health. Article 2 Scope 1. This Directive shall apply to the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications and of manufactured products derived from human tissues and cells intended for human applications. Where such manufactured products are covered by other directives, this Directive shall apply only to donation, procurement and testing. 2. This Directive shall not apply to: (a) tissues and cells used as an autologous graft within the same surgical procedure; (b) blood and blood components as defined by Directive 2002/98/EC; (c) organs or parts of organs if it is their function to be used for the same purpose as the entire organ in the human body. Article 3 Definitions For the purposes of this Directive: (a) "cells" means individual human cells or a collection of human cells when not bound by any form of connective tissue; (b) "tissue" means all constituent parts of the human body formed by cells; (c) "donor" means every human source, whether living or deceased, of human cells or tissues; (d) "donation" means donating human tissues or cells intended for human applications; (e) "organ" means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy; (f) "procurement" means a process by which tissue or cells are made available; (g) "processing" means all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications; (h) "preservation" means the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues; (i) "quarantine" means the status of retrieved tissue or cells, or tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection; (j) "storage" means maintaining the product under appropriate controlled conditions until distribution; (k) "distribution" means transportation and delivery of tissues or cells intended for human applications; (l) "human application" means the use of tissues or cells on or in a human recipient and extracorporal applications; (m) "serious adverse event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity; (n) "serious adverse reaction" means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity; (o) "tissue establishment" means a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells; (p) "allogeneic use" means cells or tissues removed from one person and applied to another; (q) "autologous use" means cells or tissues removed from and applied in the same person. Article 4 Implementation 1. Member States shall designate the competent authority or authorities responsible for implementing the requirements of this Directive. 2. This Directive shall not prevent a Member State from maintaining or introducing more stringent protective measures, provided that they comply with the provisions of the Treaty. In particular, a Member State may introduce requirements for voluntary unpaid donation, which include the prohibition or restriction of imports of human tissues and cells, to ensure a high level of health protection, provided that the conditions of the Treaty are met. 3. This Directive does not affect the decisions of the Member States prohibiting the donation, procurement, testing, processing, preservation, storage, distribution or use of any specific type of human tissues or cells or cells from any specified source, including where those decisions also concern imports of the same type of human tissues or cells. 4. In carrying out the activities covered by this Directive, the Commission may have recourse to technical and/or administrative assistance to the mutual benefit of the Commission and of the beneficiaries, relating to identification, preparation, management, monitoring, audit and control, as well as to support expenditure. CHAPTER II OBLIGATIONS ON MEMBER STATES' AUTHORITIES Article 5 Supervision of human tissue and cell procurement 1. Member States shall ensure that tissue and cell procurement and testing are carried out by persons with appropriate training and experience and that they take place in conditions accredited, designated, authorised or licensed for that purpose by the competent authority or authorities. 2. The competent authority or authorities shall take all necessary measures to ensure that tissue and cell procurement complies with the requirements referred to in Article 28(b), (e) and (f). The tests required for donors shall be carried out by a qualified laboratory accredited, designated, authorised or licensed by the competent authority or authorities. Article 6 Accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes 1. Member States shall ensure that all tissue establishments where activities of testing, processing, preservation, storage or distribution of human tissues and cells intended for human applications are undertaken have been accredited, designated, authorised or licensed by a competent authority for the purpose of those activities. 2. The competent authority or authorities, having verified that the tissue establishment complies with the requirements referred to in Article 28(a), shall accredit, designate, authorise or license the tissue establishment and indicate which activities it may undertake and which conditions apply. It or they shall authorise the tissue and cell preparation processes which the tissue establishment may carry out in accordance with the requirements referred to in Article 28(g). Agreements between tissue establishments and third parties, as referred to in Article 24, shall be examined within the framework of this procedure. 3. The tissue establishment shall not undertake any substantial changes to its activities without the prior written approval of the competent authority or authorities. 4. The competent authority or authorities may suspend or revoke the accreditation, designation, authorisation or licensing of a tissue establishment or of a tissue or cell preparation process if inspections or control measures demonstrate that such an establishment or process does not comply with the requirements of this Directive. 5. Some specified tissues and cells, which will be determined in accordance with the requirements referred to in Article 28(i), may, with the agreement of the competent authority or authorities, be distributed directly for immediate transplantation to the recipient as long as the supplier is provided with an accreditation, designation, authorisation or licence for this activity. Article 7 Inspections and control measures 1. Member States shall ensure that the competent authority or authorities organise inspections and that tissue establishments carry out appropriate control measures in order to ensure compliance with the requirements of this Directive. 2. Member States shall also ensure that appropriate control measures are in place for the procurement of human tissues and cells. 3. Inspections shall be organised and control measures shall be carried out by the competent authority or authorities on a regular basis. The interval between two inspections shall not exceed two years. 4. Such inspections and control measures shall be carried out by officials representing the competent authority, who shall be empowered to: (a) inspect tissue establishments and the facilities of any third parties as specified in Article 24; (b) evaluate and verify the procedures and the activities carried out in tissue establishments and the facilities of third parties that are relevant to the requirements of this Directive; (c) examine any documents or other records relating to the requirements of this Directive. 5. Guidelines concerning the conditions of the inspections and control measures, and on the training and qualification of the officials involved in order to reach a consistent level of competence and performance, shall be established in accordance with the procedure referred to in Article 29(2). 6. The competent authority or authorities shall organise inspections and carry out control measures as appropriate whenever there is any serious adverse reaction or serious adverse event. In addition, such an inspection shall be organised and control measures shall be carried out at the duly justified request of the competent authority or authorities in another Member State in any such case. 7. Member States shall, upon the request of another Member State or the Commission, provide information on the results of inspections and control measures carried out in relation to the requirements of this Directive. Article 8 Traceability 1. Member States shall ensure that all tissues and cells procured, processed, stored or distributed on their territory can be traced from the donor to the recipient and vice versa. This traceability shall also apply to all relevant data relating to products and materials coming into contact with these tissues and cells. 2. Member States shall ensure the implementation of a donor identification system which assigns a unique code to each donation and to each of the products associated with it. 3. All tissues and cells must be identified with a label that contains the information or references allowing a link to the information referred to in Article 28(f) and (h). 4. Tissue establishments shall keep the data necessary to ensure traceability at all stages. Data required for full traceability shall be kept for a minimum of 30 years after clinical use. Data storage may also be in electronic form. 5. The traceability requirements for tissues and cells, as well as for products and materials coming into contact with these tissues and cells and having an effect on their quality and safety, shall be established by the Commission in accordance with the procedure referred to in Article 29(2). 6. The procedures for ensuring traceability at Community level shall be established by the Commission in accordance with the procedure referred to in Article 29(2). Article 9 Import/export of human tissues and cells 1. Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive. 2. Member States shall take all necessary measures to ensure that all exports of tissues and cells to third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities. Those Member States that send such exports to third countries shall ensure that the exports comply with the requirements of this Directive. 3. (a) The import or export of tissues and cells referred to in Article 6(5) may be authorised directly by the competent authority or authorities. (b) In case of emergency, the import or export of certain tissues and cells may be authorised directly by the competent authority or authorities. (c) The competent authority or authorities shall take all necessary measures to ensure that imports and exports of tissues and cells referred to in subparagraphs (a) and (b) meet quality and safety standards equivalent to those laid down in this Directive. 4. The procedures for verifying the equivalent standards of quality and safety in accordance with paragraph 1 shall be established by the Commission, in accordance with the procedure referred to in Article 29(2). Article 10 Register of tissue establishments and reporting obligations 1. Tissue establishments shall keep a record of their activities, including the types and quantities of tissues and/or cells procured, tested, preserved, processed, stored and distributed, or otherwise disposed of, and on the origin and destination of the tissues and cells intended for human applications, in accordance with the requirements referred to in Article 28(f). They shall submit to the competent authority or authorities an annual report on these activities. This report shall be publicly accessible. 2. The competent authority or authorities shall establish and maintain a publicly accessible register of tissue establishments specifying the activities for which they have been accredited, designated, authorised or licensed. 3. Member States and the Commission shall establish a network linking the national tissue establishment registers. Article 11 Notification of serious adverse events and reactions 1. Member States shall ensure that there is a system in place to report, investigate, register and transmit information about serious adverse events and reactions which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, storage and distribution of tissues and cells, as well as any serious adverse reaction observed during or after clinical application which may be linked to the quality and safety of tissues and cells. 2. All persons or establishments using human tissues and cells regulated by this Directive shall report any relevant information to establishments engaged in the donation, procurement, testing, processing, storage and distribution of human tissues and cells in order to facilitate traceability and ensure quality and safety control. 3. The responsible person referred to in Article 17 shall ensure that the competent authority or authorities is or are notified of any serious adverse events and reactions referred to in paragraph 1 and is or are provided with a report analysing the cause and the ensuing outcome. 4. The procedure for notifying serious adverse events and reactions shall be established by the Commission, in accordance with the procedure referred to in Article 29(2). 5. Each tissue establishment shall ensure that an accurate, rapid and verifiable procedure is in place which will enable it to recall from distribution any product which may be related to an adverse event or reaction. CHAPTER III DONOR SELECTION AND EVALUATION Article 12 Principles governing tissue and cell donation 1. Member States shall endeavour to ensure voluntary and unpaid donations of tissues and cells. Donors may receive compensation, which is strictly limited to making good the expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation may be granted. Member States shall report to the Commission on these measures before 7 April 2006 and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measures it intends to take at Community level. 2. Member States shall take all necessary measures to ensure that any promotion and publicity activities in support of the donation of human tissues and cells comply with guidelines or legislative provisions laid down by the Member States. Such guidelines or legislative provisions shall include appropriate restrictions or prohibitions on advertising the need for, or availability of, human tissues and cells with a view to offering or seeking financial gain or comparable advantage. Member States shall endeavour to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis. Article 13 Consent 1. The procurement of human tissues or cells shall be authorised only after all mandatory consent or authorisation requirements in force in the Member State concerned have been met. 2. Member States shall, in keeping with their national legislation, take all necessary measures to ensure that donors, their relatives or any persons granting authorisation on behalf of the donors are provided with all appropriate information as referred to in the Annex. Article 14 Data protection and confidentiality 1. Member States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive and to which third parties have access, have been rendered anonymous so that neither donors nor recipients remain identifiable. 2. For that purpose, they shall ensure that: (a) data security measures are in place, as well as safeguards against any unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information; (b) procedures are in place to resolve data discrepancies; and (c) no unauthorised disclosure of information occurs, whilst guaranteeing the traceability of donations. 3. Member States shall take all necessary measures to ensure that the identity of the recipient(s) is not disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions for disclosure, notably in the case of gametes donation. Article 15 Selection, evaluation and procurement 1. The activities related to tissue procurement shall be carried out in such a way as to ensure that donor evaluation and selection is carried out in accordance with the requirements referred to in Article 28(d) and (e) and that the tissues and cells are procured, packaged and transported in accordance with the requirements referred to in Article 28(f). 2. In the case of an autologous donation, the suitability criteria shall be established in accordance with the requirements referred to in Article 28(d). 3. The results of the donor evaluation and testing procedures shall be documented and any major anomalies shall be reported in accordance with the requirements referred to in the Annex. 4. The competent authority or authorities shall ensure that all activities related to tissue procurement are carried out in accordance with the requirements referred to in Article 28(f). CHAPTER IV PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS Article 16 Quality management 1. Member States shall take all necessary measures to ensure that each tissue establishment puts in place and updates a quality system based on the principles of good practice. 2. The Commission shall establish the Community standards and specifications referred to in Article 28(c) for activities relating to a quality system. 3. Tissue establishments shall take all necessary measures to ensure that the quality system includes at least the following documentation: - standard operating procedures, - guidelines, - training and reference manuals, - reporting forms, - donor records, - information on the final destination of tissues or cells. 4. Tissue establishments shall take all necessary measures to ensure that this documentation is available for inspection by the competent authority or authorities. 5. Tissue establishments shall keep the data necessary to ensure traceability in accordance with Article 8. Article 17 Responsible person 1. Every tissue establishment shall designate a responsible person who shall at least fulfil the following conditions and have the following qualifications: (a) possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned; (b) at least two years' practical experience in the relevant fields. 2. The person designated in paragraph 1 shall be responsible for: (a) ensuring that human tissues and cells intended for human applications in the establishment for which that person is responsible are procured, tested, processed, stored and distributed in accordance with this Directive and with the laws in force in the Member State; (b) providing information to the competent authority or authorities as required in Article 6; (c) implementing the requirements of Articles 7, 10, 11, 15, 16 and 18 to 24 within the tissue establishment. 3. Tissue establishments shall inform the competent authority or authorities of the name of the responsible person referred to in paragraph 1. Where the responsible person is permanently or temporarily replaced, the tissue establishment shall immediately inform the competent authority of the name of the new responsible person and the date on which the duties of that person commence. Article 18 Personnel Personnel directly involved in activities relating to the procurement, processing, preservation, storage and distribution of tissues and cells in a tissue establishment shall be qualified to perform such tasks and shall be provided with the training referred to in Article 28(c). Article 19 Tissue and cell reception 1. Tissue establishments shall ensure that all donations of human tissues and cells are subjected to tests in accordance with the requirements referred to Article 28(e) and that the selection and acceptance of tissues and cells comply with the requirements referred to in Article 28(f). 2. Tissue establishments shall ensure that human tissue and cells and associated documentation comply with the requirements referred to in Article 28(f). 3. Tissue establishments shall verify and record the fact that the packaging of human tissue and cells received complies with the requirements referred to in Article 28(f). All tissues and cells that do not comply with those provisions shall be discarded. 4. The acceptance or rejection of received tissues/cells shall be documented. 5. Tissue establishments shall ensure that human tissues and cells are correctly identified at all times. Each delivery or batch of tissues or cells shall be assigned an identifying code, in accordance with Article 8. 6. Tissue and cells shall be held in quarantine until such time as the requirements relating to donor testing and information have been met in accordance with Article 15. Article 20 Tissue and cell processing 1. Tissue establishments shall include in their standard operating procedures all processes that affect quality and safety and shall ensure that they are carried out under controlled conditions. Tissue establishments shall ensure that the equipment used, the working environment and process design, validation and control conditions are in compliance with the requirements referred to in Article 28(h). 2. Any modifications to the processes used in the preparation of tissues and cells shall also meet the criteria laid down in paragraph 1. 3. Tissue establishments shall include in their standard operating procedures special provisions for the handling of tissues and cells to be discarded, in order to prevent the contamination of other tissues or cells, the processing environment or personnel. Article 21 Tissue and cell storage conditions 1. Tissue establishments shall ensure that all procedures associated with the storage of tissues and cells are documented in the standard operating procedures and that the storage conditions comply with the requirements referred to in Article 28(h). 2. Tissue establishments shall ensure that all storage processes are carried out under controlled conditions. 3. Tissue establishments shall establish and apply procedures for the control of packaging and storage areas, in order to prevent any situation arising that might adversely affect the functioning or integrity of tissues and cells. 4. Processed tissues or cells shall not be distributed until all the requirements laid down in this Directive have been met. 5. Member States shall ensure that tissue establishments have agreements and procedures in place to ensure that, in the event of termination of activities for whatever reason, stored tissues and cells shall be transferred to other tissue establishment or establishments accredited, designated, authorised or licensed in accordance with Article 6, without prejudice to Member States' legislation concerning the disposal of donated tissues or cells, according to the consent pertaining to them. Article 22 Labelling, documentation and packaging Tissue establishments shall ensure that labelling, documentation and packaging conform to the requirements referred to in Article 28(f). Article 23 Distribution Tissue establishments shall ensure the quality of tissues and cells during distribution. Distribution conditions shall comply with the requirements referred to in Article 28(h). Article 24 Relations between tissue establishments and third parties 1. Tissue establishments shall establish written agreements with a third party each time an external activity takes place which influences the quality and safety of tissues and cells processed in cooperation with a third party, and in particular in the following circumstances: (a) where a tissue establishment entrusts one of the stages of tissue or cell processing to a third party; (b) where a third party provides goods and services that affect tissue or cell quality and safety assurance, including their distribution; (c) where a tissue establishment provides services to a tissue establishment which is not accredited; (d) where a tissue establishment distributes tissue or cells processed by third parties. 2. Tissue establishments shall evaluate and select third parties on the basis of their ability to meet the standards laid down in this Directive. 3. Tissue establishments shall keep a complete list of the agreements referred to in paragraph 1 that they have established with third parties. 4. Agreements between tissue establishments and third parties shall specify the responsibilities of the third parties and detailed procedures. 5. Tissue establishments shall provide copies of agreements with third parties at the request of the competent authority or authorities. CHAPTER V EXCHANGE OF INFORMATION, REPORTS AND PENALTIES Article 25 Coding of information 1. Member States shall establish a system for the identification of human tissues and cells, in order to ensure the traceability of all human tissues and cells pursuant to Article 8. 2. The Commission, in cooperation with the Member States, shall design a single European coding system to provide information on the main characteristics and properties of tissues and cells. Article 26 Reports 1. Member States shall send the Commission, before 7 April 2009 and every three years thereafter, a report on the activities undertaken in relation to the provisions of this Directive, including an account of the measures taken in relation to inspection and control. 2. The Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions the reports submitted by the Member States on experience gained in implementing this Directive. 3. Before 7 April 2008 and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of the requirements of this Directive, in particular as regards inspection and monitoring. Article 27 Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 7 April 2006 and shall notify it without delay of any subsequent amendments affecting them. CHAPTER VI CONSULTATION OF COMMITTEES Article 28 Technical requirements and their adaptation to scientific and technical progress The following technical requirements and their adaptation to scientific and technical progress shall be decided in accordance with the procedure referred to in Article 29(2): (a) requirements for the accreditation, designation, authorisation or licensing of tissue establishments; (b) requirements for the procurement of human tissues and cells; (c) quality system, including training; (d) selection criteria for the donor of tissues and/or cells; (e) laboratory tests required for donors; (f) cell and/or tissue procurement procedures and reception at the tissue establishment; (g) requirements for the tissue and cell preparation process; (h) tissue and cell processing, storage and distribution; (i) requirements for the direct distribution to the recipient of specific tissues and cells. Article 29 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 30 Consultation of one or more scientific committees The Commission may consult the relevant scientific committee(s) when defining or adapting the technical requirements referred to in Article 28 to scientific and technical progress. CHAPTER VII FINAL PROVISIONS Article 31 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 April 2006. 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 may decide for one year after the date laid down in the first subparagraph of paragraph 1 not to apply the requirements of this Directive to tissue establishments bound by national provisions before the entry into force of this Directive. 3. Member States shall communicate to the Commission the texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive. Article 32 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 33 Addressees This Directive is addressed to the Member States.

32004L0024

2004

Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Directive 2001/83/EC(4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy. (2) Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC, he/she should not be required to provide the results of pre-clinical tests or the results of clinical trials. (3) A significant number of medicinal products, despite their long tradition, do not fulfil the requirements of a well-established medicinal use with recognised efficacy and an acceptable level of safety and are not eligible for a marketing authorisation. To maintain these products on the market, the Member States have enacted differing procedures and provisions. The differences that currently exist between the provisions laid down in the Member States may hinder trade in traditional medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers of these products. They may also have an impact on the protection of public health since the necessary guarantees of quality, safety and efficacy are not always provided at present. (4) Having regard to the particular characteristics of these medicinal products, especially their long tradition, it is desirable to provide a special, simplified registration procedure for certain traditional medicinal products. However, this simplified procedure should be used only where no marketing authorisation can be obtained pursuant to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety. It should likewise not apply to homeopathic medicinal products eligible for marketing authorisation or for registration under Directive 2001/83/EC. (5) The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use. However, even a long tradition does not exclude the possibility that there may be concerns with regard to the product's safety, and therefore the competent authorities should be entitled to ask for all data necessary for assessing the safety. The quality aspect of the medicinal product is independent of its traditional use so that no derogation should be made with regard to the necessary physico-chemical, biological and microbiological tests. Products should comply with quality standards in relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a Member State. (6) The vast majority of medicinal products with a sufficiently long and coherent tradition are based on herbal substances. It therefore seems appropriate to limit the scope of the simplified registration in a first step to traditional herbal medicinal products. (7) The simplified registration should be acceptable only where the herbal medicinal product may rely on a sufficiently long medicinal use in the Community. Medicinal use outside the Community should be taken into account only if the medicinal product has been used within the Community for a certain time. Where there is limited evidence of use within the Community, it is necessary to assess carefully the validity and relevance of use outside the Community. (8) With the objective of further facilitating the registration of certain traditional herbal medicinal products and of further enhancing harmonisation, there should be the possibility of establishing a Community list of herbal substances that fulfil certain criteria, such as having been in medicinal use for a sufficiently long time, and hence are considered not to be harmful under normal conditions of use. (9) Having regard to the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products should be established within the European Agency for the Evaluation of Medicinal Products (hereinafter "the Agency") set up by Council Regulation (EEC) No 2309/93(5). The Committee should carry out tasks concerning the simplified registration and authorisation of medicinal products as provided for in this Directive. Its tasks should relate in particular to establishing Community herbal monographs relevant for the registration as well as the authorisation of herbal medicinal products. It should be composed of experts in the field of herbal medicinal products. (10) It is important to ensure full consistency between the new Committee and the Committee for Human Medicinal Products already existing within the Agency. (11) In order to promote harmonisation, Member States should recognise registrations of traditional herbal medicinal products granted by another Member State based on Community herbal monographs or consisting of substances, preparations or combinations thereof contained in a list to be established. For other products, Member States should take due account of such registrations. (12) This Directive allows non-medicinal herbal products, fulfilling the criteria of food legislation, to be regulated under food legislation in the Community. (13) The Commission should present a report on the application of the chapter on traditional herbal medicinal products to the European Parliament and to the Council including an assessment on the possible extension of traditional-use registration to other categories of medicinal products. (14) It is therefore appropriate to amend Directive 2001/83/EC accordingly, Article 1 Directive 2001/83/EC is hereby amended as follows: 1. in Article 1 the following is added: "29. Traditional herbal medicinal product: a herbal medicinal product that fulfils the conditions laid down in Article 16a(1); 30. Herbal medicinal product: any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations; 31. Herbal substances: All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author); 32. Herbal preparations: preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates." 2. The following chapter is inserted in Title III: "CHAPTER 2a Specific provisions applicable to traditional herbal medicinal products Article 16a 1. A simplified registration procedure (hereinafter 'traditional-use registration') is hereby established for herbal medicinal products which fulfil all of the following criteria: (a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment; (b) they are exclusively for administration in accordance with a specified strength and posology; (c) they are an oral, external and/or inhalation preparation; (d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed; (e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience. 2. Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). 3. However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall not apply. Article 16b 1. The applicant and registration holder shall be established in the Community. 2. In order to obtain traditional-use registration, the applicant shall submit an application to the competent authority of the Member State concerned. Article 16c 1. The application shall be accompanied by: (a) the particulars and documents: (i) referred to in Article 8(3)(a) to (h), (j) and (k); (ii) the results of the pharmaceutical tests referred to in the second indent of Article 8(3)(i); (iii) the summary of product characteristics, without the data specified in Article 11(4); (iv) in case of combinations, as referred to in Article 1(30) or Article 16a(2), the information referred to in Article 16a(1)(e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data shall also relate to the individual active ingredients; (b) any authorisation or registration obtained by the applicant in another Member State, or in a third country, to place the medicinal product on the market, and details of any decision to refuse to grant an authorisation or registration, whether in the Community or a third country, and the reasons for any such decision; (c) bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community. At the request of the Member State where the application for traditional-use registration has been submitted, the Committee for Herbal Medicinal Products shall draw up an opinion on the adequacy of the evidence of the long-standing use of the product, or of the corresponding product. The Member State shall submit relevant documentation supporting the referral; (d) a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional request, data necessary for assessing the safety of the medicinal product. Annex I shall apply by analogy to the particulars and documents specified in point (a). 2. A corresponding product, as referred to in paragraph 1(c), is characterised by having the same active ingredients, irrespective of the excipients used, the same or similar intended purpose, equivalent strength and posology and the same or similar route of administration as the medicinal product applied for. 3. The requirement to show medicinal use throughout the period of 30 years, referred to in paragraph 1(c), is satisfied even where the marketing of the product has not been based on a specific authorisation. It is likewise satisfied if the number or quantity of ingredients of the medicinal product has been reduced during that period. 4. Where the product has been used in the Community for less than 15 years, but is otherwise eligible for simplified registration, the Member State where the application for traditional-use registration has been submitted shall refer the product to the Committee for Herbal Medicinal Products. The Member State shall submit relevant documentation supporting the referral. The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be taken into account by the Member State when taking its final decision. Article 16d 1. Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that: (a) a Community herbal monograph has been established in accordance with Article 16h(3), or (b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f. 2. For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter. Article 16e 1. Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b or 16c or if at least one of the following conditions is fulfilled: (a) the qualitative and/or quantitative composition is not as declared; (b) the indications do not comply with the conditions laid down in Article 16a; (c) the product could be harmful under normal conditions of use; (d) the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience; (e) the pharmaceutical quality is not satisfactorily demonstrated. 2. The competent authorities of the Member States shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional-use registration and the reasons for the refusal. Article 16f 1. A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products shall be established in accordance with the procedure referred to in Article 121(2). The list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product. 2. If an application for traditional-use registration relates to a herbal substance, preparation or a combination thereof contained in the list referred to in paragraph 1, the data specified in Article 16c(1)(b)(c) and (d) do not need to be provided. Article 16e(1)(c) and (d) shall not apply. 3. If a herbal substance, preparation or a combination thereof ceases to be included in the list referred to in paragraph 1, registrations pursuant to paragraph 2 for herbal medicinal products containing this substance shall be revoked unless the particulars and documents referred to in Article 16c(1) are submitted within three months. Article 16g 1. Articles 3(1) and (2), 4(4), 6(1), 12, 17(1), 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112, 116 to 118, 122, 123, 125, 126, second subparagraph, and 127 of this Directive as well as Commission Directive 91/356/EEC(6) shall apply, by analogy, to traditional-use registration granted under this chapter. 2. In addition to the requirements of Articles 54 to 65, any labelling and user package leaflet shall contain a statement to the effect that: (a) the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and (b) the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur. A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question. 3. In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use. Article 16h 1. A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency and shall have the following competence: (a) as regards simplified registrations, to: - perform the tasks arising from Article 16c(1) and (4), - perform the tasks arising from Article 16d, - prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1), and - establish Community monographs for traditional herbal medicinal products, as referred to in paragraph 3 of this Article; (b) as regards authorisations of herbal medicinal products, to establish Community herbal monographs for herbal medicinal products, as referred to in paragraph 3 of this Article; (c) as regards referrals to the Agency under Chapter 4 of Title III, in relation to herbal medicinal products as referred to in Article 16a, to perform the tasks set out in Article 32; (d) where other medicinal products containing herbal substances are referred to the Agency under Chapter 4 of Title III, to give an opinion on the herbal substance where appropriate. Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law. The appropriate coordination with the Committee for Human Medicinal Products shall be ensured by a procedure to be determined by the Executive Director of the Agency in accordance with Article 57(2) of Regulation (EEC) No 2309/93. 2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Herbal Medicinal Products. The alternates shall represent and vote for the members in their absence. Members and alternates shall be chosen for their role and experience in the evaluation of herbal medicinal products and shall represent the competent national authorities. The said Committee may coopt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. With a view to the coopting of such members, the said Committee shall identify the specific complementary scientific competence of the additional member(s). Coopted members shall be chosen among experts nominated by Member States or the Agency. The members of the said Committee may be accompanied by experts in specific scientific or technical fields. 3. The Committee for Herbal Medicinal Products shall establish Community herbal monographs for herbal medicinal products with regard to the application of Article 10(1)(a)(ii) as well as traditional herbal medicinal products. The said Committee shall fulfil further responsibilities conferred upon it by provisions of this chapter and other Community law. When Community herbal monographs within the meaning of this paragraph have been established, they shall be taken into account by the Member States when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to. When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the competent authority of the Member State concerned. The herbal monographs shall be published. 4. The general provisions of Regulation (EEC) No 2309/93 relating to the Committee for Human Medicinal Products shall apply by analogy to the Committee for Herbal Medicinal Products. Article 16i Before 30 April 2007, the Commission shall submit a report to the European Parliament and to the Council concerning the application of the provisions of this chapter. The report shall include an assessment on the possible extension of traditional-use registration to other categories of medicinal products." Article 2 1. The Member States shall take the necessary measures to comply with this Directive by 30 October 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. For the traditional herbal medicinal products as referred to in Article 1, which are already on the market on the entry into force of this Directive, the competent authorities shall apply the provisions of this Directive within seven years after its entry into force. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0043

2004

Commission Directive 2004/43/EC of 13 April 2004 amending Directive 98/53/EC and Directive 2002/26/EC as regards sampling methods and methods of analysis for the official control of the levels of aflatoxin and ochratoxin A in food for infants and young children (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(2) fixes maximum limits for aflatoxin B1, aflatoxin M1 and ochratoxin A in food for infants and young children. (2) Sampling plays a crucial part in the precision of the determination of the levels of aflatoxins and ochratoxin A. Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels of certain contaminants in foodstuffs(3) and Commission Directive 2002/26/EC of 13 March 2002 laying down the sampling methods and methods of analysis for the official control of the levels of ochratoxin A in foodstuffs(4) should be amended to include provisions related to food for infants and young children. (3) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the European Union. These interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply. (4) Directives 98/53/EC and 2002/26/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annexes I and II to Directive 98/53/EC are amended as set out in Annex I to this Directive. Article 2 Annexes I and II to Directive 2002/26/EC are amended as set out in Annex II to this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after its entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0044

2004

Commission Directive 2004/44/EC of 13 April 2004 amending Directive 2002/69/EC laying down the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof, Whereas: (1) Commission Directive 2002/69/EC of 30 July 2002 laying down the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs(2) establishes specific provisions concerning the sampling procedure and the methods of analysis to be applied for official control. (2) For the sampling of very large fish, it is necessary that the sampling is specified in order to ensure a harmonised approach throughout the Community. (3) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the Union. (4) Directive 2002/69/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/69/EC is amended as set out in Annex I to this Directive. Annex II to Directive 2002/69/EC is amended as set out in Annex II to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0045

2004

COMMISSION DIRECTIVE 2004/45/EC of 16 April 2004 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) 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 authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof, After consulting the Scientific Committee on Food, Whereas: (1) Commission Directive 96/77/EC (2) of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners sets out the purity criteria for the additives mentioned in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (3). (2) The Scientific Committee on Food concluded in its opinion of 5 March 2003 that the presence of low molecular weight carrageenan should be kept to a minimum. Consequently, the relevant criterion of the existing purity criteria for E 407 Carrageenan and E 407a (Processed Eucheuma Seaweed) set out in Directive 96/77/EC needs to be adapted. (3) It is necessary to adopt specifications for the new additives authorised through Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95/2/EC on food additives other than colours and sweeteners: E 907 Hydrogenated poly-1-decene, E 1517 Glyceryl diacetate and E 1519 Benzyl alcohol. (4) It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (5) Directive 96/77/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 96/77/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 to comply with this Directive by 1 April 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 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. Member States shall determine how such reference is to be made. 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 Products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0047

2004

Commission Directive 2004/47/EC of 16 April 2004 amending Directive 95/45/EC as regards mixed carotenes (E 160 a (i)) and beta-carotene (E 160 a (ii)) (Text with EEA relevance) 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 authorised for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof, After consulting the Scientific Committee for Food, Whereas: (1) Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs(2) sets out the purity criteria for the colours mentioned in Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs(3). (2) It is necessary, in the light of technical progress, to amend the purity criteria set out in Directive 95/45/EC for mixed carotenes (E 160 a (i)) and beta-carotene (E 160 a (ii)). (3) It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (4) Directive 95/45/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 95/45/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 to comply with this Directive by 1 April 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 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. Member States shall determine how such reference is to be made. 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 Products on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0046

2004

Commission Directive 2004/46/EC of 16 April 2004 amending Directive 95/31/EC as regards E 955 sucralose and E 962 salt of aspartame-acesulfame (Text with EEA relevance) 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 authorised for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof, After consulting the Scientific Committee on Food, Whereas: (1) Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs(2) sets out the purity criteria for the sweeteners mentioned in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs(3). (2) It is necessary to establish purity criteria for E 955 sucralose and E 962 salt of aspartame-acesulfame. (3) It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (4) Directive 95/31/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 95/31/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 to comply with this Directive by 1 April 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 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. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0055

2004

Commission Directive 2004/55/EC of 20 April 2004 amending Council Directive 66/401/EEC on the marketing of fodder plant seed (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed(1), and in particular Article 2(1a) and 21a thereof, Whereas: (1) Directive 66/401/EEC contains a list of the genera and species of plants which are considered as fodder plants within the meaning of that Directive. That list includes hybrids resulting from the crossing of meadow fescue (Festuca pratensis Hudson) with Italian ryegrass (Lolium multiflorum Lam). (2) The scope of Directive 66/401/EEC should be extended to cover crossings of Festuca spp. with Lolium spp. (3) The abovementioned directive, within the conditions to be satisfied by the seed, has established the minimum germination ( % of pure seed) of seed of field bean (Vicia faba L.). (4) The minimum germination of seed of field beans (Vicia faba L.) currently achieved in the Community is lower than that required by Directive 66/401/EEC. (5) Directive 66/401/EEC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 Directive 66/401/EEC is amended as follows: 1. in point (a) of Part A of paragraph 1 of Article 2 the words ">TABLE>" are replaced by the words ">TABLE>" 2. Annexes II and IV are amended as follows: (a) in column 2 of the table in Section I.2.A of Annex II, in the entry relating to Vicia faba, "85" is replaced by "80". (b) in point I (a) 4 and (c) 4 of Section A of Annex IV the following sentence is added: "In the case of x Festulolium the names of the species within the genus Festuca and Lolium shall be indicated" Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 3 This Directive is addressed to the Member States.

32004L0039

2004

Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC Having regard to the Treaty establishing the European Community, and in particular Article 47(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), Having regard to the opinion of the European Central Bank(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(5) sought to establish the conditions under which authorised investment firms and banks could provide specified services or establish branches in other Member States on the basis of home country authorisation and supervision. To this end, that Directive aimed to harmonise the initial authorisation and operating requirements for investment firms including conduct of business rules. It also provided for the harmonisation of some conditions governing the operation of regulated markets. (2) In recent years more investors have become active in the financial markets and are offered an even more complex wide-ranging set of services and instruments. In view of these developments the legal framework of the Community should encompass the full range of investor-oriented activities. To this end, it is necessary to provide for the degree of harmonisation needed to offer investors a high level of protection and to allow investment firms to provide services throughout the Community, being a Single Market, on the basis of home country supervision. In view of the preceding, Directive 93/22/EEC should be replaced by a new Directive. (3) Due to the increasing dependence of investors on personal recommendations, it is appropriate to include the provision of investment advice as an investment service requiring authorisation. (4) It is appropriate to include in the list of financial instruments certain commodity derivatives and others which are constituted and traded in such a manner as to give rise to regulatory issues comparable to traditional financial instruments. (5) It is necessary to establish a comprehensive regulatory regime governing the execution of transactions in financial instruments irrespective of the trading methods used to conclude those transactions so as to ensure a high quality of execution of investor transactions and to uphold the integrity and overall efficiency of the financial system. A coherent and risk-sensitive framework for regulating the main types of order-execution arrangement currently active in the European financial marketplace should be provided for. It is necessary to recognise the emergence of a new generation of organised trading systems alongside regulated markets which should be subjected to obligations designed to preserve the efficient and orderly functioning of financial markets. With a view to establishing a proportionate regulatory framework provision should be made for the inclusion of a new investment service which relates to the operation of an MTF. (6) Definitions of regulated market and MTF should be introduced and closely aligned with each other to reflect the fact that they represent the same organised trading functionality. The definitions should exclude bilateral systems where an investment firm enters into every trade on own account and not as a riskless counterparty interposed between the buyer and seller. The term "system" encompasses all those markets that are composed of a set of rules and a trading platform as well as those that only function on the basis of a set of rules. Regulated markets and MTFs are not obliged to operate a "technical" system for matching orders. A market which is only composed of a set of rules that governs aspects related to membership, admission of instruments to trading, trading between members, reporting and, where applicable, transparency obligations is a regulated market or an MTF within the meaning of this Directive and the transactions concluded under those rules are considered to be concluded under the systems of a regulated market or an MTF. The term "buying and selling interests" is to be understood in a broad sense and includes orders, quotes and indications of interest. The requirement that the interests be brought together in the system by means of non-discretionary rules set by the system operator means that they are brought together under the system's rules or by means of the system's protocols or internal operating procedures (including procedures embodied in computer software). The term "non-discretionary rules" means that these rules leave the investment firm operating an MTF with no discretion as to how interests may interact. The definitions require that interests be brought together in such a way as to result in a contract, meaning that execution takes place under the system's rules or by means of the system's protocols or internal operating procedures. (7) The purpose of this Directive is to cover undertakings the regular occupation or business of which is to provide investment services and/or perform investment activities on a professional basis. Its scope should not therefore cover any person with a different professional activity. (8) Persons administering their own assets and undertakings, who do not provide investment services and/or perform investment activities other than dealing on own account unless they are market makers or they dealon own account outside a regulated market or an MTF on an organised, frequent and systematic basis, by providing a system accessible to third parties in order to engage in dealings with them should not be covered by the scope of this Directive. (9) References in the text to persons should be understood as including both natural and legal persons. (10) Insurance or assurance undertakings the activities of which are subject to appropriate monitoring by the competent prudential-supervision authorities and which are subject to Council Directive 64/225/EEC of 25 February 1964 on the abolition of restrictions on freedom of establishment and freedom to provide services in respect of reinsurance and retrocession(6), First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of direct insurance other than life assurance(7) and Council Directive 2002/83/EC of 5 November 2002 concerning life assurance(8) should be excluded. (11) Persons who do not provide services for third parties but whose business consists in providing investment services solely for their parent undertakings, for their subsidiaries, or for other subsidiaries of their parent undertakings should not be covered by this Directive. (12) Persons who provide investment services only on an incidental basis in the course of professional activity should also be excluded from the scope of this Directive, provided that activity is regulated and the relevant rules do not prohibit the provision, on an incidental basis, of investment services. (13) Persons who provide investment services consisting exclusively in the administration of employee-participation schemes and who therefore do not provide investment services for third parties should not be covered by this Directive. (14) It is necessary to exclude from the scope of this Directive central banks and other bodies performing similar functions as well as public bodies charged with or intervening in the management of the public debt, which concept covers the investment thereof, with the exception of bodies that are partly or wholly State-owned the role of which is commercial or linked to the acquisition of holdings. (15) It is necessary to exclude from the scope of this Directive collective investment undertakings and pension funds whether or not coordinated at Community level, and the depositaries or managers of such undertakings, since they are subject to specific rules directly adapted to their activities. (16) In order to benefit from the exemptions from this Directive the person concerned should comply on a continuous basis with the conditions laid down for such exemptions. In particular, if a person provides investment services or performs investment activities and is exempted from this Directive because such services or activities are ancillary to his main business, when considered on a group basis, he should no longer be covered by the exemption related to ancillary services where the provision of those services or activities ceases to be ancillary to his main business. (17) Persons who provide the investment services and/or perform investment activities covered by this Directive should be subject to authorisation by their home Member States in order to protect investors and the stability of the financial system. (18) Credit institutions that are authorised under Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions(9) should not need another authorisation under this Directive in order to provide investment services or perform investment activities. When a credit institution decides to provide investment services or perform investment activities the competent authorities, before granting an authorisation, should verify that it complies with the relevant provisions of this Directive. (19) In cases where an investment firm provides one or more investment services not covered by its authorisation, or performs one or more investment activities not covered by its authorisation, on a non-regular basis it should not need an additional authorisation under this Directive. (20) For the purposes of this Directive, the business of the reception and transmission of orders should also include bringing together two or more investors thereby bringing about a transaction between those investors. (21) In the context of the forthcoming revision of the Capital Adequacy framework in Basel II, Member States recognise the need to re-examine whether or not investment firms who execute client orders on a matched principal basis are to be regarded as acting as principals, and thereby be subject to additional regulatory capital requirements. (22) The principles of mutual recognition and of home Member State supervision require that the Member States' competent authorities should not grant or should withdraw authorisation where factors such as the content of programmes of operations, the geographical distribution or the activities actually carried on indicate clearly that an investment firm has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within the territory of which it intends to carry on or does carry on the greater part of its activities. An investment firm which is a legal person should be authorised in the Member State in which it has its registered office. An investment firm which is not a legal person should be authorised in the Member State in which it has its head office. In addition, Member States should require that an investment firm's head office must always be situated in its home Member State and that it actually operates there. (23) An investment firm authorised in its home Member State should be entitled to provide investment services or perform investment activities throughout the Community without the need to seek a separate authorisation from the competent authority in the Member State in which it wishes to provide such services or perform such activities. (24) Since certain investment firms are exempted from certain obligations imposed by Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions(10), they should be obliged to hold either a minimum amount of capital or professional indemnity insurance or a combination of both. The adjustments of the amounts of that insurance should take into account adjustments made in the framework of Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation(11). This particular treatment for the purposes of capital adequacy should be without prejudice to any decisions regarding the appropriate treatment of these firms under future changes to Community legislation on capital adequacy. (25) Since the scope of prudential regulation should be limited to those entities which, by virtue of running a trading book on a professional basis, represent a source of counterparty risk to other market participants, entities which deal on own account in financial instruments, including those commodity derivatives covered by this Directive, as well as those that provide investment services in commodity derivatives to the clients of their main business on an ancillary basis to their main business when considered on a group basis, provided that this main business is not the provision of investment services within the meaning of this Directive, should be excluded from the scope of this Directive. (26) In order to protect an investor's ownership and other similar rights in respect of securities and his rights in respect of funds entrusted to a firm those rights should in particular be kept distinct from those of the firm. This principle should not, however, prevent a firm from doing business in its name but on behalf of the investor, where that is required by the very nature of the transaction and the investor is in agreement, for example stock lending. (27) Where a client, in line with Community legislation and in particular Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements(12), transfers full ownership of financial instruments or funds to an investment firm for the purpose of securing or otherwise covering present or future, actual or contingent or prospective obligations, such financial instruments or funds should likewise no longer be regarded as belonging to the client. (28) The procedures for the authorisation, within the Community, of branches of investment firms authorised in third countries should continue to apply to such firms. Those branches should not enjoy the freedom to provide services under the second paragraph of Article 49 of the Treaty or the right of establishment in Member States other than those in which they are established. In view of cases where the Community is not bound by any bilateral or multilateral obligations it is appropriate to provide for a procedure intended to ensure that Community investment firms receive reciprocal treatment in the third countries concerned. (29) The expanding range of activities that many investment firms undertake simultaneously has increased potential for conflicts of interest between those different activities and the interests of their clients. It is therefore necessary to provide for rules to ensure that such conflicts do not adversely affect the interests of their clients. (30) A service should be considered to be provided at the initiative of a client unless the client demands it in response to a personalised communication from or on behalf of the firm to that particular client, which contains an invitation or is intended to influence the client in respect of a specific financial instrument or specific transaction. A service can be considered to be provided at the initiative of the client notwithstanding that the client demands it on the basis of any communication containing a promotion or offer of financial instruments made by any means that by its very nature is general and addressed to the public or a larger group or category of clients or potential clients. (31) One of the objectives of this Directive is to protect investors. Measures to protect investors should be adapted to the particularities of each category of investors (retail, professional and counterparties). (32) By way of derogation from the principle of home country authorisation, supervision and enforcement of obligations in respect of the operation of branches, it is appropriate for the competent authority of the host Member State to assume responsibility for enforcing certain obligations specified in this Directive in relation to business conducted through a branch within the territory where the branch is located, since that authority is closest to the branch, and is better placed to detect and intervene in respect of infringements of rules governing the operations of the branch. (33) It is necessary to impose an effective "best execution" obligation to ensure that investment firms execute client orders on terms that are most favourable to the client. This obligation should apply to the firm which owes contractual or agency obligations to the client. (34) Fair competition requires that market participants and investors be able to compare the prices that trading venues (i.e. regulated markets, MTFs and intermediaries) are required to publish. To this end, it is recommended that Member States remove any obstacles which may prevent the consolidation at European level of the relevant information and its publication. (35) When establishing the business relationship with the client the investment firm might ask the client or potential client to consent at the same time to the execution policy as well as to the possibility that his orders may be executed outside a regulated market or an MTF. (36) Persons who provide investment services on behalf of more than one investment firm should not be considered as tied agents but as investment firms when they fall under the definition provided in this Directive, with the exception of certain persons who may be exempted. (37) This Directive should be without prejudice to the right of tied agents to undertake activities covered by other Directives and related activities in respect of financial services or products not covered by this Directive, including on behalf of parts of the same financial group. (38) The conditions for conducting activities outside the premises of the investment firm (door-to-door selling) should not be covered by this Directive. (39) Member States' competent authorities should not register or should withdraw the registration where the activities actually carried on indicate clearly that a tied agent has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within the territory of which it intends to carry on or does carry on the greater part of its activities. (40) For the purposes of this Directive eligible counterparties should be considered as acting as clients. (41) For the purposes of ensuring that conduct of business rules (including rules on best execution and handling of client orders) are enforced in respect of those investors most in need of these protections, and to reflect well-established market practice throughout the Community, it is appropriate to clarify that conduct of business rules may be waived in the case of transactions entered into or brought about between eligible counterparties. (42) In respect of transactions executed between eligible counterparties, the obligation to disclose client limit orders should only apply where the counter party is explicitly sending a limit order to an investment firm for its execution. (43) Member States shall protect the right to privacy of natural persons with respect to the processing of personal data in accordance with 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 of the free movement of such data.(13) (44) With the two-fold aim of protecting investors and ensuring the smooth operation of securities markets, it is necessary to ensure that transparency of transactions is achieved and that the rules laid down for that purpose apply to investment firms when they operate on the markets. In order to enable investors or market participants to assess at any time the terms of a transaction in shares that they are considering and to verify afterwards the conditions in which it was carried out, common rules should be established for the publication of details of completed transactions in shares and for the disclosure of details of current opportunities to trade in shares. These rules are needed to ensure the effective integration of Member State equity markets, to promote the efficiency of the overall price formation process for equity instruments, and to assist the effective operation of "best execution" obligations. These considerations require a comprehensive transparency regime applicable to all transactions in shares irrespective of their execution by an investment firm on a bilateral basis or through regulated markets or MTFs. The obligations for investment firms under this Directive to quote a bid and offer price and to execute an order at the quoted price do not relieve investment firms of the obligation to route an order to another execution venue when such internalisation could prevent the firm from complying with "best execution" obligations. (45) Member States should be able to apply transaction reporting obligations of the Directive to financial instruments that are not admitted to trading on a regulated market. (46) A Member State may decide to apply the pre- and post-trade transparency requirements laid down in this Directive to financial instruments other than shares. In that case those requirements should apply to all investment firms for which that Member State is the home Member State for their operations within the territory of that Member State and those carried out cross-border through the freedom to provide services. They should also apply to the operations carried out within the territory of that Member State by the branches established in its territory of investment firms authorised in another Member State. (47) Investment firms should all have the same opportunities of joining or having access to regulated markets throughout the Community. Regardless of the manner in which transactions are at present organised in the Member States, it is important to abolish the technical and legal restrictions on access to regulated markets. (48) In order to facilitate the finalisation of cross-border transactions, it is appropriate to provide for access to clearing and settlement systems throughout the Community by investment firms, irrespective of whether transactions have been concluded through regulated markets in the Member State concerned. Investment firms which wish to participate directly in other Member States' settlement systems should comply with the relevant operational and commercial requirements for membership and the prudential measures to uphold the smooth and orderly functioning of the financial markets. (49) The authorisation to operate a regulated market should extend to all activities which are directly related to the display, processing, execution, confirmation and reporting of orders from the point at which such orders are received by the regulated market to the point at which they are transmitted for subsequent finalisation, and to activities related to the admission of financial instruments to trading. This should also include transactions concluded through the medium of designated market makers appointed by the regulated market which are undertaken under its systems and in accordance with the rules that govern those systems. Not all transactions concluded by members or participants of the regulated market or MTF are to be considered as concluded within the systems of a regulated market or MTF. Transactions which members or participants conclude on a bilateral basis and which do not comply with all the obligations established for a regulated market or an MTF under this Directive should be considered as transactions concluded outside a regulated market or an MTF for the purposes of the definition of systematic internaliser. In such a case the obligation for investment firms to make public firm quotes should apply if the conditions established by this Directive are met. (50) Systematic internalisers might decide to give access to their quotes only to retail clients, only to professional clients, or to both. They should not be allowed to discriminate within those categories of clients. (51) Article 27 does not oblige systematic internalisers to publish firm quotes in relation to transactions above standard market size. (52) Where an investment firm is a systematic internaliser both in shares and in other financial instruments, the obligation to quote should only apply in respect of shares without prejudice to Recital 46. (53) It is not the intention of this Directive to require the application of pre-trade transparency rules to transactions carried out on an OTC basis, the characteristics of which include that they are ad-hoc and irregular and are carried out with wholesale counterparties and are part of a business relationship which is itself characterised by dealings above standard market size, and where the deals are carried out outside the systems usually used by the firm concerned for its business as a systematic internaliser. (54) The standard market size for any class of share should not be significantly disproportionate to any share included in that class. (55) Revision of Directive 93/6/EEC should fix the minimum capital requirements with which regulated markets should comply in order to be authorised, and in so doing should take into account the specific nature of the risks associated with such markets. (56) Operators of a regulated market should also be able to operate an MTF in accordance with the relevant provisions of this Directive. (57) The provisions of this Directive concerning the admission of instruments to trading under the rules enforced by the regulated market should be without prejudice to the application of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities(14). A regulated market should not be prevented from applying more demanding requirements in respect of the issuers of securities or instruments which it is considering for admission to trading than are imposed pursuant to this Directive. (58) Member States should be able to designate different competent authorities to enforce the wide-ranging obligations laid down in this Directive. Such authorities should be of a public nature guaranteeing their independence from economic actors and avoiding conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. The designation of public authorities should not exclude delegation under the responsibility of the competent authority. (59) Any confidential information received by the contact point of one Member State through the contact point of another Member State should not be regarded as purely domestic. (60) It is necessary to enhance convergence of powers at the disposal of competent authorities so as to pave the way towards an equivalent intensity of enforcement across the integrated financial market. A common minimum set of powers coupled with adequate resources should guarantee supervisory effectiveness. (61) With a view to protecting clients and without prejudice to the right of customers to bring their action before the courts, it is appropriate that Member States encourage public or private bodies established with a view to settling disputes out-of-court, to cooperate in resolving cross-border disputes, taking into account Commission Recommendation 98/257/EC of 30 March 1998 on the principles applicable to the bodies responsible for out-of-court settlement of consumer disputes(15). When implementing provisions on complaints and redress procedures for out-of-court settlements, Member States should be encouraged to use existing cross-border cooperation mechanisms, notably the Financial Services Complaints Network (FIN-Net). (62) Any exchange or transmission of information between competent authorities, other authorities, bodies or persons should be in accordance with the rules on transfer of personal data to third countries as laid down in Directive 95/46/EC. (63) It is necessary to reinforce provisions on exchange of information between national competent authorities and to strengthen the duties of assistance and cooperation which they owe to each other. Due to increasing cross-border activity, competent authorities should provide each other with the relevant information for the exercise of their functions, so as to ensure the effective enforcement of this Directive, including in situations where infringements or suspected infringements may be of concern to authorities in two or more Member States. In the exchange of information, strict professional secrecy is needed to ensure the smooth transmission of that information and the protection of particular rights. (64) At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European Securities Markets. In its final report, the Committee of Wise Men proposed the introduction of new legislative techniques based on a four-level approach, namely framework principles, implementing measures, cooperation and enforcement. Level 1, the Directive, should confine itself to broad general "framework" principles while Level 2 should contain technical implementing measures to be adopted by the Commission with the assistance of a committee. (65) The Resolution adopted by the Stockholm European Council of 23 March 2001 endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent. (66) According to the Stockholm European Council, Level 2 implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of Level 2 work. (67) The Resolution of the European Parliament of 5 February 2002 on the implementation of financial services legislation also endorsed the Committee of Wise Men's report, on the basis of the solemn declaration made before Parliament the same day by the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the chairman of Parliament's Committee on Economic and Monetary Affairs with regard to the safeguards for the European Parliament's role in this process. (68) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(16). (69) The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, this period could be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission should re-examine the draft measures. (70) With a view to taking into account further developments in the financial markets the Commission should submit reports to the European Parliament and the Council on the application of the provisions concerning professional indemnity insurance, the scope of the transparency rules and the possible authorisation of specialised dealers in commodity derivatives as investment firms. (71) The objective of creating an integrated financial market, in which investors are effectively protected and the efficiency and integrity of the overall market are safeguarded, requires the establishment of common regulatory requirements relating to investment firms wherever they are authorised in the Community and governing the functioning of regulated markets and other trading systems so as to prevent opacity or disruption on one market from undermining the efficient operation of the European financial system as a whole. Since this objective may be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective, TITLE I DEFINITIONS AND SCOPE Article 1 Scope 1. This Directive shall apply to investment firms and regulated markets. 2. The following provisions shall also apply to credit institutions authorised under Directive 2000/12/EC, when providing one or more investment services and/or performing investment activities: - Articles 2(2), 11, 13 and 14, - Chapter II of Title II excluding Article 23(2) second subparagraph, - Chapter III of Title II excluding Articles 31(2) to 31(4) and 32(2) to 32(6), 32(8) and 32(9), - Articles 48 to 53, 57, 61 and 62, and - Article 71(1). Article 2 Exemptions 1. This Directive shall not apply to: (a) insurance undertakings as defined in Article 1 of Directive 73/239/EEC or assurance undertakings as defined in Article 1 of Directive 2002/83/EC or undertakings carrying on the reinsurance and retrocession activities referred to in Directive 64/225/EEC; (b) persons which provide investment services exclusively for their parent undertakings, for their subsidiaries or for other subsidiaries of their parent undertakings; (c) persons providing an investment service where that service is provided in an incidental manner in the course of a professional activity and that activity is regulated by legal or regulatory provisions or a code of ethics governing the profession which do not exclude the provision of that service; (d) persons who do not provide any investment services or activities other than dealing on own account unless they are market makers or deal on own account outside a regulated market or an MTF on an organised, frequent and systematic basis by providing a system accessible to third parties in order to engage in dealings with them; (e) persons which provide investment services consisting exclusively in the administration of employee-participation schemes; (f) persons which provide investment services which only involve both administration of employee-participation schemes and the provision of investment services exclusively for their parent undertakings, for their subsidiaries or for other subsidiaries of their parent undertakings; (g) the members of the European System of Central Banks and other national bodies performing similar functions and other public bodies charged with or intervening in the management of the public debt; (h) collective investment undertakings and pension funds whether coordinated at Community level or not and the depositaries and managers of such undertakings; (i) persons dealing on own account in financial instruments, or providing investment services in commodity derivatives or derivative contracts included in Annex I, Section C 10 to the clients of their main business, provided this is an ancillary activity to their main business, when considered on a group basis, and that main business is not the provision of investment services within the meaning of this Directive or banking services under Directive 2000/12/EC; (j) persons providing investment advice in the course of providing another professional activity not covered by this Directive provided that the provision of such advice is not specifically remunerated; (k) persons whose main business consists of dealing on own account in commodities and/or commodity derivatives. This exception shall not apply where the persons that deal on own account in commodities and/or commodity derivatives are part of a group the main business of which is the provision of other investment services within the meaning of this Directive or banking services under Directive 2000/12/EC; (l) firms which provide investment services and/or perform investment activities consisting exclusively in dealing on own account on markets in financial futures or options or other derivatives and on cash markets for the sole purpose of hedging positions on derivatives markets or which deal for the accounts of other members of those markets or make prices for them and which are guaranteed by clearing members of the same markets, where responsibility for ensuring the performance of contracts entered into by such firms is assumed by clearing members of the same markets; (m) associations set up by Danish and Finnish pension funds with the sole aim of managing the assets of pension funds that are members of those associations; (n) "agenti di cambio" whose activities and functions are governed by Article 201 of Italian Legislative Decree No 58 of 24 February 1998. 2. The rights conferred by this Directive shall not extend to the provision of services as counterparty in transactions carried out by public bodies dealing with public debt or by members of the European System of Central Banks performing their tasks as provided for by the Treaty and the Statute of the European System of Central Banks and of the European Central Bank or performing equivalent functions under national provisions. 3. In order to take account of developments on financial markets, and to ensure the uniform application of this Directive, the Commission, acting in accordance with the procedure referred to in Article 64(2), may, in respect of exemptions (c) (i), and (k) define the criteria for determining when an activity is to be considered as ancillary to the main business on a group level as well as for determining when an activity is provided in an incidental manner. Article 3 Optional exemptions 1. Member States may choose not to apply this Directive to any persons for which they are the home Member State that: - are not allowed to hold clients' funds or securities and which for that reason are not allowed at any time to place themselves in debit with their clients, and - are not allowed to provide any investment service except the reception and transmission of orders in transferable securities and units in collective investment undertakings and the provision of investment advice in relation to such financial instruments, and - in the course of providing that service, are allowed to transmit orders only to: (i) investment firms authorised in accordance with this Directive; (ii) credit institutions authorised in accordance with Directive 2000/12/EC; (iii) branches of investment firms or of credit institutions which are authorised in a third country and which are subject to and comply with prudential rules considered by the competent authorities to be at least as stringent as those laid down in this Directive, in Directive 2000/12/EC or in Directive 93/6/EEC; (iv) collective investment undertakings authorised under the law of a Member State to market units to the public and to the managers of such undertakings; (v) investment companies with fixed capital, as defined in Article 15(4) of Second Council Directive 77/91/EEC of 13 December 1976 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent(17), the securities of which are listed or dealt in on a regulated market in a Member State; provided that the activities of those persons are regulated at national level. 2. Persons excluded from the scope of this Directive according to paragraph 1 cannot benefit from the freedom to provide services and/or activities or to establish branches as provided for in Articles 31 and 32 respectively. Article 4 Definitions 1. For the purposes of this Directive, the following definitions shall apply: 1) "Investment firm" means any legal person whose regular occupation or business is the provision of one or more investment services to third parties and/or the performance of one or more investment activities on a professional basis; Member States may include in the definition of investment firms undertakings which are not legal persons, provided that: (a) their legal status ensures a level of protection for third parties' interests equivalent to that afforded by legal persons, and (b) they are subject to equivalent prudential supervision appropriate to their legal form. However, where a natural person provides services involving the holding of third parties' funds or transferable securities, he may be considered as an investment firm for the purposes of this Directive only if, without prejudice to the other requirements imposed in this Directive and in Directive 93/6/EEC, he complies with the following conditions: (a) the ownership rights of third parties in instruments and funds must be safeguarded, especially in the event of the insolvency of the firm or of its proprietors, seizure, set-off or any other action by creditors of the firm or of its proprietors; (b) the firm must be subject to rules designed to monitor the firm's solvency and that of its proprietors; (c) the firm's annual accounts must be audited by one or more persons empowered, under national law, to audit accounts; (d) where the firm has only one proprietor, he must make provision for the protection of investors in the event of the firm's cessation of business following his death, his incapacity or any other such event; 2) "Investment services and activities" means any of the services and activities listed in Section A of Annex I relating to any of the instruments listed in Section C of Annex I; The Commission shall determine, acting in accordance with the procedure referred to in Article 64(2): - the derivative contracts mentioned in Section C 7 of Annex I that have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are cleared and settled through recognised clearing houses or are subject to regular margin calls - the derivative contracts mentioned in Section C 10 of Annex I that have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are traded on a regulated market or an MTF, are cleared and settled through recognised clearing houses or are subject to regular margin calls; 3) "Ancillary service" means any of the services listed in Section B of Annex I; 4) "Investment advice" means the provision of personal recommendations to a client, either upon its request or at the initiative of the investment firm, in respect of one or more transactions relating to financial instruments; 5) "Execution of orders on behalf of clients" means acting to conclude agreements to buy or sell one or more financial instruments on behalf of clients; 6) "Dealing on own account" means trading against proprietary capital resulting in the conclusion of transactions in one or more financial instruments; 7) "Systematic internaliser" means an investment firm which, on an organised, frequent and systematic basis, deals on own account by executing client orders outside a regulated market or an MTF; 8) "Market maker" means a person who holds himself out on the financial markets on a continuous basis as being willing to deal on own account by buying and selling financial instruments against his proprietary capital at prices defined by him; 9) "Portfolio management" means managing portfolios in accordance with mandates given by clients on a discretionary client-by-client basis where such portfolios include one or more financial instruments; 10) "Client" means any natural or legal person to whom an investment firm provides investment and/or ancillary services; 11) "Professional client" means a client meeting the criteria laid down in Annex II; 12) "Retail client" means a client who is not a professional client; 13) "Market operator" means a person or persons who manages and/or operates the business of a regulated market. The market operator may be the regulated market itself; 14) "Regulated market" means a multilateral system operated and/or managed by a market operator, which brings together or facilitates the bringing together of multiple third-party buying and selling interests in financial instruments - in the system and in accordance with its non-discretionary rules - in a way that results in a contract, in respect of the financial instruments admitted to trading under its rules and/or systems, and which is authorised and functions regularly and in accordance with the provisions of Title III; 15) "Multilateral trading facility (MTF)" means a multilateral system, operated by an investment firm or a market operator, which brings together multiple third-party buying and selling interests in financial instruments - in the system and in accordance with non-discretionary rules - in a way that results in a contract in accordance with the provisions of Title II; 16) "Limit order" means an order to buy or sell a financial instrument at its specified price limit or better and for a specified size; 17) "Financial instrument" means those instruments specified in Section C of Annex I; 18) "Transferable securities" means those classes of securities which are negotiable on the capital market, with the exception of instruments of payment, such as: (a) shares in companies and other securities equivalent to shares in companies, partnerships or other entities, and depositary receipts in respect of shares; (b) bonds or other forms of securitised debt, including depositary receipts in respect of such securities; (c) any other securities giving the right to acquire or sell any such transferable securities or giving rise to a cash settlement determined by reference to transferable securities, currencies, interest rates or yields, commodities or other indices or measures; 19) "Money-market instruments" means those classes of instruments which are normally dealt in on the money market, such as treasury bills, certificates of deposit and commercial papers and excluding instruments of payment; 20) "Home Member State" means: (a) in the case of investment firms: (i) if the investment firm is a natural person, the Member State in which its head office is situated; (ii) if the investment firm is a legal person, the Member State in which its registered office is situated; (iii) if the investment firm has, under its national law, no registered office, the Member State in which its head office is situated; (b) in the case of a regulated market, the Member State in which the regulated market is registered or, if under the law of that Member State it has no registered office, the Member State in which the head office of the regulated market is situated; 21) "Host Member State" means the Member State, other than the home Member State, in which an investment firm has a branch or performs services and/or activities or the Member State in which a regulated market provides appropriate arrangements so as to facilitate access to trading on its system by remote members or participants established in that same Member State; 22) "Competent authority" means the authority, designated by each Member State in accordance with Article 48, unless otherwise specified in this Directive; 23) "Credit institutions" means credit institutions as defined under Directive 2000/12/EC; 24) "UCITS management company" means a management company as defined in Council Directive 85/611/EEC of 20 December 1985, on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS)(18); 25) "Tied agent" means a natural or legal person who, under the full and unconditional responsibility of only one investment firm on whose behalf it acts, promotes investment and/or ancillary services to clients or prospective clients, receives and transmits instructions or orders from the client in respect of investment services or financial instruments, places financial instruments and/or provides advice to clients or prospective clients in respect of those financial instruments or services; 26) "Branch" means a place of business other than the head office which is a part of an investment firm, which has no legal personality and which provides investment services and/or activities and which may also perform ancillary services for which the investment firm has been authorised; all the places of business set up in the same Member State by an investment firm with headquarters in another Member State shall be regarded as a single branch; 27) "Qualifying holding" means any direct or indirect holding in an investment firm which represents 10% or more of the capital or of the voting rights, as set out in Article 92 of Directive 2001/34/EC, or which makes it possible to exercise a significant influence over the management of the investment firm in which that holding subsists; 28) "Parent undertaking" means a parent undertaking as defined in Articles 1 and 2 of Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts(19); 29) "Subsidiary" means a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC, including any subsidiary of a subsidiary undertaking of an ultimate parent undertaking; 30) "Control" means control as defined in Article 1 of Directive 83/349/EEC; 31) "Close links" means a situation in which two or more natural or legal persons are linked by: (a) participation which means the ownership, direct or by way of control, of 20% or more of the voting rights or capital of an undertaking, (b) control which means 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 also being 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. 2. In order to take account of developments on financial markets, and to ensure the uniform application of this Directive, the Commission, acting in accordance with the procedure referred to in Article 64(2), may clarify the definitions laid down in paragraph 1 of this Article. TITLE II AUTHORISATION AND OPERATING CONDITIONS FOR INVESTMENT FIRMS CHAPTER I CONDITIONS AND PROCEDURES FOR AUTHORISATION Article 5 Requirement for authorisation 1. Each Member State shall require that the performance of investment services or activities as a regular occupation or business on a professional basis be subject to prior authorisation in accordance with the provisions of this Chapter. Such authorisation shall be granted by the home Member State competent authority designated in accordance with Article 48. 2. By way of derogation from paragraph 1, Member States shall allow any market operator to operate an MTF, subject to the prior verification of their compliance with the provisions of this Chapter, excluding Articles 11 and 15. 3. Member States shall establish a register of all investment firms. This register shall be publicly accessible and shall contain information on the services and/or activities for which the investment firm is authorised. It shall be updated on a regular basis. 4. Each Member State shall require that: - any investment firm which is a legal person have its head office in the same Member State as its registered office, - any investment firm which is not a legal person or any investment firm which is a legal person but under its national law has no registered office have its head office in the Member State in which it actually carries on its business. 5. In the case of investment firms which provide only investment advice or the service of reception and transmission of orders under the conditions established in Article 3, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the granting of an authorisation, in accordance with the conditions laid down in Article 48(2). Article 6 Scope of authorisation 1. The home Member State shall ensure that the authorisation specifies the investment services or activities which the investment firm is authorised to provide. The authorisation may cover one or more of the ancillary services set out in Section B of Annex I. Authorisation shall in no case be granted solely for the provision of ancillary services. 2. An investment firm seeking authorisation to extend its business to additional investment services or activities or ancillary services not foreseen at the time of initial authorisation shall submit a request for extension of its authorisation. 3. The authorisation shall be valid for the entire Community and shall allow an investment firm to provide the services or perform the activities, for which it has been authorised, throughout the Community, either through the establishment of a branch or the free provision of services. Article 7 Procedures for granting and refusing requests for authorisation 1. The competent authority shall not grant authorisation unless and until such time as it is fully satisfied that the applicant complies with all requirements under the provisions adopted pursuant to this Directive. 2. The investment firm shall provide all information, including a programme of operations setting out inter alia the types of business envisaged and the organisational structure, necessary to enable the competent authority to satisfy itself that the investment firm has established, at the time of initial authorisation, all the necessary arrangements to meet its obligations under the provisions of this Chapter. 3. An applicant shall be informed, within six months of the submission of a complete application, whether or not authorisation has been granted. Article 8 Withdrawal of authorisations The competent authority may withdraw the authorisation issued to an investment firm where such an investment firm: (a) does not make use of the authorisation within 12 months, expressly renounces the authorisation or has provided no investment services or performed no investment activity for the preceding six months, unless the Member State concerned has provided for authorisation to lapse in such cases; (b) has obtained the authorisation by making false statements or by any other irregular means; (c) no longer meets the conditions under which authorisation was granted, such as compliance with the conditions set out in Directive 93/6/EEC; (d) has seriously and systematically infringed the provisions adopted pursuant to this Directive governing the operating conditions for investment firms; (e) falls within any of the cases where national law, in respect of matters outside the scope of this Directive, provides for withdrawal. Article 9 Persons who effectively direct the business 1. Member States shall require the persons who effectively direct the business of an investment firm to be of sufficiently good repute and sufficiently experienced as to ensure the sound and prudent management of the investment firm. Where the market operator that seeks authorisation to operate an MTF and the persons that effectively direct the business of the MTF are the same as those that effectively direct the business of the regulated market, those persons are deemed to comply with the requirements laid down in the first subparagraph. 2. Member States shall require the investment firm to notify the competent authority of any changes to its management, along with all information needed to assess whether the new staff appointed to manage the firm are of sufficiently good repute and sufficiently experienced. 3. The competent authority shall refuse authorisation if it is not satisfied that the persons who will effectively direct the business of the investment firm are of sufficiently good repute or sufficiently experienced, or if there are objective and demonstrable grounds for believing that proposed changes to the management of the firm pose a threat to its sound and prudent management. 4. Member States shall require that the management of investment firms is undertaken by at least two persons meeting the requirements laid down in paragraph 1. By way of derogation from the first subparagraph, Member States may grant authorisation to investment firms that are natural persons or to investment firms that are legal persons managed by a single natural person in accordance with their constitutive rules and national laws. Member States shall nevertheless require that alternative arrangements be in place which ensure the sound and prudent management of such investment firms. Article 10 Shareholders and members with qualifying holdings 1. The competent authorities shall not authorise the performance of investment services or activities by an investment firm until they have been informed of the identities of the shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings and the amounts of those holdings. The competent authorities shall refuse authorisation if, taking into account the need to ensure the sound and prudent management of an investment firm, they are not satisfied as to the suitability of the shareholders or members that have qualifying holdings. Where close links exist between the investment firm and other natural or legal persons, the competent authority shall grant authorisation only if those links do not prevent the effective exercise of the supervisory functions of the competent authority. 2. The competent authority shall refuse authorisation if the laws, regulations or administrative provisions of a third 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 its supervisory functions. 3. Member States shall require any natural or legal person that proposes to acquire or sell, directly or indirectly, a qualifying holding in an investment firm, first to notify, in accordance with the second subparagraph, the competent authority of the size of the resulting holding. Such persons shall likewise be required to notify the competent authority if they propose to increase or reduce their qualifying holding, if in consequence the proportion of the voting rights or of the capital that they hold would reach or fall below or exceed 20%, 33% or 50% or the investment firm would become or cease to be their subsidiary. Without prejudice to paragraph 4, the competent authority shall have up to three months from the date of the notification of a proposed acquisition provided for in the first subparagraph to oppose such a plan if, in view of the need to ensure sound and prudent management of the investment firm, it is not satisfied as to the suitability of the persons referred to in the first subparagraph. If the competent authority does not oppose the plan, it may fix a deadline for its implementation. 4. If the acquirer of any holding referred to in paragraph 3 is an investment firm, a credit institution, an insurance undertaking or a UCITS management company authorised in another Member State, or the parent undertaking of an investment firm, credit institution, insurance undertaking or a UCITS management company authorised in another Member State, or a person controlling an investment firm, credit institution, insurance undertaking or a UCITS management company authorised in another Member State, and if, as a result of that acquisition, the undertaking would become the acquirer's subsidiary or come under his control, the assessment of the acquisition shall be subject to the prior consultation provided for in Article 60. 5. Member States shall require that, if an investment firm becomes aware of any acquisitions or disposals of holdings in its capital that cause holdings to exceed or fall below any of the thresholds referred to in the first subparagraph of paragraph 3, that investment firm is to inform the competent authority without delay. At least once a year, investment firms shall also inform the competent authority of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at annual general meetings of shareholders and members or as a result of compliance with the regulations applicable to companies whose transferable securities are admitted to trading on a regulated market. 6. Member States shall require that, where the influence exercised by the persons referred to in the first subparagraph of paragraph 1 is likely to be prejudicial to the sound and prudent management of an investment firm, the competent authority take appropriate measures to put an end to that situation. Such measures may consist in applications for judicial orders and/or the imposition of sanctions against directors and those responsible for management, or suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question. Similar measures shall be taken in respect of persons who fail to comply with the obligation to provide prior information in relation to the acquisition or increase of a qualifying holding. If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, for the nullity of the votes cast or for the possibility of their annulment. Article 11 Membership of an authorised Investor Compensation Scheme The competent authority shall verify that any entity seeking authorisation as an investment firm meets its obligations under Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes(20) at the time of authorisation. Article 12 Initial capital endowment Member States shall ensure that the competent authorities do not grant authorisation unless the investment firm has sufficient initial capital in accordance with the requirements of Directive 93/6/EEC having regard to the nature of the investment service or activity in question. Pending the revision of Directive 93/6/EEC, the investment firms provided for in Article 67 shall be subject to the capital requirements laid down in that Article. Article 13 Organisational requirements 1. The home Member State shall require that investment firms comply with the organisational requirements set out in paragraphs 2 to 8. 2. An investment firm shall establish adequate policies and procedures sufficient to ensure compliance of the firm including its managers, employees and tied agents with its obligations under the provisions of this Directive as well as appropriate rules governing personal transactions by such persons. 3. An investment firm shall maintain and operate effective organisational and administrative arrangements with a view to taking all reasonable steps designed to prevent conflicts of interest as defined in Article 18 from adversely affecting the interests of its clients. 4. An investment firm shall take reasonable steps to ensure continuity and regularity in the performance of investment services and activities. To this end the investment firm shall employ appropriate and proportionate systems, resources and procedures. 5. An investment firm shall ensure, when relying on a third party for the performance of operational functions which are critical for the provision of continuous and satisfactory service to clients and the performance of investment activities on a continuous and satisfactory basis, that it takes reasonable steps to avoid undue additional operational risk. Outsourcing of important operational functions may not be undertaken in such a way as to impair materially the quality of its internal control and the ability of the supervisor to monitor the firm's compliance with all obligations. An investment firm shall have sound administrative and accounting procedures, internal control mechanisms, effective procedures for risk assessment, and effective control and safeguard arrangements for information processing systems. 6. An investment firm shall arrange for records to be kept of all services and transactions undertaken by it which shall be sufficient to enable the competent authority to monitor compliance with the requirements under this Directive, and in particular to ascertain that the investment firm has complied with all obligations with respect to clients or potential clients. 7. An investment firm shall, when holding financial instruments belonging to clients, make adequate arrangements so as to safeguard clients' ownership rights, especially in the event of the investment firm's insolvency, and to prevent the use of a client's instruments on own account except with the client's express consent. 8. An investment firm shall, when holding funds belonging to clients, make adequate arrangements to safeguard the clients' rights and, except in the case of credit institutions, prevent the use of client funds for its own account. 9. In the case of branches of investment firms, the competent authority of the Member State in which the branch is located shall, without prejudice to the possibility of the competent authority of the home Member State of the investment firm to have direct access to those records, enforce the obligation laid down in paragraph 6 with regard to transactions undertaken by the branch. 10. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 2 to 9, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which specify the concrete organisational requirements to be imposed on investment firms performing different investment services and/or activities and ancillary services or combinations thereof. Article 14 Trading process and finalisation of transactions in an MTF 1. Member States shall require that investment firms or market operators operating an MTF, in addition to meeting the requirements laid down in Article 13, establish transparent and non-discretionary rules and procedures for fair and orderly trading and establish objective criteria for the efficient execution of orders. 2. Member States shall require that investment firms or market operators operating an MTF establish transparent rules regarding the criteria for determining the financial instruments that can be traded under its systems. Member States shall require that, where applicable, investment firms or market operators operating an MTF provide, or are satisfied that there is access to, sufficient publicly available information to enable its users to form an investment judgement, taking into account both the nature of the users and the types of instruments traded. 3. Member States shall ensure that Articles 19, 21 and 22 are not applicable to the transactions concluded under the rules governing an MTF between its members or participants or between the MTF and its members or participants in relation to the use of the MTF. However, the members of or participants in the MTF shall comply with the obligations provided for in Articles 19, 21 and 22 with respect to their clients when, acting on behalf of their clients, they execute their orders through the systems of an MTF. 4. Member States shall require that investment firms or market operators operating an MTF establish and maintain transparent rules, based on objective criteria, governing access to its facility. These rules shall comply with the conditions established in Article 42(3). 5. Member States shall require that investment firms or market operators operating an MTF clearly inform its users of their respective responsibilities for the settlement of the transactions executed in that facility. Member States shall require that investment firms or market operators operating an MTF have put in place the necessary arrangements to facilitate the efficient settlement of the transactions concluded under the systems of the MTF. 6. Where a transferable security, which has been admitted to trading on a regulated market, is also traded on an MTF without the consent of the issuer, the issuer shall not be subject to any obligation relating to initial, ongoing or ad hoc financial disclosure with regard to that MTF. 7. Member States shall require that any investment firm or market operator operating an MTF comply immediately with any instruction from its competent authority pursuant to Article 50(1) to suspend or remove a financial instrument from trading. Article 15 Relations with third countries 1. Member States shall inform the Commission of any general difficulties which their investment firms encounter in establishing themselves or providing investment services and/or performing investment activities in any third country. 2. Whenever it appears to the Commission, on the basis of information submitted to it under paragraph 1, that a third country does not grant Community investment firms effective market access comparable to that granted by the Community to investment firms from that third country, the Commission may submit proposals to the Council for an appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community investment firms. The Council shall act by a qualified majority. 3. Whenever it appears to the Commission, on the basis of information submitted to it under paragraph 1, that Community investment firms in a third country are not granted national treatment affording the same competitive opportunities as are available to domestic investment firms and that the conditions of effective market access are not fulfilled, the Commission may initiate negotiations in order to remedy the situation. In the circumstances referred to in the first subparagraph, the Commission may decide, in accordance with the procedure referred to in Article 64(2), at any time and in addition to the initiation of negotiations, that the competent authorities of the Member States must limit or suspend their decisions regarding requests pending or future requests for authorisation and the acquisition of holdings by direct or indirect parent undertakings governed by the law of the third country in question. Such limitations or suspensions may not be applied to the setting-up of subsidiaries by investment firms duly authorised in the Community or by their subsidiaries, or to the acquisition of holdings in Community investment firms by such firms or subsidiaries. The duration of such measures may not exceed three months. Before the end of the three-month period referred to in the second subparagraph and in the light of the results of the negotiations, the Commission may decide, in accordance with the procedure referred to in Article 64(2), to extend these measures. 4. Whenever it appears to the Commission that one of the situations referred to in paragraphs 2 and 3 obtains, the Member States shall inform it at its request: (a) of any application for the authorisation of any firm which is the direct or indirect subsidiary of a parent undertaking governed by the law of the third country in question; (b) whenever they are informed in accordance with Article 10(3) that such a parent undertaking proposes to acquire a holding in a Community investment firm, in consequence of which the latter would become its subsidiary. That obligation to provide information shall lapse whenever agreement is reached with the third country concerned or when the measures referred to in the second and third subparagraphs of paragraph 3 cease to apply. 5. Measures taken under this Article shall comply with the Community's obligations under any international agreements, bilateral or multilateral, governing the taking-up or pursuit of the business of investment firms. CHAPTER II OPERATING CONDITIONS FOR INVESTMENT FIRMS Section 1 General provisions Article 16 Regular review of conditions for initial authorisation 1. Member States shall require that an investment firm authorised in their territory comply at all times with the conditions for initial authorisation established in Chapter I of this Title. 2. Member States shall require competent authorities to establish the appropriate methods to monitor that investment firms comply with their obligation under paragraph 1. They shall require investment firms to notify the competent authorities of any material changes to the conditions for initial authorisation. 3. In the case of investment firms which provide only investment advice, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the review of the conditions for initial authorisation, in accordance with the conditions laid down in Article 48(2). Article 17 General obligation in respect of on-going supervision 1. Member States shall ensure that the competent authorities monitor the activities of investment firms so as to assess compliance with the operating conditions provided for in this Directive. Member States shall ensure that the appropriate measures are in place to enable the competent authorities to obtain the information needed to assess the compliance of investment firms with those obligations. 2. In the case of investment firms which provide only investment advice, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the regular monitoring of operational requirements, in accordance with the conditions laid down in Article 48(2). Article 18 Conflicts of interest 1. Member States shall require investment firms to take all reasonable steps to identify conflicts of interest between themselves, including their managers, employees and tied agents, or any person directly or indirectly linked to them by control and their clients or between one client and another that arise in the course of providing any investment and ancillary services, or combinations thereof. 2. Where organisational or administrative arrangements made by the investment firm in accordance with Article 13(3) to manage conflicts of interest are not sufficient to ensure, with reasonable confidence, that risks of damage to client interests will be prevented, the investment firm shall clearly disclose the general nature and/or sources of conflicts of interest to the client before undertaking business on its behalf. 3. In order to take account of technical developments on financial markets and to ensure uniform application of paragraphs 1 and 2, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures to: (a) define the steps that investment firms might reasonably be expected to take to identify, prevent, manage and/or disclose conflicts of interest when providing various investment and ancillary services and combinations thereof; (b) establish appropriate criteria for determining the types of conflict of interest whose existence may damage the interests of the clients or potential clients of the investment firm. Section 2 Provisions to ensure investor protection Article 19 Conduct of business obligations when providing investment services to clients 1. Member States shall require that, when providing investment services and/or, where appropriate, ancillary services to clients, an investment firm act honestly, fairly and professionally in accordance with the best interests of its clients and comply, in particular, with the principles set out in paragraphs 2 to 8. 2. All information, including marketing communications, addressed by the investment firm to clients or potential clients shall be fair, clear and not misleading. Marketing communications shall be clearly identifiable as such. 3. Appropriate information shall be provided in a comprehensible form to clients or potential clients about: - the investment firm and its services, - financial instruments and proposed investment strategies; this should include appropriate guidance on and warnings of the risks associated with investments in those instruments or in respect of particular investment strategies, - execution venues, and - costs and associated charges so that they are reasonably able to understand the nature and risks of the investment service and of the specific type of financial instrument that is being offered and, consequently, to take investment decisions on an informed basis. This information may be provided in a standardised format. 4. When providing investment advice or portfolio management the investment firm shall obtain the necessary information regarding the client's or potential client's knowledge and experience in the investment field relevant to the specific type of product or service, his financial situation and his investment objectives so as to enable the firm to recommend to the client or potential client the investment services and financial instruments that are suitable for him. 5. Member States shall ensure that investment firms, when providing investment services other than those referred to in paragraph 4, ask the client or potential client to provide information regarding his knowledge and experience in the investment field relevant to the specific type of product or service offered or demanded so as to enable the investment firm to assess whether the investment service or product envisaged is appropriate for the client. In case the investment firm considers, on the basis of the information received under the previous subparagraph, that the product or service is not appropriate to the client or potential client, the investment firm shall warn the client or potential client. This warning may be provided in a standardised format. In cases where the client or potential client elects not to provide the information referred to under the first subparagraph, or where he provides insufficient information regarding his knowledge and experience, the investment firm shall warn the client or potential client that such a decision will not allow the firm to determine whether the service or product envisaged is appropriate for him. This warning may be provided in a standardised format. 6. Member States shall allow investment firms when providing investment services that only consist of execution and/or the reception and transmission of client orders with or without ancillary services to provide those investment services to their clients without the need to obtain the information or make the determination provided for in paragraph 5 where all the following conditions are met: - the above services relate to shares admitted to trading on a regulated market or in an equivalent third country market, money market instruments, bonds or other forms of securitised debt (excluding those bonds or securitised debt that embed a derivative), UCITS and other non-complex financial instruments. A third country market shall be considered as equivalent to a regulated market if it complies with equivalent requirements to those established under Title III. The Commission shall publish a list of those markets that are to be considered as equivalent. This list shall be updated periodically, - the service is provided at the initiative of the client or potential client, - the client or potential client has been clearly informed that in the provision of this service the investment firm is not required to assess the suitability of the instrument or service provided or offered and that therefore he does not benefit from the corresponding protection of the relevant conduct of business rules; this warning may be provided in a standardised format, - the investment firm complies with its obligations under Article 18. 7. The investment firm shall establish a record that includes the document or documents agreed between the firm and the client that set out the rights and obligations of the parties, and the other terms on which the firm will provide services to the client. The rights and duties of the parties to the contract may be incorporated by reference to other documents or legal texts. 8. The client must receive from the investment firm adequate reports on the service provided to its clients. These reports shall include, where applicable, the costs associated with the transactions and services undertaken on behalf of the client. 9. In cases where an investment service is offered as part of a financial product which is already subject to other provisions of Community legislation or common European standards related to credit institutions and consumer credits with respect to risk assessment of clients and/or information requirements, this service shall not be additionally subject to the obligations set out in this Article. 10. In order to ensure the necessary protection of investors and the uniform application of paragraphs 1 to 8, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures to ensure that investment firms comply with the principles set out therein when providing investment or ancillary services to their clients. Those implementing measures shall take into account: (a) the nature of the service(s) offered or provided to the client or potential client, taking into account the type, object, size and frequency of the transactions; (b) the nature of the financial instruments being offered or considered; (c) the retail or professional nature of the client or potential clients. Article 20 Provision of services through the medium of another investment firm Member States shall allow an investment firm receiving an instruction to perform investment or ancillary services on behalf of a client through the medium of another investment firm to rely on client information transmitted by the latter firm. The investment firm which mediates the instructions will remain responsible for the completeness and accuracy of the information transmitted. The investment firm which receives an instruction to undertake services on behalf of a client in this way shall also be able to rely on any recommendations in respect of the service or transaction that have been provided to the client by another investment firm. The investment firm which mediates the instructions will remain responsible for the appropriateness for the client of the recommendations or advice provided. The investment firm which receives client instructions or orders through the medium of another investment firm shall remain responsible for concluding the service or transaction, based on any such information or recommendations, in accordance with the relevant provisions of this Title. Article 21 Obligation to execute orders on terms most favourable to the client 1. Member States shall require that investment firms take all reasonable steps to obtain, when executing orders, the best possible result for their clients taking into account price, costs, speed, likelihood of execution and settlement, size, nature or any other consideration relevant to the execution of the order. Nevertheless, whenever there is a specific instruction from the client the investment firm shall execute the order following the specific instruction. 2. Member States shall require investment firms to establish and implement effective arrangements for complying with paragraph 1. In particular Member States shall require investment firms to establish and implement an order execution policy to allow them to obtain, for their client orders, the best possible result in accordance with paragraph 1. 3. The order execution policy shall include, in respect of each class of instruments, information on the different venues where the investment firm executes its client orders and the factors affecting the choice of execution venue. It shall at least include those venues that enable the investment firm to obtain on a consistent basis the best possible result for the execution of client orders. Member States shall require that investment firms provide appropriate information to their clients on their order execution policy. Member States shall require that investment firms obtain the prior consent of their clients to the execution policy. Member States shall require that, where the order execution policy provides for the possibility that client orders may be executed outside a regulated market or an MTF, the investment firm shall, in particular, inform its clients about this possibility. Member States shall require that investment firms obtain the prior express consent of their clients before proceeding to execute their orders outside a regulated market or an MTF. Investment firms may obtain this consent either in the form of a general agreement or in respect of individual transactions. 4. Member States shall require investment firms to monitor the effectiveness of their order execution arrangements and execution policy in order to identify and, where appropriate, correct any deficiencies. In particular, they shall assess, on a regular basis, whether the execution venues included in the order execution policy provide for the best possible result for the client or whether they need to make changes to their execution arrangements. Member States shall require investment firms to notify clients of any material changes to their order execution arrangements or execution policy. 5. Member States shall require investment firms to be able to demonstrate to their clients, at their request, that they have executed their orders in accordance with the firm's execution policy. 6. In order to ensure the protection necessary for investors, the fair and orderly functioning of markets, and to ensure the uniform application of paragraphs 1, 3 and 4, the Commission shall, in accordance with the procedure referred to in Article 64(2), adopt implementing measures concerning: (a) the criteria for determining the relative importance of the different factors that, pursuant to paragraph 1, may be taken into account for determining the best possible result taking into account the size and type of order and the retail or professional nature of the client; (b) factors that may be taken into account by an investment firm when reviewing its execution arrangements and the circumstances under which changes to such arrangements may be appropriate. In particular, the factors for determining which venues enable investment firms to obtain on a consistent basis the best possible result for executing the client orders; (c) the nature and extent of the information to be provided to clients on their execution policies, pursuant to paragraph 3. Article 22 Client order handling rules 1. Member States shall require that investment firms authorised to execute orders on behalf of clients implement procedures and arrangements which provide for the prompt, fair and expeditious execution of client orders, relative to other client orders or the trading interests of the investment firm. These procedures or arrangements shall allow for the execution of otherwise comparable client orders in accordance with the time of their reception by the investment firm. 2. Member States shall require that, in the case of a client limit order in respect of shares admitted to trading on a regulated market which are not immediately executed under prevailing market conditions, investment firms are, unless the client expressly instructs otherwise, to take measures to facilitate the earliest possible execution of that order by making public immediately that client limit order in a manner which is easily accessible to other market participants. Member States may decide that investment firms comply with this obligation by transmitting the client limit order to a regulated market and/or MTF. Member States shall provide that the competent authorities may waive the obligation to make public a limit order that is large in scale compared with normal market size as determined under Article 44(2). 3. In order to ensure that measures for the protection of investors and fair and orderly functioning of markets take account of technical developments in financial markets, and to ensure the uniform application of paragraphs 1 and 2, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which define: (a) the conditions and nature of the procedures and arrangements which result in the prompt, fair and expeditious execution of client orders and the situations in which or types of transaction for which investment firms may reasonably deviate from prompt execution so as to obtain more favourable terms for clients; (b) the different methods through which an investment firm can be deemed to have met its obligation to disclose not immediately executable client limit orders to the market. Article 23 Obligations of investment firms when appointing tied agents 1. Member States may decide to allow an investment firm to appoint tied agents for the purposes of promoting the services of the investment firm, soliciting business or receiving orders from clients or potential clients and transmitting them, placing financial instruments and providing advice in respect of such financial instruments and services offered by that investment firm. 2. Member States shall require that where an investment firm decides to appoint a tied agent it remains fully and unconditionally responsible for any action or omission on the part of the tied agent when acting on behalf of the firm. Member States shall require the investment firm to ensure that a tied agent discloses the capacity in which he is acting and the firm which he is representing when contacting or before dealing with any client or potential client. Member States may allow, in accordance with Article 13(6), (7) and (8), tied agents registered in their territory to handle clients' money and/or financial instruments on behalf and under the full responsibility of the investment firm for which they are acting within their territory or, in the case of a cross-border operation, in the territory of a Member State which allows a tied agent to handle clients' money. Member States shall require the investment firms to monitor the activities of their tied agents so as to ensure that they continue to comply with this Directive when acting through tied agents. 3. Member States that decide to allow investment firms to appoint tied agents shall establish a public register. Tied agents shall be registered in the public register in the Member State where they are established. Where the Member State in which the tied agent is established has decided, in accordance with paragraph 1, not to allow the investment firms authorised by their competent authorities to appoint tied agents, those tied agents shall be registered with the competent authority of the home Member State of the investment firm on whose behalf it acts. Member States shall ensure that tied agents are only admitted to the public register if it has been established that they are of sufficiently good repute and that they possess appropriate general, commercial and professional knowledge so as to be able to communicate accurately all relevant information regarding the proposed service to the client or potential client. Member States may decide that investment firms can verify whether the tied agents which they have appointed are of sufficiently good repute and possess the knowledge as referred to in the third subparagraph. The register shall be updated on a regular basis. It shall be publicly available for consultation. 4. Member States shall require that investment firms appointing tied agents take adequate measures in order to avoid any negative impact that the activities of the tied agent not covered by the scope of this Directive could have on the activities carried out by the tied agent on behalf of the investment firm. Member States may allow competent authorities to collaborate with investment firms and credit institutions, their associations and other entities in registering tied agents and in monitoring compliance of tied agents with the requirements of paragraph 3. In particular, tied agents may be registered by an investment firm, credit institution or their associations and other entities under the supervision of the competent authority. 5. Member States shall require that investment firms appoint only tied agents entered in the public registers referred to in paragraph 3. 6. Member States may reinforce the requirements set out in this Article or add other requirements for tied agents registered within their jurisdiction. Article 24 Transactions executed with eligible counterparties 1. Member States shall ensure that investment firms authorised to execute orders on behalf of clients and/or to deal on own account and/or to receive and transmit orders, may bring about or enter into transactions with eligible counterparties without being obliged to comply with the obligations under Articles 19, 21 and 22(1) in respect of those transactions or in respect of any ancillary service directly related to those transactions. 2. Member States shall recognise as eligible counterparties for the purposes of this Article investment firms, credit institutions, insurance companies, UCITS and their management companies, pension funds and their management companies, other financial institutions authorised or regulated under Community legislation or the national law of a Member State, undertakings exempted from the application of this Directive under Article 2(1)(k) and (l), national governments and their corresponding offices including public bodies that deal with public debt, central banks and supranational organisations. Classification as an eligible counterparty under the first subparagraph shall be without prejudice to the right of such entities to request, either on a general form or on a trade-by-trade basis, treatment as clients whose business with the investment firm is subject to Articles 19, 21 and 22. 3. Member States may also recognise as eligible counterparties other undertakings meeting pre-determined proportionate requirements, including quantitative thresholds. In the event of a transaction where the prospective counterparties are located in different jurisdictions, the investment firm shall defer to the status of the other undertaking as determined by the law or measures of the Member State in which that undertaking is established. Member States shall ensure that the investment firm, when it enters into transactions in accordance with paragraph 1 with such undertakings, obtains the express confirmation from the prospective counterparty that it agrees to be treated as an eligible counterparty. Member States shall allow the investment firm to obtain this confirmation either in the form of a general agreement or in respect of each individual transaction. 4. Member States may recognise as eligible counterparties third country entities equivalent to those categories of entities mentioned in paragraph 2. Member States may also recognise as eligible counterparties third country undertakings such as those mentioned in paragraph 3 on the same conditions and subject to the same requirements as those laid down at paragraph 3. 5. In order to ensure the uniform application of paragraphs 2, 3 and 4 in the light of changing market practice and to facilitate the effective operation of the single market, the Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which define: (a) the procedures for requesting treatment as clients under paragraph 2; (b) the procedures for obtaining the express confirmation from prospective counterparties under paragraph 3; (c) the predetermined proportionate requirements, including quantitative thresholds that would allow an undertaking to be considered as an eligible counterparty under paragraph 3. Section 3 Market transparency and integrity Article 25 Obligation to uphold integrity of markets, report transactions and maintain records 1. Without prejudice to the allocation of responsibilities for enforcing the provisions of Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse)(21), Member States shall ensure that appropriate measures are in place to enable the competent authority to monitor the activities of investment firms to ensure that they act honestly, fairly and professionally and in a manner which promotes the integrity of the market. 2. Member States shall require investment firms to keep at the disposal of the competent authority, for at least five years, the relevant data relating to all transactions in financial instruments which they have carried out, whether on own account or on behalf of a client. In the case of transactions carried out on behalf of clients, the records shall contain all the information and details of the identity of the client, and the information required under Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering(22). 3. Member States shall require investment firms which execute transactions in any financial instruments admitted to trading on a regulated market to report details of such transactions to the competent authority as quickly as possible, and no later than the close of the following working day. This obligation shall apply whether or not such transactions were carried out on a regulated market. The competent authorities shall, in accordance with Article 58, establish the necessary arrangements in order to ensure that the competent authority of the most relevant market in terms of liquidity for those financial instruments also receives this information. 4. The reports shall, in particular, include details of the names and numbers of the instruments bought or sold, the quantity, the dates and times of execution and the transaction prices and means of identifying the investment firms concerned. 5. Member States shall provide for the reports to be made to the competent authority either by the investment firm itself, a third party acting on its behalf or by a trade-matching or reporting system approved by the competent authority or by the regulated market or MTF through whose systems the transaction was completed. In cases where transactions are reported directly to the competent authority by a regulated market, an MTF, or a trade-matching or reporting system approved by the competent authority, the obligation on the investment firm laid down in paragraph 3 may be waived. 6. When, in accordance with Article 32(7), reports provided for under this Article are transmitted to the competent authority of the host Member State, it shall transmit this information to the competent authorities of the home Member State of the investment firm, unless they decide that they do not want to receive this information. 7. In order to ensure that measures for the protection of market integrity are modified to take account of technical developments in financial markets, and to ensure the uniform application of paragraphs 1 to 5, the Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which define the methods and arrangements for reporting financial transactions, the form and content of these reports and the criteria for defining a relevant market in accordance with paragraph 3. Article 26 Monitoring of compliance with the rules of the MTF and with other legal obligations 1. Member States shall require that investment firms and market operators operating an MTF establish and maintain effective arrangements and procedures, relevant to the MTF, for the regular monitoring of the compliance by its users with its rules. Investment firms and market operators operating an MTF shall monitor the transactions undertaken by their users under their systems in order to identify breaches of those rules, disorderly trading conditions or conduct that may involve market abuse. 2. Member States shall require investment firms and market operators operating an MTF to report significant breaches of its rules or disorderly trading conditions or conduct that may involve market abuse to the competent authority. Member States shall also require investment firms and market operators operating an MTF to supply the relevant information without delay to the authority competent for the investigation and prosecution of market abuse and to provide full assistance to the latter in investigating and prosecuting market abuse occurring on or through its systems. Article 27 Obligation for investment firms to make public firm quotes 1. Member States shall require systematic internalisers in shares to publish a firm quote in those shares admitted to trading on a regulated market for which they are systematic internalisers and for which there is a liquid market. In the case of shares for which there is not a liquid market, systematic internalisers shall disclose quotes to their clients on request. The provisions of this Article shall be applicable to systematic internalisers when dealing for sizes up to standard market size. Systematic internalisers that only deal in sizes above standard market size shall not be subject to the provisions of this Article. Systematic internalisers may decide the size or sizes at which they will quote. For a particular share each quote shall include a firm bid and/or offer price or prices for a size or sizes which could be up to standard market size for the class of shares to which the share belongs. The price or prices shall also reflect the prevailing market conditions for that share. Shares shall be grouped in classes on the basis of the arithmetic average value of the orders executed in the market for that share. The standard market size for each class of shares shall be a size representative of the arithmetic average value of the orders executed in the market for the shares included in each class of shares. The market for each share shall be comprised of all orders executed in the European Union in respect of that share excluding those large in scale compared to normal market size for that share. 2. The competent authority of the most relevant market in terms of liquidity as defined in Article 25 for each share shall determine at least annually, on the basis of the arithmetic average value of the orders executed in the market in respect of that share, the class of shares to which it belongs. This information shall be made public to all market participants. 3. Systematic internalisers shall make public their quotes on a regular and continuous basis during normal trading hours. They shall be entitled to update their quotes at any time. They shall also be allowed, under exceptional market conditions, to withdraw their quotes. The quote shall be made public in a manner which is easily accessible to other market participants on a reasonable commercial basis. Systematic internalisers shall, while complying with the provisions set down in Article 21, execute the orders they receive from their retail clients in relation to the shares for which they are systematic internalisers at the quoted prices at the time of reception of the order. Systematic internalisers shall execute the orders they receive from their professional clients in relation to the shares for which they are systematic internalisers at the quoted price at the time of reception of the order. However, they may execute those orders at a better price in justified cases provided that this price falls within a public range close to market conditions and provided that the orders are of a size bigger than the size customarily undertaken by a retail investor. Furthermore, systematic internalisers may execute orders they receive from their professional clients at prices different than their quoted ones without having to comply with the conditions established in the fourth subparagraph, in respect of transactions where execution in several securities is part of one transaction or in respect of orders that are subject to conditions other than the current market price. Where a systematic internaliser who quotes only one quote or whose highest quote is lower than the standard market size receives an order from a client of a size bigger than its quotation size, but lower than the standard market size, it may decide to execute that part of the order which exceeds its quotation size, provided that it is executed at the quoted price, except where otherwise permitted under the conditions of the previous two subparagraphs. Where the systematic internaliser is quoting in different sizes and receives an order between those sizes, which it chooses to execute, it shall execute the order at one of the quoted prices in compliance with the provisions of Article 22, except where otherwise permitted under the conditions of the previous two subparagraphs. 4. The competent authorities shall check: (a) that investment firms regularly update bid and/or offer prices published in accordance with paragraph 1 and maintain prices which reflect the prevailing market conditions; (b) that investment firms comply with the conditions for price improvement laid down in the fourth subparagraph of paragraph 3. 5. Systematic internalisers shall be allowed to decide, on the basis of their commercial policy and in an objective non-discriminatory way, the investors to whom they give access to their quotes. To that end there shall be clear standards for governing access to their quotes. Systematic internalisers may refuse to enter into or discontinue business relationships with investors on the basis of commercial considerations such as the investor credit status, the counterparty risk and the final settlement of the transaction. 6. In order to limit the risk of being exposed to multiple transactions from the same client systematic internalisers shall be allowed to limit in a non-discriminatory way the number of transactions from the same client which they undertake to enter at the published conditions. They shall also be allowed, in a non-discriminatory way and in accordance with the provisions of Article 22, to limit the total number of transactions from different clients at the same time provided that this is allowable only where the number and/or volume of orders sought by clients considerably exceeds the norm. 7. In order to ensure the uniform application of paragraphs 1 to 6, in a manner which supports the efficient valuation of shares and maximises the possibility of investment firms of obtaining the best deal for their clients, the Commission shall, in accordance with the procedure referred to in Article 64(2), adopt implementing measures which: (a) specify the criteria for application of paragraphs 1 and 2; (b) specify the criteria determining when a quote is published on a regular and continuous basis and is easily accessible as well as the means by which investment firms may comply with their obligation to make public their quotes, which shall include the following possibilities: (i) through the facilities of any regulated market which has admitted the instrument in question to trading; (ii) through the offices of a third party; (iii) through proprietary arrangements; (c) specify the general criteria for determining those transactions where execution in several securities is part of one transaction or orders that are subject to conditions other than current market price; (d) specify the general criteria for determining what can be considered as exceptional market circumstances that allow for the withdrawal of quotes as well as conditions for updating quotes; (e) specify the criteria for determining what is a size customarily undertaken by a retail investor. (f) specify the criteria for determining what constitutes considerably exceeding the norm as set down in paragraph 6; (g) specify the criteria for determining when prices fall within a public range close to market conditions. Article 28 Post-trade disclosure by investment firms 1. Member States shall, at least, require investment firms which, either on own account or on behalf of clients, conclude transactions in shares admitted to trading on a regulated market outside a regulated market or MTF, to make public the volume and price of those transactions and the time at which they were concluded. This information shall be made public as close to real-time as possible, on a reasonable commercial basis, and in a manner which is easily accessible to other market participants. 2. Member States shall require that the information which is made public in accordance with paragraph 1 and the time-limits within which it is published comply with the requirements adopted pursuant to Article 45. Where the measures adopted pursuant to Article 45 provide for deferred reporting for certain categories of transaction in shares, this possibility shall apply mutatis mutandis to those transactions when undertaken outside regulated markets or MTFs. 3. In order to ensure the transparent and orderly functioning of markets and the uniform application of paragraph 1, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which: (a) specify the means by which investment firms may comply with their obligations under paragraph 1 including the following possibilities: (i) through the facilities of any regulated market which has admitted the instrument in question to trading or through the facilities of an MTF in which the share in question is traded; (ii) through the offices of a third party; (iii) through proprietary arrangements; (b) clarify the application of the obligation under paragraph 1 to transactions involving the use of shares for collateral, lending or other purposes where the exchange of shares is determined by factors other than the current market valuation of the share. Article 29 Pre-trade transparency requirements for MTFs 1. Member States shall, at least, require that investment firms and market operators operating an MTF make public current bid and offer prices and the depth of trading interests at these prices which are advertised through their systems in respect of shares admitted to trading on a regulated market. Member States shall provide for this information to be made available to the public on reasonable commercial terms and on a continuous basis during normal trading hours. 2. Member States shall provide for the competent authorities to be able to waive the obligation for investment firms or market operators operating an MTF to make public the information referred to in paragraph 1 based on the market model or the type and size of orders in the cases defined in accordance with paragraph 3. In particular, the competent authorities shall be able to waive the obligation in respect of transactions that are large in scale compared with normal market size for the share or type of share in question. 3. In order to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures as regards: (a) the range of bid and offers or designated market-maker quotes, and the depth of trading interest at those prices, to be made public; (b) the size or type of orders for which pre-trade disclosure may be waived under paragraph 2; (c) the market model for which pre-trade disclosure may be waived under paragraph 2 and in particular, the applicability of the obligation to trading methods operated by an MTF which conclude transactions under their rules by reference to prices established outside the systems of the MTF or by periodic auction. Except where justified by the specific nature of the MTF, the content of these implementing measures shall be equal to that of the implementing measures provided for in Article 44 for regulated markets. Article 30 Post-trade transparency requirements for MTFs 1. Member States shall, at least, require that investment firms and market operators operating an MTF make public the price, volume and time of the transactions executed under its systems in respect of shares which are admitted to trading on a regulated market. Member States shall require that details of all such transactions be made public, on a reasonable commercial basis, as close to real-time as possible. This requirement shall not apply to details of trades executed on an MTF that are made public under the systems of a regulated market. 2. Member States shall provide that the competent authority may authorise investment firms or market operators operating an MTF to provide for deferred publication of the details of transactions based on their type or size. In particular, the competent authorities may authorise the deferred publication in respect of transactions that are large in scale compared with the normal market size for that share or that class of shares. Member States shall require MTFs to obtain the competent authority's prior approval to proposed arrangements for deferred trade-publication, and shall require that these arrangements be clearly disclosed to market participants and the investing public. 3. In order to provide for the efficient and orderly functioning of financial markets, and to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures in respect of: (a) the scope and content of the information to be made available to the public; (b) the conditions under which investment firms or market operators operating an MTF may provide for deferred publication of trades and the criteria to be applied when deciding the transactions for which, due to their size or the type of share involved, deferred publication is allowed. Except where justified by the specific nature of the MTF, the content of these implementing measures shall be equal to that of the implementing measures provided for in Article 45 for regulated markets. CHAPTER III RIGHTS OF INVESTMENT FIRMS Article 31 Freedom to provide investment services and activities 1. Member States shall ensure that any investment firm authorised and supervised by the competent authorities of another Member State in accordance with this Directive, and in respect of credit institutions in accordance with Directive 2000/12/EC, may freely perform investment services and/or activities as well as ancillary services within their territories, provided that such services and activities are covered by its authorisation. Ancillary services may only be provided together with an investment service and/or activity. Member States shall not impose any additional requirements on such an investment firm or credit institution in respect of the matters covered by this Directive. 2. Any investment firm wishing to provide services or activities within the territory of another Member State for the first time, or which wishes to change the range of services or activities so provided, shall communicate the following information to the competent authorities of its home Member State: (a) the Member State in which it intends to operate; (b) a programme of operations stating in particular the investment services and/or activities as well as ancillary services which it intends to perform and whether it intends to use tied agents in the territory of the Member States in which it intends to provide services. In cases where the investment firm intends to use tied agents, the competent authority of the home Member State of the investment firm shall, at the request of the competent authority of the host Member State and within a reasonable time, communicate the identity of the tied agents that the investment firm intends to use in that Member State. The host Member State may make public such information. 3. The competent authority of the home Member State shall, within one month of receiving the information, forward it to the competent authority of the host Member State designated as contact point in accordance with Article 56(1). The investment firm may then start to provide the investment service or services concerned in the host Member State. 4. In the event of a change in any of the particulars communicated in accordance with paragraph 2, an investment firm shall give written notice of that change to the competent authority of the home Member State at least one month before implementing the change. The competent authority of the home Member State shall inform the competent authority of the host Member State of those changes. 5. Member States shall, without further legal or administrative requirement, allow investment firms and market operators operating MTFs from other Member States to provide appropriate arrangements on their territory so as to facilitate access to and use of their systems by remote users or participants established in their territory. 6. The investment firm or the market operator that operates an MTF shall communicate to the competent authority of its home Member State the Member State in which it intends to provide such arrangements. The competent authority of the home Member State of the MTF shall communicate, within one month, this information to the Member State in which the MTF intends to provide such arrangements. The competent authority of the home Member State of the MTF shall, on the request of the competent authority of the host Member State of the MTF and within a reasonable delay, communicate the identity of the members or participants of the MTF established in that Member State. Article 32 Establishment of a branch 1. Member States shall ensure that investment services and/or activities as well as ancillary services may be provided within their territories in accordance with this Directive and Directive 2000/12/EC through the establishment of a branch provided that those services and activities are covered by the authorisation granted to the investment firm or the credit institution in the home Member State. Ancillary services may only be provided together with an investment service and/or activity. Member States shall not impose any additional requirements save those allowed under paragraph 7, on the organisation and operation of the branch in respect of the matters covered by this Directive. 2. Member States shall require any investment firm wishing to establish a branch within the territory of another Member State first to notify the competent authority of its home Member State and to provide it with the following information: (a) the Member States within the territory of which it plans to establish a branch; (b) a programme of operations setting out inter alia the investment services and/or activities as well as the ancillary services to be offered and the organisational structure of the branch and indicating whether the branch intends to use tied agents; (c) the address in the host Member State from which documents may be obtained; (d) the names of those responsible for the management of the branch. In cases where an investment firm uses a tied agent established in a Member State outside its home Member State, such tied agent shall be assimilated to the branch and shall be subject to the provisions of this Directive relating to branches. 3. Unless the competent authority of the home Member State has reason to doubt the adequacy of the administrative structure or the financial situation of an investment firm, taking into account the activities envisaged, it shall, within three months of receiving all the information, communicate that information to the competent authority of the host Member State designated as contact point in accordance with Article 56(1) and inform the investment firm concerned accordingly. 4. In addition to the information referred to in paragraph 2, the competent authority of the home Member State shall communicate details of the accredited compensation scheme of which the investment firm is a member in accordance with Directive 97/9/EC to the competent authority of the host Member State. In the event of a change in the particulars, the competent authority of the home Member State shall inform the competent authority of the host Member State accordingly. 5. Where the competent authority of the home Member State refuses to communicate the information to the competent authority of the host Member State, it shall give reasons for its refusal to the investment firm concerned within three months of receiving all the information. 6. On receipt of a communication from the competent authority of the host Member State, or failing such communication from the latter at the latest after two months from the date of transmission of the communication by the competent authority of the home Member State, the branch may be established and commence business. 7. The competent authority of the Member State in which the branch is located shall assume responsibility for ensuring that the services provided by the branch within its territory comply with the obligations laid down in Articles 19, 21, 22, 25, 27 and 28 and in measures adopted pursuant thereto. The competent authority of the Member State in which the branch is located shall have the right to examine branch arrangements and to request such changes as are strictly needed to enable the competent authority to enforce the obligations under Articles 19, 21, 22, 25, 27 and 28 and measures adopted pursuant thereto with respect to the services and/or activities provided by the branch within its territory. 8. Each Member State shall provide that, where an investment firm authorised in another Member State has established a branch within its territory, the competent authority of the home Member State of the investment firm, in the exercise of its responsibilities and after informing the competent authority of the host Member State, may carry out on-site inspections in that branch. 9. In the event of a change in any of the information communicated in accordance with paragraph 2, an investment firm shall give written notice of that change to the competent authority of the home Member State at least one month before implementing the change. The competent authority of the host Member State shall also be informed of that change by the competent authority of the home Member State. Article 33 Access to regulated markets 1. Member States shall require that investment firms from other Member States which are authorised to execute client orders or to deal on own account have the right of membership or have access to regulated markets established in their territory by means of any of the following arrangements: (a) directly, by setting up branches in the host Member States; (b) by becoming remote members of or having remote access to the regulated market without having to be established in the home Member State of the regulated market, where the trading procedures and systems of the market in question do not require a physical presence for conclusion of transactions on the market. 2. Member States shall not impose any additional regulatory or administrative requirements, in respect of matters covered by this Directive, on investment firms exercising the right conferred by paragraph 1. Article 34 Access to central counterparty, clearing and settlement facilities and right to designate settlement system 1. Member States shall require that investment firms from other Member States have the right of access to central counterparty, clearing and settlement systems in their territory for the purposes of finalising or arranging the finalisation of transactions in financial instruments. Member States shall require that access of those investment firms to such facilities be subject to the same non-discriminatory, transparent and objective criteria as apply to local participants. Member States shall not restrict the use of those facilities to the clearing and settlement of transactions in financial instruments undertaken on a regulated market or MTF in their territory. 2. Member States shall require that regulated markets in their territory offer all their members or participants the right to designate the system for the settlement of transactions in financial instruments undertaken on that regulated market, subject to: (a) such links and arrangements between the designated settlement system and any other system or facility as are necessary to ensure the efficient and economic settlement of the transaction in question; and (b) agreement by the competent authority responsible for the supervision of the regulated market that technical conditions for settlement of transactions concluded on the regulated market through a settlement system other than that designated by the regulated market are such as to allow the smooth and orderly functioning of financial markets. This assessment of the competent authority of the regulated market shall be without prejudice to the competencies of the national central banks as overseers of settlement systems or other supervisory authorities on such systems. The competent authority shall take into account the oversight/supervision already exercised by those institutions in order to avoid undue duplication of control. 3. The rights of investment firms under paragraphs 1 and 2 shall be without prejudice to the right of operators of central counterparty, clearing or securities settlement systems to refuse on legitimate commercial grounds to make the requested services available. Article 35 Provisions regarding central counterparty, clearing and settlement arrangements in respect of MTFs 1. Member States shall not prevent investment firms and market operators operating an MTF from entering into appropriate arrangements with a central counterparty or clearing house and a settlement system of another Member State with a view to providing for the clearing and/or settlement of some or all trades concluded by market participants under their systems. 2. The competent authority of investment firms and market operators operating an MTF may not oppose the use of central counterparty, clearing houses and/or settlement systems in another Member State except where this is demonstrably necessary in order to maintain the orderly functioning of that MTF and taking into account the conditions for settlement systems established in Article 34(2). In order to avoid undue duplication of control, the competent authority shall take into account the oversight/supervision of the clearing and settlement system already exercised by the national central banks as overseers of clearing and settlement systems or by other supervisory authorities with a competence in such systems. TITLE III REGULATED MARKETS Article 36 Authorisation and applicable law 1. Member States shall reserve authorisation as a regulated market to those systems which comply with the provisions of this Title. Authorisation as a regulated market shall be granted only where the competent authority is satisfied that both the market operator and the systems of the regulated market comply at least with the requirements laid down in this Title. In the case of a regulated market that is a legal person and that is managed or operated by a market operator other than the regulated market itself, Member States shall establish how the different obligations imposed on the market operator under this Directive are to be allocated between the regulated market and the market operator. The operator of the regulated market shall provide all information, including a programme of operations setting out inter alia the types of business envisaged and the organisational structure, necessary to enable the competent authority to satisfy itself that the regulated market has established, at the time of initial authorisation, all the necessary arrangements to meet its obligations under the provisions of this Title. 2. Member States shall require the operator of the regulated market to perform tasks relating to the organisation and operation of the regulated market under the supervision of the competent authority. Member States shall ensure that competent authorities keep under regular review the compliance of regulated markets with the provisions of this Title. They shall also ensure that competent authorities monitor that regulated markets comply at all times with the conditions for initial authorisation established under this Title. 3. Member States shall ensure that the market operator is responsible for ensuring that the regulated market that he manages complies with all requirements under this Title. Member States shall also ensure that the market operator is entitled to exercise the rights that correspond to the regulated market that he manages by virtue of this Directive. 4. Without prejudice to any relevant provisions of Directive 2003/6/EC, the public law governing the trading conducted under the systems of the regulated market shall be that of the home Member State of the regulated market. 5. The competent authority may withdraw the authorisation issued to a regulated market where it: (a) does not make use of the authorisation within 12 months, expressly renounces the authorisation or has not operated for the preceding six months, unless the Member State concerned has provided for authorisation to lapse in such cases; (b) has obtained the authorisation by making false statements or by any other irregular means; (c) no longer meets the conditions under which authorisation was granted; (d) has seriously and systematically infringed the provisions adopted pursuant to this Directive; (e) falls within any of the cases where national law provides for withdrawal. Article 37 Requirements for the management of the regulated market 1. Member States shall require the persons who effectively direct the business and the operations of the regulated market to be of sufficiently good repute and sufficiently experienced as to ensure the sound and prudent management and operation of the regulated market. Member States shall also require the operator of the regulated market to inform the competent authority of the identity and any other subsequent changes of the persons who effectively direct the business and the operations of the regulated market. The competent authority shall refuse to approve proposed changes where there are objective and demonstrable grounds for believing that they pose a material threat to the sound and prudent management and operation of the regulated market. 2. Member States shall ensure that, in the process of authorisation of a regulated market, the person or persons who effectively direct the business and the operations of an already authorised regulated market in accordance with the conditions of this Directive are deemed to comply with the requirements laid down in paragraph 1. Article 38 Requirements relating to persons exercising significant influence over the management of the regulated market 1. Member States shall require the persons who are in a position to exercise, directly or indirectly, significant influence over the management of the regulated market to be suitable. 2. Member States shall require the operator of the regulated market: (a) to provide the competent authority with, and to make public, information regarding the ownership of the regulated market and/or the market operator, and in particular, the identity and scale of interests of any parties in a position to exercise significant influence over the management; (b) to inform the competent authority of and to make public any transfer of ownership which gives rise to a change in the identity of the persons exercising significant influence over the operation of the regulated market. 3. The competent authority shall refuse to approve proposed changes to the controlling interests of the regulated market and/or the market operator where there are objective and demonstrable grounds for believing that they would pose a threat to the sound and prudent management of the regulated market. Article 39 Organisational requirements Member States shall require the regulated market: (a) to have arrangements to identify clearly and manage the potential adverse consequences, for the operation of the regulated market or for its participants, of any conflict of interest between the interest of the regulated market, its owners or its operator and the sound functioning of the regulated market, and in particular where such conflicts of interest might prove prejudicial to the accomplishment of any functions delegated to the regulated market by the competent authority; (b) to be adequately equipped to manage the risks to which it is exposed, to implement appropriate arrangements and systems to identify all significant risks to its operation, and to put in place effective measures to mitigate those risks; (c) to have arrangements for the sound management of the technical operations of the system, including the establishment of effective contingency arrangements to cope with risks of systems disruptions; (d) to have transparent and non-discretionary rules and procedures that provide for fair and orderly trading and establish objective criteria for the efficient execution of orders; (e) to have effective arrangements to facilitate the efficient and timely finalisation of the transactions executed under its systems; (f) to have available, at the time of authorisation and on an ongoing basis, sufficient financial resources to facilitate its orderly functioning, having regard to the nature and extent of the transactions concluded on the market and the range and degree of the risks to which it is exposed. Article 40 Admission of financial instruments to trading 1. Member States shall require that regulated markets have clear and transparent rules regarding the admission of financial instruments to trading. Those rules shall ensure that any financial instruments admitted to trading in a regulated market are capable of being traded in a fair, orderly and efficient manner and, in the case of transferable securities, are freely negotiable. 2. In the case of derivatives, the rules shall ensure in particular that the design of the derivative contract allows for its orderly pricing as well as for the existence of effective settlement conditions. 3. In addition to the obligations set out in paragraphs 1 and 2, Member States shall require the regulated market to establish and maintain effective arrangements to verify that issuers of transferable securities that are admitted to trading on the regulated market comply with their obligations under Community law in respect of initial, ongoing or ad hoc disclosure obligations. Member States shall ensure that the regulated market establishes arrangements which facilitate its members or participants in obtaining access to information which has been made public under Community law. 4. Member States shall ensure that regulated markets have established the necessary arrangements to review regularly the compliance with the admission requirements of the financial instruments which they admit to trading. 5. A transferable security that has been admitted to trading on a regulated market can subsequently be admitted to trading on other regulated markets, even without the consent of the issuer and in compliance with the relevant provisions of Directive 2003/71/EC of the European Parliament and of the Council of... on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC(23). The issuer shall be informed by the regulated market of the fact that its securities are traded on that regulated market. The issuer shall not be subject to any obligation to provide information required under paragraph 3 directly to any regulated market which has admitted the issuer's securities to trading without its consent. 6. In order to ensure the uniform application of paragraphs 1 to 5, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures which: (a) specify the characteristics of different classes of instruments to be taken into account by the regulated market when assessing whether an instrument is issued in a manner consistent with the conditions laid down in the second subparagraph of paragraph 1 for admission to trading on the different market segments which it operates; (b) clarify the arrangements that the regulated market is to implement so as to be considered to have fulfilled its obligation to verify that the issuer of a transferable security complies with its obligations under Community law in respect of initial, ongoing or ad hoc disclosure obligations; (c) clarify the arrangements that the regulated market has to establish pursuant to paragraph 3 in order to facilitate its members or participants in obtaining access to information which has been made public under the conditions established by Community law. Article 41 Suspension and removal of instruments from trading 1. Without prejudice to the right of the competent authority under Article 50(2)(j) and (k) to demand suspension or removal of an instrument from trading, the operator of the regulated market may suspend or remove from trading a financial instrument which no longer complies with the rules of the regulated market unless such a step would be likely to cause significant damage to the investors' interests or the orderly functioning of the market. Notwithstanding the possibility for the operators of regulated markets to inform directly the operators of other regulated markets, Member States shall require that an operator of a regulated market that suspends or removes from trading a financial instrument make public this decision and communicates relevant information to the competent authority. The competent authority shall inform the competent authorities of the other Member States. 2. A competent authority which demands the suspension or removal of a financial instrument from trading on one or more regulated markets shall immediately make public its decision and inform the competent authorities of the other Member States. Except where it could cause significant damage to the investors' interests or the orderly functioning of the market the competent authorities of the other Member States shall demand the suspension or removal of that financial instrument from trading on the regulated markets and MTFs that operate under their authority. Article 42 Access to the regulated market 1. Member States shall require the regulated market to establish and maintain transparent and non-discriminatory rules, based on objective criteria, governing access to or membership of the regulated market. 2. Those rules shall specify any obligations for the members or participants arising from: (a) the constitution and administration of the regulated market; (b) rules relating to transactions on the market; (c) professional standards imposed on the staff of the investment firms or credit institutions that are operating on the market; (d) the conditions established, for members or participants other than investment firms and credit institutions, under paragraph 3; (e) the rules and procedures for the clearing and settlement of transactions concluded on the regulated market. 3. Regulated markets may admit as members or participants investment firms, credit institutions authorised under Directive 2000/12/EC and other persons who: (a) are fit and proper; (b) have a sufficient level of trading ability and competence; (c) have, where applicable, adequate organisational arrangements; (d) have sufficient resources for the role they are to perform, taking into account the different financial arrangements that the regulated market may have established in order to guarantee the adequate settlement of transactions. 4. Member States shall ensure that, for the transactions concluded on a regulated market, members and participants are not obliged to apply to each other the obligations laid down in Articles 19, 21 and 22. However, the members or participants of the regulated market shall apply the obligations provided for in Articles 19, 21 and 22 with respect to their clients when they, acting on behalf of their clients, execute their orders on a regulated market. 5. Member States shall ensure that the rules on access to or membership of the regulated market provide for the direct or remote participation of investment firms and credit institutions. 6. Member States shall, without further legal or administrative requirements, allow regulated markets from other Member States to provide appropriate arrangements on their territory so as to facilitate access to and trading on those markets by remote members or participants established in their territory. The regulated market shall communicate to the competent authority of its home Member State the Member State in which it intends to provide such arrangements. The competent authority of the home Member State shall communicate, within one month, this information to the Member State in which the regulated market intends to provide such arrangements. The competent authority of the home Member State of the regulated market shall, on the request of the competent authority of the host Member State and within a reasonable time, communicate the identity of the members or participants of the regulated market established in that Member State. 7. Member States shall require the operator of the regulated market to communicate, on a regular basis, the list of the members and participants of the regulated market to the competent authority of the regulated market. Article 43 Monitoring of compliance with the rules of the regulated market and with other legal obligations 1. Member States shall require that regulated markets establish and maintain effective arrangements and procedures for the regular monitoring of the compliance by their members or participants with their rules. Regulated markets shall monitor the transactions undertaken by their members or participants under their systems in order to identify breaches of those rules, disorderly trading conditions or conduct that may involve market abuse. 2. Member States shall require the operators of the regulated markets to report significant breaches of their rules or disorderly trading conditions or conduct that may involve market abuse to the competent authority of the regulated market. Member States shall also require the operator of the regulated market to supply the relevant information without delay to the authority competent for the investigation and prosecution of market abuse on the regulated market and to provide full assistance to the latter in investigating and prosecuting market abuse occurring on or through the systems of the regulated market. Article 44 Pre-trade transparency requirements for regulated markets 1. Member States shall, at least, require regulated markets to make public current bid and offer prices and the depth of trading interests at those prices which are advertised through their systems for shares admitted to trading. Member States shall require this information to be made available to the public on reasonable commercial terms and on a continuous basis during normal trading hours. Regulated markets may give access, on reasonable commercial terms and on a non-discriminatory basis, to the arrangements they employ for making public the information under the first subparagraph to investment firms which are obliged to publish their quotes in shares pursuant to Article 27. 2. Member States shall provide that the competent authorities are to be able to waive the obligation for regulated markets to make public the information referred to in paragraph 1 based on the market model or the type and size of orders in the cases defined in accordance with paragraph 3. In particular, the competent authorities shall be able to waive the obligation in respect of transactions that are large in scale compared with normal market size for the share or type of share in question. 3. In order to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures as regards: (a) the range of bid and offers or designated market-maker quotes, and the depth of trading interest at those prices, to be made public; (b) the size or type of orders for which pre-trade disclosure may be waived under paragraph 2; (c) the market model for which pre-trade disclosure may be waived under paragraph 2, and in particular, the applicability of the obligation to trading methods operated by regulated markets which conclude transactions under their rules by reference to prices established outside the regulated market or by periodic auction. Article 45 Post-trade transparency requirements for regulated markets 1. Member States shall, at least, require regulated markets to make public the price, volume and time of the transactions executed in respect of shares admitted to trading. Member States shall require details of all such transactions to be made public, on a reasonable commercial basis and as close to real-time as possible. Regulated markets may give access, on reasonable commercial terms and on a non-discriminatory basis, to the arrangements they employ for making public the information under the first subparagraph to investment firms which are obliged to publish the details of their transactions in shares pursuant to Article 28. 2. Member States shall provide that the competent authority may authorise regulated markets to provide for deferred publication of the details of transactions based on their type or size. In particular, the competent authorities may authorise the deferred publication in respect of transactions that are large in scale compared with the normal market size for that share or that class of shares. Member States shall require regulated markets to obtain the competent authority's prior approval of proposed arrangements for deferred trade-publication, and shall require that these arrangements be clearly disclosed to market participants and the investing public. 3. In order to provide for the efficient and orderly functioning of financial markets, and to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures in respect of: (a) the scope and content of the information to be made available to the public; (b) the conditions under which a regulated market may provide for deferred publication of trades and the criteria to be applied when deciding the transactions for which, due to their size or the type of share involved, deferred publication is allowed. Article 46 Provisions regarding central counterparty and clearing and settlement arrangements 1. Member States shall not prevent regulated markets from entering into appropriate arrangements with a central counterparty or clearing house and a settlement system of another Member State with a view to providing for the clearing and/or settlement of some or all trades concluded by market participants under their systems. 2. The competent authority of a regulated market may not oppose the use of central counterparty, clearing houses and/or settlement systems in another Member State except where this is demonstrably necessary in order to maintain the orderly functioning of that regulated market and taking into account the conditions for settlement systems established in Article 34(2). In order to avoid undue duplication of control, the competent authority shall take into account the oversight/supervision of the clearing and settlement system already exercised by the national central banks as overseers of clearing and settlement systems or by other supervisory authorities with competence in relation to such systems. Article 47 List of regulated markets Each Member State shall draw up a list of the regulated markets for which it is the home Member State and shall forward that list to the other Member States and the Commission. A similar communication shall be effected in respect of each change to that list. The Commission shall publish a list of all regulated markets in the Official Journal of the European Union and update it at least once a year. The Commission shall also publish and update the list at its website, each time the Member States communicate changes to their lists. TITLE IV COMPETENT AUTHORITIES CHAPTER I DESIGNATION, POWERS AND REDRESS PROCEDURES Article 48 Designation of competent authorities 1. Each Member State shall designate the competent authorities which are to carry out each of the duties provided for under the different provisions of this Directive. Member States shall inform the Commission and the competent authorities of other Member States of the identity of the competent authorities responsible for enforcement of each of those duties, and of any division of those duties. 2. The competent authorities referred to in paragraph 1 shall be public authorities, without prejudice to the possibility of delegating tasks to other entities where that is expressly provided for in Articles 5(5), 16(3), 17(2) and 23(4). Any delegation of tasks to entities other than the authorities referred to in paragraph 1 may not involve either the exercise of public authority or the use of discretionary powers of judgement. Member States shall require that, prior to delegation, competent authorities take all reasonable steps to ensure that the entity to which tasks are to be delegated has the capacity and resources to effectively execute all tasks and that the delegation takes place only if a clearly defined and documented framework for the exercise of any delegated tasks has been established stating the tasks to be undertaken and the conditions under which they are to be carried out. These conditions shall include a clause obliging the entity in question to act and be organised in such a manner as to avoid conflict of interest and so that information obtained from carrying out the delegated tasks is not used unfairly or to prevent competition. In any case, the final responsibility for supervising compliance with this Directive and with its implementing measures shall lie with the competent authority or authorities designated in accordance with paragraph 1. Member States shall inform the Commission and the competent authorities of other Member States of any arrangements entered into with regard to delegation of tasks, including the precise conditions regulating such delegation. 3. The Commission shall publish a list of the competent authorities referred to in paragraphs 1 and 2 in the Official Journal of the European Union at least once a year and update it continuously on its website. Article 49 Cooperation between authorities in the same Member State If a Member State designates more than one competent authority to enforce a provision of this Directive, their respective roles shall be clearly defined and they shall cooperate closely. Each Member State shall require that such cooperation also take place between the competent authorities for the purposes of this Directive and the competent authorities responsible in that Member State for the supervision of credit and other financial institutions, pension funds, UCITS, insurance and reinsurance intermediaries and insurance undertakings. Member States shall require that competent authorities exchange any information which is essential or relevant to the exercise of their functions and duties. Article 50 Powers to be made available to competent authorities 1. Competent authorities shall be given all supervisory and investigatory powers that are necessary for the exercise of their functions. Within the limits provided for in their national legal frameworks they shall exercise such powers: (a) directly; or (b) in collaboration with other authorities; or (c) under their responsibility by delegation to entities to which tasks have been delegated according to Article 48(2); or (d) by application to the competent judicial authorities. 2. The powers referred to in paragraph 1 shall be exercised in conformity with national law and shall include, at least, the rights to: (a) have access to any document in any form whatsoever and to receive a copy of it; (b) demand information from any person and if necessary to summon and question a person with a view to obtaining information; (c) carry out on-site inspections; (d) require existing telephone and existing data traffic records; (e) require the cessation of any practice that is contrary to the provisions adopted in the implementation of this Directive; (f) request the freezing and/or the sequestration of assets; (g) request temporary prohibition of professional activity; (h) require authorised investment firms and regulated markets' auditors to provide information; (i) adopt any type of measure to ensure that investment firms and regulated markets continue to comply with legal requirements; (j) require the suspension of trading in a financial instrument; (k) require the removal of a financial instrument from trading, whether on a regulated market or under other trading arrangements; (l) refer matters for criminal prosecution; (m) allow auditors or experts to carry out verifications or investigations. Article 51 Administrative sanctions 1. Without prejudice to the procedures for the withdrawal of authorisation or to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that the appropriate administrative measures can be taken or administrative sanctions be imposed against the persons responsible where the provisions adopted in the implementation of this Directive have not been complied with. Member States shall ensure that these measures are effective, proportionate and dissuasive. 2. Member States shall determine the sanctions to be applied for failure to cooperate in an investigation covered by Article 50. 3. Member States shall provide that the competent authority may disclose to the public any measure or sanction that will be imposed for infringement of the provisions adopted in the implementation of this Directive, unless such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved. Article 52 Right of appeal 1. Member States shall ensure that any decision taken under laws, regulations or administrative provisions adopted in accordance with this Directive is properly reasoned and is subject to the right to apply to the courts. The right to apply to the courts shall also apply where, in respect of an application for authorisation which provides all the information required, no decision is taken within six months of its submission. 2. Member States shall provide that one or more of the following bodies, as determined by national law, may, in the interests of consumers and in accordance with national law, take action before the courts or competent administrative bodies to ensure that the national provisions for the implementation of this Directive are applied: (a) public bodies or their representatives; (b) consumer organisations having a legitimate interest in protecting consumers; (c) professional organisations having a legitimate interest in acting to protect their members. Article 53 Extra-judicial mechanism for investors' complaints 1. Member States shall encourage the setting-up of efficient and effective complaints and redress procedures for the out-of-court settlement of consumer disputes concerning the provision of investment and ancillary services provided by investment firms, using existing bodies where appropriate. 2. Member States shall ensure that those bodies are not prevented by legal or regulatory provisions from cooperating effectively in the resolution of cross-border disputes. Article 54 Professional secrecy 1. Member States shall ensure that competent authorities, all persons who work or who have worked for the competent authorities or entities to whom tasks are delegated pursuant to Article 48(2), as well as auditors and experts instructed by the competent authorities, are bound by the obligation of professional secrecy. No confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, save in summary or aggregate form such that individual investment firms, market operators, regulated markets or any other person cannot be identified, without prejudice to cases covered by criminal law or the other provisions of this Directive. 2. Where an investment firm, market operator or regulated market has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties may be divulged in civil or commercial proceedings if necessary for carrying out the proceeding. 3. Without prejudice to cases covered by criminal law, the competent authorities, bodies or natural or legal persons other than competent authorities which receive confidential information pursuant to this Directive may use it only in the performance of their duties and for the exercise of their functions, in the case of the competent authorities, within the scope of this Directive or, in the case of other authorities, bodies or natural or legal persons, for the purpose for which such information was provided to them and/or in the context of administrative or judicial proceedings specifically related to the exercise of those functions. However, where the competent authority or other authority, body or person communicating information consents thereto, the authority receiving the information may use it for other purposes. 4. Any confidential information received, exchanged or transmitted pursuant to this Directive shall be subject to the conditions of professional secrecy laid down in this Article. Nevertheless, this Article shall not prevent the competent authorities from exchanging or transmitting confidential information in accordance with this Directive and with other Directives applicable to investment firms, credit institutions, pension funds, UCITS, insurance and reinsurance intermediaries, insurance undertakings regulated markets or market operators or otherwise with the consent of the competent authority or other authority or body or natural or legal person that communicated the information. 5. This Article shall not prevent the competent authorities from exchanging or transmitting in accordance with national law, confidential information that has not been received from a competent authority of another Member State. Article 55 Relations with auditors 1. Member States shall provide, at least, that any person authorised within the meaning of Eighth Council Directive 84/253/EEC of 10 April 1984 on the approval of persons responsible for carrying out the statutory audits of accounting documents(24), performing in an investment firm the task described in Article 51 of Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies(25), Article 37 of Directive 83/349/EEC or Article 31 of Directive 85/611/EEC or any other task prescribed by law, shall have a duty to report promptly to the competent authorities any fact or decision concerning that undertaking of which that person has become aware while carrying out that task and which is liable to: (a) constitute a material breach of the laws, regulations or administrative provisions which lay down the conditions governing authorisation or which specifically govern pursuit of the activities of investment firms; (b) affect the continuous functioning of the investment firm; (c) lead to refusal to certify the accounts or to the expression of reservations. That person shall also have a duty to report any facts and decisions of which the person becomes aware in the course of carrying out one of the tasks referred to in the first subparagraph in an undertaking having close links with the investment firm within which he is carrying out that task. 2. The disclosure in good faith to the competent authorities, by persons authorised 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 contractual or legal restriction on disclosure of information and shall not involve such persons in liability of any kind. CHAPTER II COOPERATION BETWEEN COMPETENT AUTHORITIES OF DIFFERENT MEMBER STATES Article 56 Obligation to cooperate 1. Competent authorities of different Member States shall cooperate with each other whenever necessary for the purpose of carrying out their duties under this Directive, making use of their powers whether set out in this Directive or in national law. Competent authorities shall render assistance to competent authorities of the other Member States. In particular, they shall exchange information and cooperate in any investigation or supervisory activities. In order to facilitate and accelerate cooperation, and more particularly exchange of information, Member States shall designate one single competent authority as a contact point for the purposes of this Directive. Member States shall communicate to the Commission and to the other Member States the names of the authorities which are designated to receive requests for exchange of information or cooperation pursuant to this paragraph. 2. When, taking into account the situation of the securities markets in the host Member State, the operations of a regulated market that has established arrangements in a host Member State have become of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State, the home and host competent authorities of the regulated market shall establish proportionate cooperation arrangements. 3. Member States shall take the necessary administrative and organisational measures to facilitate the assistance provided for in paragraph 1. Competent authorities may use their powers for the purpose of cooperation, even in cases where the conduct under investigation does not constitute an infringement of any regulation in force in that Member State. 4. Where a competent authority has good reasons to suspect that acts contrary to the provisions of this Directive, carried out by entities not subject to its supervision, are being or have been carried out on the territory of another Member State, it shall notify this in as specific a manner as possible to the competent authority of the other Member State. The latter authority shall take appropriate action. It shall inform the notifying competent authority of the outcome of the action and, to the extent possible, of significant interim developments. This paragraph shall be without prejudice to the competences of the competent authority that has forwarded the information. 5. In order to ensure the uniform application of paragraph 2 the Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures to establish the criteria under which the operations of a regulated market in a host Member State could be considered as of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State. Article 57 Cooperation in supervisory activities, on-the-spot verifications or in investigations A competent authority of one Member State may request the cooperation of the competent authority of another Member State in a supervisory activity or for an on-the-spot verification or in an investigation. In the case of investment firms that are remote members of a regulated market the competent authority of the regulated market may choose to address them directly, in which case it shall inform the competent authority of the home Member State of the remote member accordingly. Where a competent authority receives a request with respect to an on-the-spot verification or an investigation, it shall, within the framework of its powers: (a) carry out the verifications or investigations itself; or (b) allow the requesting authority to carry out the verification or investigation; or (c) allow auditors or experts to carry out the verification or investigation. Article 58 Exchange of information 1. Competent authorities of Member States having been designated as contact points for the purposes of this Directive in accordance with Article 56(1) shall immediately supply one another with the information required for the purposes of carrying out the duties of the competent authorities, designated in accordance to Article 48(1), set out in the provisions adopted pursuant to this Directive. Competent authorities exchanging information with other competent authorities under this Directive may indicate at the time of communication that such information must not be disclosed without their express agreement, in which case such information may be exchanged solely for the purposes for which those authorities gave their agreement. 2. The competent authority having been designated as the contact point may transmit the information received under paragraph 1 and Articles 55 and 63 to the authorities referred to in Article 49. They shall not transmit it to other bodies or natural or legal persons without the express agreement of the competent authorities which disclosed it and solely for the purposes for which those authorities gave their agreement, except in duly justified circumstances. In this last case, the contact point shall immediately inform the contact point that sent the information. 3. Authorities as referred to in Article 49 as well as other bodies or natural and legal persons receiving confidential information under paragraph 1 of this Article or under Articles 55 and 63 may use it only in the course of their duties, in particular: (a) to check that the conditions governing the taking-up of the business of investment firms are met and to facilitate the monitoring, on a non-consolidated or consolidated basis, of the conduct of that business, especially with regard to the capital adequacy requirements imposed by Directive 93/6/EEC, administrative and accounting procedures and internal-control mechanisms; (b) to monitor the proper functioning of trading venues; (c) to impose sanctions; (d) in administrative appeals against decisions by the competent authorities; (e) in court proceedings initiated under Article 52; or (f) in the extra-judicial mechanism for investors' complaints provided for in Article 53. 4. The Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures concerning procedures for the exchange of information between competent authorities. 5. Articles 54, 58 and 63 shall not prevent a competent authority from transmitting to central banks, the European System of Central Banks and the European Central Bank, in their capacity as monetary authorities, and, where appropriate, to other public authorities responsible for overseeing payment and settlement systems, confidential information intended for the performance of their tasks; likewise such authorities or bodies shall not be prevented from communicating to the competent authorities such information as they may need for the purpose of performing their functions provided for in this Directive. Article 59 Refusal to cooperate A competent authority may refuse to act on a request for cooperation in carrying out an investigation, on-the-spot verification or supervisory activity as provided for in Article 57 or to exchange information as provided for in Article 58 only where: (a) such an investigation, on-the-spot verification, supervisory activity or exchange of information might adversely affect the sovereignty, security or public policy of the State addressed; (b) judicial proceedings have already been initiated in respect of the same actions and the same persons before the authorities of the Member State addressed; (c) final judgment has already been delivered in the Member State addressed in respect of the same persons and the same actions. In the case of such a refusal, the competent authority shall notify the requesting competent authority accordingly, providing as detailed information as possible. Article 60 Inter-authority consultation prior to authorisation 1. The competent authorities of the other Member State involved shall be consulted prior to granting authorisation to an investment firm which is: (a) a subsidiary of an investment firm or credit institution authorised in another Member State; or (b) a subsidiary of the parent undertaking of an investment firm or credit institution authorised in another Member State; or (c) controlled by the same natural or legal persons as control an investment firm or credit institution authorised in another Member State. 2. The competent authority of the Member State responsible for the supervision of credit institutions or insurance undertakings shall be consulted prior to granting an authorisation to an investment firm which is: (a) a subsidiary of a credit institution or insurance undertaking authorised in the Community; or (b) a subsidiary of the parent undertaking of a credit institution or insurance undertaking authorised in the Community; or (c) controlled by the same person, whether natural or legal, who controls a credit institution or insurance undertaking authorised in the Community. 3. The relevant competent authorities referred to in paragraphs 1 and 2 shall in particular consult each other when assessing the suitability of the shareholders or members and the reputation and experience of persons who effectively direct the business involved in the management of another entity of the same group. They shall exchange all information regarding the suitability of shareholders or members and the reputation and experience of persons who effectively direct the business that is of relevance to the other competent authorities involved, for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions. Article 61 Powers for host Member States 1. Host Member States may, for statistical purposes, require all investment firms with branches within their territories to report to them periodically on the activities of those branches. 2. In discharging their responsibilities under this Directive, host Member States may require branches of investment firms to provide the information necessary for the monitoring of their compliance with the standards set by the host Member State that apply to them for the cases provided for in Article 32(7). Those requirements may not be more stringent than those which the same Member State imposes on established firms for the monitoring of their compliance with the same standards. Article 62 Precautionary measures to be taken by host Member States 1. Where the competent authority of the host Member State has clear and demonstrable grounds for believing that an investment firm acting within its territory under the freedom to provide services is in breach of the obligations arising from the provisions adopted pursuant to this Directive or that an investment firm that has a branch within its territory is in breach of the obligations arising from the provisions adopted pursuant to this Directive which do not confer powers on the competent authority of the host Member State, it shall refer those findings to the competent authority of the home Member State. If, despite the measures taken by the competent authority of the home Member State or because such measures prove inadequate, the investment firm persists in acting in a manner that is clearly prejudicial to the interests of host Member State investors or the orderly functioning of markets, the competent authority of the host Member State, after informing the competent authority of the home Member State shall take all the appropriate measures needed in order to protect investors and the proper functioning of the markets. This shall include the possibility of preventing offending investment firms from initiating any further transactions within their territories. The Commission shall be informed of such measures without delay. 2. Where the competent authorities of a host Member State ascertain that an investment firm that has a branch within its territory is in breach of the legal or regulatory provisions adopted in that State pursuant to those provisions of this Directive which confer powers on the host Member State's competent authorities, those authorities shall require the investment firm concerned to put an end to its irregular situation. If the investment firm concerned fails to take the necessary steps, the competent authorities of the host Member State shall take all appropriate measures to ensure that the investment firm concerned puts an end to its irregular situation. The nature of those measures shall be communicated to the competent authorities of the home Member State. If, despite the measures taken by the host Member State, the investment firm persists in breaching the legal or regulatory provisions referred to in the first subparagraph in force in the host Member State, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or to penalise further irregularities and, in so far as necessary, to prevent that investment firm from initiating any further transactions within its territory. The Commission shall be informed of such measures without delay. 3. Where the competent authority of the host Member State of a regulated market or an MTF has clear and demonstrable grounds for believing that such regulated market or MTF is in breach of the obligations arising from the provisions adopted pursuant to this Directive, it shall refer those findings to the competent authority of the home Member State of the regulated market or the MTF. If, despite the measures taken by the competent authority of the home Member State or because such measures prove inadequate, the said regulated market or the MTF persists in acting in a manner that is clearly prejudicial to the interests of host Member State investors or the orderly functioning of markets, the competent authority of the host Member State, after informing the competent authority of the home Member State, shall take all the appropriate measures needed in order to protect investors and the proper functioning of the markets. This shall include the possibility of preventing the said regulated market or the MTF from making their arrangements available to remote members or participants established in the host Member State. The Commission shall be informed of such measures without delay. 4. Any measure adopted pursuant to paragraphs 1, 2 or 3 involving sanctions or restrictions on the activities of an investment firm or of a regulated market shall be properly justified and communicated to the investment firm or to the regulated market concerned. CHAPTER III COOPERATION WITH THIRD COUNTRIES Article 63 Exchange of information with third countries 1. Member States may conclude cooperation agreements providing for the exchange of information with the competent authorities of third countries only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those required under Article 54. Such exchange of information must be intended for the performance of the tasks of those competent authorities. Member States may transfer personal data to a third country in accordance to Chapter IV of Directive 95/46/EC. Member States may also conclude cooperation agreements providing for the exchange of information with third country authorities, bodies and natural or legal persons responsible for: (i) the supervision of credit institutions, other financial organisations, insurance undertakings and the supervision of financial markets; (ii) the liquidation and bankruptcy of investment firms and other similar procedures; (iii) carrying out statutory audits of the accounts of investment firms and other financial institutions, credit institutions and insurance undertakings, in the performance of their supervisory functions, or which administer compensation schemes, in the performance of their functions; (iv) overseeing the bodies involved in the liquidation and bankruptcy of investment firms and other similar procedures; (v) overseeing persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions, only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those required under Article 54. Such exchange of information must be intended for the performance of the tasks of those authorities or bodies or natural or legal persons. 2. Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have transmitted it and, where appropriate, solely for the purposes for which those authorities gave their agreement. The same provision applies to information provided by third country competent authorities. TITLE V FINAL PROVISIONS Article 64 Committee procedure 1. The Commission shall be assisted by the European Securities Committee established by Commission Decision 2001/528/EC(26) (hereinafter referred to as "the Committee"). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof, provided that the implementing measures adopted in accordance with that procedure do not modify the essential provisions of this Directive. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following the entry into force of this Directive, the application of its provisions requiring the adoption of technical rules and decisions in accordance with paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of that period. Article 65 Reports and review 1. Before...(27), the Commission shall, on the basis of public consultation and in the light of discussions with competent authorities, report to the European Parliament and Council on the possible extension of the scope of the provisions of the Directive concerning pre and post-trade transparency obligations to transactions in classes of financial instrument other than shares. 2. Before...(28), the Commission shall present a report to the European Parliament and to the Council on the application of Article 27. 3. Before...(29), the Commission shall, on the basis of public consultations and in the light of discussions with competent authorities, report to the European Parliament and Council on: (a) the continued appropriateness of the exemption under Article 2(1)(k) for undertakings whose main business is dealing on own account in commodity derivatives; (b) the content and form of proportionate requirements for the authorisation and supervision of such undertakings as investment firms within the meaning of this Directive; (c) the appropriateness of rules concerning the appointment of tied agents in performing investment services and/or activities, in particular with respect to the supervision on them; (d) the continued appropriateness of the exemption under of Article 2(1)(i). 4. Before...(30), the Commission shall present a report to the European Parliament and the Council on the state of the removal of the obstacles which may prevent the consolidation at the European level of the information that trading venues are required to publish. 5. On the basis of the reports referred to in paragraphs 1 to 4, the Commission may submit proposals for related amendments to this Directive. 6. Before...(31), the Commission shall, in the light of discussions with competent authorities, report to the European Parliament and Council on the continued appropriateness of the requirements for professional indemnity insurance imposed on intermediaries under Community law. Article 66 Amendment of Directive 85/611/EEC In Article 5 of Directive 85/611/EEC, paragraph 4 shall be replaced by the following: "4. Articles 2(2), 12, 13 and 19 of Directive 2004//EC(32) of the European Parliament and of the Council of... on markets in financial instruments(33), shall apply to the provision of the services referred to in paragraph 3 of this Article by management companies". Article 67 Amendment of Directive 93/6/EEC Directive 93/6/EEC shall be amended as follows: 1) Article 2(2) shall be replaced by the following: "2. Investment firms shall mean all institutions that satisfy the definition in Article 4(1) of Directive 2004//EC(34) of the European Parliament and of the Council of... on markets in financial instruments(35), which are subject to the requirements imposed by the same Directive, excluding: (a) credit institutions, (b) local firms as defined in 20, and (c) firms which are only authorised to provide the service of investment advice and/or receive and transmit orders from investors without in both cases holding money or securities belonging to their clients and which for that reason may not at any time place themselves in debit with their clients." 2) Article 3(4) shall be replaced by the following: "4. The firms referred to in point (b) of Article 2(2) shall have initial capital of EUR 50000 in so far as they benefit from the freedom of establishment or to provide services under Articles 31 or 32 of Directive 2004/39/EC."; 3) In Article 3 the following paragraphs shall be inserted: "(4a) Pending revision of Directive 93/6/EC, the firms referred to in point (c) of Article 2(2) shall have: (a) initial capital of EUR 50000; or (b) professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, representing at least EUR 1000000 applying to each claim and in aggregate EUR 1500000 per year for all claims; or (c) a combination of initial capital and professional indemnity insurance in a form resulting in a level of coverage equivalent to points (a) or (b). The amounts referred to in this paragraph shall be periodically reviewed by the Commission in order to take account of changes in the European Index of Consumer Prices as published by Eurostat, in line with and at the same time as the adjustments made under Article 4(7) of Directive 2002/92/EC of the European Parliament and the Council of 9 December 2002 on insurance mediation(36). (4b) When an investment firm referred to in Article 2(2)(c), is also registered under Directive 2002/92/EC it has to comply with the requirement established by Article 4(3), of that Directive and in addition it has to have: (a) initial capital of EUR 25000; or (b) professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, representing at least EUR 500000 applying to each claim and in aggregate EUR 750000 per year for all claims; or (c) a combination of initial capital and professional indemnity insurance in a form resulting in a level of coverage equivalent to points (a) or (b)." Article 68 Amendment of Directive 2000/12/EC Annex I of Directive 2000/12/EC shall be amended as follows: At the end of the Annex I the following sentence is added: "The services and activities provided for in Section A and B of Annex I of Directive 2004//EC(37) of the European Parliament and of the Council of... on markets in financial instruments(38) when referring to the financial instruments provided for in Section C of Annex I of that Directive are subject to mutual recognition according to this Directive." Article 69 Repeal of Directive 93/22/EEC Directive 93/22/EEC shall be repealed with effect from(39). References to Directive 93/22/EEC shall be construed as references to this Directive. References to terms defined in, or Articles of, Directive 93/22/EEC shall be construed as references to the equivalent term defined in, or Article of, this Directive. Article 70 Transposition Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by...(40) 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 the Member States. Article 71 Transitional provisions 1. Investment firms already authorised in their home Member State to provide investment services before the...(41), shall be deemed to be so authorised for the purpose of this Directive, if the laws of those Member States provide that to take up such activities they must comply with conditions comparable to those imposed in Articles 9 to 14. 2. A regulated market or a market operator already authorised in its home Member State before the...(42), shall be deemed to be so authorised for the purposes of this Directive, if the laws of such Member State provide that the regulated market or market operator (as the case may be) must comply with conditions comparable to those imposed in Title III. 3. Tied agents already entered in a public register before the...(43), shall be deemed to be so registered for the purposes of this Directive, if the laws of those Member States provide that tied agents must comply with conditions comparable to those imposed in Article 23. 4. Information communicated before the...(44), for the purposes of Articles 17, 18 or 30 of Directive 93/22/EEC shall be deemed to have been communicated for the purposes of Articles 31 and 32 of this Directive. 5. Any existing system falling under the definition of an MTF operated by a market operator of a regulated market, shall be authorised as an MTF at the request of the market operator of the regulated market provided it complies with rules equivalent to those required by this Directive for the authorisation and operation of MTFs, and provided that the request concerned is made within 18 months of the date referred to in Article 70. 6. Investment firms shall be authorised to continue considering existing professional clients as such provided that this categorisation has been granted by the investment firm on the basis of an adequate assessment of the expertise, experience and knowledge of the client which gives reasonable assurance, in light of the nature of the transactions or services envisaged, that the client is capable of making his own investment decisions and understands the risks involved. Those investment firms shall inform their clients about the conditions established in the Directive for the categorisation of clients. Article 72 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 73 Addressees This Directive is addressed to the Member States.

32004L0025

2004

DIRECTIVE 2004/25/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 April 2004 on takeover bids (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 44(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) In accordance with Article 44(2)(g) of the Treaty, it is necessary to coordinate certain safeguards which, for the protection of the interests of members and others, Member States require of companies governed by the law of a Member State the securities of which are admitted to trading on a regulated market in a Member State, with a view to making such safeguards equivalent throughout the Community. (2) It is necessary to protect the interests of holders of the securities of companies governed by the law of a Member State when those companies are the subject of takeover bids or of changes of control and at least some of their securities are admitted to trading on a regulated market in a Member State. (3) It is necessary to create Community-wide clarity and transparency in respect of legal issues to be settled in the event of takeover bids and to prevent patterns of corporate restructuring within the Community from being distorted by arbitrary differences in governance and management cultures. (4) In view of the public-interest purposes served by the central banks of the Member States, it seems inconceivable that they should be the targets of takeover bids. Since, for historical reasons, the securities of some of those central banks are listed on regulated markets in Member States, it is necessary to exclude them explicitly from the scope of this Directive. (5) Each Member State should designate an authority or authorities to supervise those aspects of bids that are governed by this Directive and to ensure that parties to takeover bids comply with the rules made pursuant to this Directive. All those authorities should cooperate with one another. (6) In order to be effective, takeover regulation should be flexible and capable of dealing with new circumstances as they arise and should accordingly provide for the possibility of exceptions and derogations. However, in applying any rules or exceptions laid down or in granting any derogations, supervisory authorities should respect certain general principles. (7) Self-regulatory bodies should be able to exercise supervision. (8) In accordance with general principles of Community law, and in particular the right to a fair hearing, decisions of a supervisory authority should in appropriate circumstances be susceptible to review by an independent court or tribunal. However, Member States should be left to determine whether rights are to be made available which may be asserted in administrative or judicial proceedings, either in proceedings against a supervisory authority or in proceedings between parties to a bid. (9) Member States should take the necessary steps to protect the holders of securities, in particular those with minority holdings, when control of their companies has been acquired. The Member States should ensure such protection by obliging the person who has acquired control of a company to make an offer to all the holders of that company’s securities for all of their holdings at an equitable price in accordance with a common definition. Member States should be free to establish further instruments for the protection of the interests of the holders of securities, such as the obligation to make a partial bid where the offeror does not acquire control of the company or the obligation to announce a bid at the same time as control of the company is acquired. (10) The obligation to make a bid to all the holders of securities should not apply to those controlling holdings already in existence on the date on which the national legislation transposing this Directive enters into force. (11) The obligation to launch a bid should not apply in the case of the acquisition of securities which do not carry the right to vote at ordinary general meetings of shareholders. Member States should, however, be able to provide that the obligation to make a bid to all the holders of securities relates not only to securities carrying voting rights but also to securities which carry voting rights only in specific circumstances or which do not carry voting rights. (12) To reduce the scope for insider dealing, an offeror should be required to announce his/her decision to launch a bid as soon as possible and to inform the supervisory authority of the bid. (13) The holders of securities should be properly informed of the terms of a bid by means of an offer document. Appropriate information should also be given to the representatives of the company’s employees or, failing that, to the employees directly. (14) The time allowed for the acceptance of a bid should be regulated. (15) To be able to perform their functions satisfactorily, supervisory authorities should at all times be able to require the parties to a bid to provide information concerning themselves and should cooperate and supply information in an efficient and effective manner, without delay, to other authorities supervising capital markets. (16) In order to prevent operations which could frustrate a bid, the powers of the board of an offeree company to engage in operations of an exceptional nature should be limited, without unduly hindering the offeree company in carrying on its normal business activities. (17) The board of an offeree company should be required to make public a document setting out its opinion of the bid and the reasons on which that opinion is based, including its views on the effects of implementation on all the company’s interests, and specifically on employment. (18) In order to reinforce the effectiveness of existing provisions concerning the freedom to deal in the securities of companies covered by this Directive and the freedom to exercise voting rights, it is essential that the defensive structures and mechanisms envisaged by such companies be transparent and that they be regularly presented in reports to general meetings of shareholders. (19) Member States should take the necessary measures to afford any offeror the possibility of acquiring majority interests in other companies and of fully exercising control of them. To that end, restrictions on the transfer of securities, restrictions on voting rights, extraordinary appointment rights and multiple voting rights should be removed or suspended during the time allowed for the acceptance of a bid and when the general meeting of shareholders decides on defensive measures, on amendments to the articles of association or on the removal or appointment of board members at the first general meeting of shareholders following closure of the bid. Where the holders of securities have suffered losses as a result of the removal of rights, equitable compensation should be provided for in accordance with the technical arrangements laid down by Member States. (20) All special rights held by Member States in companies should be viewed in the framework of the free movement of capital and the relevant provisions of the Treaty. Special rights held by Member States in companies which are provided for in private or public national law should be exempted from the ‘breakthrough’ rule if they are compatible with the Treaty. (21) Taking into account existing differences in Member States' company law mechanisms and structures, Member States should be allowed not to require companies established within their territories to apply the provisions of this Directive limiting the powers of the board of an offeree company during the time allowed for the acceptance of a bid and those rendering ineffective barriers, provided for in the articles of association or in specific agreements. In that event Member States should at least allow companies established within their territories to make the choice, which must be reversible, to apply those provisions. Without prejudice to international agreements to which the European Community is a party, Member States should be allowed not to require companies which apply those provisions in accordance with the optional arrangements to apply them when they become the subject of offers launched by companies which do not apply the same provisions, as a consequence of the use of those optional arrangements. (22) Member States should lay down rules to cover the possibility of a bid’s lapsing, the offeror’s right to revise his/her bid, the possibility of competing bids for a company’s securities, the disclosure of the result of a bid, the irrevocability of a bid and the conditions permitted. (23) The disclosure of information to and the consultation of representatives of the employees of the offeror and the offeree company should be governed by the relevant national provisions, in particular those adopted pursuant to Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees (4), Council Directive 98/59/EC of 20 July 1998 on the approximation of the laws of the Member States relating to collective redundancies (5), Council Directive 2001/86/EC of 8 October 2001 supplementing the statute for a European Company with regard to the involvement of employees (6) and Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community — Joint declaration of the European Parliament, the Council and the Commission on employee representation (7). The employees of the companies concerned, or their representatives, should nevertheless be given an opportunity to state their views on the foreseeable effects of the bid on employment. Without prejudice to the rules of Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) (8), Member States may always apply or introduce national provisions concerning the disclosure of information to and the consultation of representatives of the employees of the offeror before an offer is launched. (24) Member States should take the necessary measures to enable an offeror who, following a takeover bid, has acquired a certain percentage of a company’s capital carrying voting rights to require the holders of the remaining securities to sell him/her their securities. Likewise, where, following a takeover bid, an offeror has acquired a certain percentage of a company’s capital carrying voting rights, the holders of the remaining securities should be able to require him/her to buy their securities. These squeeze-out and sell-out procedures should apply only under specific conditions linked to takeover bids. Member States may continue to apply national rules to squeeze-out and sell-out procedures in other circumstances. (25) Since the objectives of the action envisaged, namely to establish minimum guidelines for the conduct of takeover bids and ensure an adequate level of protection for holders of securities throughout the Community, cannot be sufficiently achieved by the Member States because of the need for transparency and legal certainty in the case of cross-border takeovers and acquisitions of control, and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary to achieve those objectives. (26) The adoption of a Directive is the appropriate procedure for the establishment of a framework consisting of certain common principles and a limited number of general requirements which Member States are to implement through more detailed rules in accordance with their national systems and their cultural contexts. (27) Member States should, however, provide for sanctions for any infringement of the national measures transposing this Directive. (28) Technical guidance and implementing measures for the rules laid down in this Directive may from time to time be necessary, to take account of new developments on financial markets. For certain provisions, the Commission should accordingly be empowered to adopt implementing measures, provided that these do not modify the essential elements of this Directive and the Commission acts in accordance with the principles set out in this Directive, after consulting the European Securities Committee established by Commission Decision 2001/528/EC (9). The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (10) and with due regard to the declaration made by the Commission in the European Parliament on 5 February 2002 concerning the implementation of financial services legislation. For the other provisions, it is important to entrust a contact committee with the task of assisting Member States and the supervisory authorities in the implementation of this Directive and of advising the Commission, if necessary, on additions or amendments to this Directive. In so doing, the contact committee may make use of the information which Member States are to provide on the basis of this Directive concerning takeover bids that have taken place on their regulated markets. (29) The Commission should facilitate movement towards the fair and balanced harmonisation of rules on takeovers in the European Union. To that end, the Commission should be able to submit proposals for the timely revision of this Directive, Article 1 Scope 1. This Directive lays down measures coordinating the laws, regulations, administrative provisions, codes of practice and other arrangements of the Member States, including arrangements established by organisations officially authorised to regulate the markets (hereinafter referred to as ‘rules’), relating to takeover bids for the securities of companies governed by the laws of Member States, where all or some of those securities are admitted to trading on a regulated market within the meaning of Directive 93/22/EEC (11) in one or more Member States (hereinafter referred to as a ‘regulated market’). 2. This Directive shall not apply to takeover bids for securities issued by companies, the object of which is the collective investment of capital provided by the public, which operate on the principle of risk-spreading and the units of which are, at the holders' request, repurchased or redeemed, directly or indirectly, out of the assets of those companies. Action taken by such companies to ensure that the stock exchange value of their units does not vary significantly from their net asset value shall be regarded as equivalent to such repurchase or redemption. 3. This Directive shall not apply to takeover bids for securities issued by the Member States' central banks. Article 2 Definitions 1. For the purposes of this Directive: (a) ‘takeover bid’ or ‘bid’ shall mean a public offer (other than by the offeree company itself) made to the holders of the securities of a company to acquire all or some of those securities, whether mandatory or voluntary, which follows or has as its objective the acquisition of control of the offeree company in accordance with national law; (b) ‘offeree company’ shall mean a company, the securities of which are the subject of a bid; (c) ‘offeror’ shall mean any natural or legal person governed by public or private law making a bid; (d) ‘persons acting in concert’ shall mean natural or legal persons who cooperate with the offeror or the offeree company on the basis of an agreement, either express or tacit, either oral or written, aimed either at acquiring control of the offeree company or at frustrating the successful outcome of a bid; (e) ‘securities’ shall mean transferable securities carrying voting rights in a company; (f) ‘parties to the bid’ shall mean the offeror, the members of the offeror’s board if the offeror is a company, the offeree company, holders of securities of the offeree company and the members of the board of the offeree company, and persons acting in concert with such parties; (g) ‘multiple-vote securities’ shall mean securities included in a distinct and separate class and carrying more than one vote each. 2. For the purposes of paragraph 1(d), persons controlled by another person within the meaning of Article 87 of Directive 2001/34/EC (12) shall be deemed to be persons acting in concert with that other person and with each other. Article 3 General principles 1. For the purpose of implementing this Directive, Member States shall ensure that the following principles are complied with: (a) all holders of the securities of an offeree company of the same class must be afforded equivalent treatment; moreover, if a person acquires control of a company, the other holders of securities must be protected; (b) the holders of the securities of an offeree company must have sufficient time and information to enable them to reach a properly informed decision on the bid; where it advises the holders of securities, the board of the offeree company must give its views on the effects of implementation of the bid on employment, conditions of employment and the locations of the company’s places of business; (c) the board of an offeree company must act in the interests of the company as a whole and must not deny the holders of securities the opportunity to decide on the merits of the bid; (d) false markets must not be created in the securities of the offeree company, of the offeror company or of any other company concerned by the bid in such a way that the rise or fall of the prices of the securities becomes artificial and the normal functioning of the markets is distorted; (e) an offeror must announce a bid only after ensuring that he/she can fulfil in full any cash consideration, if such is offered, and after taking all reasonable measures to secure the implementation of any other type of consideration; (f) an offeree company must not be hindered in the conduct of its affairs for longer than is reasonable by a bid for its securities. 2. With a view to ensuring compliance with the principles laid down in paragraph 1, Member States: (a) shall ensure that the minimum requirements set out in this Directive are observed; (b) may lay down additional conditions and provisions more stringent than those of this Directive for the regulation of bids. Article 4 Supervisory authority and applicable law 1. Member States shall designate the authority or authorities competent to supervise bids for the purposes of the rules which they make or introduce pursuant to this Directive. The authorities thus designated shall be either public authorities, associations or private bodies recognised by national law or by public authorities expressly empowered for that purpose by national law. Member States shall inform the Commission of those designations, specifying any divisions of functions that may be made. They shall ensure that those authorities exercise their functions impartially and independently of all parties to a bid. 2. (a) The authority competent to supervise a bid shall be that of the Member State in which the offeree company has its registered office if that company’s securities are admitted to trading on a regulated market in that Member State. (b) If the offeree company’s securities are not admitted to trading on a regulated market in the Member State in which the company has its registered office, the authority competent to supervise the bid shall be that of the Member State on the regulated market of which the company’s securities are admitted to trading. If the offeree company’s securities are admitted to trading on regulated markets in more than one Member State, the authority competent to supervise the bid shall be that of the Member State on the regulated market of which the securities were first admitted to trading. (c) If the offeree company’s securities were first admitted to trading on regulated markets in more than one Member State simultaneously, the offeree company shall determine which of the supervisory authorities of those Member States shall be the authority competent to supervise the bid by notifying those regulated markets and their supervisory authorities on the first day of trading. If the offeree company’s securities have already been admitted to trading on regulated markets in more than one Member State on the date laid down in Article 21(1) and were admitted simultaneously, the supervisory authorities of those Member States shall agree which one of them shall be the authority competent to supervise the bid within four weeks of the date laid down in Article 21(1). Otherwise, the offeree company shall determine which of those authorities shall be the competent authority on the first day of trading following that four-week period. (d) Member States shall ensure that the decisions referred to in (c) are made public. (e) In the cases referred to in (b) and (c), matters relating to the consideration offered in the case of a bid, in particular the price, and matters relating to the bid procedure, in particular the information on the offeror’s decision to make a bid, the contents of the offer document and the disclosure of the bid, shall be dealt with in accordance with the rules of the Member State of the competent authority. In matters relating to the information to be provided to the employees of the offeree company and in matters relating to company law, in particular the percentage of voting rights which confers control and any derogation from the obligation to launch a bid, as well as the conditions under which the board of the offeree company may undertake any action which might result in the frustration of the bid, the applicable rules and the competent authority shall be those of the Member State in which the offeree company has its registered office. 3. Member States shall ensure that all persons employed or formerly employed by their supervisory authorities are bound by professional secrecy. No information covered by professional secrecy may be divulged to any person or authority except under provisions laid down by law. 4. The supervisory authorities of the Member States for the purposes of this Directive and other authorities supervising capital markets, in particular in accordance with Directive 93/22/EEC, Directive 2001/34/EC, Directive 2003/6/EC and Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading shall cooperate and supply each other with information wherever necessary for the application of the rules drawn up in accordance with this Directive and in particular in cases covered by paragraph 2(b), (c) and (e). Information thus exchanged shall be covered by the obligation of professional secrecy to which persons employed or formerly employed by the supervisory authorities receiving the information are subject. Cooperation shall include the ability to serve the legal documents necessary to enforce measures taken by the competent authorities in connection with bids, as well as such other assistance as may reasonably be requested by the supervisory authorities concerned for the purpose of investigating any actual or alleged breaches of the rules made or introduced pursuant to this Directive. 5. The supervisory authorities shall be vested with all the powers necessary for the purpose of carrying out their duties, including that of ensuring that the parties to a bid comply with the rules made or introduced pursuant to this Directive. Provided that the general principles laid down in Article 3(1) are respected, Member States may provide in the rules that they make or introduce pursuant to this Directive for derogations from those rules: (i) by including such derogations in their national rules, in order to take account of circumstances determined at national level and/or (ii) by granting their supervisory authorities, where they are competent, powers to waive such national rules, to take account of the circumstances referred to in (i) or in other specific circumstances, in which case a reasoned decision must be required. 6. This Directive shall not affect the power of the Member States to designate judicial or other authorities responsible for dealing with disputes and for deciding on irregularities committed in the course of bids or the power of Member States to regulate whether and under which circumstances parties to a bid are entitled to bring administrative or judicial proceedings. In particular, this Directive shall not affect the power which courts may have in a Member State to decline to hear legal proceedings and to decide whether or not such proceedings affect the outcome of a bid. This Directive shall not affect the power of the Member States to determine the legal position concerning the liability of supervisory authorities or concerning litigation between the parties to a bid. Article 5 Protection of minority shareholders, the mandatory bid and the equitable price 1. Where a natural or legal person, as a result of his/her own acquisition or the acquisition by persons acting in concert with him/her, holds securities of a company as referred to in Article 1(1) which, added to any existing holdings of those securities of his/hers and the holdings of those securities of persons acting in concert with him/her, directly or indirectly give him/her a specified percentage of voting rights in that company, giving him/her control of that company, Member States shall ensure that such a person is required to make a bid as a means of protecting the minority shareholders of that company. Such a bid shall be addressed at the earliest opportunity to all the holders of those securities for all their holdings at the equitable price as defined in paragraph 4. 2. Where control has been acquired following a voluntary bid made in accordance with this Directive to all the holders of securities for all their holdings, the obligation laid down in paragraph 1 to launch a bid shall no longer apply. 3. The percentage of voting rights which confers control for the purposes of paragraph 1 and the method of its calculation shall be determined by the rules of the Member State in which the company has its registered office. 4. The highest price paid for the same securities by the offeror, or by persons acting in concert with him/her, over a period, to be determined by Member States, of not less than six months and not more than 12 before the bid referred to in paragraph 1 shall be regarded as the equitable price. If, after the bid has been made public and before the offer closes for acceptance, the offeror or any person acting in concert with him/her purchases securities at a price higher than the offer price, the offeror shall increase his/her offer so that it is not less than the highest price paid for the securities so acquired. Provided that the general principles laid down in Article 3(1) are respected, Member States may authorise their supervisory authorities to adjust the price referred to in the first subparagraph in circumstances and in accordance with criteria that are clearly determined. To that end, they may draw up a list of circumstances in which the highest price may be adjusted either upwards or downwards, for example where the highest price was set by agreement between the purchaser and a seller, where the market prices of the securities in question have been manipulated, where market prices in general or certain market prices in particular have been affected by exceptional occurrences, or in order to enable a firm in difficulty to be rescued. They may also determine the criteria to be applied in such cases, for example the average market value over a particular period, the break-up value of the company or other objective valuation criteria generally used in financial analysis. Any decision by a supervisory authority to adjust the equitable price shall be substantiated and made public. 5. By way of consideration the offeror may offer securities, cash or a combination of both. However, where the consideration offered by the offeror does not consist of liquid securities admitted to trading on a regulated market, it shall include a cash alternative. In any event, the offeror shall offer a cash consideration at least as an alternative where he/she or persons acting in concert with him/her, over a period beginning at the same time as the period determined by the Member State in accordance with paragraph 4 and ending when the offer closes for acceptance, has purchased for cash securities carrying 5 % or more of the voting rights in the offeree company. Member States may provide that a cash consideration must be offered, at least as an alternative, in all cases. 6. In addition to the protection provided for in paragraph 1, Member States may provide for further instruments intended to protect the interests of the holders of securities in so far as those instruments do not hinder the normal course of a bid. Article 6 Information concerning bids 1. Member States shall ensure that a decision to make a bid is made public without delay and that the supervisory authority is informed of the bid. They may require that the supervisory authority must be informed before such a decision is made public. As soon as the bid has been made public, the boards of the offeree company and of the offeror shall inform the representatives of their respective employees or, where there are no such representatives, the employees themselves. 2. Member States shall ensure that an offeror is required to draw up and make public in good time an offer document containing the information necessary to enable the holders of the offeree company’s securities to reach a properly informed decision on the bid. Before the offer document is made public, the offeror shall communicate it to the supervisory authority. When it is made public, the boards of the offeree company and of the offeror shall communicate it to the representatives of their respective employees or, where there are no such representatives, to the employees themselves. Where the offer document referred to in the first subparagraph is subject to the prior approval of the supervisory authority and has been approved, it shall be recognised, subject to any translation required, in any other Member State on the market of which the offeree company’s securities are admitted to trading, without its being necessary to obtain the approval of the supervisory authorities of that Member State. Those authorities may require the inclusion of additional information in the offer document only if such information is specific to the market of a Member State or Member States on which the offeree company’s securities are admitted to trading and relates to the formalities to be complied with to accept the bid and to receive the consideration due at the close of the bid as well as to the tax arrangements to which the consideration offered to the holders of the securities will be subject. 3. The offer document referred to in paragraph 2 shall state at least: (a) the terms of the bid; (b) the identity of the offeror and, where the offeror is a company, the type, name and registered office of that company; (c) the securities or, where appropriate, the class or classes of securities for which the bid is made; (d) the consideration offered for each security or class of securities and, in the case of a mandatory bid, the method employed in determining it, with particulars of the way in which that consideration is to be paid; (e) the compensation offered for the rights which might be removed as a result of the breakthrough rule laid down in Article 11(4), with particulars of the way in which that compensation is to be paid and the method employed in determining it; (f) the maximum and minimum percentages or quantities of securities which the offeror undertakes to acquire; (g) details of any existing holdings of the offeror, and of persons acting in concert with him/her, in the offeree company; (h) all the conditions to which the bid is subject; (i) the offeror’s intentions with regard to the future business of the offeree company and, in so far as it is affected by the bid, the offeror company and with regard to the safeguarding of the jobs of their employees and management, including any material change in the conditions of employment, and in particular the offeror’s strategic plans for the two companies and the likely repercussions on employment and the locations of the companies' places of business; (j) the time allowed for acceptance of the bid; (k) where the consideration offered by the offeror includes securities of any kind, information concerning those securities; (l) information concerning the financing for the bid; (m) the identity of persons acting in concert with the offeror or with the offeree company and, in the case of companies, their types, names, registered offices and relationships with the offeror and, where possible, with the offeree company; (n) the national law which will govern contracts concluded between the offeror and the holders of the offeree company’s securities as a result of the bid and the competent courts. 4. The Commission shall adopt rules for the application of paragraph 3 in accordance with the procedure referred to in Article 18(2). 5. Member States shall ensure that the parties to a bid are required to provide the supervisory authorities of their Member State at any time on request with all the information in their possession concerning the bid that is necessary for the supervisory authority to discharge its functions. Article 7 Time allowed for acceptance 1. Member States shall provide that the time allowed for the acceptance of a bid may not be less than two weeks nor more than 10 weeks from the date of publication of the offer document. Provided that the general principle laid down in Article 3(1)(f) is respected, Member States may provide that the period of 10 weeks may be extended on condition that the offeror gives at least two weeks' notice of his/her intention of closing the bid. 2. Member States may provide for rules changing the period referred to in paragraph 1 in specific cases. A Member State may authorise a supervisory authority to grant a derogation from the period referred to in paragraph 1 in order to allow the offeree company to call a general meeting of shareholders to consider the bid. Article 8 Disclosure 1. Member States shall ensure that a bid is made public in such a way as to ensure market transparency and integrity for the securities of the offeree company, of the offeror or of any other company affected by the bid, in particular in order to prevent the publication or dissemination of false or misleading information. 2. Member States shall provide for the disclosure of all information and documents required by Article 6 in such a manner as to ensure that they are both readily and promptly available to the holders of securities at least in those Member States on the regulated markets of which the offeree company’s securities are admitted to trading and to the representatives of the employees of the offeree company and the offeror or, where there are no such representatives, to the employees themselves. Article 9 Obligations of the board of the offeree company 1. Member States shall ensure that the rules laid down in paragraphs 2 to 5 are complied with. 2. During the period referred to in the second subparagraph, the board of the offeree company shall obtain the prior authorisation of the general meeting of shareholders given for this purpose before taking any action, other than seeking alternative bids, which may result in the frustration of the bid and in particular before issuing any shares which may result in a lasting impediment to the offeror’s acquiring control of the offeree company. Such authorisation shall be mandatory at least from the time the board of the offeree company receives the information referred to in the first sentence of Article 6(1) concerning the bid and until the result of the bid is made public or the bid lapses. Member States may require that such authorisation be obtained at an earlier stage, for example as soon as the board of the offeree company becomes aware that the bid is imminent. 3. As regards decisions taken before the beginning of the period referred to in the second subparagraph of paragraph 2 and not yet partly or fully implemented, the general meeting of shareholders shall approve or confirm any decision which does not form part of the normal course of the company’s business and the implementation of which may result in the frustration of the bid. 4. For the purpose of obtaining the prior authorisation, approval or confirmation of the holders of securities referred to in paragraphs 2 and 3, Member States may adopt rules allowing a general meeting of shareholders to be called at short notice, provided that the meeting does not take place within two weeks of notification’s being given. 5. The board of the offeree company shall draw up and make public a document setting out its opinion of the bid and the reasons on which it is based, including its views on the effects of implementation of the bid on all the company’s interests and specifically employment, and on the offeror’s strategic plans for the offeree company and their likely repercussions on employment and the locations of the company’s places of business as set out in the offer document in accordance with Article 6(3)(i). The board of the offeree company shall at the same time communicate that opinion to the representatives of its employees or, where there are no such representatives, to the employees themselves. Where the board of the offeree company receives in good time a separate opinion from the representatives of its employees on the effects of the bid on employment, that opinion shall be appended to the document. 6. For the purposes of paragraph 2, where a company has a two-tier board structure ‘board’ shall mean both the management board and the supervisory board. Article 10 Information on companies as referred to in Article 1(1) 1. Member States shall ensure that companies as referred to in Article 1(1) publish detailed information on the following: (a) the structure of their capital, including securities which are not admitted to trading on a regulated market in a Member State, where appropriate with an indication of the different classes of shares and, for each class of shares, the rights and obligations attaching to it and the percentage of total share capital that it represents; (b) any restrictions on the transfer of securities, such as limitations on the holding of securities or the need to obtain the approval of the company or other holders of securities, without prejudice to Article 46 of Directive 2001/34/EC; (c) significant direct and indirect shareholdings (including indirect shareholdings through pyramid structures and cross-shareholdings) within the meaning of Article 85 of Directive 2001/34/EC; (d) the holders of any securities with special control rights and a description of those rights; (e) the system of control of any employee share scheme where the control rights are not exercised directly by the employees; (f) any restrictions on voting rights, such as limitations of the voting rights of holders of a given percentage or number of votes, deadlines for exercising voting rights, or systems whereby, with the company’s cooperation, the financial rights attaching to securities are separated from the holding of securities; (g) any agreements between shareholders which are known to the company and may result in restrictions on the transfer of securities and/or voting rights within the meaning of Directive 2001/34/EC; (h) the rules governing the appointment and replacement of board members and the amendment of the articles of association; (i) the powers of board members, and in particular the power to issue or buy back shares; (j) any significant agreements to which the company is a party and which take effect, alter or terminate upon a change of control of the company following a takeover bid, and the effects thereof, except where their nature is such that their disclosure would be seriously prejudicial to the company; this exception shall not apply where the company is specifically obliged to disclose such information on the basis of other legal requirements; (k) any agreements between the company and its board members or employees providing for compensation if they resign or are made redundant without valid reason or if their employment ceases because of a takeover bid. 2. The information referred to in paragraph 1 shall be published in the company’s annual report as provided for in Article 46 of Directive 78/660/EEC (13) and Article 36 of Directive 83/349/EEC (14). 3. Member States shall ensure, in the case of companies the securities of which are admitted to trading on a regulated market in a Member State, that the board presents an explanatory report to the annual general meeting of shareholders on the matters referred to in paragraph 1. Article 11 Breakthrough 1. Without prejudice to other rights and obligations provided for in Community law for the companies referred to in Article 1(1), Member States shall ensure that the provisions laid down in paragraphs 2 to 7 apply when a bid has been made public. 2. Any restrictions on the transfer of securities provided for in the articles of association of the offeree company shall not apply vis-à-vis the offeror during the time allowed for acceptance of the bid laid down in Article 7(1). Any restrictions on the transfer of securities provided for in contractual agreements between the offeree company and holders of its securities, or in contractual agreements between holders of the offeree company’s securities entered into after the adoption of this Directive, shall not apply vis-à-vis the offeror during the time allowed for acceptance of the bid laid down in Article 7(1). 3. Restrictions on voting rights provided for in the articles of association of the offeree company shall not have effect at the general meeting of shareholders which decides on any defensive measures in accordance with Article 9. Restrictions on voting rights provided for in contractual agreements between the offeree company and holders of its securities, or in contractual agreements between holders of the offeree company’s securities entered into after the adoption of this Directive, shall not have effect at the general meeting of shareholders which decides on any defensive measures in accordance with Article 9. Multiple-vote securities shall carry only one vote each at the general meeting of shareholders which decides on any defensive measures in accordance with Article 9. 4. Where, following a bid, the offeror holds 75 % or more of the capital carrying voting rights, no restrictions on the transfer of securities or on voting rights referred to in paragraphs 2 and 3 nor any extraordinary rights of shareholders concerning the appointment or removal of board members provided for in the articles of association of the offeree company shall apply; multiple-vote securities shall carry only one vote each at the first general meeting of shareholders following closure of the bid, called by the offeror in order to amend the articles of association or to remove or appoint board members. To that end, the offeror shall have the right to convene a general meeting of shareholders at short notice, provided that the meeting does not take place within two weeks of notification. 5. Where rights are removed on the basis of paragraphs 2, 3, or 4 and/or Article 12, equitable compensation shall be provided for any loss suffered by the holders of those rights. The terms for determining such compensation and the arrangements for its payment shall be set by Member States. 6. Paragraphs 3 and 4 shall not apply to securities where the restrictions on voting rights are compensated for by specific pecuniary advantages. 7. This Article shall not apply either where Member States hold securities in the offeree company which confer special rights on the Member States which are compatible with the Treaty, or to special rights provided for in national law which are compatible with the Treaty or to cooperatives. Article 12 Optional arrangements 1. Member States may reserve the right not to require companies as referred to in Article 1(1) which have their registered offices within their territories to apply Article 9(2) and (3) and/or Article 11. 2. Where Member States make use of the option provided for in paragraph 1, they shall nevertheless grant companies which have their registered offices within their territories the option, which shall be reversible, of applying Article 9(2) and (3) and/or Article 11, without prejudice to Article 11(7). The decision of the company shall be taken by the general meeting of shareholders, in accordance with the law of the Member State in which the company has its registered office in accordance with the rules applicable to amendment of the articles of association. The decision shall be communicated to the supervisory authority of the Member State in which the company has its registered office and to all the supervisory authorities of Member States in which its securities are admitted to trading on regulated markets or where such admission has been requested. 3. Member States may, under the conditions determined by national law, exempt companies which apply Article 9(2) and (3) and/or Article 11 from applying Article 9(2) and (3) and/or Article 11 if they become the subject of an offer launched by a company which does not apply the same Articles as they do, or by a company controlled, directly or indirectly, by the latter, pursuant to Article 1 of Directive 83/349/EEC. 4. Member States shall ensure that the provisions applicable to the respective companies are disclosed without delay. 5. Any measure applied in accordance with paragraph 3 shall be subject to the authorisation of the general meeting of shareholders of the offeree company, which must be granted no earlier than 18 months before the bid was made public in accordance with Article 6(1). Article 13 Other rules applicable to the conduct of bids Member States shall also lay down rules which govern the conduct of bids, at least as regards the following: (a) the lapsing of bids; (b) the revision of bids; (c) competing bids; (d) the disclosure of the results of bids; (e) the irrevocability of bids and the conditions permitted. Article 14 Information for and consultation of employees' representatives This Directive shall be without prejudice to the rules relating to information and to consultation of representatives of and, if Member States so provide, co-determination with the employees of the offeror and the offeree company governed by the relevant national provisions, and in particular those adopted pursuant to Directives 94/45/EC, 98/59/EC, 2001/86/EC and 2002/14/EC. Article 15 The right of squeeze-out 1. Member States shall ensure that, following a bid made to all the holders of the offeree company’s securities for all of their securities, paragraphs 2 to 5 apply. 2. Member States shall ensure that an offeror is able to require all the holders of the remaining securities to sell him/her those securities at a fair price. Member States shall introduce that right in one of the following situations: (a) where the offeror holds securities representing not less than 90 % of the capital carrying voting rights and 90 % of the voting rights in the offeree company, or (b) where, following acceptance of the bid, he/she has acquired or has firmly contracted to acquire securities representing not less than 90 % of the offeree company’s capital carrying voting rights and 90 % of the voting rights comprised in the bid. In the case referred to in (a), Member States may set a higher threshold that may not, however, be higher than 95 % of the capital carrying voting rights and 95 % of the voting rights. 3. Member States shall ensure that rules are in force that make it possible to calculate when the threshold is reached. Where the offeree company has issued more than one class of securities, Member States may provide that the right of squeeze-out can be exercised only in the class in which the threshold laid down in paragraph 2 has been reached. 4. If the offeror wishes to exercise the right of squeeze-out he/she shall do so within three months of the end of the time allowed for acceptance of the bid referred to in Article 7. 5. Member States shall ensure that a fair price is guaranteed. That price shall take the same form as the consideration offered in the bid or shall be in cash. Member States may provide that cash shall be offered at least as an alternative. Following a voluntary bid, in both of the cases referred to in paragraph 2(a) and (b), the consideration offered in the bid shall be presumed to be fair where, through acceptance of the bid, the offeror has acquired securities representing not less than 90 % of the capital carrying voting rights comprised in the bid. Following a mandatory bid, the consideration offered in the bid shall be presumed to be fair. Article 16 The right of sell-out 1. Member States shall ensure that, following a bid made to all the holders of the offeree company’s securities for all of their securities, paragraphs 2 and 3 apply. 2. Member States shall ensure that a holder of remaining securities is able to require the offeror to buy his/her securities from him/her at a fair price under the same circumstances as provided for in Article 15(2). 3. Article 15(3) to (5) shall apply mutatis mutandis. Article 17 Sanctions Member States shall determine the sanctions to be imposed for infringement of the national measures adopted pursuant to this Directive and shall take all necessary steps to ensure that they are put into effect. The sanctions thus provided for shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those measures no later than the date laid down in Article 21(1) and of any subsequent change thereto at the earliest opportunity. Article 18 Committee procedure 1. The Commission shall be assisted by the European Securities Committee established by Decision 2001/528/EC (hereinafter referred to as ‘the Committee’). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof, provided that the implementing measures adopted in accordance with this procedure do not modify the essential provisions of this Directive. The period referred to in Article 5(6) of Decision 1999/468/EC shall be three months. 3. Without prejudice to the implementing measures already adopted, four years after the entry into force of this Directive, the application of those of its provisions that require the adoption of technical rules and decisions in accordance with paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them before the end of the period referred to above. Article 19 Contact committee 1. A contact committee shall be set up which has as its functions: (a) to facilitate, without prejudice to Articles 226 and 227 of the Treaty, the harmonised application of this Directive through regular meetings dealing with practical problems arising in connection with its application; (b) to advise the Commission, if necessary, on additions or amendments to this Directive. 2. It shall not be the function of the contact committee to appraise the merits of decisions taken by the supervisory authorities in individual cases. Article 20 Revision Five years after the date laid down in Article 21(1), the Commission shall examine this Directive in the light of the experience acquired in applying it and, if necessary, propose its revision. That examination shall include a survey of the control structures and barriers to takeover bids that are not covered by this Directive. To that end, Member States shall provide the Commission annually with information on the takeover bids which have been launched against companies the securities of which are admitted to trading on their regulated markets. That information shall include the nationalities of the companies involved, the results of the offers and any other information relevant to the understanding of how takeover bids operate in practice. Article 21 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 20 May 2006. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law that they adopt in the fields covered by this Directive. Article 22 Entry into force This Directive shall enter into force on the 20th day after that of its publication in the Official Journal of the European Union. Article 23 Addressees This Directive is addressed to the Member States.

32004L0056

2004

Council Directive 2004/56/EC of 21 April 2004 amending Directive 77/799/EEC concerning mutual assistance by the competent authorities of the Member States in the field of direct taxation, certain excise duties and taxation of insurance premiums Having regard to the Treaty establishing the European Community, and in particular Articles 93 and 94 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament(1), Having regard to the opinion of the European Economic and Social Committee(2), Whereas: (1) Council Directive 77/799/EEC of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct taxation, certain excise duties and taxation of insurance premiums(3) established the ground rules for administrative cooperation and the exchange of information between Member States in order to detect and prevent tax evasion and tax fraud and to enable Member States to carry out a correct tax assessment. It is essential to improve, expand and modernise those rules. (2) When a Member State conducts enquiries in order to obtain the information necessary to respond to a request for assistance, that State should be regarded as acting on its own account; in that way, there will only be one set of rules applying to the information-gathering process and the investigation will not be undermined by delays. (3) It is inappropriate, if the fight against tax fraud is to be effective, that a Member State which has received information from another Member State should subsequently have to request permission to disclose the information in public hearings or judgements. (4) It should be made clear that a Member State is not under any obligation to carry out enquiries in order to obtain the information necessary to respond to a request for assistance where either its legislation or administrative practices do not permit its competent authority to conduct enquiries or to collect such information. (5) It should be possible for the competent authority of a Member State to refuse information or assistance when the requesting Member State is not in a position to supply the same type of information, whether for reasons of fact or of law. (6) In view of the legal requirement in certain Member States that a taxpayer be notified of decisions and instruments concerning his tax liability and of the ensuing difficulties for the tax authorities, including cases where the taxpayer has relocated to another Member State, it is desirable that, in such circumstances, the tax authorities should be able to call upon the assistance of the competent authorities of the Member State to which the taxpayer has relocated. (7) Since the tax situation of one or more persons liable to tax established in several Member States often is of common or complementary interest, it should be made possible for simultaneous controls to be carried out to such persons by two or more Member States, by mutual agreement and on a voluntary basis, whenever such controls appear to be more effective than controls carried out by only one Member State. (8) The Commission submitted its proposal for a Directive on the basis of Article 95 of the Treaty. The Council, taking the view that the proposal for a Directive related to the harmonisation of legislation in the field of both direct and indirect taxation and that the act should therefore be adopted on the basis of Articles 93 and 94 of the Treaty, consulted the European Parliament by letter dated 12 November 2003 informing it of the Council's intention of changing the legal basis. (9) Directive 77/799/EEC should therefore be amended accordingly, Article 1 Directive 77/799/EEC is hereby amended as follows: 1. Article 1(5) shall be amended as follows: (a) the wording under "in Italy" shall be replaced by the following: "il Capo del Dipartimento per le Politiche Fiscali or his authorised representatives" (b) the wording under "in Sweden" shall be replaced by the following: "Chefen för Finansdepartementet or his authorised representative" 2. in Article 2(2), the following subparagraph shall be added:"In order to obtain the information sought, the requested authority or the administrative authority to which it has recourse shall proceed as though acting on its own account or at the request of another authority in its own Member State." 3. Article 7(1) shall be replaced by the following: "1. All information made known to a Member State under this Directive shall be kept secret in that State in the same manner as information received under its national legislation. In any case, such information: - may be made available only to the persons directly involved in the assessment of the tax or in the administrative control of this assessment, - may be made known only in connection with judicial proceedings or administrative proceedings involving sanctions undertaken with a view to, or relating to, the making or reviewing the tax assessment and only to persons who are directly involved in such proceedings; such information may, however, be disclosed during public hearings or in judgements if the competent authority of the Member State supplying the information raises no objection at the time when it first supplies the information, - shall in no circumstances be used other than for taxation purposes or in connection with judicial proceedings or administrative proceedings involving sanctions undertaken with a view to, or in relation to, the making or reviewing of the tax assessment. In addition, Member States may provide for the information referred to in the first subparagraph to be used for assessment of other levies, duties and taxes covered by Article 2 of Directive 76/308/EEC(4)." 4. Article 8 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. This Directive does not impose any obligation upon a Member State from which information is requested to carry out inquiries or to communicate information, if it would be contrary to its legislation or administrative practices for the competent authority of that State to conduct such inquiries or to collect the information sought." (b) paragraph 3 shall be replaced by the following: "3. The competent authority of a Member State may decline transmission of information when the Member State requesting it is unable, for reasons of fact or law, to provide the same type of information." 5. the following Articles shall be inserted: "Article 8a Notification 1. At the request of the competent authority of a Member State, the competent authority of another Member State shall, in accordance with the rules governing the notification of similar instruments in the requested Member State, notify the addressee of all instruments and decisions which emanate from the administrative authorities of the requesting Member State and concern the application in its territory of legislation on taxes covered by this Directive. 2. Requests for notification shall indicate the subject of the instrument or decision to be notified and shall specify the name and address of the addressee, together with any other information which may facilitate identification of the addressee. 3. The requested authority shall inform the requesting authority immediately of its response to the request for notification and shall notify it, in particular, of the date of notification of the decision or instrument to the addressee. Article 8b Simultaneous controls 1. Where the tax situation of one or more persons liable to tax is of common or complementary interest to two or more Member States, those States may agree to conduct simultaneous controls, in their own territory, with a view to exchanging the information thus obtained, whenever they would appear to be more effective than controls conducted by one Member State alone. 2. The competent authority in each Member State shall identify independently the persons liable to tax whom it intends to propose for simultaneous control. It shall notify the respective competent authorities in the other Member States concerned of the cases which, in its view, should be subject to simultaneous control. It shall give reasons for its choice, as far as possible, by providing the information which led to its decision. It shall specify the period of time during which such controls should be conducted. 3. The competent authority of each Member State concerned shall decide whether it wishes to take part in the simultaneous control. On receipt of a proposal for a simultaneous control, the competent authority shall confirm its agreement or communicate its reasoned refusal to its counterpart authority. 4. Each competent authority of the Member States concerned shall appoint a representative with responsibility for supervising and coordinating the control operation." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2005. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and 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 methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0041

2004

DIRECTIVE 2004/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152(4)(b) thereof, Having regard to the proposal from the Commission (1), Having regard to the Opinion of the European Economic and Social Committee (2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Several Directives lay down animal and public health rules for the production and placing on the market of products of animal origin. (2) The following acts contain new rules recasting and updating the rules in those Directives: — Regulation (EC) No ... /2003 of the European Parliament and of the Council of ... on the hygiene of foodstuffs (4); — Regulation (EC) No ... /2003 of the European Parliament and of the Council of ... laying down specific hygiene rules for food of animal origin (5); — Regulation (EC) No ... /2003 of the European Parliament and of the Council of ... laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (6); and — Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (7). (3) It is therefore appropriate to repeal the earlier Directives. Since Regulation (EC) No ... 72003 (8) provides for the repeal of Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (9), this Directive need only repeal the Directives concerning products of animal origin. (4) The requirements of Council Directive 72/462/EEC (10) should continue to apply only to the import of live animals, since the new hygiene rules and Directive 2002/99/EC will supersede its rules on fresh meat and meat products. (5) It is necessary, however, to provide for certain implementing rules to remain in force pending the taking of necessary measures under the new legal framework. (6) Amendments to Council Directives 89/662/EEC (11) and 92/118/EEC (12) and to Council Decision 95/408/EC (13) are also necessary to take account of the recasting exercise, Article 1 For the purposes of this Directive, the "relevant date" shall mean the date of application of Regulations (EC) No ... /2003 (14), No ... /2003 (15) and No ... 72003 (16). Article 2 The following Directives shall be repealed with effect from the relevant date: 1) Council Directive 64/433/EEC of 26 June 1964 on health conditions for the production and marketing of fresh meat; (17) 2) Council Directive 71/118/EEC of 15 February 1971 on health problems affecting the production and placing on the market of fresh poultry meat; (18) 3) Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat; (19) 4) Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (Trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine; (20) 5) Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin; (21) 6) Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-. Community trade in meat products; (22) 7) Commission Directive 89/362/EEC of 26 May 1989 on general conditions of hygiene in milk production holdings; (23) 8) Council Directive 89/43 7/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products; (24) 9) Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs; (25) 10) 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; (26) 11) Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultry meat; (27) 12) Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat; (28) 13) Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat; (29) 14) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products; (30) 15) Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3(l)(a)(i) of Directive 91/493/EEC; (31) and 16) 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. (32) Article 3 Directive 92/118/EEC shall be amended as follows with effect from the relevant date: 1) all references to "Annexes I and II" shall be replaced by references to "Annex I"; 2) in Article 4(1), the words "and Annex II as regards public health aspects" shall be deleted; and 3) Annex II shall be repealed. Article 4 1. With effect from the relevant date, references to the Directives referred to in Article 2 or to Annex II to Directive 92/118/EEC shall be construed as being made, as the context demands, to: (a) Regulation (EC) No .../2003 (33); (b) Regulation (EC) No ... 72003 (34) or (c) Directive 2002/99/EC. 2. Pending the adoption of microbiological criteria and temperature control requirements in accordance with Article 4 of Regulation (EC) No .../2003 (35), any such criteria or requirements laid down in the Directives referred to in Article 2, Annex II to Directive 92/118/EEC, or their implementing rules shall continue to apply. 3. Pending the adoption of the necessary provisions on the basis of Regulations (EC) No ... /2003 (36), No ... /2003 (37), No ... 72003 (38), or Directive 2002/99/EC, the following acts shall continue to apply mutatis mutandis: (a) implementing rules adopted on the basis of the Directives referred to in Article 2; (b) implementing rules adopted on the basis of Annex II to Directive 92/118/EEC, with the exception of Decision 94/371/EC (39); (c) implementing rules adopted on the basis of Directive 72/462/EEC; and (d) provisional lists of third countries and third country establishments drawn up in accordance with Decision 95/408/EC. Article 5 1. As from 1 January 2005, the animal health rules laid down in Directive 72/462/EEC shall continue to apply only to the import of live animals. 2. With effect from the relevant date, Directive 72/462/EEC shall continue to apply only to the import of live animals. Article 6 Directive 89/662/EEC shall be amended as follows with effect from the relevant date: 1) The references: (a) in Article 1, to "products of animal origin which are covered by the Directives listed in Annex A"; and (b) in Article 4(1), to "products obtained in accordance with the Directives referred to in Annex A", shall be replaced by "products of animal origin covered by the acts referred to in Annex A"; 2) Annex A shall be replaced by the following: "ANNEX A CHAPTER I Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (40) Regulation (EC) No /2003 (41) of the European Parliament and of the Council of ... laying down specific hygiene rules for food of animal origin (42) CHAPTER II Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A, Chapter I to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (44) Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (45) (45) OJ L 273, 10.10.2002, p. 1. Regulation as amended by Commission Regulation (EC) No 808/2003 (OJ L 117, 13.5.2003, p. 1)"." Article 7 Article 9 of Decision 95/408/EC shall be replaced by the following, with effect from the date of entry into force of this Directive: "Article 9 This Decision shall apply until the "relevant date", as defined in Article 1 of Directive 2003/.../EC (46) of the European Parliament and of the Council ofrepealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (47). Article 8 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the relevant date 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 be accompanied by such reference on the occasion of their official publication. The methods of making such references shall be laid down by Member States. Article 9 This Directive shall enter into force on the date of its publication in the Official Journal of the European Union. Article 10 This Directive is addressed to the Member States.

32004L0036

2004

Directive 2004/36/CE of the European Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 26 February 2004, Whereas: (1) The Resolution on the air disaster off the coast of the Dominican Republic adopted by the European Parliament on 15 February 1996(4) highlights the need for the Community to take a more active stance and develop a strategy to improve the safety of its citizens travelling by air or living near airports. (2) The Commission has issued a Communication to the European Parliament and the Council entitled "Defining a Community Aviation Safety Improvement Strategy". (3) That Communication clearly states that safety may be effectively enhanced by ensuring that aircraft comply fully with the international safety standards contained in the Annexes to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 ("the Chicago Convention"). (4) In order to establish and maintain a high uniform level of civil aviation safety in Europe, a harmonised approach to the effective enforcement of international safety standards within the Community should be introduced. To that end, it is necessary to harmonise the rules and procedures for ramp inspections of third-country aircraft landing at airports located in the Member States. (5) A harmonised approach to the effective enforcement of international safety standards by the Member States will avoid distortions of competition. A common stance on third-country aircraft that fail to comply with international safety standards will be of benefit to the position of the Member States. (6) Aircraft landing in the Member States should undergo an inspection when it is suspected that they do not comply with international safety standards. (7) Inspections may also be carried out in accordance with a spot-check procedure in the absence of any particular suspicion, provided that Community and international law is observed. In particular, the inspections should be carried out in a non-discriminatory way. (8) Inspections could be stepped up in the case of aircraft in which defects have already been identified frequently in the past, or on aircraft belonging to airlines whose aircraft have frequently attracted attention. (9) Information gathered in each Member State should be made available to all the other Member States and the Commission in order to ensure the most efficient monitoring of the compliance of third country aircraft with international safety standards. (10) For these reasons there is a need to establish, at Community level, a procedure for the assessment of third-country aircraft and related cooperation mechanisms between the competent authorities of the Member States to exchange information. (11) The sensitive nature of safety-related information requires that Member States should take necessary measures, in accordance with their national law, to ensure appropriate confidentiality of the information received by them. (12) Without prejudice to the public's right of access to the Commission's documents as laid down in Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(5), the Commission should adopt measures for the dissemination to interested parties of such information and the associated conditions. (13) Aircraft on which corrective measures are required should, where the identified deficiencies are clearly hazardous to safety, be grounded until the non-compliance with international safety standards has been rectified. (14) The facilities in the airport of inspection may be such that the competent authority will be obliged to authorise the aircraft to transfer to an appropriate airport, provided that conditions for a safe transfer are complied with. (15) In order to carry out its tasks under this Directive, the Commission should be assisted by the committee instituted by Article 12 of Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation(6). (16) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7). (17) The Commission should place at the disposal of the committee instituted by Article 12 of Regulation (EEC) No 3922/91 statistics and information collected in compliance with other Community measures concerning specific incidents that could be relevant to uncovering deficiencies representing a threat to civil aviation safety. (18) It is necessary to take into account the cooperation and information exchanges occurring within the framework of the Joint Aviation Authorities (JAA) and the European Civil Aviation Conference (ECAC). Moreover, the greatest possible use should be made of existing expertise in procedures of Safety Assessment of Foreign Aircraft (SAFA). (19) Account should be taken of the role of the European Aviation Safety Agency (EASA) in civil aviation safety policy, including the establishment of procedures that aim to establish and maintain a high uniform level of civil aviation safety in Europe. (20) Arrangements for greater cooperation over the use of Gibraltar airport were agreed in London on 2 December 1987 by the Kingdom of Spain and the United Kingdom in a joint declaration by the Ministers of Foreign Affairs of the two countries, and such arrangements have yet to come into operation, Article 1 Scope and objective 1. Within the framework of the Community's overall strategy to establish and maintain a high uniform level of civil aviation safety in Europe, this Directive introduces a harmonised approach to the effective enforcement of international safety standards within the Community by harmonising the rules and procedures for ramp inspections of third-country aircraft landing at airports located in the Member States. 2. This Directive shall be without prejudice to the Member States' right to carry out inspections not covered by this Directive and to ground, ban, or impose conditions on any aircraft landing at their airports in accordance with Community and international law. 3. State aircraft, as defined in the Chicago Convention, and aircraft of a maximum take-off weight of less than 5700 kg not engaged in commercial air transport are excluded from the scope of this Directive. 4. The application of this Directive to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated. 5. The application of this Directive to Gibraltar airport shall be suspended until the arrangements in the Joint Declaration made by the Foreign Ministers of the Kingdom of Spain and the United Kingdom on 2 December 1987 have come into operation. The Governments of Spain and the United Kingdom will inform the Council of such date of entry into operation. Article 2 Definitions For the purpose of this Directive: (a) "grounding" means the formal prohibition of an aircraft to leave an airport, and the taking of such steps as are necessary to detain it; (b) "international safety standards" means the safety standards contained in the Chicago Convention and its Annexes, as in force at the time of the inspection; (c) "ramp inspection" means the examination of third-country aircraft in accordance with Annex II; (d) "third-country aircraft" means an aircraft which is not used or operated under the control of a competent authority of a Member State. Article 3 Collection of information Member States shall put in place a mechanism to collect any information deemed useful for the fulfilment of the objective stated in Article 1, including: (a) important safety information accessible, in particular, through: - pilot reports, - maintenance organisation reports, - incident reports, - other organisations, independent from the competent authorities of the Member States, - complaints; (b) information on action taken subsequent to a ramp inspection, such as: - aircraft grounded, - aircraft or operator banned from the Member State concerned, - corrective action required, - contacts with the operator's competent authority; (c) follow-up information concerning the operator, such as: - corrective action implemented, - recurrence of discrepancy. This information shall be kept, using a standard report form containing the items described, in the form set out in Annex I. Article 4 Ramp inspection 1. Each Member State shall put in place the appropriate means to ensure that third-country aircraft suspected of non-compliance with international safety standards landing at any of its airports open to international air traffic shall be subject to ramp inspections. In implementing such procedures, particular attention shall be given by the competent authority to aircraft: - where information has been received indicating poor maintenance condition or obvious damage or defects; - which have been reported as performing abnormal manoeuvres since entering the airspace of a Member State such as to give rise to serious safety concerns; - in respect of which a previous ramp inspection has revealed deficiencies which give rise to serious concern that the aircraft does not comply with international safety standards and where the Member State is concerned that the defects may not have been corrected; - where there is evidence that the competent authorities of the country of registration may not be exercising proper safety oversight; or - where information collected under Article 3 gives cause for concern about the operator or where a previous ramp inspection of an aircraft used by the same operator has revealed deficiencies. 2. Member States may establish rules in order to carry out ramp inspections in accordance with a spot-check procedure in the absence of any particular suspicion, provided that such rules comply with Community and international law. Such a procedure shall, however, be carried out in a non-discriminatory way. 3. Member States shall ensure that appropriate ramp inspections and other surveillance measures as decided within the framework of Article 8(3) will be implemented. 4. The ramp inspection shall be performed in accordance with the procedure described in Annex II and using a ramp inspection report form containing at least the items described in the form set out in Annex II. On completion of the ramp inspection, the commander of the aircraft or a representative of the aircraft operator shall be informed of the ramp inspection findings and, if significant defects have been found, the report shall be sent to the operator of the aircraft and to the competent authorities concerned. 5. When performing a ramp inspection under this Directive, the competent authority concerned shall make all possible efforts to avoid an unreasonable delay of the aircraft inspected. Article 5 Exchange of information 1. The competent authorities of the Member States shall participate in a mutual exchange of information. Such information shall, at the request of a competent authority, include a list of airports of the Member State concerned that are open to international air traffic with an indication, for each calendar year, of the number of ramp inspections performed and the number of movements of third-country aircraft at each airport on that list. 2. All standard reports referred to in Article 3 and the ramp inspection reports referred to in Article 4(4) shall be made available without delay to the Commission and, at their request, to the competent authorities of the Member States and to the European Aviation Safety Agency (EASA). 3. Whenever a standard report shows the existence of a potential safety threat, or a ramp inspection report shows that an aircraft does not comply with international safety standards and may pose a potential safety threat, the report will be communicated without delay to each competent authority of the Member States and the Commission. Article 6 Protection and dissemination of information 1. Member States shall, in accordance with their national legislation, take the necessary measures to ensure appropriate confidentiality of the information received by them under Article 5. They shall use this information solely for the purpose of this Directive. 2. The Commission shall publish yearly an aggregated information report available to the public and the industry stakeholders containing an analysis of all information received in accordance with Article 5. That analysis shall be simple and easy to understand and shall indicate whether there exists an increased safety risk to air passengers. In the analysis, the source of that information shall be disidentified. 3. Without prejudice to the public's right of access to the Commission's documents as laid down in Regulation (EC) No 1049/2001, the Commission shall adopt, on its own initiative and in accordance with the procedure referred to in Article 10(2), measures for the dissemination to interested parties of the information referred to in paragraph 1 and the associated conditions. These measures, which may be general or individual, shall be based on the need: - to provide persons and organisations with the information they need to improve civil aviation safety; - to limit the dissemination of information to what is strictly required for the purposes of its users, in order to ensure appropriate confidentiality of that information. 4. Whenever information concerning aircraft deficiencies is given voluntarily, the ramp inspection reports referred to in Article 4(4) shall be disidentified regarding the source of such information. Article 7 Grounding of aircraft 1. Where non-compliance with international safety standards is clearly hazardous to flight safety, measures should be taken by the aircraft operator to rectify the deficiencies before flight departure. If the competent authority performing the ramp inspection is not satisfied that corrective action will be carried out before the flight, it shall ground the aircraft until the hazard is removed and shall immediately inform the competent authorities of the operator concerned and of the State of registration of the aircraft. 2. The competent authority of the Member State performing the ramp inspection may, in coordination with the State responsible for the operation of the aircraft concerned or the State of registration of the aircraft, prescribe the necessary conditions under which the aircraft can be allowed to fly to an airport at which the deficiencies can be corrected. If the deficiency affects the validity of the certificate of airworthiness for the aircraft, the grounding may only be lifted if the operator obtains permission from the State or States which will be overflown on that flight. Article 8 Safety improvement and implementation measures 1. Member States shall report to the Commission on the operational measures taken to implement the requirements of Articles 3, 4 and 5. 2. On the basis of the information collected under paragraph 1, the Commission may, in accordance with the procedure referred to in Article 10(2), take any appropriate measures to facilitate the implementation of Articles 3, 4 and 5 such as: - establish the list of information to be collected; - detail the content of, and procedures for, ramp inspections; - define the format for the storage and dissemination of data; - create or support the appropriate bodies for managing or operating the tools necessary for the collection and exchange of information. 3. On the basis of the information received under Articles 3, 4 and 5, and in accordance with the procedure referred to in Article 10(2), a decision may be taken on appropriate ramp inspection and other surveillance measures, in particular those of a specific operator or of operators of a specific third country, pending the adoption by the competent authority of that third country of satisfactory arrangements for corrective measures. 4. The Commission may take any appropriate measures to cooperate with and assist third countries to improve their aviation safety oversight capabilities. Article 9 Imposition of a ban or conditions on operation If a Member State decides to ban from its airports or impose conditions on the operation of a specific operator or operators of a specific third country pending the adoption by the competent authority of that third country of satisfactory arrangements for corrective measures: (a) that Member State shall notify the Commission of the measures taken, and the Commission shall transmit the information to the other Member States; (b) the Commission, acting in accordance with the procedure referred to in Article 10(3), may issue such recommendations and take such actions as it considers necessary; it may, moreover, extend the measures notified under (a) to the whole Community following the submission of a draft of the measures to be taken in accordance with the procedure referred to in Article 10(2). Article 10 Committee procedure 1. The Commission shall be assisted by the committee set up by Article 12 of Regulation (EEC) No 3922/91. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. The Committee shall adopt its rules of procedure. 5. The Committee may furthermore be consulted by the Commission on any other matter concerning the application of this Directive. Article 11 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 12 Amendment of Annexes The Annexes to this Directive may be amended in accordance with the procedure referred to in Article 10(2). Article 13 Report By 30 April 2008 the Commission shall submit a report to the European Parliament and the Council on the application of this Directive, and in particular on Article 9, which, inter alia, takes into account developments in the Community and in international fora. The report may be accompanied by proposals for an amendment of this Directive. Article 14 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 15 This Directive is addressed to the Member States.

32004L0060

2004

COMMISSION DIRECTIVE 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to include quinoxyfen as active substance (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 2003/82/EC (2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 1 August 1995 an application from Dow Elanco Europe (now Dow Agro Sciences), for the inclusion of the active substance quinoxyfen in Annex I to Directive 91/414/EEC. Commission Decision 96/457/EEC (3) confirmed that the dossier was‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member State, submitted a draft assessment report concerning the substance to the Commission on 11 October 1996. (3) The draft assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 28 November 2003 in the format of the Commission review report for quinoxyfen. (4) The documents and information were also submitted to the Scientific Committee for Plants for separate consultation. The Committee was asked to comment on the accumulation of the substance in soil and on its potential environmental impact. In its opinion (4), the Committee noted that the available studies and the field study on organic matter degradation (litter bag study) in particular did not convincingly demonstrate an acceptable impact on the environment, mainly due to insufficient statistical power of the experimental design. The Committee further noted that a fraction of the applied quinoxyfen may volatilise after application to a crop. Although available results indicate a rapid decomposition of the substance in air, the Committee suggested that measurements of the half-life should be repeated after appropriate schemes have been developed for assessing the environmental risks of atmospheric transport of plant protection products. This recommendation of the Committee was taken into account in the review report of the active substance. The insufficient field study on organic matter breakdown was repeated with an upgraded test protocol. No effect of quinoxyfen on organic matter decomposition was detected. (5) In accordance with Article 6(4) of Directive 91/414/EEC and in view of a possible unfavourable decision for quinoxyfen the Commission organised a tripartite meeting with the main data submitter and the rapporteur Member State on 13 February 2003. The main data submitter provided further data in order to meet the initial concerns. (6) It has appeared from the various examinations made that plant protection products containing quinoxyfen may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include quinoxyfen in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (7) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, should be kept available or made available by the Member States for consultation by any interested parties. (8) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing quinoxyfen and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish, by 28 February 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 March 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing quinoxyfen to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw the authorisation in accordance with Directive 91/414/EEC before 28 February 2005. 2. Member States shall, for each authorised plant protection product containing quinoxyfen as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2004, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 28 February 2006 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. Article 4 This Directive shall enter into force on 1 September 2004. Article 5 This Directive is addressed to the Member States.

32004L0058

2004

Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to include alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as active substances (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), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(2), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham. (2) For those active substances the effects on human health and the environment has been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the Rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(3), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For alpha-cypermethrin the rapporteur Member State was Belgium, and all relevant information was submitted on 16 September 1999. For benalaxyl the rapporteur Member State was Portugal, and all relevant information was submitted on 27 April 2000. For bromoxynil the rapporteur Member State was France, and all relevant formation was submitted on 16 March 2000. For desmedipham the rapporteur Member State was Finland, and all relevant information was submitted on 8 May 2000. For ioxynil the rapporteur Member State was France, and all relevant information was submitted on 16 March 2000. For phenmedipham the rapporteur Member State was Finland, and all relevant information was submitted on 5 January 2000. (3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) The reviews of all active substances were finalised on 13 February 2004 in the format of the Commission review reports for alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham. (5) The reviews of alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (6) It has appeared from the various examinations made that plant protection products containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. For efficiency reasons and considering the short deadlines it is appropriate that the rapporteur Member State coordinate such reviews between Member States. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 August 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 September 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 31 August 2005 at the latest, they shall amend or withdraw the authorisation. The respective rapporteur Member State shall organise the co-operation between Member States when carrying out such review. 2. For each authorised plant protection product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 28 February 2005 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2009 at the latest; or (b) in the case of a product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2009 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 March 2005. Article 5 This Directive is addressed to the Member States.

32004L0068

2004

COUNCIL DIRECTIVE 2004/68/EC of 26.4.2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Parliament (1), Having regard to the Opinion of the European Economic and Social Committee (2), Having regard to the Opinion of the Committee of the Regions (3), Whereas: (1) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries (4) ensures a high level of animal health protection by laying down the general sanitary requirements for certain imports from third countries. (2) It is necessary to rationalise and update the animal health provisions concerning international trade in animals provided for in Directive 72/462/EEC due to the evolution of the international standards of the Office International des Epizooties (OIE) and the adoption by this Office of new standards, together with their implications in the framework of the World Trade Organisation (WTO) and its Agreement on the Application of Sanitary and Phytosanitary Measures. (3) In addition, Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (5) replaces the requirements for meat and meat products provided for in Directive 72/462/EEC. It is therefore necessary and appropriate to lay down similar and updated animal health provisions for imports of live ungulate animals into the Community in this Directive. (4) In order to protect animal health, these new provisions should be extended to cover other ungulate animals that may present a similar risk of disease transmission. However, their application to such animals should be without prejudice to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (6). (5) Under Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (7), imports into the Community of equidae are allowed only from third countries appearing on a list drawn up in accordance with Directive 72/462/EEC. The provisions for establishing lists of third countries for imports of such equidae should be included in Directive 90/426/EEC. (6) Scientific knowledge concerning the susceptibility and testing of certain animals to diseases changes regularly. A procedure should therefore be established so that the scope of the list of animal species and the diseases to which they are susceptible can be rapidly updated in response to such developments. (7) In the interests of animal welfare and consistency of Community legislation, the general requirements of Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport (8), in particular as regards watering and feeding should be taken into account in this Directive. (8) In the interests of the protection of animal health and consistency of Community legislation, Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries (9) should also be taken into account. (9) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers on the Commission (10). (10) The public health and official control rules which apply to meat and meat products by virtue of Directive 72/462/EEC have been replaced by those of Regulation (EC) No /of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (11), which should apply as from 1 January 2006. The other rules of the said Directive have been replaced by Directive 2002/99/EC, the provisions of which apply as from 1 January 2005, or will be replaced by those of this Directive. (11) Directive 72/462/EEC should therefore be repealed when all the texts replacing the provisions thereof will be applicable. (12) It is necessary, however, in the interest of clarity of Community legislation, to repeal certain Decisions that are no longer applicable and at the same time to provide for certain implementing rules to remain in force until the necessary measures have been adopted under the new legal framework. (13) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of protecting animal health to lay down rules on the conditions for the importation of live ungulate animals. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. (14) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (12), establishes new committee procedures and terminology. In the interests of consistency of Community legislation, those procedures and terminology should be taken into account in this Directive. (15) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (13) lays down the conditions for the importation into the Community of ungulate animals other than domestic bovine, ovine, caprine, porcine and equine animals, and provides for a list to be laid down of third countries from which Member States may import such animals as well as the health requirements to be met. This Directive should be amended in order to exclude from its scope the animal species covered by the present act. (16) It is also appropriate to provide that the testing requirements upon importation of live animals covered by Directive 92/65/EEC should be updated or established by committee procedure. (17) Directives 90/426/EEC and 92/65/EEC should therefore be amended accordingly, Chapter I Subject matter, scope and definitions Article 1 Subject matter and scope This Directive lays down the animal health requirements for the importation into and transit through the Community of live ungulates. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: (a) "third countries" shall mean countries other than Member States, and those territories of Member States to which 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 (14) and 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 (15) do not apply; (b) "authorised third country" shall mean a third country, or a part of a third country, from which the importation into the Community of live ungulate animals listed in Annex I is authorised as provided for in Article 3(1); (c) "official veterinarian" shall mean a veterinarian authorised by the veterinary administration of a third country to perform health inspections of live animals, and to perform official certification; (d) "ungulates" shall mean those animals listed in Annex 1. Chapter II Animal health requirements applicable to imports into the community of certain live ungulate animals Article 3 Authorised third countries 1. The importation of live ungulates into and transit through the Community shall only be authorised from third countries that appear on a list or lists to be drawn up or amended in accordance with the procedure referred to in Article 14(2). Taking into account the health situation and the guarantees provided by the third country for the animals listed in Annex I, it may be decided in accordance with the procedure referred to in Article 14(2), that the authorisation provided for in the preceding subparagraph shall apply to the whole territory of an authorised third country or to only part of its territory. For that purpose and on the basis of the relevant international standards, account shall be taken of how the authorised third country applies and implements those standards, in particular the principle of regionalisation within its own territory and in relation to its sanitary requirements for importation from other third countries and from the Community. 2. The authorisation for importation of live ungulates into or transiting through the Community as provided for in paragraph 1 and the specific animal health conditions provided for in Article 6(3) may be suspended or withdrawn in accordance with the procedure referred to in Article 14(2) where the animal health situation in the authorised third country justifies such suspension or withdrawal. Article 4 Preparation of the lists of authorised third countries When the lists of authorised third countries are drawn up or amended, particular account shall be taken of: (a) the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health and the environmental situation in the third country which may pose a risk to the health and the environmental status of the Community; (b) the legislation of the third country in relation to animal health and welfare; (c) the organisation of the competent veterinary authority and its inspection services, the powers of those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply national legislation effectively; (d) the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community; (e) whether the third country is a member of the OIE and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious animal diseases in its territory, in particular those diseases listed by the OIE; (f) the guarantees given by the third country directly to inform the Commission and the Member States: (i) within 24 hours of the confirmation of the occurrence of any of the diseases listed in Annex II and of any change in the vaccination policy concerning such diseases; (ii) within an appropriate period, of any proposed changes in the national health rules concerning live ungulate animals, in particular regarding importation; (iii) at regular intervals, of the animal health status of its territory; (g) any experience of previous imports of live animals from the third country and the results of any import controls carried out; (h) the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities on the inspections which they have carried out; (i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on the importation from other third countries. Article 5 Publication of lists of authorised third countries by the Commission The Commission shall arrange for up-to-date versions of all lists drawn up or amended as provided for in Article 3(1) to be made available to the public. Those lists may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates. Article 6 Specific animal health conditions for imports and transit from authorised third countries of live ungulates into the Community 1. Specific animal health conditions for the importation and transit of live ungulates from authorised third countries into the Community shall be laid down in accordance with the procedure referred to in Article 14(2). They may take account of the following: (a) the animal species concerned; (b) the age and sex of the animals; (c) the intended destination or purpose of the animals; (d) the measures to be applied after importation of the animals into the Community; (e) any special provisions applicable in the framework of intra-Community trade. 2. The specific animal health conditions provided for in paragraph 1 shall be based on the rules laid down in Community legislation for the diseases to which the animals are susceptible. 3. However, where the equivalence of the official health guarantees provided for by the third country concerned can be formally recognised by the Community, the specific animal health conditions may be based on those guarantees. Article 7 Guarantees from the authorised third country regarding imports of live ungulates into the Community Imports of live ungulates into the Community shall be allowed only if the authorised third country provides the following guarantees: (a) the animals must come from a disease-free territory, in accordance with the basic general criteria listed in Annex II and into which the entry of animals vaccinated against the diseases listed in that Annex must be prohibited; (b) the animals must comply with the specific animal health conditions provided for in Article 6; (c) before the day of loading for shipment to the Community, the animals must have remained in the territory of the authorised third country for a period of time to be set out in the specific animal health conditions referred to in Article 6; (d) before shipment to the Community, the animals must have undergone a check by an official veterinarian to ensure mat they are healthy and that the transport conditions provided for in Directive 91/628/EEC are complied with, in particular as regards watering and feeding; (e) the animals must be accompanied by a veterinary certificate which complies with Article 11 and with a specimen veterinary certificate established in accordance with the procedure referred to in Article 14(2). Provision may be made for the use of electronic documents under the same procedure; (f) upon arrival in the Community, the animals must be checked at an agreed border inspection post in accordance with Article 4 of Directive 91/496/EEC. Article 8 Derogation from guarantees to be provided by authorised third countries By way of derogation from Articles 6 and 7, specific provisions, including model veterinary certificates, may be laid down in accordance with the procedure referred to in Article 14(2) for the importation or transit of live ungulates from third countries authorised under Article 3(1) if those animals: (a) are intended exclusively for grazing or draught purposes, on a temporary basis, in the vicinity of the Community frontiers; (b) are related to sporting events, circuses, shows and exhibitions but not related to commercial transactions of the animals themselves; (c) are intended for a zoo, an amusement park, an experimental laboratory, or as defined in Article 2(c) of Directive 92/65/EEC, approved body, approved institute or approved centre; (d) exclusively transit the territory of the Community through approved Community border inspection posts under customs and official veterinary approval and supervision, with no stop in the Community other than those necessary for animal welfare purposes; (e) accompany their owners as pet animals or; (f) are presented at an approved Community border inspection post after they have left the Community: — within a period of 30 days for one of the purposes referred to in points (a), (b) and (e) or, — transiting a third country or; (g) which belong to endangered species. Article 9 Derogation from Article 7(a) as regards imports or transit from authorised third countries where diseases listed in Annex II are present and/or vaccinations are carried out By way of derogation from Article 7(a), and in accordance with the procedure referred to in Article 14(2), conditions may be established for the importation or transit of live ungulates into the Community from an authorised third country where certain diseases listed in Annex II are present and/or vaccinations against those diseases are carried out. Such derogations shall be established country by country. Article 10 Derogation from Article 7(a) as regards imports or transit from authorised third countries where imports or transit have been suspended or prohibited By way of derogation from Article 7(a), and in accordance with the procedure referred to in Article 14(2), a specific period may be determined after which the importation or transit of live ungulates from an authorised third country may be resumed after the suspension or prohibition of importation or transit due to any change in the health situation, together with any additional conditions to be fulfilled after such resumption. When deciding to resume the importation or transit of such animals, account shall be taken of: — international standards, — whether an outbreak or a number of epizootiologically interrelated outbreaks of one of the diseases listed in Annex II occurs within a geographically limited area in an authorised third country or region, — whether the outbreak or outbreaks are successfully eradicated within a limited period of time. Article 11 Veterinary Certificates 1. A veterinary certificate complying with the requirements set out in Annex III shall be presented with each consignment of animals upon their import or transit into the Community. 2. The veterinary certificate shall certify that the requirements of this Directive and other Community legislation on animal health, or where applicable in accordance with Article 6(3), provisions that are equivalent to those requirements, have been complied with. 3. The veterinary certificate may include certification statements required under other Community legislation on public health, animal health and animal welfare. 4. The use of the veterinary certificate provided for in paragraph 1 may be suspended or withdrawn in accordance with the procedure referred to in Article 14(2) where the animal health situation in the authorised third country justifies such suspension or withdrawal. Article 12 Inspections and audits in third countries 1. Inspections and/or audits may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules. The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out such inspections and/or audits. 2. The inspections and/or audits provided for in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred. 3. The procedure for carrying out the inspections and/or audits in third countries as provided for in paragraph 1 may be established or amended in accordance with the procedure referred to in Article 14(2). 4. If a serious animal health risk is identified during an inspection and/or audit as provided for in paragraph 1, even if it is not directly related to the objectives of the inspection/audit, the Commission shall immediately, take the measures necessary to safeguard animal health, as laid down in Article 18 of Directive 91/496/EEC, including the suspension or withdrawal of the authorisation provided for in Article 3(1). Article 13 Empowering provisions 1. The following may be established in accordance with the procedure referred to in Article 14(2): (a) detailed rules for the application of this Directive; (b) rules regarding the origin of animals; (c) the criteria for classifying authorised third countries or regions thereof with regard to animal diseases; (d) provisions for the use of electronic documents relating to model veterinary certificates as provided for in Article 7(e); (e) models of veterinary certificates as provided for in Article 11(1). 2. The Annexes to this Directive may be amended in accordance with the procedure referred to in Article 14(2) in order to take account, in particular of: (a) scientific opinions and scientific knowledge particularly concerning new risk assessments; (b) technical developments and/or amendments to international standards; (c) the setting of safety targets for animal health. Article 14 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days. 3. The Committee shall adopt its rules of procedure. Article 15 Amendment to Directive 90/426/EEC Directive 90/426/EEC is hereby amended as follows: 1) Article 12 shall be replaced by the following: "Article 12 1. The importation of equidae into the Community shall only be authorised from third countries that appear on a list or lists to be drawn up or amended in accordance with the procedure referred to in Article 24(2). Taking into account the health situation and the guarantees provided by the third country for equidae, it may be decided in accordance with the procedure referred to in Article 24(2) that the authorisation provided for in the preceding subparagraph shall apply to the whole territory of the third country or to only part of its territory. For that purpose and on the basis of the relevant international standards, account shall be taken of how the third country applies and implements those standards, in particular the principle of regionalisation, within its own territory and in relation to its sanitary requirements for importation from other third countries and from the Community. 2) when the lists provided for in paragraph 1 are drawn up or amended, particular account shall be taken of: (a) the health status of the equidae, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health and the environmental situation in the third country which may pose a risk to the health and environmental status of the Community; (b) the legislation of the third country in relation to animal health and welfare; (c) the organisation of the competent veterinary authority and its inspection services, the powers of those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply national legislation effectively; (d) the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community; (e) whether the third country is a member of the "Office International des Epizooties" (OIE) and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious diseases of equidae in its territory, in particular those diseases listed by the OIE and in Annex A of this Directive; (f) the guarantees given by the third country to directly inform the Commission and the Member States: (i) within 24 hours, of the confirmation of the occurrence of infectious diseases of equidae listed in Annex A and of any change in the vaccination policy concerning such diseases; (ii) within an appropriate period, of any proposed changes in the national sanitary rules concerning equidae, in particular regarding the importation of equidae; (iii) at regular intervals, of the animal health status of its territory concerning equida; (g) any experience of previous imports of live equidae from the third country and the results of any import controls carried out; (h) the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities on the inspections which they have carried out; (i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on importation of equidae from other third countries. 3. The Commission shall arrange for up-to-date versions of all lists drawn up or amended as provided for in paragraph 1 to be made available to the public. Those lists may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates. 4. Special import conditions for each third country or group of third countries, having regard to the animal health situation concerning equidae in the third country or countries concerned shall be established in accordance with the procedure referred to in Article 24(2). 5. Detailed rules for the application of this Article and criteria for including third countries or parts of third countries in the lists provided for in paragraph 1 may be adopted in accordance with the procedure referred to in Article 24(2)." 2) the following point shall be added to Article 19: "(iv) may designate a Community reference laboratory for one or more of the diseases of equidae listed in Annex A and shall stipulate the functions, tasks and procedures regarding collaboration with laboratories responsible for diagnosing infectious diseases of equidae in the Member States.". Article 16 Amendment to Directive 92/65/EEC Directive 92/65/EEC is hereby amended as follows: 1) the first subparagraph of Article 1 shall be replaced by the following: "This Directive lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to in Annex F.". 2) Article 6 shall be amended as follows: (a) in A(l), point (e) shall be replaced by; "(e) must be accompanied by a certificate corresponding to the specimen given in Annex E part 1, bearing the following declaration: Declaration I, the undersigned (official veterinarian), certify that the ruminant(s) (16)/suida(e) (16) other than that (16)/those (16) covered by Directive 64/432/EEC: (i) belong/belongs (16) to the; (species) (ii) at the time of examination, do (16)/does (16) not show any clinical sign of any disease to which it (16)/they (16) is (16)/are (16) susceptible; (iii) come(s) from an officially tuberculosis free (16)/officially brucellosis free (16) or brucellosis free herd (16)/holding (16) not subject to swine fever restrictions or from a holding where it (16)/they (16) was (16)/were (16) subjected with negative results to the test(s) laid down in Article 6(2)(b) of Directive 92/65/EEC. (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (16) Delete where inapplicable.;" (b) In A(l), point (f) shall be deleted; (c) in A(2), point (b) shall be replaced by: "where they do not come from a herd meeting the conditions laid down in (a), they must come from a holding in which no case of brucellosis or tuberculosis has been recorded in the 42 days preceding loading of the animals and in which the ruminants have in the 30 days prior to dispatch undergone with negative results a test for brucellosis and tuberculosis."; (d) in A(3), points (e), (f) and (g) shall be deleted; (e) the following point shall be added to (A): "4) The testing requirements referred to in this Article and their criteria may be established in accordance with the procedure laid down in Article 26. These decisions shall take into consideration the case of ruminants reared in the arctic regions of the Community. Pending the decisions provided for in the preceding subparagraph, national rules shall continue to apply."; 3) Article 17 shall be amended as follows: (a) in paragraph 3, points (a) and (b) shall be replaced by the following: "(a) a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos and, (b) without prejudice to Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (17), a list of the collection centres for which these third countries are able to give the guarantees provided for in Article 11." The Commission shall inform the Member States of any proposed amendments to the lists of centres and the Member States shall have ten working days, from the date of receipt of the proposed amendments, to send written comments to the Commission. Where no written comments are received from the Member States within that period of ten working days, the proposed amendments shall be considered to have been accepted by the Member States and imports shall be authorised in accordance with the amended lists when the Commission notifies the competent authorities of the Member States and the third country concerned that the amendments are published on the web site of the Commission. Where written comments are received from at least one Member State within the period of ten working days, the Commission shall inform the Member States and the Standing Committee on the Food Chain and Animal Health at its next meeting for a decision to be adopted in accordance with the procedure referred to in the second subparagraph of Article 26. (17) OJ L 28, 2.2.1994, p. 47. Decision as last amended by Decision 2004/211/EC";" 4) in Article 23, the words "from Article 6 (A)(l)(e) and" shall be deleted; 5) Article 26 shall be replaced by the following: "Article 26 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council. (18) 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC (19) shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. (18) OJ L 31, 1.2.2002, p. 1." (19) OJ L 184, 17.7.1999, p. 23.";" 6) The text in Annex IV to this Directive shall be added as Annex F. Chapter III Final provisions Article 17 Transitional measures Transitional measures may be laid down in accordance with the procedure referred to in Article 14(2). Article 18 Transposal into national law 1. Member States shall bring into force the laws, regulations, and administrative provisions necessary to comply with this Directive before (20). 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 covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 19 Repeal of Directive 72/462/EEC Directive 72/462/EEC shall be repealed with effect from the date of application of Regulation (21). Article 20 Implementing rules established under Decisions adopted for the import of live animals, meat and meat products under Directive 72/462/EEC, as listed in Annex V to this Directive, shall remain in force until replaced by measures adopted under the new regulatory framework. Article 21 Entry into force and applicability This Directive shall enter into force on the twentieth day following that of its publication in the OJ of the European Union. Article 22 This Directive is addressed to the Member States.

32004L0066

2004

COUNCIL DIRECTIVE 2004/66/EC of 26 April 2004 adapting Directives 1999/45/EC, 2002/83/EC, 2003/37/EC and 2003/59/EC of the European Parliament and of the Council and Council Directives 77/388/EEC, 91/414/EEC, 96/26/EC, 2003/48/EC and 2003/49/EC, in the fields of free movement of goods, freedom to provide services, agriculture, transport policy and taxation, by reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia Having regard to the Treaty establishing the European Community, Having regard to the Treaty on the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union (1) (hereinafter referred to as the ‘Treaty of Accession’), and in particular Article 2(3) thereof, Having regard to the Act of Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (2) (hereinafter referred to as the ‘Act of Accession’), and in particular Article 57 thereof, Having regard to the proposal from the Commission, Whereas: (1) For certain acts which remain valid beyond 1 May 2004 and require adaptation by reason of accession, the necessary adaptations were not provided for in the Act of Accession, or were provided for but need further adaptation. All these adaptations need to be adopted before accession so as to be applicable as from accession. (2) Pursuant to Article 57(2) of the Act of Accession, such adaptations are to be adopted by the Council in all cases where the Council alone or jointly with the European Parliament adopted the original act. (3) Directives 1999/45/EC (3), 2002/83/EC (4), 2003/37/EC (5) and 2003/59/EC (6) of the European Parliament and of the Council and Council Directives 77/388/EEC (7), 91/414/EEC (8), 96/26/EC (9), 2003/48/EC (10) and 2003/49/EC (11) should therefore be amended accordingly, Article 1 Directives 1999/45/EC, 2002/83/EC, 2003/37/EC, 2003/59/EC, 77/388/EEC, 91/414/EEC, 96/26/EC, 2003/48/EC and 2003/49/EC are amended as set out in the Annex of this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of entry into force of the Treaty of Accession. As regards the provisions of this Directive adapting Directive 91/414/EC as amended, as well as Directives 2002/83/EC, 2003/37/EC and 2003/59/EC, the date of transposition shall be that laid down therein. Member States shall forthwith submit the text of the provisions transposing this Directive to the Commission, with a table setting out their correlation with the specific provisions of this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force only subject to and on the date of the entry into force of the Treaty of Accession. Article 4 This Directive is addressed to the Member States.

32004L0067

2004

Council Directive 2004/67/EC of 26 April 2004 concerning measures to safeguard security of natural gas supply (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Having regard to the opinion of the European Parliament(3), Whereas: (1) Natural gas (gas) is becoming an increasingly important component in Community energy supply, and, as indicated in the Green Paper "Towards a European strategy for the security of energy supply", the European Union is expected in the longer term to become increasingly dependent on gas imported from non-EU sources of supply. (2) Following Directive 98/30/EC of the European Parliament and of the Council of 22 June 1998 concerning common rules for the internal market in natural gas(4) and Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas and repealing Directive 98/30/EC(5), the Community gas market is being liberalised. Consequently, regarding security of supply, any difficulty having the effect of reducing gas supply could cause serious disturbances in the economic activity of the Community; for this reason, there is a growing need to ensure security of gas supply. (3) The completion of the internal gas market necessitates a minimum common approach to security of supply, in particular through transparent and non-discriminatory security of supply policies compatible with the requirements of such a market, in order to avoid market distortions. Definition of clear roles and responsibilities of all market players is therefore crucial in safeguarding security of gas supply and the well-functioning of the internal market. (4) Security of supply obligations imposed on companies should not impede the well functioning of the internal market and should not impose unreasonable and disproportionate burden on gas market players, including new market entrants and small market players. (5) In view of the growing gas market in the Community, it is important that the security of gas supply is maintained, in particular as regards household customers. (6) A large choice of instruments are available for the industry and, if appropriate, for Member States, to comply with the security of supply obligations. Bilateral agreements between Member States could be one of the means to contribute to the achievement of the minimum security of supply standards, having due regard to the Treaty and secondary legislation, in particular Article 3(2) of Directive 2003/55/EC. (7) Indicative minimum targets for gas storage could be set either at national level or by the industry. It is understood that this should not create any additional investment obligations. (8) Considering the importance of securing gas supply, i.e. on the basis of long-term contracts, the Commission should monitor the developments on the gas market on the basis of reports from Member States. (9) In order to meet growing demand for gas and diversify gas supplies as a condition for a competitive internal gas market, the Community will need to mobilise significant additional volumes of gas over the coming decades much of which will have to come from distant sources and transported over long distances. (10) The Community has a strong common interest with gas supplying and transit countries in ensuring continued investments in gas supply infrastructure. (11) Long-term contracts have played a very important role in securing gas supplies for Europe and will continue to do so. The current level of long term contracts is adequate on the Community level, and it is believed that such contracts will continue to make a significant contribution to overall gas supplies as companies continue to include such contracts in their overall supply portfolio. (12) Considerable progress has been made in developing liquid trading platforms and through gas release programmes at national level. This trend is expected to continue. (13) The establishment of genuine solidarity between Member States in major emergency supply situations is essential, even more so as Member States become increasingly interdependent regarding security of supply. (14) The sovereign rights of Member States over their own natural resources are not affected by this Directive. (15) A Gas Coordination Group should be established, which should facilitate coordination of security of supply measures at Community level in the event of a major supply disruption, and may also assist member States in coordinating measures taken at a national level. In addition, it should exchange information on security of gas supply on a regular basis, and should consider aspects relevant in the context of a major supply disruption. (16) Member States should adopt and publish national emergency provisions. (17) This Directive should provide rules applicable in the event of a major supply disruption; the foreseeable length of such a supply disruption should cover a significant period of time of at least eight weeks. (18) Regarding the handling of a major supply disruption, this Directive should provide for a mechanism based on a three step approach. The first step would involve the reactions of the industry to the supply disruption; if this were not sufficient, Member States should take measures to solve the supply disruption. Only if the measures taken at stage one and two have failed should appropriate measures be taken at Community level. (19) Since the objective of this Directive, namely ensuring an adequate level for the security of gas supply, in particular in the event of a major supply disruption, whilst contributing to the proper functioning of the internal gas market, cannot, in all circumstances, be sufficiently achieved by the Member States, particularly in light of the increasing interdependency of the Member States regarding security of gas supply, and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Objective This Directive establishes measures to safeguard an adequate level for the security of gas supply. These measures also contribute to the proper functioning of the internal gas market. It establishes a common framework within which Member States shall define general, transparent and non-discriminatory security of supply policies compatible with the requirements of a competitive internal gas market; clarify the general roles and responsibilities of the different market players and implement specific non-discriminatory procedures to safeguard security of gas supply. Article 2 Definitions For the purpose of this Directive: 1. "long-term gas supply contract" means a gas supply contract with a duration of more than 10 years; 2. "major supply disruption" shall mean a situation where the Community would risk to lose more than 20 % of its gas supply from third countries and the situation at Community level is not likely to be adequately managed with national measures. Article 3 Policies for securing gas supply 1. In establishing their general policies with respect to ensuring adequate levels of security of gas supply, Member States shall define the roles and responsibilities of the different gas market players in achieving these policies, and specify adequate minimum security of supply standards that must be complied with by the players on the gas market of the Member State in question. The standards shall be implemented in a non-discriminatory and transparent way and shall be published. 2. Member States shall take the appropriate steps to ensure that the measures referred to in this Directive do not place an unreasonable and disproportionate burden on gas market players and are compatible with the requirements of a competitive internal gas market. 3. A non-exhaustive list of instruments for the security of gas supply is given in the Annex. Article 4 Security of supply for specific customers 1. Member States shall ensure that supplies for household customers inside their territory are protected to an appropriate extent at least in the event of: (a) a partial disruption of national gas supplies during a period to be determined by Member States taking into account national circumstances; (b) extremely cold temperatures during a nationally determined peak period; (c) periods of exceptionally high gas demand during the coldest weather periods statistically occurring every 20 years, These criteria are referred to in this Directive as "security of supply standards". 2. Member States may extend the scope of paragraph 1 in particular to small and medium-sized enterprises and other customers that cannot switch their gas consumption to other energy sources, including measures for the security of their national electricity system if it depends on gas supplies. 3. A non-exhaustive list in the Annex sets out examples of instruments which may be used in order to achieve the security of supply standards. 4. Member States, having due regard to the geological conditions of their territory and the economic and technical feasibility, may also take the necessary measures to ensure that gas storage facilities located within their territory contribute to an appropriate degree to achieving the security of supply standards. 5. If an adequate level of interconnection is available, Member States may take the appropriate measures in cooperation with another Member State, including bilateral agreements, to achieve the security of supply standards using gas storage facilities located within that other Member State. These measures, in particular bilateral agreements, shall not impede the proper functioning of the internal gas market. 6. Member States may set or require the industry to set indicative minimum targets for a possible future contribution of storage, either located within or outside the Member State, to security of supply. These targets shall be published. Article 5 Reporting 1. In the report published by Member States pursuant to Article 5 of Directive 2003/55/EC, Member States shall also cover the following: (a) the competitive impact of the measures taken pursuant to Articles 3 and 4 on all gas market players; (b) the levels of storage capacity; (c) the extent of long-term gas supply contracts concluded by companies established and registered on their territory, and in particular their remaining duration, based on information provided by the companies concerned, but excluding commercially sensitive information, and the degree of liquidity of the gas market; (d) the regulatory frameworks to provide adequate incentives for new investment in exploration and production, storage, LNG and transport of gas, taking into account Article 22 of Directive 2003/55/EC as far as implemented by the Member State. 2. This information shall be considered by the Commission in the reports that it issues pursuant to Article 31 of Directive 2003/55/EC in the light of the consequences of that Directive for the Community as a whole and the overall efficient and secure operation of the internal gas market. Article 6 Monitoring 1. The Commission shall monitor, on the basis of the reports referred to in Article 5(1): (a) the degree of new long-term gas supply import contracts from third countries; (b) the existence of adequate liquidity of gas supplies; (c) the level of working gas and of the withdrawal capacity of gas storage; (d) the level of interconnection of the national gas systems of Member States; (e) the foreseeable gas supply situation in function of demand, supply autonomy and available supply sources at Community level concerning specific geographic areas in the Community. 2. Where the Commission concludes that gas supplies in the Community will be insufficient to meet foreseeable gas demand in the long term, it may submit proposals in accordance with the Treaty. 3. By 19 May 2008 the Commission shall submit a review report to the European Parliament and the Council on the experience gained from the application of this Article. Article 7 Gas Coordination Group 1. A Gas Coordination Group is hereby established in order to facilitate the coordination of security of supply measure (the Group). 2. The Group shall be composed of the representatives of Member States and representative bodies of the industry concerned and of relevant consumers, under the chairmanship of the Commission. 3. The Group shall adopt its Rules of Procedure. Article 8 National emergency measures 1. Member States shall prepare in advance and, if appropriate, update national emergency measures and shall communicate these to the Commission. Member States shall publish their national emergency measures. 2. Member States' emergency measures shall ensure, where appropriate, that market players are given sufficient opportunity to provide an initial response to the emergency situation. 3. Subject to Article 4(1), Member States may indicate to the Chair of the Group events which they consider, because of their magnitude and exceptional character, cannot be adequately managed with national measures. Article 9 Community mechanism 1. If an event occurs that is likely to develop into a major supply disruption for a significant period of time, or in the case of an event indicated by a Member State according to Article 8(3), the Commission shall convene the Group as soon as possible, at the request of a Member State or on its own initiative. 2. The Group shall examine, and, where appropriate, assist the Member States in coordinating the measures taken at national level to deal with the major supply disruption. 3. In carrying out its work, the Group shall take full account of: (a) the measures taken by the gas industry as a first response to the major supply disruption; (b) the measures taken by Member States, such as those taken pursuant to Article 4, including relevant bilateral agreements. 4. Where the measures taken at national level referred to in paragraph 3 are inadequate to deal with the effects of an event referred to in paragraph 1, the Commission may, in consultation with the Group, provide guidance to Member States regarding further measures to assist those Member States particularly affected by the major supply disruption. 5. Where the measures taken at national level pursuant to paragraph 4 are inadequate to deal with the effects of an event referred to in paragraph 1, the Commission may submit a proposal to the Council regarding further necessary measures. 6. Any measures at Community level referred to in this Article shall contain provisions aimed at ensuring fair and equitable compensation of the undertakings concerned by the measures to be taken. Article 10 Monitoring of implementation 1. By 19 May 2008, the Commission shall, in the light of the manner in which Member States have implemented this Directive, report on the effectiveness of the instruments used with regard to Article 3 and 4 and their effect on the internal gas market and on the evolution of competition on the internal gas market. 2. In the light of the results of this monitoring, where appropriate, the Commission may issue recommendations or present proposals regarding further measures to enhance security of supply. Article 11 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 19 May 2006. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 12 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 13 This Directive is addressed to the Member States.

32004L0064

2004

Commission Directive 2004/64/EC of 26 April 2004 amending Commission Directive 2003/84/EC as regards time limits (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), and in particular Article 6(1) thereof, Whereas: (1) Commission Directive 2003/84/EC(2) amends Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances in Annex I to that Directive. (2) After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing this active substance and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (3) The timelines for the implementation given in Directive 2003/84/EEC are not in line with the timelines given for other new active substances. In order to harmonise the approach for all substances under the current review phase, any considerable difference between the timelines applicable for different new active substances should be avoided. (4) It is therefore appropriate to amend Directive 2003/84/EC accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Article 3 of Directive 2003/84/EC is amended as follows: Paragraph 2 is replaced by the following: "2. For each authorised plant protection product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2003 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2005 at the latest; or (b) in the case of a product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2005 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest." Article 2 This Directive shall enter into force on the twentieth day after the date of publication. Article 3 This Directive is addressed to the Member States.

32004L0062

2004

Commission Directive 2004/62/EC of 26 April 2004 amending Council Directive 91/414/EEC to include mepanipyrim as active substance (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), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 24 October 1997 an application from Kumiai Chemical Industry Co., Ltd for the inclusion of the active substance mepanipyrim (former name: KIF 3535) in Annex I to Directive 91/414/EEC. Commission Decision 98/676/EC(2) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member State submitted a draft assessment report concerning the substance to the Commission on 12 July 2000. (3) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 30 March 2004 in the format of the Commission review report for mepanipyrim. (4) The dossier and the information from the review were also submitted to the Scientific Panel on Plant Health, Plant Protection Products and their Residues. The report of this Panel was formally adopted on 23 October 2003(3). The Panel was asked to comment on the liver tumors found in rats and mice exposed to mepanipyrim and to give its opinion on the question whether a threshold of tumor formation can be assumed. In its opinion the Panel concluded that mepanipyrim induces tumors in rats and mice by a mechanism which is currently unknown but nevertheless involves a threshold below which tumors are not expected to develop and that therefore a safe level of human exposure can be assigned. The recommendations of the Scientific Panel were taken into account during the further review and in this Directive and in the Review Report. The evaluation within the Standing Committee concluded that there would be no unacceptable human exposure under the proposed conditions of use. (5) It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include mepanipyrim in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive. (6) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing mepanipyrim and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (7) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 31 March 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 April 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 1. Member States shall review the authorisation for each plant protection product containing mepanipyrim to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 31 March 2005 at the latest. 2. For each authorised plant protection product containing mepanipyrim as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2004 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing mepanipyrim as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2006 at the latest; or (b) in the case of a product containing mepanipyrim as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 October 2004. Article 5 This Directive is addressed to the Member States.

32004L0065

2004

Commission Directive 2004/65/EC of 26 April 2004 amending Directive 2003/68/EC as regards time limits (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), and in particular Article 6(1) thereof, Whereas: (1) Commission Directive 2003/68/EC(2) amends Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances in Annex I to that Directive. (2) After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing this active substance and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (3) The timelines for the implementation given in Directive 2003/68 are not in line with the timelines given for other new active substances. In order to harmonise the approach for all substances under the current review phase, any considerable difference between the timelines applicable for different new active substances should be avoided. (4) It is therefore appropriate to amend Directive 2003/68/EC accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Article 3 of Directive 2003/68/EC is amended as follows: Paragraph 2 is replaced by the following: "2. For each authorised plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole as either the only active substance or as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC, by 30 September 2003 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2005 at the latest; or (b) in the case of a product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2005 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest." Article 2 This Directive shall enter into force on the 20th day after the date of publication. Article 3 This Directive is addressed to the Member States.

32004L0063

2004

Commission Directive 2004/63/EC of 26 April 2004 amending Commission Directive 2003/79/EC as regards time limits (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), and in particular Article 6(1) thereof, Whereas: (1) Commission Directive 2003/79/EC(2) amends Council Directive 91/414/EEC to include Coniothyrium minitans as active substance in Annex I to that Directive. (2) After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing this active substance and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (3) The timelines for the implementation given in Directive 2003/79 are not in line with the timelines given for other new active substances. In order to harmonise the approach for all substances under the current review phase, any considerable difference between the timelines applicable for different new active substances should be avoided. (4) It is therefore appropriate to amend Directive 2003/79/EC accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Article 3 of Directive 2003/79/EC is amended as follows: Paragraph 2 is replaced by the following: "2. For each authorised plant protection product containing Coniothyrium minitans as either the only active substance or as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2003 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing Coniothyrium minitans as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2005 at the latest; or (b) in the case of a product containing Coniothyrium minitans as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2005 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest." Article 2 This Directive shall enter into force on the 20th day after the date of publication. Article 3 This Directive is addressed to the Member States.

32004L0070

2004

Commission Directive 2004/70/EC of 28 April 2004 amending Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof, Whereas: (1) Article 20 of the Act of Accession of 2003, refers to Annex II to that Act, which contains adaptations to the acquis required by accession. However, Annex II in principle only takes into account adaptations to acts adopted before the cut-off date for the accession negotiations, i.e. 1 November 2002. (2) It is however necessary to make additional adaptations to the acquis, in particular to acts adopted after that date as well as to acts which could not be included in Annex II or which, because of changed circumstances, require new adaptations. (3) Directive 2000/29/EC was amended at several occasions after 1 November 2002 in respect of certain provisions that were adapted by the Act of Accession of 2003. (4) By the Act of Accession of 2003, Lithuania was granted the status of a protected zone as regards Beet necrotic yellow vein virus for a limited period of time expiring on 31 March 2006. It is appropriate to amend the text of Annex IV to reflect the changes made by the Act of Accession. (5) By the Act of Accession of 2003, Latvia, Slovenia and Slovakia were granted the status of a protected zone as regards Globodera pallida (Stone) Behrens for a limited period of time expiring on 31 March 2006. It is appropriate to amend the text of Annex IV to reflect the changes made by the Act of Accession. (6) By the Act of Accession of 2003, Malta was granted the status of a protected zone as regards Citrus tristeza virus (European strains) for a limited period of time expiring on 31 March 2006. It is appropriate to amend the text of Annex IV to reflect the changes made by the Act of Accession. (7) In the interest of clarity it is appropriate to combine in one text some of the amendments made since 1 November 2002. An appropriate period should be given for the Member States to implement those provisions of this Directive which do not reflect existing legislation. (8) Directive 2000/29/EC should, therefore, be amended accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 2000/29/EC is amended as follows: 1. Annexes I, II, III and IV are amended in accordance with Annex I to this Directive. 2. Part B of Annex IV is amended in accordance with Annex II to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Annex II to this Directive at the latest by 1 June 2004. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force subject to, and as from the date of, the entry into force of the Treaty of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia. Article 4 This Directive is addressed to the Member States.

32004L0071

2004

Commission Directive 2004/71/EC of 28 April 2004 amending Council Directive 91/414/EEC to include Pseudomonas chlororaphis as active substance (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), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC the Swedish authorities received on 15 December 1994 an application from Bio Agri AB, hereafter referred to as the applicant, for the inclusion of the active substance Pseudomonas chlororaphis in Annex I to the Directive. Decision 97/248/EC(2) of 25 March 1997 confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member State submitted a draft assessment report concerning the substance to the Commission on 7 April 1998. (3) The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 30 March 2004 in the format of the Commission review report for Pseudomonas chlororaphis. (4) The dossier and the information from the review were also submitted to the Scientific Committee for Plants. The Committee was asked to comment (a) on residue levels in food and feed; (b) on operator exposure; (c) whether with regard to possible hazard to humans a tiered approach should include repeated dosing as part of the primary data set; (d) on the toxicological safety of the antibiotic metabolites of the active substance; (e) on the necessity to monitor the health of workers; and (f) on a potential of Pseudomonas chlororaphis to cause wound infection or other pathogenic effects. In its opinion(3) the Committee concluded that (a) the issue of residues has been adequately addressed that there is no cause for concern; (b) operator exposure to Pseudomonas chlororaphis formulations has been adequately addressed; (c) in the specific case of Pseudomonas chlororaphis, and in the light of the results of the available studies, repeated dosing is not necessary to assess hazard to humans; (d) more studies would be needed for a more complete assessment of the mutagenicity potential of the metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR). However, the Committee considered the potential for human exposure to DDR as well as to other possible antibiotic metabolites so low that, even in the absence of further information, no major concern exists for consumer and operator safety; (e) a study based on the medical surveillance of workers should be conveniently carried out when introducing this agent in the field as a microbial pesticide; (f) there is no cause for concern for human safety with regard to wound infection. The recommendations of the Scientific Committee as well as further information by the notifier were taken into account during the further review and in this Directive and in the Review Report, where the need for monitoring of operators and worker based on medical surveillance to detect negative effects without delay as well as monitoring studies to quantify DDR contamination under practical conditions is stressed. The evaluation within the Standing Committee concluded that there would be no unacceptable risk for operators if appropriate risk mitigation measures are applied. (5) It has appeared from the various examinations made that plant protection products containing Pseudomonas chlororaphis may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC in the light of Article 5(3) thereof, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include this active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (6) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing Pseudomonas chlororaphis and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (7) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 31 March 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 April 2005. 2. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing Pseudomonas chlororaphis to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 31 March 2005 at the latest. 2. For each authorised plant protection product containing Pseudomonas chlororaphis as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2004 at the latest, Member States shall re-evaluate the product on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing Pseudomonas chlororaphis as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2006 at the latest; or (b) in the case of a product containing Pseudomonas chlororaphis as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 October 2004. Article 5 This Directive is addressed to the Member States.

32004L0078

2004

COMMISSION DIRECTIVE 2004/78/C of 29 April 2004 amending Directive 2001/56/EC of the European Parliament and of the Council relating to heating systems for motor vehicles and their trailers and Council Directive 70/156/EEC for the purposes of adapting to technical progress (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) and in particular Article 13(2) thereof, Having regard to Directive 2001/56/EC of the European Parliament and of the Council of 27 September 2001 relating to heating systems for motor vehicles and their trailers (2), and in particular Article 5 thereof, Whereas: (1) Directive 2001/56/EC is one of the separate directives under the EC type-approval procedure which has been established by Directive 70/156/EEC. Directive 2001/56/EC lays down requirements for the type approval of vehicles fitted with combustion heaters and for combustion heaters as components. (2) Pursuant to Article 5 of Directive 2001/56/EC the Commission has to examine additional safety requirements with respect to liquefied petroleum gas (LPG) fuelled heating systems of motor vehicles. (3) Until now Member States have applied individual national requirements on vehicles fitted with LPG heating systems. In order to provide a harmonised approach to the technical requirements for LPG appliances and heating systems, two European Standards which are now available should be applied within the type approval system for motor vehicles and their trailers. In the light of technical progress it is therefore considered necessary to introduce these two EN standards as well as main elements of UN/ECE Regulation No. 67 into Directive 2001/56/EC. (4) Directive 2001/56/EC should therefore be amended accordingly, in particular, in the interest of clarity Annex VIII should be replaced. (5) Exceptions relating to heating systems for special purpose vehicles, in particular for motor caravans and trailer caravans that are quite often fitted with LPG heating systems, are no longer required due to the introduction of requirements for LPG heating systems. Therefore the harmonised safety provisions of Directive 2001/56/EC have to apply to all vehicles including special purpose vehicles as referred to in Annex XI of Directive 70/156/EEC. (6) Directive 70/156/EEC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established under Article 13 of Directive 70/156/EEC, Article 1 Amendment to Directive 2001/56/EC Directive 2001/56/EC is amended as follows: (1) Annexes I and II are amended in accordance with part A of Annex I to this Directive; (2) Annex VIII is replaced by the text set out in part B of Annex I to this Directive. Article 2 Amendment to Directive 70/156/EEC Directive 70/156/EEC is amended in accordance with Annex II to this Directive. Article 3 Transitional provisions 1. With effect from 1 October 2004, in respect of a new type of vehicle fitted with an LPG fuelled heating system which complies with the requirements laid down in Annexes I, II and IV to VIII of Directive 2001/56/EC, as amended by this Directive, Member States may not, on grounds relating to heating systems: (a) refuse to grant EC type-approval, or national type-approval, or (b) prohibit registration, sale or entry into service. 2. With effect from 1 October 2004, in respect of a new type of LPG fuelled combustion heater as a component which complies with the requirements laid down in Annexes I, II and IV to VIE of Directive 2001/56/EC, as amended by this Directive, Member States may not: (a) refuse to grant EC type-approval, or national type-approval, or (b) prohibit sale or entry into service. 3. With effect from 1 January 2006, in respect of a type of vehicle fitted with an LPG fuelled heating system, or a type of LPG fuelled combustion heater as a component, which does not comply with the requirements laid down in Annexes I, II and IV to VIII of Directive 2001/56/EC, as amended by this Directive, Member States shall refuse to grant EC type-approval and may refuse national type-approval. 4. With effect from 1 January 2007, in respect of vehicles fitted with LPG fuelled heating systems which do not comply with the requirements laid down in Annexes I, II, and IV to VIII of Directive 2001/56/EC, as amended by this Directive, Member States: (a) 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 (b) may refuse the registration, sale or entry into service of new vehicles on grounds relating to heating systems. 5. With effect from 1 January 2007 +the requirements of Annexes I, II and IV to VIII of Directive 2001/56/EC, as amended by this Directive, in relation to LPG fuelled combustion heaters as components shall apply for the purposes of Article 7(2) of Directive 70/156/EEC. Article 4 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 5 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 Union. Article 6 Addressees This Directive is addressed to the Member States.

32004L0076

2004

COUNCIL DIRECTIVE 2004/76/EC of 29.4.2004 amending Directive 2003/49/EC as regards the possibility for certain Member States to apply transitional periods for the application of a common system of taxation applicable to interest and royalty payments made between associated companies of different Member States Having regard to the Treaty establishing the European Community, and in particular Article 94 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 European Economic and Social Committee (3), Whereas: (1) Council Directive 2003/49/EC of 3 June 2003 on the common system of taxation applicable to interest and royalty payments made between associated companies of different Member States (4) provides for the abolition of taxation on those payments in the Member State where they arise, but also ensures that these payments are subject to tax once in a Member State. (2) The application of Directive 2003/49/EC is liable to cause budgetary difficulties for the Czech Republic, Latvia, Lithuania, Poland and Slovakia given the rates of withholding tax applied under national law and on the basis of tax conventions on income and capital and the revenue thus collected. (3) Those Acceding States should therefore be permitted, on a temporary basis, until the date of application referred to in Article 17(2) and (3) of Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments (5) not to apply certain provisions of Directive 2003/49/EC concerning, in the case of Latvia and Lithuania, interest and royalty payments, and in the case of the Czech Republic, Poland and Slovakia, royalty payments only. (4) The measure provided for in this Directive is not an adaptation within the meaning of Article 57 of the 2003 Act of Accession. (5) Since the Member States are required to grant credit for tax deducted from interest and royalty payments, it is necessary to ensure that this Directive is transposed by the date of entry into force of the 2003 Act of Accession. (6) The provisions in this Directive must apply from the date of accession of the new Member States. The urgency of the matter justifies an exception to the six-week period provided for in point I.3. of the Protocol on the role of national parliaments in the European Union, Article 1 Article 6 of Directive 2003/49/EC is hereby amended as follows: 1) The title shall be replaced by the following: "Transitional rules for the Czech Republic, Greece, Spain, Latvia, Lithuania, Poland, Portugal and Slovakia" 2) Paragraphs 1, 2 and 3 shall be replaced by the following: " 1. Greece, Latvia, Poland and Portugal shall be authorised not to apply the provisions of Article 1 until the date of application referred to in Article 17(2) and (3) of Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments (6). During a transitional period of eight years starting on the aforementioned date, the rate of tax on payments of interest or royalties made to an associated company of another Member State or to a permanent establishment situated in another Member State of an associated company of a Member State must not exceed 10% during the first four years and 5% during the final four years. Lithuania shall be authorised not to apply the provisions of Article 1 until the date of application referred to in Article 17(2) and (3) of Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments (7). During a transitional period of six years starting on the aforementioned date, the rate of tax on payments of royalties made to an associated company of another Member State or to a permanent establishment situated in another Member State of an associated company of a Member State must not exceed 10%. During the first four years of the six-year transitional period, the rate of tax on payments of interest made to an associated company of another Member State or to a permanent establishment situated in another Member State must not exceed 10%; and for the following two years, the rate of tax on such payments of interest must not exceed 5%. Spain and the Czech Republic shall be authorised, for royalty payments only, not to apply the provisions of Article 1 until the date of application referred to in Article 17(2) and (3) of Directive 2003/48/EC. During a transitional period of six years starting on the aforementioned date, the rate of tax on payments of royalties made to an associated company of another Member State or to a permanent establishment situated in another Member State of an associated company of a Member State must not exceed 10%. Slovakia shall be authorised, for royalty payments only, not to apply the provisions of Article 1 during a transitional period of two years starting on 1 May 2004. These transitional rules shall, however, remain subject to the continued application of any rate of tax lower than those referred to in the first, second and third subparagraphs provided by bilateral agreements concluded between the Czech Republic, Greece, Spain, Latvia, Lithuania, Poland, Portugal or Slovakia and other Member States. Before the end of any of the transitional periods mentioned in this paragraph the Council may decide unanimously, on a proposal from the Commission, on a possible extension of the said transitional periods. 2. Where a company of a Member State, or a permanent establishment situated in that Member State of a company of a Member State: — receives interest or royalties from an associated company of Greece, Latvia, Lithuania, Poland or Portugal, — receives royalties from an associated company of the Czech Republic, Spain or Slovakia, — receives interest or royalties from a permanent establishment situated in Greece, Latvia, Lithuania, Poland or Portugal, of an associated company of a Member State, or — receives royalties from a permanent establishment situated in the Czech Republic, Spain or Slovakia, of an associated company of a Member State, the first Member State shall allow an amount equal to the tax paid in the Czech Republic, Greece, Spain, Latvia, Lithuania, Poland, Portugal, or Slovakia in accordance with paragraph 1 on that income as a deduction from the tax on the income of the company or permanent establishment which received that income. 3. The deduction provided for in paragraph 2 need not exceed the lower of: (a) the tax payable in the Czech Republic, Greece, Spain, Latvia, Lithuania, Poland, Portugal or Slovakia, on such income on the basis of paragraph 1, or (b) that part of the tax on the income of the company or permanent establishment which received the interest or royalties, as computed before the deduction is given, which is attributable to those payments under the domestic law of the Member State of which it is a company or in which the permanent establishment is situated. (6) L 157, 26.6.2003, p. 38." (7) L 157, 26.6.2003, p. 38"." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive from the date of its entry into force. They shall immediately forward to the Commission the text of these measures, together with a correlation table between such measures and this Directive. When Member States adopt such measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 subject to, and as on the date of, the entry into force of the Treaty of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia. Article 4 This Directive is addressed to the Member States.

32004L0072

2004

Commission Directive 2004/72/EC of 29 April 2004 implementing Directive 2003/6/EC of the European Parliament and of the Council as regards accepted market practices, the definition of inside information in relation to derivatives on commodities, the drawing up of lists of insiders, the notification of managers' transactions and the notification of suspicious transactions (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse)(1), and in particular the second paragraph of point 1 and point 2(a) of Article 1 and the fourth, fifth and seventh indents of Article 6(10) thereof, After consulting the Committee of European Securities Regulators (CESR)(2) for technical advice, Whereas: (1) Practising fairness and efficiency by market participants is required in order not to create prejudice to normal market activity and market integrity. In particular, market practices inhibiting the interaction of supply and demand by limiting the opportunities for other market participants to respond to transactions can create higher risks for market integrity and are, therefore, less likely to be accepted by competent authorities. On the other hand, market practices which enhance liquidity are more likely to be accepted than those practices reducing them. Market practices breaching rules and regulations designed to prevent market abuse, or codes of conduct, are less likely to be accepted by competent authorities. Since market practices change rapidly in order to meet investors' needs, competent authorities need to be alert to new and emerging market practice. (2) Transparency of market practices by market participants is crucial for considering whether a particular market practice can be accepted by competent authorities. The less transparent a practice is, the more likely it is not to be accepted. However, practices on non regulated markets might for structural reasons be less transparent than similar practices on regulated markets. Such practices should not be in themselves considered as unacceptable by competent authorities. (3) Particular market practices in a given market should not put at risk market integrity of other, directly or indirectly, related markets throughout the Community, whether those markets be regulated or not. Therefore, the higher the risk for market integrity on such a related market within the Community, the less those practices are likely to be accepted by competent authorities. (4) Competent authorities, while considering the acceptance of a particular market practice, should consult other competent authorities, particularly for cases where there exist comparable markets to the one under scrutiny. However, there might be circumstances in which a market practice can be deemed to be acceptable on one particular market and unacceptable on another comparable market within the Community. In case of discrepancies between market practices which are accepted in one Member State and not in another one, discussion could take place in the Committee of European Securities Regulators in order to find a solution. With regard to their decisions about such acceptance, competent authorities should ensure a high degree of consultation and transparency vis-à-vis market participants and end-users. (5) It is essential for market participants on derivative markets the underlying of which is not a financial instrument, to get greater legal certainty on what constitutes inside information. (6) The establishment, by issuers or persons acting on their behalf or for their account, of lists of persons working for them under a contract of employment or otherwise and having access to inside information relating, directly or indirectly, to the issuer, is a valuable measure for protecting market integrity. These lists may serve issuers or such persons to control the flow of such inside information and thereby manage their confidentiality duties. Moreover, these lists may also constitute a useful tool for competent authorities when monitoring the application of market abuse legislation. Identifying inside information to which any insider has access and the date on which it gained access thereto is necessary for issuers and competent authorities. Access to inside information relating, directly or indirectly, to the issuer by persons included on such a list is without prejudice to their duty to refrain from insider dealing on the basis of any inside information as defined in Directive 2003/6/EC. (7) The notification of transactions conducted by persons discharging managerial responsibilities within an issuer on their own account, or by persons closely associated with them, is not only a valuable information for market participants, but also constitutes an additional means for competent authorities to supervise markets. The obligation by senior executives to notify transactions is without prejudice to their duty to refrain from insider dealing on the basis of any inside information as defined in Directive 2003/6/EC. (8) Notification of transactions should be in accordance with the rules on transfer of personal data laid down in Directive 95/46/EC(3) 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 movement of such data. (9) Notification of suspicious transactions by persons professionally arranging transactions in financial instruments to the competent authority requires sufficient indications that the transactions might constitute market abuse, i.e. transactions which give reasonable ground for suspecting that insider dealing or market manipulation is involved. Certain transactions by themselves may seem completely void of anything suspicious, but might deliver such indications of possible market abuse, when seen in perspective with other transactions, certain behaviour or other information. (10) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charta of Fundamental Rights of the European Union and in particular by Article 8 of the European Convention on Human Rights. (11) The measures provided for in this Directive are in accordance with the opinion of the European Securities Committee, Article 1 Definitions For the purpose of applying Article 6(10) of Directive 2003/6/EC: 1. "Person discharging managerial responsibilities within an issuer" shall mean a person who is (a) a member of the administrative, management or supervisory bodies of the issuer: (b) a senior executive, who is not a member of the bodies as referred to in point (a), having regular access to inside information relating, directly or indirectly, to the issuer, and the power to make managerial decisions affecting the future developments and business prospects of this issuer. 2. 'Person closely associated with a person discharging managerial responsibilities within an issuer of financial instruments' shall mean: (a) the spouse of the person discharging managerial responsibilities, or any partner of that person considered by national law as equivalent to the spouse; (b) according to national law, dependent children of the person discharging managerial responsibilities; (c) other relatives of the person discharging managerial responsibilities, who have shared the same household as that person for at least one year on the date of the transaction concerned; (d) any legal person, trust or partnership, whose managerial responsibilities are discharged by a person referred to in point 1 of this Article or in letters (a), (b) and (c) of this point, or which is directly or indirectly controlled by such a person, or that is set up for the benefit of such a person, or whose economic interests are substantially equivalent to those of such person. 3. "Person professionally arranging transactions" shall mean at least an investment firm or a credit institution. 4. "Investment firm" shall mean any person as defined in Article 1(2) of Council Directive 93/22/EEC(4); 5. "Credit institution" shall mean any person as defined in Article 1(1) of Directive 2000/12/EC of the European Parliament and of the Council(5); 6. "Competent authority" shall mean the competent authority as defined in Article 1(7) of Directive 2003/6/EC. Article 2 Factors to be taken into account when considering market practices 1. For the purposes of applying paragraph 2 of point 1 and point 2(a) of Article 1 of Directive 2003/6/EC, Member States shall ensure that the following non exhaustive factors are taken into account by competent authorities, without prejudice to collaboration with other authorities, when assessing whether they can accept a particular market practice: (a) the level of transparency of the relevant market practice to the whole market; (b) the need to safeguard the operation of market forces and the proper interplay of the forces of supply and demand.; (c) the degree to which the relevant market practice has an impact on market liquidity and efficiency; (d) the degree to which the relevant practice takes into account the trading mechanism of the relevant market and enables market participants to react properly and in a timely manner to the new market situation created by that practice; (e) the risk inherent in the relevant practice for the integrity of, directly or indirectly, related markets, whether regulated or not, in the relevant financial instrument within the whole Community; (f) the outcome of any investigation of the relevant market practice by any competent authority or other authority mentioned in Article 12(1) of Directive 2003/6/EC, in particular whether the relevant market practice breached rules or regulations designed to prevent market abuse, or codes of conduct, be it on the market in question or on directly or indirectly related markets within the Community; (g) the structural characteristics of the relevant market including whether it is regulated or not, the types of financial instruments traded and the type of market participants, including the extent of retail investors participation in the relevant market. Member States shall ensure that competent authorities shall, when considering the need for safeguard referred to in point (b) of the first subparagraph, in particular analyse the impact of the relevant market practice against the main market parameters, such as the specific market conditions before carrying out the relevant market practice, the weighted average price of a single session or the daily closing price. 2. Member States shall ensure that practices, in particular new or emerging market practices are not assumed to be unacceptable by the competent authority simply because they have not been previously accepted by it. 3. Member States shall ensure that competent authorities review regularly the market practices they have accepted, in particular taking into account significant changes to the relevant market environment, such as changes to trading rules or to market infrastructure. Article 3 Consultation procedures and disclosure of decisions 1. For the purposes of applying paragraph 2 of point 1 and point 2(a) of Article 1 of Directive 2003/6/EC, Member States shall ensure that the procedures set out in paragraphs 2 and 3 of this Article are observed by competent authorities when considering whether to accept or continue to accept a particular market practice. 2. Without prejudice to Article 11(2) of Directive 2003/6/EC, Member States shall ensure that competent authorities, before accepting or not the market practice concerned, consult as appropriate relevant bodies such as representatives of issuers, financial services providers, consumers, other authorities and market operators. The consultation procedure shall include consultation of other competent authorities, in particular where there exist comparable markets, i.e. in structures, volume, type of transactions. 3. Member States shall ensure that competent authorities publicly disclose their decisions regarding the acceptability of the market practice concerned, including appropriate descriptions of such practices. Member States shall further ensure that competent authorities transmit their decisions as soon as possible to the Committee of European Securities Regulators which shall make them immediately available on its website. The disclosure shall include a description of the factors taken into account in determining whether the relevant practice is regarded as acceptable, in particular where different conclusions have been reached regarding the acceptability of the same practice on different Member States markets. 4. When investigatory actions on specific cases have already started, the consultation procedures set out in paragraphs 1 to 3 may be delayed until the end of such investigation and possible related sanctions. 5. A market practice which was accepted following the consultation procedures set out in paragraphs 1 to 3 shall not be changed without using the same consultation procedures. Article 4 Inside information in relation to derivatives on commodities For the purposes of applying the second paragraph of point 1 of Article 1 of Directive 2003/6/EC, users of markets on which derivatives on commodities are traded, are deemed to expect to receive information relating, directly or indirectly, to one or more such derivatives which is: (a) routinely made available to the users of those markets, or (b) required to be disclosed in accordance with legal or regulatory provisions, market rules, contracts or customs on the relevant underlying commodity market or commodity derivatives market. Article 5 Lists of insiders 1. For the purposes of applying the third subparagraph of Article 6(3) of Directive 2003/6/EC, Member States shall ensure that lists of insiders include all persons covered by that Article who have access to inside information relating, directly or indirectly, to the issuer, whether on a regular or occasional basis. 2. Lists of insiders shall state at least: (a) the identity of any person having access to inside information; (b) the reason why any such person is on the list; (c) the date at which the list of insiders was created and updated. 3. Lists of insiders shall be promptly updated (a) whenever there is a change in the reason why any person is already on the list; (b) whenever any new person has to be added to the list; (c) by mentioning whether and when any person already on the list has no longer access to inside information. 4. Member States shall ensure that lists of insiders will be kept for at least five years after being drawn up or updated. 5. Member States shall ensure that the persons required to draw up lists of insiders take the necessary measures to ensure that any person on such a list that has access to inside information acknowledges the legal and regulatory duties entailed and is aware of the sanctions attaching to the misuse or improper circulation of such information. Article 6 Managers' Transactions 1. For the purposes of applying Article 6(4) of Directive 2003/6/EC, and without prejudice to the right of Member States to provide for other notification obligations than those covered by that Article, Member States shall ensure that all transactions related to shares admitted to trading on a regulated market, or to derivatives or other financial instruments linked to them, conducted on the own account of persons referred to in Article 1 points 1 and 2 above, are notified to the competent authorities. The rules of notification to which those persons have to comply with shall be those of the Member State where the issuer is registered. The notification shall be made within five working days of the transaction date to the competent authority of that Member State. When the issuer is not registered in a Member State, this notification shall be made to the competent authority of the Member State in which it is required to file the annual information in relation to the shares in accordance with Article 10 of Directive 2003/71/EC. 2. Member States may decide that, until the total amount of transactions has reached five thousand Euros at the end of a calendar year, no notification is required or notification may be delayed until the 31 January of the following year. The total amount of transactions shall be computed by summing up the transactions conducted on the own account of persons referred to in Article 1 point 1 with the transactions conducted on the own account of persons referred to in Article 1 point 2. 3. The notification shall contain the following information: (a) name of the person discharging managerial responsibilities within the issuer, or, where applicable, name of the person closely associated with such a person, (b) reason for responsibility to notify, (c) name of the relevant issuer, (d) description of the financial instrument, (e) nature of the transaction (e.g. acquisition or disposal), (f) date and place of the transaction (g) price and volume of the transaction. Article 7 Suspicious transactions to be notified For the purposes of applying Article 6(9) of Directive 2003/6/EC, Member States shall ensure that persons referred to in Article 1 point 3 above shall decide on a case-by-case basis whether there are reasonable grounds for suspecting that a transaction involves insider dealing or market manipulation, taking into account the elements constituting insider dealing or market manipulation, referred to in Articles 1 to 5 of Directive 2003/6/EC, in Commission Directive 2003/124/EC(6) implementing Directive 2003/6/EC as regards the definition and public disclosure of inside information and the definition of market manipulation, and in Article 4 of this Directive. Without prejudice to Article 10 of Directive 2003/6/EC, persons professionally arranging transactions shall be subject to the rules of notification of the Member State in which they are registered or have their head office, or in the case of a branch, the Member State where the branch is situated. The notification shall be addressed to the competent authority of this Member State. Member States shall ensure that competent authorities receiving the notification of suspicious transactions transmit such information immediately to the competent authorities of the regulated markets concerned. Article 8 Timeframe for notification Member States shall ensure that in the event that persons, as referred to in Article 1 point 3, become aware of a fact or information that gives reasonable ground for suspicion concerning the relevant transaction, make a notification without delay. Article 9 Content of notification 1. Member States shall ensure that persons subject to the notification obligation transmit to the competent authority the following information: (a) description of the transactions, including the type of order (such as limit order, market order or other characteristics of the order) and the type of trading market (such as block trade); (b) reasons for suspicion that the transactions might constitute market abuse; (c) means for identification of the persons on behalf of whom the transactions have been carried out, and of other persons involved in the relevant transactions; (d) capacity in which the person subject to the notification obligation operates (such as for own account or on behalf of third parties); (e) any information which may have significance in reviewing the suspicious transactions. 2. Where that information is not available at the time of notification, the notification shall include at least the reasons why the notifying persons suspect that the transactions might constitute insider dealing or market manipulation. All remaining information shall be provided to the competent authority as soon as it becomes available. Article 10 Means of notification Member States shall ensure that notification to the competent authority can be done by mail, electronic mail, telecopy or telephone, provided that in the latter case confirmation is notified by any written form upon request by the competent authority. Article 11 Liability and professional secrecy 1. Member States shall ensure that the person notifying to the competent authority as referred to in Articles 7 to 10 shall not inform any other person, in particular the persons on behalf of whom the transactions have been carried out or parties related to those persons, of this notification, except by virtue of provisions laid down by law. The fulfilment of this requirement shall not involve the notifying person in liability of any kind, providing the notifying person acts in good faith. 2. Member States shall ensure that competent authorities do not disclose to any person the identity of the person having notified these transactions, if disclosure would, or would be likely to harm the person having notified the transactions. This provision is without prejudice to the requirements of the enforcement and the sanctioning regimes under Directive 2003/6/EC and to the rules on transfer of personal data laid down in Directive 95/46/EC. 3. The notification in good faith to the competent authority as referred to in Articles 7 to 10 shall not constitute a breach of any restriction on disclosure of information imposed by contract or by any legislative, regulatory or administrative provision, and shall not involve the person notifying in liability of any kind related to such notification. Article 12 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 12 October 2004 at the latest. They shall forthwith communicate to the Commission the text of the provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 13 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 14 Addressees This Directive is addressed to the Member States.

32004L0038

2004

DIRECTIVE 2004/38/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Articles 12, 18, 40, 44 and 52 thereof, Having regard to the proposal from the Commission (1), Having regard to the Opinion of the European 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 251 of the Treaty (4), Whereas: (1) Citizenship of the Union confers on every citizen of the Union a primary and individual right to move and reside freely within the territory of the Member States, subject to the limitations and conditions laid down in the Treaty and to the measures adopted to give it effect. (2) The free movement of persons constitutes one of the fundamental freedoms of the internal market, which comprises an area without internal frontiers, in which freedom is ensured in accordance with the provisions of the Treaty. (3) Union citizenship should be the fundamental status of nationals of the Member States when they exercise their right of free movement and residence. It is therefore necessary to codify and review the existing Community instruments dealing separately with workers, self-employed persons, as well as students and other inactive persons in order to simplify and strengthen the right of free movement and residence of all Union citizens. (4) With a view to remedying this sector-by-sector, piecemeal approach to the right of free movement and residence and facilitating the exercise of this right, there needs to be a single legislative act to amend Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (5) and to repeal the following acts: Council Directive 68/360/EEC of 15 October 1968 on the abolition of restrictions on movement and residence within the Community for workers of Member States and their families (6), Council Directive 73/148/EEC of 21 May 1973 on the abolition of restrictions on movement and residence within the Community for nationals of Member States with regard to establishment and the provision of services (7), Council Directive 90/364/EEC of 28 June 1990 on the right of residence (8), Council Directive 90/365/EEC of 28 June 1990 on the right of residence for employees and self-employed persons who have ceased their occupational activity (9) and Council Directive 93/96/EEC of 29 October 1993 on the right of residence for students (10). (5) The right of all Union citizens to move and reside freely within the territory of the Member States should, if it is to be exercised under objective conditions of freedom and dignity, be also granted to their family members, irrespective of nationality. For the purposes of this Directive, the definition of "family member" should also include the registered partner if the legislation of the host Member State treats registered partnership as equivalent to marriage. (6) In order to maintain the unity of the family in a broader sense and without prejudice to the prohibition of discrimination on grounds of nationality, the situation of those persons who are not included in the definition of family members under this Directive, and who therefore do not enjoy an automatic right of entry and residence in the host Member State, should be examined by the host Member State on the basis of its own national legislation, in order to decide whether entry and residence could be granted to such persons, taking into consideration their relationship with the Union citizen or any other circumstances, such as their financial or physical dependence on the Union citizen. (7) The formalities connected with the free movement of Union citizens within the territory of Member States should be clearly defined, without prejudice to the provisions applicable to national border controls. (8) With a view to facilitating the free movement of family members who are not nationals of a Member State, those who have already obtained a residence card should be exempted from the requirement to obtain an entry visa within the meaning of Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (11) or, where appropriate, of the applicable national legislation. (9) Union citizens should have the right of residence in the host Member State for a period not exceeding three months without being subject to any conditions or any formalities other than the requirement to hold a valid identity card or passport, without prejudice to a more favourable treatment applicable to job-seekers as recognised by the case-law of the Court of Justice. (10) Persons exercising their right of residence should not, however, become an unreasonable burden on the social assistance system of the host Member State during an initial period of residence. Therefore, the right of residence for Union citizens and their family members for periods in excess of three months should be subject to conditions. (11) The fundamental and personal right of residence in another Member State is conferred directly on Union citizens by the Treaty and is not dependent upon their having fulfilled administrative procedures. (12) For periods of residence of longer than three months, Member States should have the possibility to require Union citizens to register with the competent authorities in the place of residence, attested by a registration certificate issued to that effect. (13) The residence card requirement should be restricted to family members of Union citizens who are not nationals of a Member State for periods of residence of longer than three months. (14) The supporting documents required by the competent authorities for the issuing of a registration certificate or of a residence card should be comprehensively specified in order to avoid divergent administrative practices or interpretations constituting an undue obstacle to the exercise of the right of residence by Union citizens and their family members. (15) Family members should be legally safeguarded in the event of the death of the Union citizen, divorce, annulment of marriage or termination of a registered partnership. With due regard for family life and human dignity, and in certain conditions to guard against abuse, measures should therefore be taken to ensure that in such circumstances family members already residing within the territory of the host Member State retain their right of residence exclusively on a personal basis. (16) As long as the beneficiaries of the right of residence do not become an unreasonable burden on the social assistance system of the host Member State they should not be expelled. Therefore, an expulsion measure should not be the automatic consequence of recourse to the social assistance system. The host Member State should examine whether it is a case of temporary difficulties and take into account the duration of residence, the personal circumstances and the amount of aid granted in order to consider whether the beneficiary has become an unreasonable burden on its social assistance system and to proceed to his expulsion. In no case should an expulsion measure be adopted against workers, self-employed persons or job-seekers as defined by the Court of Justice save on grounds of public policy or public security. (17) Enjoyment of permanent residence by Union citizens who have chosen to settle long term in the host Member State would strengthen the feeling of Union citizenship and is a key element in promoting social cohesion, which is one of the fundamental objectives of the Union. A right of permanent residence should therefore be laid down for all Union citizens and their family members who have resided in the host Member State in compliance with the conditions laid down in this Directive during a continuous period of five years without becoming subject to an expulsion measure. (18) In order to be a genuine vehicle for integration into the society of the host Member State in which the Union citizen resides, the right of permanent residence, once obtained, should not be subject to any conditions. (19) Certain advantages specific to Union citizens who are workers or self-employed persons and to their family members, which may allow these persons to acquire a right of permanent residence before they have resided five years in the host Member State, should be maintained, as these constitute acquired rights, conferred by Commission Regulation (EEC) No 1251/70 of 29 June 1970 on the right of workers to remain in the territory of a Member State after having been employed in that State (12) and Council Directive 75/34/EEC of 17 December 1974 concerning the right of nationals of a Member State to remain in the territory of another Member State after having pursued therein an activity in a self-employed capacity (13). (20) In accordance with the prohibition of discrimination on grounds of nationality, all Union citizens and their family members residing in a Member State on the basis of this Directive should enjoy, in that Member State, equal treatment with nationals in areas covered by the Treaty, subject to such specific provisions as are expressly provided for in the Treaty and secondary law. (21) However, it should be left to the host Member State to decide whether it will grant social assistance during the first three months of residence, or for a longer period in the case of job-seekers, to Union citizens other than those who are workers or self-employed persons or who retain that status or their family members, or maintenance assistance for studies, including vocational training, prior to acquisition of the right of permanent residence, to these same persons. (22) The Treaty allows restrictions to be placed on the right of free movement and residence on grounds of public policy, public security or public health. In order to ensure a tighter definition of the circumstances and procedural safeguards subject to which Union citizens and their family members may be denied leave to enter or may be expelled, this Directive should replace Council Directive 64/221/EEC of 25 February 1964 on the coordination of special measures concerning the movement and residence of foreign nationals, which are justified on grounds of public policy, public security or public health (14). (23) Expulsion of Union citizens and their family members on grounds of public policy or public security is a measure that can seriously harm persons who, having availed themselves of the rights and freedoms conferred on them by the Treaty, have become genuinely integrated into the host Member State. The scope for such measures should therefore be limited in accordance with the principle of proportionality to take account of the degree of integration of the persons concerned, the length of their residence in the host Member State, their age, state of health, family and economic situation and the links with their country of origin. (24) Accordingly, the greater the degree of integration of Union citizens and their family members in the host Member State, the greater the degree of protection against expulsion should be. Only in exceptional circumstances, where there are imperative grounds of public security, should an expulsion measure be taken against Union citizens who have resided for many years in the territory of the host Member State, in particular when they were born and have resided there throughout their life. In addition, such exceptional circumstances should also apply to an expulsion measure taken against minors, in order to protect their links with their family, in accordance with the United Nations Convention on the Rights of the Child, of 20 November 1989. (25) Procedural safeguards should also be specified in detail in order to ensure a high level of protection of the rights of Union citizens and their family members in the event of their being denied leave to enter or reside in another Member State, as well as to uphold the principle that any action taken by the authorities must be properly justified. (26) In all events, judicial redress procedures should be available to Union citizens and their family members who have been refused leave to enter or reside in another Member State. (27) In line with the case-law of the Court of Justice prohibiting Member States from issuing orders excluding for life persons covered by this Directive from their territory, the right of Union citizens and their family members who have been excluded from the territory of a Member State to submit a fresh application after a reasonable period, and in any event after a three year period from enforcement of the final exclusion order, should be confirmed. (28) To guard against abuse of rights or fraud, notably marriages of convenience or any other form of relationships contracted for the sole purpose of enjoying the right of free movement and residence, Member States should have the possibility to adopt the necessary measures. (29) This Directive should not affect more favourable national provisions. (30) With a view to examining how further to facilitate the exercise of the right of free movement and residence, a report should be prepared by the Commission in order to evaluate the opportunity to present any necessary proposals to this effect, notably on the extension of the period of residence with no conditions. (31) This Directive respects the fundamental rights and freedoms and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In accordance with the prohibition of discrimination contained in the Charter, Member States should implement this Directive without discrimination between the beneficiaries of this Directive on grounds such as sex, race, colour, ethnic or social origin, genetic characteristics, language, religion or beliefs, political or other opinion, membership of an ethnic minority, property, birth, disability, age or sexual orientation, CHAPTER I General provisions Article 1 Subject This Directive lays down: (a) the conditions governing the exercise of the right of free movement and residence within the territory of the Member States by Union citizens and their family members; (b) the right of permanent residence in the territory of the Member States for Union citizens and their family members; (c) the limits placed on the rights set out in (a) and (b) on grounds of public policy, public security or public health. Article 2 Definitions For the purposes of this Directive: 1) "Union citizen" means any person having the nationality of a Member State; 2) "Family member" means: (a) the spouse; (b) the partner with whom the Union citizen has contracted a registered partnership, on the basis of the legislation of a Member State, if the legislation of the host Member State treats registered partnerships as equivalent to marriage and in accordance with the conditions laid down in the relevant legislation of the host Member State; (c) the direct descendants who are under the age of 21 or are dependants and those of the spouse or partner as defined in point (b); (d) the dependent direct relatives in the ascending line and those of the spouse or partner as defined in point (b); 3) "Host Member State" means the Member State to which a Union citizen moves in order to exercise his/her right of free movement and residence. Article 3 Beneficiaries 1. This Directive shall apply to all Union citizens who move to or reside in a Member State other than that of which they are a national, and to their family members as defined in point 2 of Article 2 who accompany or join them. 2. Without prejudice to any right to free movement and residence the persons concerned may have in their own right, the host Member State shall, in accordance with its national legislation, facilitate entry and residence for the following persons: (a) any other family members, irrespective of their nationality, not falling under the definition in point 2 of Article 2 who, in the country from which they have come, are dependants or members of the household of the Union citizen having the primary right of residence, or where serious health grounds strictly require the personal care of the family member by the Union citizen; (b) the partner with whom the Union citizen has a durable relationship, duly attested. The host Member State shall undertake an extensive examination of the personal circumstances and shall justify any denial of entry or residence to these people. CHAPTER II Right of exit and entry Article 4 Right of exit 1. Without prejudice to the provisions on travel documents applicable to national border controls, all Union citizens with a valid identity card or passport and their family members who are not nationals of a Member State and who hold a valid passport shall have the right to leave the territory of a Member State to travel to another Member State. 2. No exit visa or equivalent formality may be imposed on the persons to whom paragraph 1 applies. 3. Member States shall, acting in accordance with their laws, issue to their own nationals, and renew, an identity card or passport stating their nationality. 4. The passport shall be valid at least for all Member States and for countries through which the holder must pass when travelling between Member States. Where the law of a Member State does not provide for identity cards to be issued, the period of validity of any passport on being issued or renewed shall be not less than five years. Article 5 Right of entry 1. Without prejudice to the provisions on travel documents applicable to national border controls, Member States shall grant Union citizens leave to enter their territory with a valid identity card or passport and shall grant family members who are not nationals of a Member State leave to enter their territory with a valid passport. No entry visa or equivalent formality may be imposed on Union citizens. 2. Family members who are not nationals of a Member State shall only be required to have an entry visa in accordance with Regulation (EC) No 539/2001 or, where appropriate, with national law. For the purposes of this Directive, possession of the valid residence card referred to in Article 10 shall exempt such family members from the visa requirement. Member States shall grant such persons every facility to obtain the necessary visas. Such visas shall be issued free of charge as soon as possible and on the basis of an accelerated procedure. 3. The host Member State shall not place an entry or exit stamp in the passport of family members who are not nationals of a Member State provided that they present the residence card provided for in Article 10. 4. Where a Union citizen, or a family member who is not a national of a Member State, does not have the necessary travel documents or, if required, the necessary visas, the Member State concerned shall, before turning them back, give such persons every reasonable opportunity to obtain the necessary documents or have them brought to them within a reasonable period of time or to corroborate or prove by other means that they are covered by the right of free movement and residence. 5. The Member State may require the person concerned to report his/her presence within its territory within a reasonable and non-discriminatory period of time. Failure to comply with this requirement may make the person concerned liable to proportionate and non-discriminatory sanctions. CHAPTER III Right of residence Article 6 Right of residence for up to three months 1. Union citizens shall have the right of residence on the territory of another Member State for a period of up to three months without any conditions or any formalities other than the requirement to hold a valid identity card or passport. 2. The provisions of paragraph 1 shall also apply to family members in possession of a valid passport who are not nationals of a Member State, accompanying or joining the Union citizen. Article 7 Right of residence for more than three months 1. All Union citizens shall have the right of residence on the territory of another Member State for a period of longer than three months if they: (a) are workers or self-employed persons in the host Member State; or (b) have sufficient resources for themselves and their family members not to become a burden on the social assistance system of the host Member State during their period of residence and have comprehensive sickness insurance cover in the host Member State; or (c) — are enrolled at a private or public establishment, accredited or financed by the host Member State on the basis of its legislation or administrative practice, for the principal purpose of following a course of study, including vocational training; and — have comprehensive sickness insurance cover in the host Member State and assure the relevant national authority, by means of a declaration or by such equivalent means as they may choose, that they have sufficient resources for themselves and their family members not to become a burden on the social assistance system of the host Member State during their period of residence; or (d) are family members accompanying or joining a Union citizen who satisfies the conditions referred to in points (a), (b) or (c). 2. The right of residence provided for in paragraph 1 shall extend to family members who are not nationals of a Member State, accompanying or joining the Union citizen in the host Member State, provided that such Union citizen satisfies the conditions referred to in paragraph l(a), (b) or (c). 3. For the purposes of paragraph 1(a), a Union citizen who is no longer a worker or self-employed person shall retain the status of worker or self-employed person in the following circumstances: (a) he/she is temporarily unable to work as the result of an illness or accident; (b) he/she is in duly recorded involuntary unemployment after having been employed for more than one year and has registered as a job-seeker with the relevant employment office; (c) he/she is in duly recorded involuntary unemployment after completing a fixed-term employment contract of less than a year or after having become involuntarily unemployed during the first twelve months and has registered as a job-seeker with the relevant employment office. In this case, the status of worker shall be retained for no less than six months; (d) he/she embarks on vocational training. Unless he/she is involuntarily unemployed, the retention of the status of worker shall require the training to be related to the previous employment. 4. By way of derogation from paragraphs 1(d) and 2 above, only the spouse, the registered partner provided for in Article 2(2)(b) and dependent children shall have the right of residence as family members of a Union citizen meeting the conditions under 1(c) above. Article 3(2) shall apply to his/her dependent direct relatives in the ascending lines and those of his/her spouse or registered partner. Article 8 Administrative formalities for Union citizens 1. Without prejudice to Article 5(5), for periods of residence longer than three months, the host Member State may require Union citizens to register with the relevant authorities. 2. The deadline for registration may not be less than three months from the date of arrival. A registration certificate shall be issued immediately, stating the name and address of the person registering and the date of the registration. Failure to comply with the registration requirement may render the person concerned liable to proportionate and non-discriminatory sanctions. 3. For the registration certificate to be issued, Member States may only require that — Union citizens to whom point (a) of Article 7(1) applies present a valid identity card or passport, a confirmation of engagement from the employer or a certificate of employment, or proof that they are self-employed persons; — Union citizens to whom point (b) of Article 7(1) applies present a valid identity card or passport and provide proof that they satisfy the conditions laid down therein; — Union citizens to whom point (c) of Article 7(1) applies present a valid identity card or passport, provide proof of enrolment at an accredited establishment and of comprehensive sickness insurance cover and the declaration or equivalent means referred to in point (c) of Article 7(1). Member States may not require this declaration to refer to any specific amount of resources. 4. Member States may not lay down a fixed amount which they regard as "sufficient resources" but they must take into account the personal situation of the person concerned. In all cases this amount shall not be higher than the threshold below which nationals of the host Member State become eligible for social assistance, or, where this criterion is not applicable, higher than the minimum social security pension paid by the host Member State. 5. For the registration certificate to be issued to family members of Union citizens, who are themselves Union citizens, Member States may require the following documents to be presented: (a) a valid identity card or passport; (b) a document attesting to the existence of a family relationship or of a registered partnership; (c) where appropriate, the registration certificate of the Union citizen whom they are accompanying or joining; (d) in cases falling under points (c) and (d) of Article 2(2), documentary evidence that the conditions laid down therein are met; (e) in cases falling under Article 3(2)(a), a document issued by the relevant authority in the country of origin or country from which they are arriving certifying that they are dependants or members of the household of the Union citizen, or proof of the existence of serious health grounds which strictly require the personal care of the family member by the Union citizen; (f) in cases falling under Article 3(2)(b), proof of the existence of a durable relationship with the Union citizen. Article 9 Administrative formalities for family members who are not nationals of a Member State 1. Member States shall issue a residence card to family members of a Union citizen who are not nationals of a Member State, where the planned period of residence is for more than three months. 2. The deadline for submitting the residence card application may not be less than three months from the date of arrival. 3. Failure to comply with the requirement to apply for a residence card may make the person concerned liable to proportionate and non-discriminatory sanctions. Article 10 Issue of residence cards 1. The right of residence of family members of a Union citizen who are not nationals of a Member State shall be evidenced by the issuing of a document called "Residence card of a family member of a Union citizen" no later than six months from the date on which they submit the application. A certificate of application for the residence card shall be issued immediately. 2. For the residence card to be issued, Member States shall require presentation of the following documents: (a) a valid passport; (b) a document attesting to the existence of a family relationship or of a registered partnership; (c) the registration certificate or, in the absence of a registration system, any other proof of residence in the host Member State of the Union citizen whom they are accompanying or joining; (d) in cases falling under points (c) and (d) of Article 2(2), documentary evidence that the conditions laid down therein are met; (e) in cases falling under Article 3(2)(a), a document issued by the relevant authority in the country of origin or country from which they are arriving certifying that they are dependants or members of the household of the Union citizen, or proof of the existence of serious health grounds which strictly require the personal care of the family member by the Union citizen; (f) in cases falling under Article 3(2)(b), proof of the existence of a durable relationship with the Union citizen. Article 11 Validity of the residence card 1. The residence card provided for by Article 10(1) shall be valid for five years from the date of issue or for the envisaged period of residence of the Union citizen, if this period is less than five years. 2. The validity of the residence card shall not be affected by temporary absences not exceeding six months a year, or by absences of a longer duration for compulsory military service or by one absence of a maximum of twelve consecutive months for important reasons such as pregnancy and childbirth, serious illness, study or vocational training, or a posting in another Member State or a third country. Article 12 Retention of the right of residence by family members in the event of death or departure of the Union citizen 1. Without prejudice to the second subparagraph, the Union citizen's death or departure from the host Member State shall not affect the right of residence of his/her family members who are nationals of a Member State. Before acquiring the right of permanent residence, the persons concerned must meet the conditions laid down in points (a), (b), (c) or (d) of Article 7(1). 2. Without prejudice to the second subparagraph, the Union citizen's death shall not entail loss of the right of residence of his/her family members who are not nationals of a Member State and who have been residing in the host Member State as family members for at least one year before the Union citizen's death. Before acquiring the right of permanent residence, the right of residence of the persons concerned shall remain subject to the requirement that they are able to show that they are workers or self-employed persons or that they have sufficient resources for themselves and their family members not to become a burden on the social assistance system of the host Member State during their period of residence and have comprehensive sickness insurance cover in the host Member State, or that they are members of the family, already constituted in the host Member State, of a person satisfying these requirements. "Sufficient resources" shall be as defined in Article 8(4). Such family members shall retain their right of residence exclusively on a personal basis. 3. The Union citizen's departure from the host Member State or his/her death shall not entail loss of the right of residence of his/her children or of the parent who has actual custody of the children, irrespective of nationality, if the children reside in the host Member State and are enrolled at an educational establishment, for the purpose of studying there, until the completion of their studies. Article 13 Retention of the right of residence by family members in the event of divorce, annulment of marriage or termination of registered partnership 1. Without prejudice to the second subparagraph, divorce, annulment of the Union citizen's marriage or termination of his/her registered partnership, as referred to in point 2(b) of Article 2 shall not affect the right of residence of his/her family members who are nationals of a Member State. Before acquiring the right of permanent residence, the persons concerned must meet the conditions laid down in points (a), (b), (c) or (d) of Article 7(1). 2. Without prejudice to the second subparagraph, divorce, annulment of marriage or termination of the registered partnership referred to in point 2(b) of Article 2 shall not entail loss of the right of residence of a Union citizen's family members who are not nationals of a Member State where: (a) prior to initiation of the divorce or annulment proceedings or termination of the registered partnership referred to in point 2(b) of Article 2, the marriage or registered partnership has lasted at least three years, including one year in the host Member State; or (b) by agreement between the spouses or the partners referred to in point 2(b) of Article 2 or by court order, the spouse or partner who is not a national of a Member State has custody of the Union citizen's children; or (c) this is warranted by particularly difficult circumstances, such as having been a victim of domestic violence while the marriage or registered partnership was subsisting; or (d) by agreement between the spouses or partners referred to in point 2(b) of Article 2 or by court order, the spouse or partner who is not a national of a Member State has the right of access to a minor child, provided that the court has ruled that such access must be in the host Member State, and for as long as is required. Before acquiring the right of permanent residence, the right of residence of the persons concerned shall remain subject to the requirement that they are able to show that they are workers or self-employed persons or that they have sufficient resources for themselves and their family members not to become a burden on the social assistance system of the host Member State during their period of residence and have comprehensive sickness insurance cover in the host Member State, or that they are members of the family, already constituted in the host Member State, of a person satisfying these requirements. "Sufficient resources" shall be as defined in Article 8(4). Such family members shall retain their right of residence exclusively on personal basis. Article 14 Retention of the right of residence 1. Union citizens and their family members shall have the right of residence provided for in Article 6, as long as they do not become an unreasonable burden on the social assistance system of the host Member State. 2. Union citizens and their family members shall have the right of residence provided for in Articles 7, 12 and 13 as long as they meet the conditions set out therein. In specific cases where there is a reasonable doubt as to whether a Union citizen or his/her family members satisfies the conditions set out in Articles 7,12 and 13, Member States may verify if these conditions are fulfilled. This verification shall not be carried out systematically. 3. An expulsion measure shall not be the automatic consequence of a Union citizen's or his or her family member's recourse to the social assistance system of the host Member State. 4. By way of derogation from paragraphs 1 and 2 and without prejudice to the provisions of Chapter VI, an expulsion measure may in no case be adopted against Union citizens or their family members if: (a) the Union citizens are workers or self-employed persons, or (b) the Union citizens entered the territory of the host Member State in order to seek employment. In this case, the Union citizens and their family members may not be expelled for as long as the Union citizens can provide evidence that they are continuing to seek employment and that they have a genuine chance of being engaged. Article 15 Procedural safeguards 1. The procedures provided for by Articles 30 and 31 shall apply by analogy to all decisions restricting free movement of Union citizens and their family members on grounds other than public policy, public security or public health. 2. Expiry of the identity card or passport on the basis of which the person concerned entered the host Member State and was issued with a registration certificate or residence card shall not constitute a ground for expulsion from the host Member State. 3. The host Member State may not impose a ban on entry in the context of an expulsion decision to which paragraph 1 applies. CHAPTER IV Right of permanent residence Section I Eligibility Article 16 General rule for Union citizens and their family members 1. Union citizens who have resided legally for a continuous period of five years in the host Member State shall have the right of permanent residence there. This right shall not be subject to the conditions provided for in Chapter III. 2. Paragraph 1 shall apply also to family members who are not nationals of a Member State and have legally resided with the Union citizen in the host Member State for a continuous period of five years. 3. Continuity of residence shall not be affected by temporary absences not exceeding a total of six months a year, or by absences of a longer duration for compulsory military service, or by one absence of a maximum of twelve consecutive months for important reasons such as pregnancy and childbirth, serious illness, study or vocational training, or a posting in another Member State or a third country. 4. Once acquired, the right of permanent residence shall be lost only through absence from the host Member State for a period exceeding two consecutive years. Article 17 Exemptions for persons no longer working in the host Member State and their family members 1. By way of derogation from Article 16, the right of permanent residence in the host Member State shall be enjoyed before completion of a continuous period of five years of residence by: (a) workers or self-employed persons who, at the time they stop working, have reached the age laid down by the law of that Member State for entitlement to an old age pension or workers who cease paid employment to take early retirement, provided that they have been working in that Member State for at least the preceding twelve months and have resided there continuously for more than three years. If the law of the host Member State does not grant the right to an old age pension to certain categories of self-employed persons, the age condition shall be deemed to have been met once the person concerned has reached the age of 60; (b) workers or self-employed persons who have resided continuously in the host Member State for more than two years and stop working there as a result of permanent incapacity to work. If such incapacity is the result of an accident at work or an occupational disease entitling the person concerned to a benefit payable in full or in part by an institution in the host Member State, no condition shall be imposed as to length of residence; (c) workers or self-employed persons who, after three years of continuous employment and residence in the host Member State, work in an employed or self-employed capacity in another Member State, while retaining their place of residence in the host Member State, to which they return, as a rule, each day or at least once a week. For the purposes of entitlement to the rights referred to in points (a) and (b), periods of employment spent in the Member State in which the person concerned is working shall be regarded as having been spent in the host Member State. Periods of involuntary unemployment duly recorded by the relevant employment office, periods not worked for reasons not of the person's own making and absences from work or cessation of work due to illness or accident shall be regarded as periods of employment. 2. The conditions as to length of residence and employment laid down in point (a) of paragraph 1 and the condition as to length of residence laid down in point (b) of paragraph 1 shall not apply if the worker's or the self-employed person's spouse or partner as referred to in point 2(b) of Article 2 is a national of the host Member State or has lost the nationality of that Member State by marriage to that worker or self-employed person. 3. Irrespective of nationality, the family members of a worker or a self-employed person who are residing with him in the territory of the host Member State shall have the right of permanent residence in that Member State, if the worker or self-employed person has acquired himself the right of permanent residence in that Member State on the basis of paragraph 1. 4. If, however, the worker or self-employed person dies while still working but before acquiring permanent residence status in the host Member State on the basis of paragraph 1, his family members who are residing with him in the host Member State shall acquire the right of permanent residence there, on condition that: (a) the worker or self-employed person had, at the time of death, resided continuously on the territory of that Member State for two years; or (b) the death resulted from an accident at work or an occupational disease; or (c) the surviving spouse lost the nationality of that Member State following marriage to the worker or self-employed person. Article 18 Acquisition of the right of permanent residence by certain family members who are not nationals of a Member State Without prejudice to Article 17, the family members of a Union citizen to whom Articles 12(2) and 13(2) apply, who satisfy the conditions laid down therein, shall acquire the right of permanent residence after residing legally for a period of five consecutive years in the host Member State. Section II Administrative formalities Article 19 Document certifying permanent residence for Union citizens 1. Upon application Member States shall issue Union citizens entitled to permanent residence, after having verified duration of residence, with a document certifying permanent residence. 2. The document certifying permanent residence shall be issued as soon as possible. Article 20 Permanent residence card for family members who are not nationals of a Member State 1. Member States shall issue family members who are not nationals of a Member State entitled to permanent residence with a permanent residence card within six months of the submission of the application. The permanent residence card shall be renewable automatically every ten years. 2. The application for a permanent residence card shall be submitted before the residence card expires. Failure to comply with the requirement to apply for a permanent residence card may render the person concerned liable to proportionate and non-discriminatory sanctions. 3. Interruption in residence not exceeding two consecutive years shall not affect the validity of the permanent residence card. Article 21 Continuity of residence For the purposes of this Directive, continuity of residence may be attested by any means of proof in use in the host Member State. Continuity of residence is broken by any expulsion decision duly enforced against the person concerned. CHAPTER V Provisions common to the right of residence and the right of permanent residence Article 22 Territorial scope The right of residence and the right of permanent residence shall cover the whole territory of the host Member State. Member States may impose territorial restrictions on the right of residence and the right of permanent residence only where the same restrictions apply to their-own nationals. Article 23 Related rights Irrespective of nationality, the family members of a Union citizen who have the right of residence or the right of permanent residence in a Member State shall be entitled to take up employment or self-employment there. Article 24 Equal treatment 1. Subject to such specific provisions as are expressly provided for in the Treaty and secondary law, all Union citizens residing on the basis of this Directive in the territory of the host Member State shall enjoy equal treatment with the nationals of that Member State within the scope of the Treaty. The benefit of this right shall be extended to family members who are not nationals of a Member State and who have the right of residence or permanent residence. 2. By way of derogation from paragraph 1, the host Member State shall not be obliged to confer entitlement to social assistance during the first three months of residence or, where appropriate, the longer period provided for in Article 14(4)(b), nor shall it be obliged, prior to acquisition of the right of permanent residence, to grant maintenance aid for studies, including vocational training, consisting in student grants or student loans to persons other than workers, self-employed persons, persons who retain such status and members of their families. Article 25 General provisions concerning residence documents 1. Possession of a registration certificate as referred to in Article 8, of a document certifying permanent residence, of a certificate attesting submission of an application for a family member residence card, of a residence card or of a permanent residence card, may under no circumstances be made a precondition for the exercise of a right or the completion of an administrative formality, as entitlement to rights may be attested by any other means of proof. 2. All documents mentioned in paragraph 1 shall be issued free of charge or for a charge not exceeding that imposed on nationals for the issuing of similar documents. Article 26 Checks Member States may carry out checks on compliance with any requirement deriving from their national legislation for non-nationals always to carry their registration certificate or residence card, provided that the same requirement applies to their own nationals as regards their identity card. In the event of failure to comply with this requirement, Member States may impose the same sanctions as those imposed on their own nationals for failure to carry their identity card. CHAPTER VI Restrictions on the right of entry and the right of residence on grounds of public policy, public security or public health Article 27 General principles 1. Subject to the provisions of this Chapter, Member States may restrict the freedom of movement and residence of Union citizens and their family members, irrespective of nationality, on grounds of public policy, public security or public health. These grounds shall not be invoked to serve economic ends. 2. Measures taken on grounds of public policy or public security shall comply with the principle of proportionality and shall be based exclusively on the personal conduct of the individual concerned. Previous criminal convictions shall not in themselves constitute grounds for taking such measures. The personal conduct of the individual concerned must represent a genuine, present and sufficiently serious threat affecting one of the fundamental interests of society. Justifications that are isolated from the particulars of the case or that rely on considerations of general prevention shall not be accepted. 3. In order to ascertain whether the person concerned represents a danger for public policy or public security, when issuing the registration certificate or, in the absence of a registration system, not later than three months from the date of arrival of the person concerned on its territory or from the date of reporting his/her presence within the territory, as provided for in Article 5(5), or when issuing the residence card, the host Member State may, should it consider this essential, request the Member State of origin and, if need be, other Member States to provide information concerning any previous police record the person concerned may have. Such enquiries shall not be made as a matter of routine. The Member State consulted shall give its reply within two months. 4. The Member State which issued the passport or identity card shall allow the holder of the document who has been expelled on grounds of public policy, public security, or public health from another Member State to re-enter its territory without any formality even if the document is no longer valid or the nationality of the holder is in dispute. Article 28 Protection against expulsion 1. Before taking an expulsion decision on grounds of public policy or public security, the host Member State shall take account of considerations such as how long the individual concerned has resided on its territory, his/her age, state of health, family and economic situation, social and cultural integration into the host Member State and the extent of his/her links with the country of origin. 2. The host Member State may not take an expulsion decision against Union citizens or their family members, irrespective of nationality, who have the right of permanent residence on its territory, except on serious grounds of public policy or public security. 3. An expulsion decision may not be taken against Union citizens, except if the decision is based on imperative grounds of public security, as defined by Member States, if they: (a) have resided in the host Member State for the previous ten years; or (b) are a minor, except if the expulsion is necessary for the best interests of the child, as provided for in the United Nations Convention on the Rights of the Child of 20 November 1989. Article 29 Public health 1. The only diseases justifying measures restricting freedom of movement shall be the diseases with epidemic potential as defined by the relevant instruments of the World Health Organisation and other infectious diseases or contagious parasitic diseases if they are the subject of protection provisions applying to nationals of the host Member State. 2. Diseases occurring after a three-month period from the date of arrival shall not constitute grounds for expulsion from the territory. 3. Where there are serious indications that it is necessary, Member States may, within three months of the date of arrival, require persons entitled to the right of residence to undergo, free of charge, a medical examination to certify that they are not suffering from any of the conditions referred to in paragraph 1. Such medical examinations may not be required as a matter of routine. Article 30 Notification of decisions 1. The persons concerned shall be notified in writing of any decision taken under Article 27(1), in such a way that they are able to comprehend its content and the implications for them. 2. The persons concerned shall be informed, precisely and in full, of the public policy, public security or public health grounds on which the decision taken in their case is based, unless this is contrary to the interests of State security. 3. The notification shall specify the court or administrative authority with which the person concerned may lodge an appeal, the time limit for the appeal and, where applicable, the time allowed for the person to leave the territory of the Member State. Save in duly substantiated cases of urgency, the time allowed to leave the territory shall be not less than one month from the date of notification. Article 31 Procedural safeguards 1. The persons concerned shall have access to judicial and, where appropriate, administrative redress procedures in the host Member State to appeal against or seek review of any decision taken against them on the grounds of public policy, public security or public health. 2. Where the application for appeal against or judicial review of the expulsion decision is accompanied by an application for an interim order to suspend enforcement of that decision, actual removal from the territory may not take place until such time as the decision on the interim order has been taken, except: — where the expulsion decision is based on a previous judicial decision; or — where the persons concerned have had previous access to judicial review; or — where the expulsion decision is based on imperative grounds of public security under Article 28(3). 3. The redress procedures shall allow for an examination of the legality of the decision, as well as of the facts and circumstances on which the proposed measure is based. They shall ensure that the decision is not disproportionate, particularly in view of the requirements laid down in Article 28. 4. Member States may exclude the individual concerned from their territory pending the redress procedure, but they may not prevent the individual from submitting his/her defence in person, except when his/her appearance may cause serious troubles to public policy or public security or when the appeal or judicial review concerns a denial of entry to the territory. Article 32 Duration of exclusion orders 1. Persons excluded on grounds of public policy or public security may submit an application for lifting of the exclusion order after a reasonable period, depending on the circumstances, and in any event after three years from enforcement of the final exclusion order which has been validly adopted in accordance with Community law, by putting forward arguments to establish that there has been a material change in the circumstances which justified the decision ordering their exclusion. The Member State concerned shall reach a decision on this application within six months of its submission. 2. The persons referred to in paragraph 1 shall have no right of entry to the territory of the Member State concerned while their application is being considered. Article 33 Expulsion as a penalty or legal consequence 1. Expulsion orders may not be issued by the host Member State as a penalty or legal consequence of a custodial penalty, unless they conform to the requirements of Articles 27, 28 and 29. 2. If an expulsion order, as provided for in paragraph 1, is enforced more than two years after it was issued, the Member State shall check that the individual concerned is currently and genuinely a threat to public policy or public security and shall assess whether there has been any material change in the circumstances since the expulsion order was issued. CHAPTER VII Final provisions Article 34 Publicity Member States shall disseminate information concerning the rights and obligations of Union citizens and their family members on the subjects covered by this Directive, particularly by means of awareness-raising campaigns conducted through national and local media and other means of communication. Article 35 Abuse of rights Member States may adopt the necessary measures to refuse, terminate or withdraw any right conferred by this Directive in the case of abuse of rights or fraud, such as marriages of convenience. Any such measure shall be proportionate and subject to the procedural safeguards provided for in Articles 30 and 31. Article 36 Sanctions Member States shall lay down provisions on the sanctions applicable to breaches of national rules adopted for the implementation of this Directive and shall take the measures required for their application. The sanctions laid down shall be effective and proportionate. Member States shall notify the Commission of these provisions not later than (15) and as promptly as possible in the case of any subsequent changes. Article 37 More favourable national provisions The provisions of this Directive shall not affect any laws, regulations or administrative provisions laid down by a Member State which would be more favourable to the persons covered by this Directive. Article 38 Repeals 1. Articles 10 and 11 of Regulation (EEC) No 1612/68 shall be repealed with effect from ... (15). 2. Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC shall be repealed with effect from (15). 3. References made to the repealed provisions and Directives shall be construed as being made to this Directive. Article 39 Report No later than (16) the Commission shall submit a report on the application of this Directive to the European Parliament and the Council, together with any necessary proposals, notably on the opportunity to extend the period of time during which Union citizens and their family members may reside in the territory of the host Member State without any conditions. The Member States shall provide the Commission with the information needed to produce the report. Article 40 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by (17). When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the 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 together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 41 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 42 Addressees This Directive is addressed to the Member States.

32004L0054

2004

DIRECTIVE 2004/54/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on minimum safety requirements for tunnels in the Trans-European Road Network Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Having regard to the Opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) In its White Paper of 12 September 2001 on "European transport policy for 2010: time to decide" the Commission announced that it would propose minimum safety requirements for tunnels belonging to the Trans-European Road Network. (2) The transport system, notably the Trans-European Road Network defined in Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community guidelines for the development of the trans-European transport network (4), is of paramount importance in supporting European integration and ensuring a high level of well-being among Europe's citizens. The European Community has the responsibility of guaranteeing a high, uniform and constant level of security, service and comfort on the Trans-European Road Network. (3) Long tunnels of over 500 m in length are important structures which facilitate communication between large areas of Europe and play a decisive role in the functioning and development of regional economies. (4) The European Council has on several occasions, and notably at its meeting on 14 and 15 December 2001 in Laeken, underlined the urgency of taking measures to improve tunnel safety. (5) On 30 November 2001, the Transport Ministers of Austria, France, Germany, Italy and Switzerland met in Zurich and adopted a Common Declaration recommending the alignment of national legislations on the most recent harmonised requirements for improving safety in long tunnels. (6) Since the objective of the proposed action, namely the achievement of a uniform, constant and high level of protection for all European citizens in road tunnels, cannot be sufficiently achieved by the Member States and can therefore, by reason of the level of harmonisation required, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (7) Recent accidents in tunnels emphasise their importance in human, economic and cultural terms. (8) Some tunnels in Europe, put into operation a long time ago, were designed at a time when technical possibilities and transport conditions were very different from those of today. There are thus disparate safety levels and this must be rectified. (9) Safety in tunnels requires a number of measures relating, amongst other things, to the geometry of the tunnel and its design, safety equipment, including road signs, traffic management, training of the emergency services, incident management, the provision of information to users on how best to behave in tunnels, and better communication between the authorities in charge and emergency services such as the police, fire-brigades and rescue teams. (10) As the work of the United Nations Economic Commission for Europe (UNECE) has already made clear, the conduct of road users is a decisive aspect of tunnel safety. (11) Safety measures should enable people involved in incidents to rescue themselves, allow road users to act immediately so as to prevent more serious consequences, ensure that emergency services can act effectively and protect the environment as well as limit material damage. (12) The improvements brought about by this Directive will improve safety conditions for all users, including disabled persons. However, as disabled persons have more difficulty in escaping in an emergency, particular consideration should be given to their safety. (13) In order to implement a balanced approach and due to the high cost of the measures, minimum safety equipment should be defined taking into account the type and the expected traffic volume of each tunnel. (14) International bodies such as the World Road Association and the UNECE have for a long time been making invaluable recommendations to help improve and harmonise safety equipment and traffic rules in road tunnels. However, as these recommendations are not binding, their full potential can only be maximised if the requirements they identify are made mandatory through legislation. (15) Maintaining a high safety level requires proper maintenance of the safety facilities in tunnels. An exchange of information on modern safety techniques and accident/incident data between the Member States should be systematically organised. (16) In order to ensure that the requirements of this Directive are properly applied by Tunnel Managers, Member States should designate one or more authorities at national, regional or local level with responsibility for ensuring that all aspects of tunnel safety are assured. (17) A flexible and progressive timetable is needed for implementation of this Directive. This will allow for completion of the most urgent works without creating major disturbances in the transport system or bottlenecks in public works in the Member States. (18) The cost of refurbishing existing tunnels varies considerably from one Member State to another, particularly for geographical reasons, and Member States should be allowed to stagger any refurbishment works needed to meet the requirements of this Directive where the density of tunnels on their territory is well in excess of the European average. (19) For tunnels already in operation or tunnels whose design has been approved but which have not been opened to the public within 24 months following the entry into force of this Directive, Member States should be allowed to accept the adoption of risk reduction measures as an alternative to application of the requirements of the Directive, where the tunnel does not allow for structural solutions to be implemented at reasonable cost. (20) Further technical progress is still necessary to improve tunnel safety. A procedure should be introduced to allow the Commission to adapt the requirements of this Directive to technical progress. That procedure should also be used to adopt a harmonised risk analysis method. (21) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (22) Member States should submit a report to the Commission on the measures they plan to adopt to meet the requirements of this Directive, with a view to synchronising works at Community level in order to reduce traffic disturbances, (23) Where the requirements of this Directive necessitate the construction of a second tube for a tunnel in the design or construction phase, this second tube to be constructed should be considered as a new tunnel. The same applies if the requirements of this Directive necessitate the opening of new legally binding planning procedures, including planning permission hearings for all related measures. (24) Work should continue in the appropriate fora in order to arrive at a large degree of harmonisation as regards the signs and pictogrammes used on variable message signs in tunnels. Member States should be encouraged to harmonise the user interface for all tunnels on their territory. (25) Member States should be encouraged to implement comparable safety levels for road tunnels located in their territory that do not form part of the Trans-European Road Network and consequently do not fall within the scope of this Directive. (26) Member States should be encouraged to develop national provisions aiming at a higher tunnel safety level, Article 1 Subject matter and scope 1. This Directive aims at ensuring a minimum level of safety for road users in tunnels in the Trans-European Road Network by the prevention of critical events that may endanger human life, the environment and tunnel installations, as well as by the provision of protection in case of accidents. 2. It shall apply to all tunnels in the Trans-European Road Network with lengths of over 500 m, whether they are in operation, under construction or at the design stage. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1) "Trans-European Road Network" means the road network identified in Section 2 of Annex I to Decision No 1692/96/EC and illustrated by maps and/or described in Annex II to that Decision. 2) "Emergency services" means all local services, whether public or private or part of the tunnel staff, which intervene in the event of an accident, including police services, fire brigades and rescue teams. 3) "Tunnel length" means the length of the longest traffic lane, measured on the fully enclosed part of the tunnel. Article 3 Safety Measures 1. Member States shall ensure that tunnels in their territory, falling within the scope of this Directive meet the minimum safety requirements laid down in Annex I. 2. Where certain structural requirements laid down in Annex I can only be satisfied through technical solutions which either cannot be achieved or can be achieved only at disproportionate cost, the Administrative Authority as referred to in Article 4 may accept the implementation of risk reduction measures as an alternative to application of those requirements, provided that the alternative measures will result in equivalent or improved protection. The efficiency of these measures shall be demonstrated through a risk analysis in conformity with the provisions of Article 13. Member States shall inform the Commission of the risk reduction measures accepted as an alternative and provide justification therefor. This paragraph shall not apply to runnels at the design stage as referred to in Article 9. 3. Member States may specify stricter requirements, provided that they do not contravene the requirements of this Directive. Article 4 Administrative Authority 1. Member States shall designate (an) administrative authority(ies), hereinafter referred to as "the Administrative Authority", which shall have responsibility for ensuring that all aspects of the safety of a tunnel are assured and which shall take the necessary steps to ensure compliance with this Directive. 2. The Administrative Authority may be set up at national, regional or local level. 3. Each tunnel in the Trans-European Road Network located on the territory of a single Member State shall fall under the responsibility of a single Administrative Authority. For each tunnel located on the territory of two Member States, each Member State shall designate an Administrative Authority or, alternatively, the two Member States shall designate a joint Administrative Authority. If there are two different Administrative Authorities, the decisions of either taken in the exercise of its respective competencies and responsibilities with regard to tunnel safety shall be adopted with the prior agreement of the other Authority. 4. The Administrative Authority shall commission tunnels in accordance with the procedure laid down in Annex II. 5. Without prejudice to further arrangements on this subject at national level, the Administrative Authority shall have power to suspend or restrict the operation of a tunnel if safety requirements are not met. It shall specify the conditions under which normal traffic may be resumed. 6. The Administrative Authority shall ensure that the following tasks are performed: (a) testing and inspecting tunnels on a regular basis and drawing up safety requirements pertaining thereto; (b) putting in place organisational and operational schemes (including emergency response plans) for the training and equipping of emergency services; (c) defining the procedure for immediate closure of a tunnel in an emergency; (d) implementing the necessary risk reduction measures. 7. Where bodies designated as Administrative Authorities existed prior to the designation referred to in this Article, those Administrative Authorities may continue their previous activities provided that they comply with this Directive. Article 5 Tunnel Manager 1. For each tunnel located on the territory of one Member State, whether it is in the design, construction or operating stage, the Administrative Authority shall identify as Tunnel Manager the public or private body responsible for the management of the tunnel at the stage in question. The Administrative Authority itself may perform this function. 2. For each tunnel located on the territory of two Member States, the two Administrative Authorities or the joint Administrative Authority shall recognise only one body in charge of the operation of the tunnel. 3. Any significant incident or accident occurring in a tunnel shall be the subject of an incident report prepared by the Tunnel Manager. This report shall be forwarded to the Safety Officer referred to in Article 6, to the Administrative Authority and to the emergency services within a maximum period of one month. 4. Where an investigation report is drawn up analysing the circumstances of the incident or accident referred to in paragraph 3 or the conclusions that can be drawn from it, the Tunnel Manager shall forward this report to the Safety Officer, the Administrative Authority and the emergency services no later than one month after he receives it himself. Article 6 Safety Officer 1. For each tunnel, the Tunnel Manager shall, with the prior approval of the Administrative Authority, nominate one Safety Officer who shall coordinate all preventive and safeguards measures to ensure the safety of users and operational staff. The Safety Officer may be a member of the tunnel staff or the emergency services, shall be independent in all road tunnel safety issues and shall not be under instructions from an employer in respect of those issues. A Safety Officer may perform his tasks and functions at several tunnels in a region. 2. The Safety Officer shall perform the following tasks/functions: (a) ensure coordination with emergency services and take part in the preparation of operational schemes; (b) take part in the planning, implementation and evaluation of emergency operations; (c) take part in the definition of safety schemes and the specification of the structure, equipment and operation in respect of both new tunnels and modifications to existing tunnels; (d) verify that operational staff and emergency services are trained, and he shall take part in the organisation of exercises held at regular intervals; (e) give advice on the commissioning of the structure, equipment and operation of tunnels; (f) verify that the tunnel structure and equipment are maintained and repaired; (g) take part in the evaluation of any significant incident or accident as referred to in Article 5(3) and (4). Article 7 Inspection Entity Member States shall ensure that inspections, evaluations and tests are carried out by Inspection Entities. The Administrative Authority may perform this function. Any entity performing the inspections, evaluations and tests must have a high level of competence and high quality procedures and must be functionally independent from the Tunnel Manager. Article 8 Notification of the Administrative Authority The Member States shall notify the Commission of the name and address of the Administrative Authority by ... (6). In the event of a change in this information they shall notify the Commission thereof within three months. Article 9 Tunnels whose design has not yet been approved 1. Any runnel whose design has not been approved by the responsible authority by [...] (7) shall be subject to the requirements of this Directive. 2. The tunnel shall be commissioned in accordance with the procedure laid down in Annex II. Article 10 Tunnels whose design has been approved but which are not yet open 1. In the case of tunnels whose design has been approved but which have not been opened to public traffic by [...] (7), the Administrative Authority shall assess their compliance with the requirements of this Directive, with specific reference to the safety documentation provided for in Annex II. 2. Where the Administrative Authority finds that a tunnel does not comply with the provisions of this Directive, it shall notify the Tunnel Manager that appropriate measures must be taken to increase safety and shall inform the Safety Officer. 3. The tunnel shall then be commissioned in accordance with the procedure laid down in Annex II. Article 11 Tunnels already in operation 1. In the case of tunnels which are already open to public traffic by [...] (8), the Administrative Authority shall have until [...] (9) to assess their compliance with the requirements of this Directive, with specific reference to the safety documentation provided for in Annex II and on the basis of an inspection. 2. The Tunnel Manager shall, if necessary, propose to the Administrative Authority a plan for adapting the tunnel to the provisions of this Directive and the remedial measures he intends to put in place. 3. The Administrative Authority shall give its approval to the remedial measures or ask for them to be modified. 4. Thereafter, if the remedial measures include any substantial modification in the construction or operation, then once these measures have been taken, the procedure laid down in Annex II shall be implemented. 5. Member States shall by (10) submit a report to the Commission on how they plan to meet the requirements of this Directive, on planned measures, and, where appropriate, on the consequences of opening or closing the main access roads to the tunnels. In order to minimise disturbances to traffic at European level, the Commission may comment on the timetable of the work intended to ensure that tunnels comply with the requirements of this Directive. 6. The refurbishment of tunnels shall be carried out according to a schedule and shall be finished by [...] (11). 7. Where the total tube length of existing tunnels divided by the total length of the part of the Trans-European Road Network located on their territory exceeds the European average, Members States may extend the period stipulated in paragraph 6 by five years. Article 12 Periodic inspections 1. The Administrative Authority shall verify that regular inspections are carried out by the Inspection Entity to ensure that all tunnels falling within the scope of this Directive comply with its provisions. 2. The period between two consecutive inspections of any given tunnel shall not exceed six years. 3. Where, on the basis of the report of the Inspection Entity, the Administrative Authority finds that a tunnel does not comply with the provisions of this Directive, it shall notify the Tunnel Manager and the Safety Officer that measures to increase tunnel safety must be adopted. The Administrative Authority shall define the conditions for continuing to operate the tunnel or for re-opening the tunnel which will apply until the remedial measures and any further relevant restrictions or conditions are implemented. 4. If the remedial measures include any substantial modification in the tunnel's construction or operation, then once these measures have been taken, the tunnel shall be made the subject of a new authorisation to operate in accordance with the procedure laid down in Annex II. Article 13 Risk analysis 1. Risk analyses, where necessary, shall be carried out by a body which is functionally independent from the Tunnel Manager. The content and the results of the risk analysis shall be included in the safety documentation submitted to the Administrative Authority. A risk analysis is an analysis of risks for a given tunnel, taking into account all design factors and traffic conditions that affect safety, notably traffic characteristics and type, tunnel length and tunnel geometry, as well as the forecast number of heavy goods vehicles per day. 2. Member States shall ensure that, at national level, a detailed and well-defined methodology, corresponding to the best available practices, is used and shall inform the Commission of the methodology applied; the Commission shall make this information available in electronic form to other Member States. 3. By [...] (12) the Commission shall publish a report on the practice followed in the Members States. Where necessary, it shall make proposals for the adoption of a common harmonised risk analysis methodology in accordance with the procedure referred to in Article 17(2). Article 14 Derogation for innovative techniques 1. In order to allow the installation and use of innovative safety equipment or the use of innovative safety procedures which provide an equivalent or higher level of protection than current technologies, as prescribed in this Directive, the Administrative Authority may grant a derogation from the requirements of the Directive on the basis of a duly documented request from the Tunnel Manager. 2. If the Administrative Authority intends to grant such a derogation, the Member State shall first submit a derogation application to the Commission containing the initial request and the opinion of the Inspection Entity. 3. The Commission shall notify the application to the Member States within one month of receipt. 4. If, within a period of three months, neither the Commission nor a Member State formulates objections, the derogation shall be treated as granted and the Commission shall inform all Member States accordingly. 5. If objections are expressed, the Commission shall make a proposal in accordance with the procedure referred to in Article 17(2). Where the decision is negative, the Administrative Authority shall not grant the derogation. 6. After an examination in accordance with the procedure referred to in Article 17(2), a decision to grant a derogation may allow this derogation to be applied to other tunnels. 7. Whenever justified by the derogation requests submitted to it, the Commission shall publish a report on the practice followed in the Member States and, if necessary, make proposals for amendment of this Directive. Article 15 Reporting 1. Every two years, Member States shall compile reports on fires in tunnels and on accidents which clearly affect the safety of road users in tunnels, and on the frequency and causes of such incidents, and shall evaluate them and provide information on the actual role and effectiveness of safety facilities and measures. These reports shall be transmitted to the Commission by the Member States before the end of September of the year following the reporting period. The Commission shall make the reports available to all Member States. 2. Member States shall make a plan which includes a timetable for the gradual application of the provisions of this Directive to tunnels already in operation as described in Article 11 and notify it by [...] (13) to the Commission. Thereafter, Member States shall inform the Commission every two years of the state of implementation of the plan and of any changes made to it, until the end of the period referred to in Article 11(6) and (7). Article 16 Adaptation to technical progress The Commission shall adapt the Annexes to this Directive to technical progress, in accordance with the procedure referred to in Article 17(2). Article 17 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 18 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [...] (14). They shall immediately forward to the Commission the text of those provisions, together with a table correlating those provisions with this Directive. 2. The provisions adopted by the Member States shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 19 Entry into force This Directive shall enter into force on the date of its publication in the Official Journal of the European Union. Article 20 This Directive is addressed to the Member States.

32004L0049

2004

DIRECTIVE 2004/49/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001 /14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the Opinion of the European 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 251 of the Treaty (4), in the light of the joint text approved by the Conciliation Committee on 23 March 2004, Whereas: (1) In order to pursue efforts to establish a single market for rail transport services, initiated by Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways (5), it is necessary to establish a common regulatory framework for railway safety. Member States have until now developed their safety rules and standards mainly on national lines, based on national technical and operational concepts. Simultaneously, differences in principles, approach and culture have made it difficult to break through the technical barriers and establish international transport operations. (2) Directive 91/440/EEC, Council Directive 95/18/EC of 19 June 1995 on the licensing of railway undertakings (6) and Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (7) provide the first steps towards regulation of the European rail transport market by opening the market for international rail freight services. However, the provisions on safety have proved to be insufficient and differences between safety requirements remain, which affect the optimum functioning of rail transport in the Community. It is of particular importance to harmonise the content of safety rules, safety certification of railway undertakings, the tasks and roles of the safety authorities and the investigation of accidents. (3) Metros, trams and other light rail systems are in many Member States subject to local or regional safety rules and are often supervised by local or regional authorities and not covered by the requirements on Community interoperability or licensing. Trams are furthermore often subject to road safety legislation and could therefore not be fully covered by railway safety rules. For these reasons and in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty, Member States should be allowed to exclude such local rail systems from the scope of this Directive. (4) Safety levels in the Community rail system are generally high, in particular compared to road transport. It is important that safety is at the very least maintained during the current restructuring phase, which will separate functions of previously integrated railway companies and move the railway sector further from self-regulation to public regulation. In line with technical and scientific progress, safety should be further improved, when reasonably practicable and taking into account the competitiveness of the rail transport mode. (5) All those operating the railway system, infrastructure managers and railway undertakings, should bear the full responsibility for the safety of the system, each for their own part. Whenever it is appropriate, they should cooperate in implementing risk control measures. Member States should make a clear distinction between this immediate responsibility for safety and the safety authorities' task of providing a national regulatory framework and supervising the performance of the operators. (6) The responsibility of infrastructure managers and railway undertakings for operating the railway system does not preclude other actors such as manufacturers, maintenance suppliers, wagon keepers, service providers and procurement entities from assuming responsibility for their products or services in accordance with the provisions of Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system (8) and of Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the trans-European conventional rail system (9) or of other relevant Community legislation. (7) Requirements on safety of the subsystems of the trans-European rail networks are laid down in Directive 96/48/EC and Directive 2001/16/EC. However, those Directives do not define common requirements at system level and do not deal in detail with the regulation, management and supervision of safety. When minimum safety levels of the subsystems are defined by technical specifications for interoperability (TSIs) it will be increasingly important to establish safety targets at the system level as well. (8) Common safety targets (CSTs) and common safety methods (CSMs) should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved. They should provide tools for assessment of the safety level and the performance of the operators at Community level as well as in the Member States. (9) Information on safety of the railway system is scarce and not generally publicly available. It is thus necessary to establish common safety indicators (CSIs) in order to assess that the system complies with the CSTs and to facilitate the monitoring of railway safety performance. However, national definitions relating to the CSIs may apply during a transitional period and due account should therefore be taken of the extent of the development of common definitions of the CSIs when the first set of CSTs is drafted. (10) National safety rules, which are often based on national technical standards, should gradually be replaced by rules based on common standards, established by TSIs. The introduction of new specific national rules which are not based on such common standards should be kept to a minimum. New national rules should be in line with Community legislation and facilitate migration towards a common approach to railway safety. All interested parties should therefore be consulted before a Member State adopts a national safety rule that requires a higher safety level than the CSTs. In such cases the new draft rule should be subject to examination by the Commission, which should adopt a Decision if it appears that the draft rule is not in conformity with Community legislation or constitutes a means of arbitrary discrimination or a disguised restriction on rail transport operation between Member States. (11) The current situation, in which national safety rules continue to play a role, should be regarded as a transitional stage, leading ultimately to a situation in which European rules will apply. (12) The development of CSTs, CSMs and CSIs as well as the need to facilitate progress towards a common approach to railway safety requires technical support at Community level. The European Railway Agency established by Regulation (EC) No /of the European Parliament and of the Council OJ L is set up to issue recommendations concerning CSTs, CSMs and CSIs and further harmonisation measures and to monitor the development of railway safety in the Community. (13) In carrying out their duties and fulfilling their responsibilities, infrastructure managers and railway undertakings should implement a safety management system, fulfilling Community requirements and containing common elements. Information on safety and the implementation of the safety management system should be submitted to the safety authority in the Member State concerned. (14) The safety management system should take into account the fact that Council Directive 89/391/EC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (10) and its relevant individual directives are fully applicable to the protection of the health and safety of workers engaged in railway transport. The safety management system should also take account of Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (11). (15) To ensure a high level of railway safety and equal conditions for all railway undertakings, they should be subject to the same safety requirements. The safety certificate should give evidence that the railway undertaking has established its safety management system and is able to comply with the relevant safety standards and rules. For international transport services it should be enough to approve the safety management system in one Member State and give the approval Community validity. Adherence to national rules on the other hand should be subject to additional certification in each Member State. The ultimate aim should be to establish a common safety certificate with Community validity. (16) In addition to the safety requirements laid down in the safety certificate, licensed railway undertakings must comply with national requirements, compatible with Community law and applied in a non-discriminatory manner, relating to health, safety and social conditions, including legal provisions relating to driving time, and the rights of workers and consumers as provided for in Articles 6 and 12 of Directive 95/18/EC. (17) Every infrastructure manager has a key responsibility for the safe design, maintenance and operation of its rail network. In parallel to safety certification of railway undertakings the infrastructure manager should be subject to safety authorisation by the safety authority concerning its safety management system and other provisions to meet safety requirements. (18) Member States should make efforts to assist applicants wishing to enter the market as railway undertakings. In particular they should provide information and act promptly on requests for safety certification. For railway undertakings operating international transport services, it is important for the procedures to be similar in different Member States. Although the safety certificate will contain national parts for the foreseeable future, it should nevertheless be possible to harmonise the common parts of it and facilitate the creation of a common template. (19) Certification of train staff and authorisation of placing in service of in-use rolling stock for the different national networks are often insurmountable barriers to new entrants. Member States should ensure that facilities for the training and certification of train staff necessary to meet requirements under national rules are available to railway undertakings applying for a safety certificate. A common procedure should be established for authorisation of placing in service of in-use rolling stock. (20) Driving times and rest periods for train drivers and train staff performing safety tasks have an important impact on the safety level of the rail system. These aspects fall under Articles 137 to 139 of the Treaty and are already subject to negotiations between the social partners under the Sectoral Dialogue Committee set up in accordance with Commission Decision 98/500/EC (12). (21) The development of a safe Community railway system requires the establishment of harmonised conditions for delivering the appropriate licences to train drivers and on-board accompanying staff performing safety tasks, for which the Commission has announced its intention to propose further legislation in the near future. As far as other staff charged with safety-critical tasks are concerned, their qualifications are already being specified under Directives 96/48/EC and 2001/16/EC. (22) As part of the new common regulatory framework for railway safety, national authorities should be set up in all Member States to regulate and supervise railway safety. To facilitate cooperation between them at Community level, they should be given the same minimum tasks and responsibilities. The national safety authorities should be granted a high degree of independence. They should carry out their tasks in an open and non-discriminatory way to help to create a single Community rail system and cooperate to coordinate their decision-making criteria, in particular concerning safety certification of railway undertakings operating international transport services. (23) Serious accidents on the railways are rare. However, they can have disastrous consequences and raise concern among the public about the safety performance of the railway system. All such accidents should, therefore, be investigated from a safety perspective to avoid recurrence and the results of the investigations should be made public. Other accidents and incidents could be significant precursors to serious accidents and should also be subject to safety investigations, when it is necessary. (24) A safety investigation should be kept separate from the judicial inquiry into the same incident and be granted access to evidence and witnesses. It should be carried out by a permanent body that is independent of the actors of the rail sector. The body should function in a way which avoids any conflict of interest and any possible involvement in the causes of the occurrences that are investigated; in particular, its functional independence should not be affected if it is closely linked to the national safety authority or regulator of railways for organisational and legal structure purposes. Its investigations should be carried out under as much openness as possible. For each occurrence the investigation body should establish the relevant investigation group with necessary expertise to find the immediate causes and underlying causes. (25) The reports on investigations and any findings and recommendations provide crucial information for the further improvement of railway safety and should be made publicly available at Community level. Safety recommendations should be acted upon by the addressees and actions reported back to the investigating body. (26) Since the objectives of the proposed action, namely to coordinate activities in the Member States to regulate and supervise safety and to investigate accidents and to establish at Community level common safety targets, common safety methods, common safety indicators and common requirements of safety certificates, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (27) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the Commission (13). (28) This Directive aims at reorganising and bringing together the relevant Community legislation on railway safety. Consequently, provisions for safety certification of railway undertakings that were previously set out in Directive 2001/14/EC should, together with all references to safety certification, be repealed. Directive 95/18/EC included requirements on safety qualifications of operational staff and on safety of rolling stock that are covered by the requirements on safety certification of this Directive and should therefore no longer be part of the licensing requirements. A licensed railway undertaking should hold a safety certificate in order to be granted access to the railway infrastructure. (29) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive, CHAPTER I INTRODUCTORY PROVISIONS Article 1 Purpose The purpose of this Directive is to ensure the development and improvement of safety on the Community's railways and improved access to the market for rail transport services by: (a) harmonising the regulatory structure in the Member States; (b) defining responsibilities between the actors; (c) developing common safety targets and common safety methods with a view to greater harmonisation of national rules; (d) requiring the establishment, in every Member State, of a safety authority and an accident and incident investigating body; (e) defining common principles for the management, regulation and supervision of railway safety. Article 2 Scope 1. This Directive applies to the railway system in the Member States, which may be broken down into subsystems for structural and operational areas. It covers safety requirements on the system as a whole, including the safe management of infrastructure and of traffic operation and the interaction between railway undertakings and infrastructure managers. 2. Member States may exclude from the measures they adopt in implementation of this Directive: (a) metros, trams and other light rail systems; (b) networks that are functionally separate from the rest of the railway system and intended only for the operation of local, urban or suburban passenger services, as well as railway undertakings operating solely on these networks; (c) privately owned railway infrastructure that exists solely for use by the infrastructure owner for its own freight operations. Article 3 Definitions For the purpose of this Directive, the following definitions shall apply: (a) "railway system" means the totality of the subsystems for structural and operational areas, as defined in Directives 96/48/EC and 2001/16/EC, as well as the management and operation of the system as a whole; (b) "infrastructure manager" means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings; (c) "railway undertaking" means railway undertaking as defined in Directive 2001/14/EC, and any other public or private undertaking, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction; this also includes undertakings which provide traction only; (d) "technical specification for interoperability (TSI)" means the specifications by which each subsystem or part of a subsystem is covered in order to meet the essential requirements and ensure the interoperability of the trans-European high-speed and conventional rail systems as defined in Directive 96/48/EC and Directive 2001/16/EC; (e) "common safety targets (CSTs)" means the safety levels that must at least be reached by different parts of the rail system (such as the conventional rail system, the high speed rail system, long railway tunnels or lines solely used for freight transport) and by the system as a whole, expressed in risk acceptance criteria; (f) "common safety methods (CSMs)" means the methods to be developed to describe how safety levels and achievement of safety targets and compliance with other safety requirements are assessed; (g) "safety authority" means the national body entrusted with the tasks regarding railway safety in accordance with this Directive or any binational body entrusted by Member States with these tasks in order to ensure a unified safety regime for specialised cross-border infrastructures; (h) "national safety rules" means all rules containing railway safety requirements imposed at Member State level and applicable to more than one railway undertaking, irrespective of the body issuing them; (i) "safety management system" means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations; (j) "investigator-in-charge" means a person responsible for the organisation, conduct and control of an investigation; (k) "accident" means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences; accidents are divided into the following categories: collisions, derailments, level-crossing accidents, accidents to persons caused by rolling stock in motion, fires and others; (l) "serious accident" means any train collision or derailment of trains, resulting in the death of at least one person or serious injuries to five or more persons or extensive damage to rolling stock, the infrastructure or the environment, and any other similar accident with an obvious impact on railway safety regulation or the management of safety; "extensive damage" means damage that can immediately be assessed by the investigating body to cost at least EUR 2 million in total; (m) "incident" means any occurrence, other than accident or serious accident, associated with the operation of trains and affecting the safety of operation; (n) "investigation" means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of causes and, when appropriate, the making of safety recommendations; (o) "causes" means actions, omissions, events or conditions, or a combination thereof, which led to the accident or incident; (p) "Agency" means the European Railway Agency, the Community agency for railway safety and interoperability; (q) "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, as defined in Directives 96/48/EC and 2001/16/EC; (r) "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 high-speed or conventional rail system depends directly or indirectly, as defined in Directive 96/48/EC and 2001/16/EC. The concept of a "constituent" covers both tangible objects and intangible objects such as software. CHAPTER II DEVELOPMENT AND MANAGEMENT OF SAFETY Article 4 Development and improvement of railway safety 1. Member States shall ensure that railway safety is generally maintained and, where reasonably practicable, continuously improved, taking into consideration the development of Community legislation and technical and scientific progress and giving priority to the prevention of serious accidents. Member States shall ensure that safety rules are laid down, applied and enforced in an open and non-discriminatory manner, fostering the development of a single European rail transport system. 2. Member States shall ensure that measures to develop and improve railway safety take account of the need for a system-based approach. 3. Member States shall ensure that the responsibility for the safe operation of the railway system and the control of risks associated with it is laid upon the infrastructure managers and railway undertakings, obliging them to implement necessary risk control measures, where appropriate in cooperation with each other, to apply national safety rules and standards, and to establish safety management systems in accordance with this Directive. Without prejudice to civil liability in accordance with the legal requirements of the Member States, each infrastructure manager and railway undertaking shall be made responsible for its part of the system and its safe operation, including supply of material and contracting of services, vis-à-vis users, customers, the workers concerned and third parties. 4. This shall be without prejudice to the responsibility of each manufacturer, maintenance supplier, wagon keeper, service provider and procurement entity to ensure that rolling stock, installations, accessories and equipment and services supplied by them comply with the requirements and the conditions for use specified, so that they can be safely put into operation by the railway undertaking and/or infrastructure manager. Article 5 Common safety indicators 1. In order to facilitate the assessment of the achievement of the CST and to provide for the monitoring of the general development of railway safety Member States shall collect information on common safety indicators (CSIs) through the annual reports of the safety authorities as referred to in Article 18. The first reference year for the CSIs shall be - - (14); they shall be reported on in the annual report the following year. The CSIs shall be established as set out in Annex I. 2. Before ... (15) Annex I shall be revised in accordance with the procedure referred to in Article 27(2), in particular to include common definitions of the CSI and common methods to calculate accident costs. Article 6 Common safety methods 1. A first set of CSMs, covering at least the methods described in paragraph 3(a), shall be adopted by the Commission, before... (16), in accordance with the procedure referred to in Article 27(2). They shall be published in the Official Journal of the European Union. A second set of CSMs, covering the remaining part of the methods as described in paragraph 3, shall be adopted by the Commission before... (17), in accordance with the procedure referred 1 in Article 27(2). They shall be published in the Official Journal of the European Union. 2. Draft CSMs and draft revised CSMs shall be drawn up by the Agency under mandates which shall be adopted in accordance with the procedure referred to in Article 27(2). The draft CSMs shall be based on an examination of existing methods in the Member States. 3. The CSMs shall describe how the safety level, and the achievement of safety targets and compliance with other safety requirements, are assessed by elaborating and defining: (a) risk evaluation and assessment methods, (b) methods for assessing conformity with requirements in safety certificates and safety authorisations issued in accordance with Articles 10 and 11, and (c) as far as they are not yet covered by TSIs, methods to check that the structural subsystems of the trans-European high-speed and conventional rail systems are operated and maintained in accordance with the relevant essential requirements. 4. The CSMs shall be revised at regular intervals, in accordance with the procedure referred to in Article 27(2), taking into account the experience gained from their application and the global development of railway safety and the obligations on Member States laid down in Article 4(1). 5. Member States shall make any necessary amendments to their national safety rules in the light of the adoption of CSMs and revisions to them. Article 7 Common safety targets 1. The CSTs shall be developed, adopted and revised following the procedures laid down in this Article. 2. Draft CSTs and draft revised CSTs shall be drawn up by the Agency under mandates which shall be adopted in accordance with the procedure referred to in Article 27(2). 3. The first set of draft CSTs shall be based on an examination of existing targets and safety performance in the Member States and shall ensure that the current safety performance of the rail system is not reduced in any Member State. They shall be adopted by the Commission, before... (18), in accordance with the procedure referred to in Article 27(2), and shall be published in the Official Journal of the European Union. The second set of draft CSTs shall be based on the experiences gained from the first set of CSTs and their implementation. They shall reflect any priority areas where safety needs to be further improved. They shall be adopted by the Commission, before... (19), in accordance with the procedure referred to in Article 27(2) and shall be published in the Official Journal of the European Union. All proposals for draft and revised CSTs shall reflect the obligations on Member States laid down in Article 4(1). Such proposals shall be accompanied by an assessment of the estimated costs and benefits, indicating their likely impact for all the operators and economic agents involved and their impact on the societal acceptance of risk. They shall contain a timetable for gradual implementation, where necessary, in particular to take account of the nature and extent of investment required to apply them. They shall analyse the possible impact on TSI for the subsystems and contain, where appropriate, consequential proposals for amendments to the TSI. 4. The CSTs shall define the safety levels that must at least be reached by different parts of the railway system and by the system as a whole in each Member State, expressed in risk acceptance criteria for: (a) individual risks relating to passengers, staff including the staff of contractors, level crossing users and others, and, without prejudice to existing national and international liability rules, individual risks relating to unauthorised persons on railway premises; (b) societal risks. 5. The CSTs shall be revised at regular intervals, in accordance with the procedure referred to in Article 27(2), taking into account the global development of railway safety. 6. Member States shall make any necessary amendments to their national safety rules in order to achieve at least the CSTs, and any revised CSTs, in accordance with the implementation timetables attached to them. They shall notify these rules to the Commission in accordance with Article 8(3). Article 8 National safety rules 1. In application of this Directive, Member States shall establish binding national safety rules and shall ensure that they are published and made available to all infrastructure managers, railway undertakings, applicants for a safety certificate and applicants for a safety authorisation in clear language that can be understood by the parties concerned. 2. Before... (20) Member States shall notify the Commission of all the relevant national safety rules in force, as set out in Annex II, and indicate their area of application. The notification shall further provide information on the principal content of the rules with references to the legal texts, on the form of legislation and on which body or organisation is responsible for its publication. 3. Not later than four years after the entry into force of this Directive, the Agency shall evaluate the way in which national safety rules are published and made available in accordance with paragraph 1. It shall also make appropriate recommendations to the Commission for the publication of such rules in order to make the relevant information more easily accessible. 4. Member States shall forthwith notify the Commission of any amendment to the notified national safety rules and of any new such rule that might be adopted, unless the rule is wholly relating to the implementation of TSIs. 5. In order to keep the introduction of new specific national rules to a minimum and thus prevent further barriers from being created, and with a view to the gradual harmonisation of safety rules, the Commission shall monitor the introduction of new national rules by Member States. 6. If, after the adoption of CSTs, a Member State intends to introduce a new national safety rule which requires a higher safety level than the CSTs, or if a Member State intends to introduce a new national safety rule which may affect operations of railway undertakings from other Member States on the territory of the Member State concerned, the Member State shall consult all interested parties in due time and the procedure in paragraph 7 shall apply. 7. The Member State shall submit the draft safety rule to the Commission for examination, stating the reasons for introducing it. If the Commission finds that the draft safety rule is incompatible with the CSMs or with achieving at least the CSTs, or that it constitutes a means of arbitrary discrimination or a disguised restriction on rail transport operations between Member States, a Decision, addressed to the Member State concerned, shall be adopted in accordance with the procedure referred to in Article 27(2). If the Commission has serious doubts as to the compatibility of the draft safety rule with the CSMs or with achieving at least the CSTs, or considers that it constitutes a means of arbitrary discrimination or a disguised restriction on rail transport operations between Member States, the Commission shall immediately inform the Member State concerned, which shall suspend the adoption, entry into force or implementation of the rule until a Decision is adopted, within a period of six months, in accordance with the procedure referred to in Article 27(2). Article 9 Safety management systems 1. Infrastructure managers and railway undertakings shall establish their safety management systems to ensure that the railway system can achieve at least the CSTs, is in conformity with the national safety rules described in Article 8 and Annex II and with safety requirements laid down in the TSIs, and that the relevant parts of CSMs are applied. 2. The safety management system shall meet the requirements and contain the elements laid down in Annex III, adapted to the character, extent and other conditions of the activity pursued. It shall ensure the control of all risks associated with the activity of the infrastructure manager or railway undertaking, including the supply of maintenance and material and the use of contractors. Without prejudice to existing national and international liability rules, the safety management system shall also take into account, where appropriate and reasonable, the risks arising as a result of activities by other parties 3. The safety management system of any infrastructure manager shall take into account the effects of operations by different railway undertakings on the network and make provisions to allow all railway undertakings to operate in accordance with TSIs and national safety rules and with conditions laid down in their safety certificate. It shall furthermore be developed with the aim of coordinating the emergency procedures of the infrastructure manager with all railway undertakings that operate on its infrastructure. 4. Each year all infrastructure managers and railway undertakings shall submit to the safety authority before 30 June an annual safety report concerning the preceding calendar year. The safety report shall contain: (a) information on how the organisation's corporate safety targets are met and the results of safety plans; (b) the development of national safety indicators, and of the CSIs laid down in Annex I, as far as it is relevant to the reporting organisation; (c) the results of internal safety auditing; (d) observations on deficiencies and malfunctions of railway operations and infrastructure management that might be relevant for the safety authority. CHAPTER III SAFETY CERTIFICATION AND AUTHORISATION Article 10 Safety certificates 1. In order to be granted access to the railway infrastructure, a railway undertaking must hold a safety certificate as provided for in this Chapter. The safety certificate may cover the whole railway network of a Member State or only a defined part thereof. The purpose of the safety certificate is to provide evidence that the railway undertaking has established its safety management system and can meet requirements laid down in TSIs and other relevant Community legislation and in national safety rules in order to control risks and operate safely on the network. 2. The safety certificate shall comprise: (a) certification confirming acceptance of the railway undertaking's safety management system as described in Article 9 and Annex III, and (b) certification confirming acceptance of the provisions adopted by the railway undertaking to meet specific requirements necessary for the safe operation of the relevant network. The requirements may include application of TSIs and national safety rules, acceptance of staff's certificates and authorisation to place in service the rolling stock used by the railway undertaking. The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV. 3. The safety authority in the Member State where the railway undertaking first establishes its operation shall grant the certification in accordance with paragraph 2. The certification granted in accordance with paragraph 2 must specify the type and extent of the railway operations covered. The certification granted in accordance with paragraph 2(a) shall be valid throughout the Community for equivalent rail transport operations. 4. The safety authority in the Member State in which the railway undertaking is planning to operate additional rail transport services shall grant the additional national certification necessary in accordance with paragraph 2(b). 5. The safety certificate shall be renewed upon application by the railway undertaking at intervals not exceeding five years. It shall be wholly or partly updated whenever the type or extent of the operation is substantially altered. The holder of the safety certificate shall without delay inform the competent safety authority of all major changes in the conditions of the relevant part of the safety certificate. It shall furthermore notify the competent safety authority whenever new categories of staff or new types of rolling stock are introduced. The safety authority may require that the relevant part of the safety certificate be revised following substantial changes in the safety regulatory framework. If the safety authority finds that the holder of the safety certificate no longer satisfies the conditions for a certification which it has issued, it shall revoke part (a) and/or (b) of the certificate, giving reasons for its decision. The safety authority that has revoked an additional national certification granted in accordance with paragraph 4 shall promptly inform the safety authority that granted the certification under paragraph 2(a) of its decision Similarly, a safety authority must revoke a safety certificate if it is apparent that the holder of the safety certificate has not used it as intended in the year following its issue. 6. The safety authority shall inform the Agency within one month of the safety certificates referred to in paragraph 2(a) that have been issued, renewed, amended or revoked. It shall state the name and address of the railway undertaking, the issue date, scope and validity of the safety certificate and, in case of revocation, the reasons for its decision. 7. Before... (21) the Agency shall evaluate the development of safety certification and submit a report to the Commission with recommendations on a strategy for migration towards a single Community safety certificate. The Commission shall take appropriate action following the recommendation. Article 11 Safety authorisation of infrastructure managers 1. In order to be allowed to manage and operate a rail infrastructure the infrastructure manager must obtain a safety authorisation from the safety authority in the Member State where he is established. The safety authorisation shall comprise: (a) authorisation confirming acceptance of the infrastructure manager's safety management system as described in Article 9 and Annex III, and (b) authorisation confirming acceptance of the provisions of the infrastructure manager to meet specific requirements necessary for the safe design, maintenance and operation of the railway infrastructure including, where appropriate, the maintenance and operation of the traffic control and signalling system. 2. The safety authorisation shall be renewed upon application by the infrastructure manager at intervals not exceeding five years. It shall be wholly or partly updated whenever substantial changes are made to the infrastructure, signalling or energy supply or to the principles of its operation and maintenance. The holder of the safety authorisation shall without delay inform the safety authority of all such changes. The safety authority may require that the safety authorisation be revised following substantial changes to the safety regulatory framework. If the safety authority finds that an authorised infrastructure manager no longer satisfies the conditions for a safety authorisation it shall revoke the authorisation, giving reasons for its decisions. 3. The safety authority shall inform the Agency within one month of the safety authorisations that have been issued, renewed, amended or revoked. It shall state the name and address of the infrastructure manager, the issue date, the scope and validity of the safety authorisation and, in case of revocation, the reasons for its decision. Article 12 Application requirements relating to safety certification and safety authorisation 1. The safety authority shall take a decision on an application for safety certification or safety authorisation without delay and in any event not more than four months after all information required and any supplementary information requested by the safety authority has been submitted. If the applicant is requested to submit supplementary information, such information shall be submitted promptly. 2. In order to facilitate the establishment of new railway undertakings and the submission of applications from railway undertakings from other Member States, the safety authority shall give detailed guidance on how to obtain the safety certificate. It shall list all requirements that have been laid down for the purpose of Article 10(2) and make all relevant documents available to the applicant. Special guidance shall be given to railway undertakings that apply for a safety certificate concerning services on a defined limited part of an infrastructure, specifically identifying the rules that are valid for the part in question. 3. An application guidance document describing and explaining the requirements for the safety certificates and listing the documents that must be submitted shall be made available to the applicants free of charge. All applications for safety certificates shall be submitted in the language required by the safety authority. Article 13 Access to training facilities 1. Member States shall ensure that railway undertakings applying for a safety certificate have fair and non-discriminatory access to training facilities for train drivers and staff accompanying the trains, whenever such training is necessary for the fulfilment of requirements to obtain the safety certificate. The services offered must include training on necessary route knowledge, operating rules and procedures, the signalling and control command system and emergency procedures applied on the routes operated. Member States shall also ensure that infrastructure managers and their staff performing vital safety tasks have fair and non-discriminatory access to training facilities. If the training services do not include examinations and granting of certificates, Member States shall ensure that railway undertakings have access to such certification if it is a requirement of the safety certificate. The safety authority shall ensure that the provision of training services or, where appropriate, the granting of certificates meets the safety requirements laid down in TSIs or national safety rules described in Article 8 and Annex II. 2. If the training facilities are available only through the services of one single railway undertaking or the infrastructure manager, Member States shall ensure that they are made available to other railway undertakings at a reasonable and non-discriminatory price, which is cost-related and may include a profit, margin. 3. When recruiting new train drivers, staff on board trains and staff performing vital safety tasks, railway undertakings must be able to take into account any training, qualifications and experience acquired previously from other railway undertakings. For this purpose, such members of staff shall be entitled to have access to, obtain copies and communicate all documents attesting to their training, qualifications and experience. 4. In every case each railway undertaking and each infrastructure manager shall be responsible for the level of training and qualifications of its staff carrying out safety-related work as set out in Article 9 and Annex III. Article 14 Placing in service of in-use rolling stock 1. Rolling stock that has been authorised to be placed in service in one Member State in accordance with Article 10(2)(b) and is not fully covered by the relevant TSIs shall be authorised to be placed in service in another or other Member States in accordance with this Article, if an authorisation is required by the latter Member State or States. 2. The railway undertaking applying for authorisation to place rolling stock in service in another Member State shall submit a technical file concerning the rolling stock or type of rolling stock to the relevant safety authority, indicating its intended use on the network. The file shall contain the following information: (a) evidence that the rolling stock has been authorised to be placed in service in another Member State and records that show its history of operation, maintenance and, where applicable, technical modifications undertaken after the authorisation; (b) relevant technical data, maintenance programme and operational characteristics requested by the safety authority and needed for its complementary authorisation; (c) evidence on technical and operational characteristics that shows that the rolling stock is in compliance with the energy supply system, the signalling and control command system, the track gauge and infrastructure gauges, the maximum allowed axle load and other constraints of the network; (d) information on exemptions from national safety rules that are needed to grant authorisation and evidence, based on risk assessment, showing that the acceptance of the rolling stock does not introduce undue risks to the network. 3. The safety authority may request that test runs on the network be undertaken to verify compliance with the restrictive parameters referred to in paragraph 2(c) and shall in that case prescribe their range and content. 4. The safety authority shall adopt its decision on an application in accordance with this Article without delay and not later than four months after the complete technical file, including documentation of the test runs, has been submitted. The certificate of authorisation may contain conditions for use and other restrictions. Article 15 Harmonisation of safety certificates 1. Before... (22), decisions on common harmonised requirements in accordance with Article 10(2)(b) and Annex IV and a common format for application guidance documents shall be adopted in accordance with the procedure referred to in Article 27(2). 2. The Agency shall recommend common harmonised requirements and a common format for application guidance documents under a mandate which shall be adopted in accordance with the procedure referred to in Article 27(2). CHAPTER IV SAFETY AUTHORITY Article 16 Tasks 1. Each Member State shall establish a safety authority. This authority may be the Ministry responsible for transport matters and shall be independent in its organisation, legal structure and decision making from any railway undertaking, infrastructure manager, applicant and procurement entity. 2. The safety authority shall be entrusted with at least the following tasks: (a) authorising the bringing into service of the structural subsystems constituting the trans-European high-speed rail system in accordance with Article 14 of Directive 96/48/EC and checking that they are operated and maintained in accordance with the relevant essential requirements; (b) authorising the bringing into service of the structural subsystems constituting the trans-European conventional rail system, in accordance with Article 14 of Directive 2001/16/EC and checking that they are operated and maintained in accordance with the relevant essential requirements; (c) supervising that the interoperability constituents are in compliance with the essential requirements as required by Article 12 of Directives 96/48/EC and 2001/16/EC; (d) authorising the placing in service of new and substantially altered rolling stock that is not yet covered by a TSI; (e) the issue, renewal, amendments and revocation of relevant parts of safety certificates and of safety authorisations granted in accordance with Articles 10 and 11 and checking that conditions and requirements laid down in them are met and that infrastructure managers and railway undertakings are operating under the requirements of Community or national law; (f) monitoring, promoting, and, where appropriate, enforcing and developing the safety regulatory framework including the system of national safety rules; (g) supervising that rolling stock is duly registered and that safety-related information in the national register, established in accordance with Article 14 of Directive 96/48/EC and of Directive 2001/16/EC, is accurate and kept up-to-date; 3. The tasks referred to in paragraph 2 may not be transferred or subcontracted to any infrastructure manager, railway undertaking or procurement entity. Article 17 Decision-making principles 1. The safety authority shall carry out its tasks in an open, non-discriminatory and transparent way. In particular it shall allow all parties to be heard and give reasons for its decisions. It shall promptly respond to requests and applications and communicate its requests for information without delay and adopt all its decisions within four months after all requested information has been provided. It may at any time request the technical assistance of infrastructure managers and railway undertakings or other qualified bodies when it is carrying out the tasks referred to in Article 16. In the process of developing the national regulatory framework, the safety authority shall consult all persons involved and interested parties, including infrastructure managers, railway undertakings, manufacturers and maintenance providers, users and staff representatives. 2. The safety authority shall be free to carry out all inspections and investigations that are needed for accomplishment of its tasks and it shall be granted access to all relevant documents and to premises, installations and equipment of infrastructure managers and railway undertakings. 3. Member States shall take the measures necessary to ensure that decisions taken by the safety authority are subject to judicial review. 4. The safely authorities shall conduct an active exchange of views and experience for the purpose of harmonising their decision-making criteria across the Community. Their cooperation shall in particular aim at facilitating and coordinating the safety certification of railway undertakings which have been granted international train paths in accordance with the procedure laid down in Article 15 of Directive 2001/14/EC. The Agency shall support the safety authorities in these tasks. Article 18 Annual report Each year the safety authority shall publish an annual report concerning its activities in the preceding year and send it to the Agency by 30 September at the latest. The report shall contain information on: (a) the development of railway safety, including an aggregation at Member State level of the CSIs laid down in Annex I; (b) important changes in legislation and regulation concerning railway safety; (c) the development of safety certification and safety authorisation; (d) results of and experience relating to the supervision of infrastructure managers and railway undertakings. CHAPTER V ACCIDENT AND INCIDENT INVESTIGATION Article 19 Obligation to investigate 1. Member States shall ensure that an investigation is carried out by the investigating body referred to in Article 21 after serious accidents on the railway system, the objective of which is possible improvement of railway safety and the prevention of accidents. 2. In addition to serious accidents, the investigating body referred to in Article 21 may investigate those accidents and incidents which under slightly different conditions might have led to serious accidents, including technical failures of the structural subsystems or of interoperability constituents of the trans-European high-speed or conventional rail systems. The investigating body shall, at its discretion, decide whether or not an investigation of such an accident or incident shall be undertaken. In its decision it shall take into account: (a) the seriousness of the accident or incident; (b) whether it forms part of a series of accidents or incidents relevant to the system as a whole; (c) its impact on railway safety on a Community level, and (d) requests from infrastructure managers, railway undertakings, the safety authority or the Member States. 3. The extent of investigations and the procedure to be followed in carrying out such investigations shall be determined by the investigating body, taking into account the principles and the objectives of Articles 20 and 22 and depending on the lessons it expects to draw from the accident or incident for the improvement of safety. 4. The investigation shall in no case be concerned with apportioning blame or liability. Article 20 Status of investigation 1. Member States shall define, in the framework of their respective legal system, the legal status of the investigation that will enable the investigators-in-charge to carry out their task in the most efficient way and within the shortest time. 2. In accordance with the legislation in force in the Member States and, where appropriate, in cooperation with the authorities responsible for the judicial inquiry, the investigators shall, as soon as possible, be given: (a) access to the site of the accident or incident as well as to the rolling stock involved, the related infrastructure and traffic control and signalling installations; (b) the right to an immediate listing of evidence and controlled removal of wreckage, infrastructure installations or components for examination or analysis purposes; (c) access to and use of the contents of on-board recorders and equipment for recording of verbal messages and registration of the operation of the signalling and traffic control system; (d) access to the results of examination of the bodies of victims; (e) access to the results of examinations of the train staff and other railway staff involved in the accident or incident; (f) the opportunity to question the railway staff involved and other witnesses; (g) access to any relevant information or records held by the infrastructure manager, the railway undertakings involved and the safety authority. 3. The investigation shall be accomplished independently of any judicial inquiry. Article 21 Investigating body 1. Each Member State shall ensure that investigations of accidents and incidents referred to in Article 19 are conducted by a permanent body, which shall comprise at least one investigator able to perform the function of investigator-in-charge in the event of an accident or incident. This body shall be independent in its organisation, legal structure and decision-making from any infrastructure manager, railway undertaking, charging body, allocation body and notified body, and from any party whose interests could conflict with the tasks entrusted to the investigating body. It shall furthermore be functionally independent from the safety authority and from any regulator of railways. 2. The investigating body shall perform its tasks independently of the organisations referred to in paragraph 1 and shall be able to obtain sufficient resources to do so. Its investigators shall be afforded status giving them the necessary guarantees of independence. 3. Member States shall make provision that railway undertakings, infrastructure managers and, where appropriate, the safety authority, are obliged immediately to report accidents and incidents referred to in Article 19 to the investigating body. The investigating body shall be able to respond to such reports and make the necessary arrangements to start the investigation no later than one week after receipt of the report concerning the accident or incident. 4. The investigating body may combine its tasks under this Directive with the work of investigating occurrences other than railway accidents and incidents as long as such investigations do not endanger its independence. 5. If necessary the investigating body may request the assistance of investigating bodies from other Member States or from the Agency to supply expertise or to carry out technical inspections, analyses or evaluations. 6. Member States may entrust the investigating body with the task of carrying out investigations of railway accidents and incidents other than those referred to in Article 19. 7. The investigating bodies shall conduct an active exchange of views and experience for the purpose of developing common investigation methods, drawing up common principles for follow-up of safety recommendations and adaptation to the development of technical and scientific progress. The Agency shall support the investigating bodies in this task. Article 22 Investigation procedure 1. An accident or incident referred to in Article 19 shall be investigated by the investigation body of the Member State in which it occurred. If it is not possible to establish in which Member State it occurred or if it occurred on or close to a border installation between two Member States the relevant bodies shall agree which one of them will carry out the investigation or shall agree to carry it out in cooperation. The other body shall in the first case be allowed to participate in the investigation and fully share its results. Investigation bodies from another Member State shall be invited to participate in an investigation whenever a railway undertaking established and licensed in that Member State is involved in the accident or incident. This paragraph shall not preclude Member States from agreeing that the relevant bodies should carry out investigations in cooperation in other circumstances. 2. For each accident or incident the body responsible for the investigation shall arrange for the appropriate means, comprising the necessary operational and technical expertise to carry out the investigation. The expertise may be obtained from inside or outside the body, depending on the character of the accident or incident to be investigated. 3. The investigation shall be carried out with as much openness as possible, so that all parties can be heard and can share the results. The relevant infrastructure manager and railway undertakings, the safety authority, victims and their relatives, owners of damaged property, manufacturers, the emergency services involved and representatives of staff and users shall be regularly informed of the investigation and its progress and, as far as practicable, shall be given an opportunity to submit their opinions and views to the investigation and be allowed to comment on the information in draft reports. 4. The investigating body shall conclude its examinations at the accident site in the shortest possible time in order to enable the infrastructure manager to restore the infrastructure and open it to rail transport services as soon as possible. Article 23 Reports 1. An investigation of an accident or incident referred to in Article 19 shall be the subject of reports in a form appropriate to the type and seriousness of the accident or incident and the relevance of the investigation findings. The reports shall state the objectives of the investigations as referred to in Article 19(1) and contain, where appropriate, safety recommendations. 2. The investigating body shall make public the final report in the shortest possible time and normally not later than 12 months after the date of the occurrence. The report shall, as close as possible, follow the reporting structure laid down in Annex V. The report, including the safety recommendations, shall be communicated to the relevant parties referred to in Article 22(3) and to bodies and parties concerned in other Member States. 3. Each year the investigating body shall publish by 30 September at the latest an annual report accounting for the investigations carried out in the preceding year, the safety recommendations that were issued and actions taken in accordance with recommendations issued previously. Article 24 Information to be sent to the Agency 1. Within one week after the decision to open an investigation the investigating body shall inform the Agency thereof. The information shall indicate the date, time and place of the occurrence, as well as its type and its consequences as regards fatalities, injuries and material damage. 2. The investigating body shall send the Agency a copy of the final report referred to in Article 23(2) and of the annual report referred to in Article 23(3). Article 25 Safety recommendations 1. A safety recommendation issued by an investigating body shall in no case create a presumption of blame or liability for an accident or incident. 2. Recommendations shall be addressed to the safety authority and, where needed by reason of the character of the recommendation, to other bodies or authorities in the Member State or to other Member States. Member States and their safety authorities shall take the necessary measures to ensure that the safety recommendations issued by the investigating bodies are duly taken into consideration, and, where appropriate, acted upon. 3. The safety authority and other authorities or bodies or, when appropriate, other Member States to which recommendations have been addressed, shall report back at least annually to the investigating body on measures that are taken or planned as a consequence of the recommendation. CHAPTER VI IMPLEMENTING POWERS Article 26 Adaptation of Annexes The Annexes shall be adapted to technical and scientific progress, in accordance with the procedure referred to in Article 27(2). Article 27 Committee procedure 1. The Commission shall be assisted by the Committee set up by Article 21 of Directive 96/48/EC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. The Committee shall adopt its Rules of Procedure. Article 28 Implementing measures 1. Member States may bring any measures concerning the implementation of this Directive to the attention of the Commission. Appropriate decisions shall be adopted in accordance with the procedure referred to in Article 27(2). 2. At the request of a Member State or on its own initiative the Commission shall, in a specific case, examine the application and enforcement of provisions concerning safety certification and safety authorisation, and within two months of receipt of such a request decide in accordance with the procedure referred to in Article 27(2) whether the related measure may continue to be applied. The Commission shall communicate its decision to the European Parliament, the Council and the Member States. CHAPTER VII GENERAL AND FINAL PROVISIONS Article 29 Amendments to Directive 95/18/EC Directive 95/18/EC is hereby amended as follows: 1) Article 8 shall be replaced by the following: "Article 8 The requirements relating to professional competence shall be met when an applicant railway undertaking has or will have a management organisation 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". 2) In the Annex, Section II shall be deleted. Article 30 Amendments to Directive 2001/14/EC Directive 2001/14/EC is hereby amended as follows: 1) The title shall be replaced by the following: "Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure". 2) In Article 30(2), point (f) shall be replaced by the following: "(f) arrangements for access in accordance with Article 10 of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways (23) as amended by Directive 2004/xx/EC of the European Parliament and of the Council of... amending Council Directive 91/440/EEC on the development of the Community's railways (24). (23) OJ L 237, 24.8.1991, p. 25." (24) OJ L "" 3) Article 32 shall be deleted. 4) In Article 34, paragraph 2 shall be replaced by the following: "2. At the request of a Member State or on its own initiative the Commission shall, in a specific case, examine the application and enforcement of provisions concerning charging, capacity allocation, and within two months of receipt of such a request decide in accordance with the procedure referred to in Article 35(2) whether the related measure may continue to be applied. The Commission shall communicate its decision to the European Parliament, the Council and to the Member States." Article 31 Report and further Community action The Commission shall submit to the European Parliament and to the Council before... (25) and every five years thereafter a report on the implementation of this Directive. The report shall be accompanied where necessary by proposals for further Community action. Article 32 Penalties The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, non-discriminatory and dissuasive. The Member States shall notify those rules to the Commission by the date specified in Article 33 and shall notify it without delay of any subsequent amendment affecting them. Article 33 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... (26) at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those 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 34 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 35 Addressees This Directive is addressed to the Member States.

32004L0083

2004

COUNCIL DIRECTIVE 2004/83/EC of 29 April 2004 on minimum standards for the qualification and status of third country nationals or stateless persons as refugees or as persons who otherwise need international protection and the content of the protection granted Having regard to the Treaty establishing the European Community, and in particular points 1(c), 2(a) and 3(a) of Article 63 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 European Economic and Social Committee (3), Having regard to the opinion of the Committee of the Regions (4), Whereas: (1) A common policy on asylum, including a Common European Asylum System, is a constituent part of the European Union's objective of progressively establishing an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the Community. (2) The European Council at its special meeting in Tampere on 15 and 16 October 1999 agreed to work towards establishing a Common European Asylum System, based on the full and inclusive application of the Geneva Convention relating to the Status of Refugees of 28 July 1951 (Geneva Convention), as supplemented by the New York Protocol of 31 January 1967 (Protocol), thus affirming the principle of non-refoulement and ensuring that nobody is sent back to persecution. (3) The Geneva Convention and Protocol provide the cornerstone of the international legal regime for the protection of refugees. (4) The Tampere conclusions provide that a Common European Asylum System should include, in the short term, the approximation of rules on the recognition of refugees and the content of refugee status. (5) The Tampere conclusions also provide that rules regarding refugee status should be complemented by measures on subsidiary forms of protection, offering an appropriate status to any person in need of such protection. (6) The main objective of this Directive is, on the one hand, to ensure that Member States apply common criteria for the identification of persons genuinely in need of international protection, and, on the other hand, to ensure that a minimum level of benefits is available for these persons in all Member States. (7) The approximation of rules on the recognition and content of refugee and subsidiary protection status should help to limit the secondary movements of applicants for asylum between Member States, where such movement is purely caused by differences in legal frameworks. (8) It is in the very nature of minimum standards that Member States should have the power to introduce or maintain more favourable provisions for third country nationals or stateless persons who request international protection from a Member State, where such a request is understood to be on the grounds that the person concerned is either a refugee within the meaning of Article 1(A) of the Geneva Convention, or a person who otherwise needs international protection. (9) Those third country nationals or stateless persons, who are allowed to remain in the territories of the Member States for reasons not due to a need for international protection but on a discretionary basis on compassionate or humanitarian grounds, fall outside the scope of this Directive. (10) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular this Directive seeks to ensure full respect for human dignity and the right to asylum of applicants for asylum and their accompanying family members. (11) With respect to the treatment of persons falling within the scope of this Directive, Member States are bound by obligations under instruments of international law to which they are party and which prohibit discrimination. (12) The ‘best interests of the child’ should be a primary consideration of Member States when implementing this Directive. (13) This Directive is without prejudice to the Protocol on asylum for nationals of Member States of the European Union as annexed to the Treaty Establishing the European Community. (14) The recognition of refugee status is a declaratory act. (15) Consultations with the United Nations High Commissioner for Refugees may provide valuable guidance for Member States when determining refugee status according to Article 1 of the Geneva Convention. (16) Minimum standards for the definition and content of refugee status should be laid down to guide the competent national bodies of Member States in the application of the Geneva Convention. (17) It is necessary to introduce common criteria for recognising applicants for asylum as refugees within the meaning of Article 1 of the Geneva Convention. (18) In particular, it is necessary to introduce common concepts of protection needs arising sur place; sources of harm and protection; internal protection; and persecution, including the reasons for persecution. (19) Protection can be provided not only by the State but also by parties or organisations, including international organisations, meeting the conditions of this Directive, which control a region or a larger area within the territory of the State. (20) It is necessary, when assessing applications from minors for international protection, that Member States should have regard to child-specific forms of persecution. (21) It is equally necessary to introduce a common concept of the persecution ground ‘membership of a particular social group’. (22) Acts contrary to the purposes and principles of the United Nations are set out in the Preamble and Articles 1 and 2 of the Charter of the United Nations and are, amongst others, embodied in the United Nations Resolutions relating to measures combating terrorism, which declare that ‘acts, methods and practices of terrorism are contrary to the purposes and principles of the United Nations’ and that ‘knowingly financing, planning and inciting terrorist acts are also contrary to the purposes and principles of the United Nations’. (23) As referred to in Article 14, ‘status’ can also include refugee status. (24) Minimum standards for the definition and content of subsidiary protection status should also be laid down. Subsidiary protection should be complementary and additional to the refugee protection enshrined in the Geneva Convention. (25) It is necessary to introduce criteria on the basis of which applicants for international protection are to be recognised as eligible for subsidiary protection. Those criteria should be drawn from international obligations under human rights instruments and practices existing in Member States. (26) Risks to which a population of a country or a section of the population is generally exposed do normally not create in themselves an individual threat which would qualify as serious harm. (27) Family members, merely due to their relation to the refugee, will normally be vulnerable to acts of persecution in such a manner that could be the basis for refugee status. (28) The notion of national security and public order also covers cases in which a third country national belongs to an association which supports international terrorism or supports such an association. (29) While the benefits provided to family members of beneficiaries of subsidiary protection status do not necessarily have to be the same as those provided to the qualifying beneficiary, they need to be fair in comparison to those enjoyed by beneficiaries of subsidiary protection status. (30) Within the limits set out by international obligations, Member States may lay down that the granting of benefits with regard to access to employment, social welfare, health care and access to integration facilities requires the prior issue of a residence permit. (31) This Directive does not apply to financial benefits from the Member States which are granted to promote education and training. (32) The practical difficulties encountered by beneficiaries of refugee or subsidiary protection status concerning the authentication of their foreign diplomas, certificates or other evidence of formal qualification should be taken into account. (33) Especially to avoid social hardship, it is appropriate, for beneficiaries of refugee or subsidiary protection status, to provide without discrimination in the context of social assistance the adequate social welfare and means of subsistence. (34) With regard to social assistance and health care, the modalities and detail of the provision of core benefits to beneficiaries of subsidiary protection status should be determined by national law. The possibility of limiting the benefits for beneficiaries of subsidiary protection status to core benefits is to be understood in the sense that this notion covers at least minimum income support, assistance in case of illness, pregnancy and parental assistance, in so far as they are granted to nationals according to the legislation of the Member State concerned. (35) Access to health care, including both physical and mental health care, should be ensured to beneficiaries of refugee or subsidiary protection status. (36) The implementation of this Directive should be evaluated at regular intervals, taking into consideration in particular the evolution of the international obligations of Member States regarding non-refoulement, the evolution of the labour markets in the Member States as well as the development of common basic principles for integration. (37) Since the objectives of the proposed Directive, namely to establish minimum standards for the granting of international protection to third country nationals and stateless persons by Member States and the content of the protection granted, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the Directive, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (38) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom has notified, by letter of 28 January 2002, its wish to take part in the adoption and application of this Directive. (39) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Ireland has notified, by letter of 13 February 2002, its wish to take part in the adoption and application of this Directive. (40) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application, CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope The purpose of this Directive is to lay down minimum standards for the qualification of third country nationals or stateless persons as refugees or as persons who otherwise need international protection and the content of the protection granted. Article 2 Definitions For the purposes of this Directive: (a) ‘international protection’ means the refugee and subsidiary protection status as defined in (d) and (f); (b) ‘Geneva Convention’ means the Convention relating to the status of refugees done at Geneva on 28 July 1951, as amended by the New York Protocol of 31 January 1967; (c) ‘refugee’ means a third country national who, owing to a well-founded fear of being persecuted for reasons of race, religion, nationality, political opinion or membership of a particular social group, is outside the country of nationality and is unable or, owing to such fear, is unwilling to avail himself or herself of the protection of that country, or a stateless person, who, being outside of the country of former habitual residence for the same reasons as mentioned above, is unable or, owing to such fear, unwilling to return to it, and to whom Article 12 does not apply; (d) ‘refugee status’ means the recognition by a Member State of a third country national or a stateless person as a refugee; (e) ‘person eligible for subsidiary protection’ means a third country national or a stateless person who does not qualify as a refugee but in respect of whom substantial grounds have been shown for believing that the person concerned, if returned to his or her country of origin, or in the case of a stateless person, to his or her country of former habitual residence, would face a real risk of suffering serious harm as defined in Article 15, and to whom Article 17(1) and (2) do not apply, and is unable, or, owing to such risk, unwilling to avail himself or herself of the protection of that country; (f) ‘subsidiary protection status’ means the recognition by a Member State of a third country national or a stateless person as a person eligible for subsidiary protection; (g) ‘application for international protection’ means a request made by a third country national or a stateless person for protection from a Member State, who can be understood to seek refugee status or subsidiary protection status, and who does not explicitly request another kind of protection, outside the scope of this Directive, that can be applied for separately; (h) ‘family members’ means, insofar as the family already existed in the country of origin, the following members of the family of the beneficiary of refugee or subsidiary protection status who are present in the same Member State in relation to the application for international protection: — the spouse of the beneficiary of refugee or subsidiary protection status or his or her unmarried partner in a stable relationship, where the legislation or practice of the Member State concerned treats unmarried couples in a way comparable to married couples under its law relating to aliens, — the minor children of the couple referred to in the first indent or of the beneficiary of refugee or subsidiary protection status, on condition that they are unmarried and dependent and regardless of whether they were born in or out of wedlock or adopted as defined under the national law; (i) ‘unaccompanied minors’ means third-country nationals or stateless persons below the age of 18, who arrive on the territory of the Member States unaccompanied by an adult responsible for them whether by law or custom, and for as long as they are not effectively taken into the care of such a person; it includes minors who are left unaccompanied after they have entered the territory of the Member States; (j) ‘residence permit’ means any permit or authorisation issued by the authorities of a Member State, in the form provided for under that State's legislation, allowing a third country national or stateless person to reside on its territory; (k) ‘country of origin’ means the country or countries of nationality or, for stateless persons, of former habitual residence. Article 3 More favourable standards Member States may introduce or retain more favourable standards for determining who qualifies as a refugee or as a person eligible for subsidiary protection, and for determining the content of international protection, in so far as those standards are compatible with this Directive. CHAPTER II ASSESSMENT OF APPLICATIONS FOR INTERNATIONAL PROTECTION Article 4 Assessment of facts and circumstances 1. Member States may consider it the duty of the applicant to submit as soon as possible all elements needed to substantiate the application for international protection. In cooperation with the applicant it is the duty of the Member State to assess the relevant elements of the application. 2. The elements referred to in of paragraph 1 consist of the applicant's statements and all documentation at the applicants disposal regarding the applicant's age, background, including that of relevant relatives, identity, nationality(ies), country(ies) and place(s) of previous residence, previous asylum applications, travel routes, identity and travel documents and the reasons for applying for international protection. 3. The assessment of an application for international protection is to be carried out on an individual basis and includes taking into account: (a) all relevant facts as they relate to the country of origin at the time of taking a decision on the application; including laws and regulations of the country of origin and the manner in which they are applied; (b) the relevant statements and documentation presented by the applicant including information on whether the applicant has been or may be subject to persecution or serious harm; (c) the individual position and personal circumstances of the applicant, including factors such as background, gender and age, so as to assess whether, on the basis of the applicant's personal circumstances, the acts to which the applicant has been or could be exposed would amount to persecution or serious harm; (d) whether the applicant's activities since leaving the country of origin were engaged in for the sole or main purpose of creating the necessary conditions for applying for international protection, so as to assess whether these activities will expose the applicant to persecution or serious harm if returned to that country; (e) whether the applicant could reasonably be expected to avail himself of the protection of another country where he could assert citizenship. 4. The fact that an applicant has already been subject to persecution or serious harm or to direct threats of such persecution or such harm, is a serious indication of the applicant's well-founded fear of persecution or real risk of suffering serious harm, unless there are good reasons to consider that such persecution or serious harm will not be repeated. 5. Where Member States apply the principle according to which it is the duty of the applicant to substantiate the application for international protection and where aspects of the applicant's statements are not supported by documentary or other evidence, those aspects shall not need confirmation, when the following conditions are met: (a) the applicant has made a genuine effort to substantiate his application; (b) all relevant elements, at the applicant's disposal, have been submitted, and a satisfactory explanation regarding any lack of other relevant elements has been given; (c) the applicant's statements are found to be coherent and plausible and do not run counter to available specific and general information relevant to the applicant's case; (d) the applicant has applied for international protection at the earliest possible time, unless the applicant can demonstrate good reason for not having done so; and (e) the general credibility of the applicant has been established. Article 5 International protection needs arising sur place 1. A well-founded fear of being persecuted or a real risk of suffering serious harm may be based on events which have taken place since the applicant left the country of origin. 2. A well-founded fear of being persecuted or a real risk of suffering serious harm may be based on activities which have been engaged in by the applicant since he left the country of origin, in particular where it is established that the activities relied upon constitute the expression and continuation of convictions or orientations held in the country of origin. 3. Without prejudice to the Geneva Convention, Member States may determine that an applicant who files a subsequent application shall normally not be granted refugee status, if the risk of persecution is based on circumstances which the applicant has created by his own decision since leaving the country of origin. Article 6 Actors of persecution or serious harm Actors of persecution or serious harm include: (a) the State; (b) parties or organisations controlling the State or a substantial part of the territory of the State; (c) non-State actors, if it can be demonstrated that the actors mentioned in (a) and (b), including international organisations, are unable or unwilling to provide protection against persecution or serious harm as defined in Article 7. Article 7 Actors of protection 1. Protection can be provided by: (a) the State; or (b) parties or organisations, including international organisations, controlling the State or a substantial part of the territory of the State. 2. Protection is generally provided when the actors mentioned in paragraph 1 take reasonable steps to prevent the persecution or suffering of serious harm, inter alia, by operating an effective legal system for the detection, prosecution and punishment of acts constituting persecution or serious harm, and the applicant has access to such protection. 3. When assessing whether an international organisation controls a State or a substantial part of its territory and provides protection as described in paragraph 2, Member States shall take into account any guidance which may be provided in relevant Council acts. Article 8 Internal protection 1. As part of the assessment of the application for international protection, Member States may determine that an applicant is not in need of international protection if in a part of the country of origin there is no well-founded fear of being persecuted or no real risk of suffering serious harm and the applicant can reasonably be expected to stay in that part of the country. 2. In examining whether a part of the country of origin is in accordance with paragraph 1, Member States shall at the time of taking the decision on the application have regard to the general circumstances prevailing in that part of the country and to the personal circumstances of the applicant. 3. Paragraph 1 may apply notwithstanding technical obstacles to return to the country of origin. CHAPTER III QUALIFICATION FOR BEING A REFUGEE Article 9 Acts of persecution 1. Acts of persecution within the meaning of article 1 A of the Geneva Convention must: (a) be sufficiently serious by their nature or repetition as to constitute a severe violation of basic human rights, in particular the rights from which derogation cannot be made under Article 15(2) of the European Convention for the Protection of Human Rights and Fundamental Freedoms; or (b) be an accumulation of various measures, including violations of human rights which is sufficiently severe as to affect an individual in a similar manner as mentioned in (a). 2. Acts of persecution as qualified in paragraph 1, can, inter alia, take the form of: (a) acts of physical or mental violence, including acts of sexual violence; (b) legal, administrative, police, and/or judicial measures which are in themselves discriminatory or which are implemented in a discriminatory manner; (c) prosecution or punishment, which is disproportionate or discriminatory; (d) denial of judicial redress resulting in a disproportionate or discriminatory punishment; (e) prosecution or punishment for refusal to perform military service in a conflict, where performing military service would include crimes or acts falling under the exclusion clauses as set out in Article 12(2); (f) acts of a gender-specific or child-specific nature. 3. In accordance with Article 2(c), there must be a connection between the reasons mentioned in Article 10 and the acts of persecution as qualified in paragraph 1. Article 10 Reasons for persecution 1. Member States shall take the following elements into account when assessing the reasons for persecution: (a) the concept of race shall in particular include considerations of colour, descent, or membership of a particular ethnic group; (b) the concept of religion shall in particular include the holding of theistic, non-theistic and atheistic beliefs, the participation in, or abstention from, formal worship in private or in public, either alone or in community with others, other religious acts or expressions of view, or forms of personal or communal conduct based on or mandated by any religious belief; (c) the concept of nationality shall not be confined to citizenship or lack thereof but shall in particular include membership of a group determined by its cultural, ethnic, or linguistic identity, common geographical or political origins or its relationship with the population of another State; (d) a group shall be considered to form a particular social group where in particular: — members of that group share an innate characteristic, or a common background that cannot be changed, or share a characteristic or belief that is so fundamental to identity or conscience that a person should not be forced to renounce it, and — that group has a distinct identity in the relevant country, because it is perceived as being different by the surrounding society; depending on the circumstances in the country of origin, a particular social group might include a group based on a common characteristic of sexual orientation. Sexual orientation cannot be understood to include acts considered to be criminal in accordance with national law of the Member States: Gender related aspects might be considered, without by themselves alone creating a presumption for the applicability of this Article; (e) the concept of political opinion shall in particular include the holding of an opinion, thought or belief on a matter related to the potential actors of persecution mentioned in Article 6 and to their policies or methods, whether or not that opinion, thought or belief has been acted upon by the applicant. 2. When assessing if an applicant has a well-founded fear of being persecuted it is immaterial whether the applicant actually possesses the racial, religious, national, social or political characteristic which attracts the persecution, provided that such a characteristic is attributed to the applicant by the actor of persecution. Article 11 Cessation 1. A third country national or a stateless person shall cease to be a refugee, if he or she: (a) has voluntarily re-availed himself or herself of the protection of the country of nationality; or (b) having lost his or her nationality, has voluntarily re-acquired it; or (c) has acquired a new nationality, and enjoys the protection of the country of his or her new nationality; or (d) has voluntarily re-established himself or herself in the country which he or she left or outside which he or she remained owing to fear of persecution; or (e) can no longer, because the circumstances in connection with which he or she has been recognised as a refugee have ceased to exist, continue to refuse to avail himself or herself of the protection of the country of nationality; (f) being a stateless person with no nationality, he or she is able, because the circumstances in connection with which he or she has been recognised as a refugee have ceased to exist, to return to the country of former habitual residence. 2. In considering points (e) and (f) of paragraph 1, Member States shall have regard to whether the change of circumstances is of such a significant and non-temporary nature that the refugee's fear of persecution can no longer be regarded as well-founded. Article 12 Exclusion 1. A third country national or a stateless person is excluded from being a refugee, if: (a) he or she falls within the scope of Article 1 D of the Geneva Convention, relating to protection or assistance from organs or agencies of the United Nations other than the United Nations High Commissioner for Refugees. When such protection or assistance has ceased for any reason, without the position of such persons being definitely settled in accordance with the relevant resolutions adopted by the General Assembly of the United Nations, these persons shall ipso facto be entitled to the benefits of this Directive; (b) he or she is recognised by the competent authorities of the country in which he or she has taken residence as having the rights and obligations which are attached to the possession of the nationality of that country; or rights and obligations equivalent to those. 2. A third country national or a stateless person is excluded from being a refugee where there are serious reasons for considering that: (a) he or she has committed a crime against peace, a war crime, or a crime against humanity, as defined in the international instruments drawn up to make provision in respect of such crimes; (b) he or she has committed a serious non-political crime outside the country of refuge prior to his or her admission as a refugee; which means the time of issuing a residence permit based on the granting of refugee status; particularly cruel actions, even if committed with an allegedly political objective, may be classified as serious non-political crimes; (c) he or she has been guilty of acts contrary to the purposes and principles of the United Nations as set out in the Preamble and Articles 1 and 2 of the Charter of the United Nations. 3. Paragraph 2 applies to persons who instigate or otherwise participate in the commission of the crimes or acts mentioned therein. CHAPTER IV REFUGEE STATUS Article 13 Granting of refugee status Member States shall grant refugee status to a third country national or a stateless person, who qualifies as a refugee in accordance with Chapters II and III. Article 14 Revocation of, ending of or refusal to renew refugee status 1. Concerning applications for international protection filed after the entry into force of this Directive, Member States shall revoke, end or refuse to renew the refugee status of a third country national or a stateless person granted by a governmental, administrative, judicial or quasi-judicial body, if he or she has ceased to be a refugee in accordance with Article 11. 2. Without prejudice to the duty of the refugee in accordance with Article 4(1) to disclose all relevant facts and provide all relevant documentation at his/her disposal, the Member State, which has granted refugee status, shall on an individual basis demonstrate that the person concerned has ceased to be or has never been a refugee in accordance with paragraph 1 of this Article. 3. Member States shall revoke, end or refuse to renew the refugee status of a third country national or a stateless person, if, after he or she has been granted refugee status, it is established by the Member State concerned that: (a) he or she should have been or is excluded from being a refugee in accordance with Article 12; (b) his or her misrepresentation or omission of facts, including the use of false documents, were decisive for the granting of refugee status. 4. Member States may revoke, end or refuse to renew the status granted to a refugee by a governmental, administrative, judicial or quasi-judicial body, when: (a) there are reasonable grounds for regarding him or her as a danger to the security of the Member State in which he or she is present; (b) he or she, having been convicted by a final judgement of a particularly serious crime, constitutes a danger to the community of that Member State. 5. In situations described in paragraph 4, Member States may decide not to grant status to a refugee, where such a decision has not yet been taken. 6. Persons to whom paragraphs 4 or 5 apply are entitled to rights set out in or similar to those set out in Articles 3, 4, 16, 22, 31 and 32 and 33 of the Geneva Convention in so far as they are present in the Member State. CHAPTER V QUALIFICATION FOR SUBSIDIARY PROTECTION Article 15 Serious harm Serious harm consists of: (a) death penalty or execution; or (b) torture or inhuman or degrading treatment or punishment of an applicant in the country of origin; or (c) serious and individual threat to a civilian's life or person by reason of indiscriminate violence in situations of international or internal armed conflict. Article 16 Cessation 1. A third country national or a stateless person shall cease to be eligible for subsidiary protection when the circumstances which led to the granting of subsidiary protection status have ceased to exist or have changed to such a degree that protection is no longer required. 2. In applying paragraph 1, Member States shall have regard to whether the change of circumstances is of such a significant and non-temporary nature that the person eligible for subsidiary protection no longer faces a real risk of serious harm. Article 17 Exclusion 1. A third country national or a stateless person is excluded from being eligible for subsidiary protection where there are serious reasons for considering that: (a) he or she has committed a crime against peace, a war crime, or a crime against humanity, as defined in the international instruments drawn up to make provision in respect of such crimes; (b) he or she has committed a serious crime; (c) he or she has been guilty of acts contrary to the purposes and principles of the United Nations as set out in the Preamble and Articles 1 and 2 of the Charter of the United Nations; (d) he or she constitutes a danger to the community or to the security of the Member State in which he or she is present. 2. Paragraph 1 applies to persons who instigate or otherwise participate in the commission of the crimes or acts mentioned therein. 3. Member States may exclude a third country national or a stateless person from being eligible for subsidiary protection, if he or she prior to his or her admission to the Member State has committed one or more crimes, outside the scope of paragraph 1, which would be punishable by imprisonment, had they been committed in the Member State concerned, and if he or she left his or her country of origin solely in order to avoid sanctions resulting from these crimes. CHAPTER VI SUBSIDIARY PROTECTION STATUS Article 18 Granting of subsidiary protection status Member States shall grant subsidiary protection status to a third country national or a stateless person eligible for subsidiary protection in accordance with Chapters II and V. Article 19 Revocation of, ending of or refusal to renew subsidiary protection status 1. Concerning applications for international protection filed after the entry into force of this Directive, Member States shall revoke, end or refuse to renew the subsidiary protection status of a third country national or a stateless person granted by a governmental, administrative, judicial or quasi-judicial body, if he or she has ceased to be eligible for subsidiary protection in accordance with Article 16. 2. Member States may revoke, end or refuse to renew the subsidiary protection status of a third country national or a stateless person granted by a governmental, administrative, judicial or quasi-judicial body, if after having been granted subsidiary protection status, he or she should have been excluded from being eligible for subsidiary protection in accordance with Article 17(3). 3. Member States shall revoke, end or refuse to renew the subsidiary protection status of a third country national or a stateless person, if: (a) he or she, after having been granted subsidiary protection status, should have been or is excluded from being eligible for subsidiary protection in accordance with Article 17(1) and (2); (b) his or her misrepresentation or omission of facts, including the use of false documents, were decisive for the granting of subsidiary protection status. 4. Without prejudice to the duty of the third country national or stateless person in accordance with Article 4(1) to disclose all relevant facts and provide all relevant documentation at his/her disposal, the Member State, which has granted the subsidiary protection status, shall on an individual basis demonstrate that the person concerned has ceased to be or is not eligible for subsidiary protection in accordance with paragraphs 1, 2 and 3 of this Article. CHAPTER VII CONTENT OF INTERNATIONAL PROTECTION Article 20 General rules 1. This Chapter shall be without prejudice to the rights laid down in the Geneva Convention. 2. This Chapter shall apply both to refugees and persons eligible for subsidiary protection unless otherwise indicated. 3. When implementing this Chapter, Member States shall take into account the specific situation of vulnerable persons such as minors, unaccompanied minors, disabled people, elderly people, pregnant women, single parents with minor children and persons who have been subjected to torture, rape or other serious forms of psychological, physical or sexual violence. 4. Paragraph 3 shall apply only to persons found to have special needs after an individual evaluation of their situation. 5. The best interest of the child shall be a primary consideration for Member States when implementing the provisions of this Chapter that involve minors. 6. Within the limits set out by the Geneva Convention, Member States may reduce the benefits of this Chapter, granted to a refugee whose refugee status has been obtained on the basis of activities engaged in for the sole or main purpose of creating the necessary conditions for being recognised as a refugee. 7. Within the limits set out by international obligations of Member States, Member States may reduce the benefits of this Chapter, granted to a person eligible for subsidiary protection, whose subsidiary protection status has been obtained on the basis of activities engaged in for the sole or main purpose of creating the necessary conditions for being recognised as a person eligible for subsidiary protection. Article 21 Protection from refoulement 1. Member States shall respect the principle of non-refoulement in accordance with their international obligations. 2. Where not prohibited by the international obligations mentioned in paragraph 1, Member States may refoule a refugee, whether formally recognised or not, when: (a) there are reasonable grounds for considering him or her as a danger to the security of the Member State in which he or she is present; or (b) he or she, having been convicted by a final judgement of a particularly serious crime, constitutes a danger to the community of that Member State. 3. Member States may revoke, end or refuse to renew or to grant the residence permit of (or to) a refugee to whom paragraph 2 applies. Article 22 Information Member States shall provide persons recognised as being in need of international protection, as soon as possible after the respective protection status has been granted, with access to information, in a language likely to be understood by them, on the rights and obligations relating to that status. Article 23 Maintaining family unity 1. Member States shall ensure that family unity can be maintained. 2. Member States shall ensure that family members of the beneficiary of refugee or subsidiary protection status, who do not individually qualify for such status, are entitled to claim the benefits referred to in Articles 24 to 34, in accordance with national procedures and as far as it is compatible with the personal legal status of the family member. In so far as the family members of beneficiaries of subsidiary protection status are concerned, Member States may define the conditions applicable to such benefits. In these cases, Member States shall ensure that any benefits provided guarantee an adequate standard of living. 3. Paragraphs 1 and 2 are not applicable where the family member is or would be excluded from refugee or subsidiary protection status pursuant to Chapters III and V. 4. Notwithstanding paragraphs 1 and 2, Member States may refuse, reduce or withdraw the benefits referred therein for reasons of national security or public order. 5. Member States may decide that this Article also applies to other close relatives who lived together as part of the family at the time of leaving the country of origin, and who were wholly or mainly dependent on the beneficiary of refugee or subsidiary protection status at that time. Article 24 Residence permits 1. As soon as possible after their status has been granted, Member States shall issue to beneficiaries of refugee status a residence permit which must be valid for at least three years and renewable unless compelling reasons of national security or public order otherwise require, and without prejudice to Article 21(3). Without prejudice to Article 23(1), the residence permit to be issued to the family members of the beneficiaries of refugee status may be valid for less than three years and renewable. 2. As soon as possible after the status has been granted, Member States shall issue to beneficiaries of subsidiary protection status a residence permit which must be valid for at least one year and renewable, unless compelling reasons of national security or public order otherwise require. Article 25 Travel document 1. Member States shall issue to beneficiaries of refugee status travel documents in the form set out in the Schedule to the Geneva Convention, for the purpose of travel outside their territory unless compelling reasons of national security or public order otherwise require. 2. Member States shall issue to beneficiaries of subsidiary protection status who are unable to obtain a national passport, documents which enable them to travel, at least when serious humanitarian reasons arise that require their presence in another State, unless compelling reasons of national security or public order otherwise require. Article 26 Access to employment 1. Member States shall authorise beneficiaries of refugee status to engage in employed or self-employed activities subject to rules generally applicable to the profession and to the public service, immediately after the refugee status has been granted. 2. Member States shall ensure that activities such as employment-related education opportunities for adults, vocational training and practical workplace experience are offered to beneficiaries of refugee status, under equivalent conditions as nationals. 3. Member States shall authorise beneficiaries of subsidiary protection status to engage in employed or self-employed activities subject to rules generally applicable to the profession and to the public service immediately after the subsidiary protection status has been granted. The situation of the labour market in the Member States may be taken into account, including for possible prioritisation of access to employment for a limited period of time to be determined in accordance with national law. Member States shall ensure that the beneficiary of subsidiary protection status has access to a post for which the beneficiary has received an offer in accordance with national rules on prioritisation in the labour market. 4. Member States shall ensure that beneficiaries of subsidiary protection status have access to activities such as employment-related education opportunities for adults, vocational training and practical workplace experience, under conditions to be decided by the Member States. 5. The law in force in the Member States applicable to remuneration, access to social security systems relating to employed or self-employed activities and other conditions of employment shall apply. Article 27 Access to education 1. Member States shall grant full access to the education system to all minors granted refugee or subsidiary protection status, under the same conditions as nationals. 2. Member States shall allow adults granted refugee or subsidiary protection status access to the general education system, further training or retraining, under the same conditions as third country nationals legally resident. 3. Member States shall ensure equal treatment between beneficiaries of refugee or subsidiary protection status and nationals in the context of the existing recognition procedures for foreign diplomas, certificates and other evidence of formal qualifications. Article 28 Social welfare 1. Member States shall ensure that beneficiaries of refugee or subsidiary protection status receive, in the Member State that has granted such statuses, the necessary social assistance, as provided to nationals of that Member State. 2. By exception to the general rule laid down in paragraph 1, Member States may limit social assistance granted to beneficiaries of subsidiary protection status to core benefits which will then be provided at the same levels and under the same eligibility conditions as nationals. Article 29 Health care 1. Member States shall ensure that beneficiaries of refugee or subsidiary protection status have access to health care under the same eligibility conditions as nationals of the Member State that has granted such statuses. 2. By exception to the general rule laid down in paragraph 1, Member States may limit health care granted to beneficiaries of subsidiary protection to core benefits which will then be provided at the same levels and under the same eligibility conditions as nationals. 3. Member States shall provide, under the same eligibility conditions as nationals of the Member State that has granted the status, adequate health care to beneficiaries of refugee or subsidiary protection status who have special needs, such as pregnant women, disabled people, persons who have undergone torture, rape or other serious forms of psychological, physical or sexual violence or minors who have been victims of any form of abuse, neglect, exploitation, torture, cruel, inhuman and degrading treatment or who have suffered from armed conflict. Article 30 Unaccompanied minors 1. As soon as possible after the granting of refugee or subsidiary protection status Member States shall take the necessary measures, to ensure the representation of unaccompanied minors by legal guardianship or, where necessary, by an organisation responsible for the care and well-being of minors, or by any other appropriate representation including that based on legislation or Court order. 2. Member States shall ensure that the minor's needs are duly met in the implementation of this Directive by the appointed guardian or representative. The appropriate authorities shall make regular assessments. 3. Member States shall ensure that unaccompanied minors are placed either: (a) with adult relatives; or (b) with a foster family; or (c) in centres specialised in accommodation for minors; or (d) in other accommodation suitable for minors. In In this context, the views of the child shall be taken into account in accordance with his or her age and degree of maturity. 4. As far as possible, siblings shall be kept together, taking into account the best interests of the minor concerned and, in particular, his or her age and degree of maturity. Changes of residence of unaccompanied minors shall be limited to a minimum. 5. Member States, protecting the unaccompanied minor's best interests, shall endeavour to trace the members of the minor's family as soon as possible. In cases where there may be a threat to the life or integrity of the minor or his or her close relatives, particularly if they have remained in the country of origin, care must be taken to ensure that the collection, processing and circulation of information concerning those persons is undertaken on a confidential basis. 6. Those working with unaccompanied minors shall have had or receive appropriate training concerning their needs. Article 31 Access to accommodation The Member States shall ensure that beneficiaries of refugee or subsidiary protection status have access to accommodation under equivalent conditions as other third country nationals legally resident in their territories. Article 32 Freedom of movement within the Member State Member States shall allow freedom of movement within their territory to beneficiaries of refugee or subsidiary protection status, under the same conditions and restrictions as those provided for other third country nationals legally resident in their territories. Article 33 Access to integration facilities 1. In order to facilitate the integration of refugees into society, Member States shall make provision for integration programmes which they consider to be appropriate or create pre-conditions which guarantee access to such programmes. 2. Where it is considered appropriate by Member States, beneficiaries of subsidiary protection status shall be granted access to integration programmes. Article 34 Repatriation Member States may provide assistance to beneficiaries of refugee or subsidiary protection status who wish to repatriate. CHAPTER VIII ADMINISTRATIVE COOPERATION Article 35 Cooperation Member States shall each appoint a national contact point, whose address they shall communicate to the Commission, which shall communicate it to the other Member States. Member States shall, in liaison with the Commission, take all appropriate measures to establish direct cooperation and an exchange of information between the competent authorities. Article 36 Staff Member States shall ensure that authorities and other organisations implementing this Directive have received the necessary training and shall be bound by the confidentiality principle, as defined in the national law, in relation to any information they obtain in the course of their work. CHAPTER IX FINAL PROVISIONS Article 37 Reports 1. By 10 April 2008, the Commission shall report to the European Parliament and the Council on the application of this Directive and shall propose any amendments that are necessary. These proposals for amendments shall be made by way of priority in relation to Articles 15, 26 and 33. Member States shall send the Commission all the information that is appropriate for drawing up that report by 10 October 2007. 2. After presenting the report, the Commission shall report to the European Parliament and the Council on the application of this Directive at least every five years. Article 38 Transposition 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 10 October 2006. 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 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 covered by this Directive. Article 39 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 Union. Article 40 Addressees This Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.

32004L0037

2004

DIRECTIVE 2004/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (3) has been substantially amended several times (4). In the interests of clarity and rationality, the said Directive should therefore be codified. (2) Compliance with the minimum requirements designed to guarantee a better standard of health and safety as regards the protection of workers from the risks related to exposure to carcinogens or mutagens at work is essential to ensure the health and safety of workers and is also intended to provide a level of minimum protection for all workers in the Community. (3) This Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5). Therefore the provisions of that Directive are fully applicable to the exposure of workers to carcinogens or mutagens, without prejudice to more stringent and/or specific provisions contained in this Directive. (4) A consistent level of protection from the risks related to carcinogens or mutagens has to be established for the Community as a whole and that level of protection has to be set not by detailed prescriptive requirements but by a framework of general principles to enable Member States to apply the minimum requirements consistently. (5) Germ cell mutagens are substances that can cause a permanent change in the amount or structure of the genetic material of a cell resulting in a change in the phenotypic characteristics of that cell, which may be transferred to descendent daughter cells. (6) Because of their mechanism of action, germ cell mutagens are likely to have carcinogenic effects. (7) Annex VI 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 (6) contains the classification criteria and labelling procedures in respect of each substance. (8) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (7) contains particulars on the classification criteria and labelling procedures in respect of such preparations. (9) In all work situations workers must be protected in respect of preparations containing one or more carcinogens or mutagens and from carcinogenic or mutagenic compounds arising at work. (10) For some agents it is necessary to consider all absorption pathways, including the possibility of penetration through the skin, in order to ensure the best possible level of protection. (11) Although current scientific knowledge is not such that a level can be established below which risks to health cease to exist, a reduction in exposure to carcinogens or mutagens will nonetheless reduce those risks. (12) In order to contribute to a reduction in these risks, limit values and other directly related provisions should be established for all those carcinogens or mutagens for which the available information, including scientific and technical data, make this possible. (13) Occupational exposure limit values must be regarded as an important component of the general arrangements for the protection of workers. Such limit values must be revised whenever this becomes necessary in the light of more recent scientific data. (14) The precautionary principle should be applied in the protection of workers' health. (15) Preventive measures must be taken for the protection of the health and safety of workers exposed to carcinogens or mutagens. (16) This Directive constitutes a practical aspect of the realisation of the social dimension of the internal market. (17) Pursuant to Council Decision 74/325/EEC (8), the Commission consulted the Advisory Committee on Safety and Health at Work with a view to drawing up proposals for the Directives taken over in this Directive. (18) This Directive is without prejudice to the obligations of the Member States concerning the time limits for transposition set out in Part B of Annex IV, CHAPTER I GENERAL PROVISIONS Article 1 Objective 1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagens at work. It lays down particular minimum requirements in this area, including limit values. 2. This Directive shall not apply to workers exposed only to radiation covered by the Treaty establishing the European Atomic Energy Community. 3. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. 4. As regards asbestos, which is dealt with by Directive 83/477/EEC (9), the provisions of this Directive shall apply whenever they are more favourable to health and safety at work. Article 2 Definitions For the purposes of this Directive, a) "carcinogen" means: i) a substance which meets the criteria for classification as a category 1 or 2 carcinogen set out in Annex VI to Directive 67/548/EEC; ii) a preparation composed of one or more substances referred to in point (i) where the concentration of one or more of the individual substances meets the requirements for concentration limits for the classification of a preparation as a category 1 or 2 carcinogen set out either: in Annex I to Directive 67/548/EEC; or in Part B of Annex II to Directive 1999/45/EC where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; iii) a substance, preparation or process referred to in Annex I to this Directive as well as a substance or preparation released by a process referred to in that Annex; b) "mutagen" means: i) a substance which meets the criteria for classification as a category 1 or 2 mutagen set out in Annex VI to Directive 67/548/EEC; ii) a preparation composed of one or more substances referred to in point (i) where the concentration of one or more of the individual substances meets the requirements for concentration limits for the classification of a preparation as a category 1 or 2 mutagen set out in either: Annex I to Directive 67/548/EEC; or Part B of Annex II to Directive 1999/45/EC where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; c) "limit value" means, unless otherwise specified, the limit of the time-weighted average of the concentration for a "carcinogen or mutagen" in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III to this Directive. Article 3 Scope — determination and assessment of risks 1. This Directive shall apply to activities in which workers are or are likely to be exposed to carcinogens or mutagens as a result of their work. 2. In the case of any activity likely to involve a risk of exposure to carcinogens or mutagens, the nature, degree and duration of workers' exposure shall be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken. The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens or mutagens. The employer shall supply the authorities responsible at their request with the information used for making the assessment. 3. When assessing the risk, account shall be taken of all other routes of exposure, such as absorption into and/or through the skin. 4. When the risk assessment is carried out, employers shall give particular attention to any effects concerning the health or safety of workers at particular risk and shall, inter alia, take account of the desirability of not employing such workers in areas where they may come into contact with carcinogens or mutagens. CHAPTER II EMPLOYERS' OBLIGATIONS Article 4 Reduction and replacement 1. The employer shall reduce the use of a carcinogen or mutagen at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, preparation or process which, under its conditions of use, is not dangerous or is less dangerous to workers' health or safety, as the case may be. 2. The employer shall, upon request, submit the findings of his investigations to the relevant authorities. Article 5 Prevention and reduction of exposure 1. Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, workers' exposure must be prevented. 2. Where it is not technically possible to replace the carcinogen or mutagen by a substance, preparation or process which, under its conditions of use, is not dangerous or is less dangerous to health or safety, the employer shall ensure that the carcinogen or mutagen is, in so far as is technically possible, manufactured and used in a closed system. 3. Where a closed system is not technically possible, the employer shall ensure that the level of exposure of workers is reduced to as low a level as is technically possible. 4. Exposure shall not exceed the limit value of a carcinogen as set out in Annex III. 5. Wherever a carcinogen or mutagen is used, the employer shall apply all the following measures: a) limitation of the quantities of a carcinogen or mutagen at the place of work; b) keeping as low as possible the number of workers exposed or likely to be exposed; c) design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or mutagens into the place of work; d) evacuation of carcinogens or mutagens at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment; e) use of existing appropriate procedures for the measurement of carcinogens or mutagens, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident; f) application of suitable working procedures and methods; g) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures; h) hygiene measures, in particular regular cleaning of floors, walls and other surfaces; i) information for workers; j) demarcation of risk areas and use of adequate warning and safety signs including "no smoking" signs in areas where workers are exposed or likely to be exposed to carcinogens or mutagens; k) drawing up plans to deal with emergencies likely to result in abnormally high exposure; l) means for safe storage, handling and transportation, in particular by using sealed and clearly and visibly labelled containers; m) means for safe collection, storage and disposal of waste by workers, including the use of sealed and clearly and visibly labelled containers. Article 6 Information for the competent authority Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on: a) the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagens are used; b) the quantities of substances or preparations manufactured or used which contain carcinogens or mutagens; c) the number of workers exposed; d) the preventive measures taken; e) the type of protective equipment used; f) the nature and degree of exposure; g) the cases of replacement. Article 7 Unforeseen exposure 1. In the event of an unforeseeable event or an accident which is likely to result in an abnormal exposure of workers, the employer shall inform the workers thereof. 2. Until the situation has been restored to normal and the causes of the abnormal exposure have been eliminated: a) only those workers who are essential to the carrying out of repairs and other necessary work shall be permitted to work in the affected area; b) the workers concerned shall be provided with protective clothing and individual respiratory protection equipment which they must wear; the exposure may not be permanent and shall be kept to the strict minimum of time necessary for each worker; c) unprotected workers shall not be allowed to work in the affected area. Article 8 Foreseeable exposure 1. For certain activities such as maintenance, in respect of which it is foreseeable that there is the potential for a significant increase in exposure of workers, and in respect of which all scope for further technical preventive measures for limiting workers' exposure has already been exhausted, the employer shall determine, after consultation of the workers and/or their representatives in the undertaking or establishment, without prejudice to the employer's responsibility, the measures necessary to reduce the duration of workers' exposure to the minimum possible and to ensure protection of workers while they are engaged in such activities. Pursuant to the first subparagraph, the workers concerned shall be provided with protective clothing and individual respiratory protection equipment which they must wear as long as the abnormal exposure persists; that exposure may not be permanent and shall be kept to the strict minimum of time necessary for each worker. 2. Appropriate measures shall be taken to ensure that the areas in which the activities referred to in the first subparagraph of paragraph 1 take place are clearly demarcated and indicated or that unauthorised persons are prevented by other means from having access to such areas. Article 9 Access to risk areas Appropriate measures shall be taken by employers to ensure that access to areas in which the activities in respect of which the results of the assessment referred to in Article 3(2) reveal a risk to workers' safety or health take place are accessible solely to workers who, by reason of their work or duties, are required to enter them. Article 10 Hygiene and individual protection 1. Employers shall be obliged, in the case of all activities for which there is a risk of contamination by carcinogens or mutagens, to take appropriate measures to ensure that: a) workers do not eat, drink or smoke in working areas where there is a risk of contamination by carcinogens or mutagens; b) workers are provided with appropriate protective clothing or other appropriate special clothing; c) separate storage places are provided for working or protective clothing and for street clothes; d) workers are provided with appropriate and adequate washing and toilet facilities; e) protective equipment is properly stored in a well-defined place and is checked and cleaned if possible before, and in any case after, each use; f) defective equipment is repaired or replaced before further use. 2. Workers may not be charged for the cost of the measures set out in paragraph 1. Article 11 Information and training of workers 1. Appropriate measures shall be taken by the employer to ensure that workers and/or workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning: a) potential risks to health, including the additional risks due to tobacco consumption; b) precautions to be taken to prevent exposure; c) hygiene requirements; d) wearing and use of protective equipment and clothing; e) steps to be taken by workers, including rescue workers, in the case of incidents and to prevent incidents. The training shall be: adapted to take account of new or changed risk; and repeated periodically if necessary. 2. Employers shall inform workers of installations and related containers containing carcinogens or mutagens, ensure that all containers, packages and installations containing carcinogens or mutagens are labelled clearly and legibly, and display clearly visible warning and hazard signs. Article 12 Information for workers Appropriate measures shall be taken to ensure that: a) workers and/or any workers' representatives in the undertaking or establishment can check that this Directive is applied or can be involved in its application, in particular with regard to: i) the consequences for workers' safety and health of the selection, wearing and use of protective clothing and equipment, without prejudice to the employer's responsibility for determining the effectiveness of protective clothing and equipment; ii) the measures determined by the employer which are referred to in the first subparagraph of Article 8(1), without prejudice to the employer's responsibility for determining such measures; b) workers and/or any workers' representatives in the undertaking or establishment are informed as quickly as possible of abnormal exposures, including those referred to in Article 8, of the causes thereof and of the measures taken or to be taken to rectify the situation; c) the employer keeps an up-to-date list of the workers engaged in the activities in respect of which the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, indicating, if the information is available, the exposure to which they have been subjected; d) the doctor and/or the competent authority as well as all other persons who have responsibility for health and safety at work have access to the list referred to in point (c); e) each worker has access to the information on the list which relates to him personally; f) workers and/or any workers' representatives in the undertaking or establishment have access to anonymous collective information. Article 13 Consultation and participation of workers Consultation and participation of workers and/or their representatives in connection with matters covered by this Directive shall take place in accordance with Article 11 of Directive 89/391/EEC. CHAPTER III MISCELLANEOUS PROVISIONS Article 14 Health surveillance 1. The Member States shall establish, in accordance with national laws and/or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3(2) reveal a risk to health or safety. 2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance: prior to exposure; at regular intervals thereafter. Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures. 3. If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens or mutagens, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance. In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3(2). 4. In cases where health surveillance is carried out, an individual medical record shall be kept and the doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual workers. 5. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure. 6. In accordance with national laws and/or practice: workers shall have access to the results of the health surveillance which concern them; and the workers concerned or the employer may request a review of the results of the health surveillance. 7. Practical recommendations for the health surveillance of workers are given in Annex II. 8. All cases of cancer identified in accordance with national laws and/or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority. Article 15 Record-keeping 1. The list referred to in point (c) of Article 12 and the medical record referred to in Article 14(4) shall be kept for at least 40 years following the end of exposure, in accordance with national laws and/or practice. 2. Those documents shall be made available to the responsible authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice. Article 16 Limit values 1. The Council shall, in accordance with the procedure laid down in Article 137(2) of the Treaty, set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible, and, where necessary, other directly related provisions. 2. Limit values and other directly related provisions are set out in Annex III. Article 17 Annexes 1. Annexes I and III may be amended in accordance only with the procedure laid down in Article 137(2) of the Treaty. 2. Purely technical adjustments to Annex II in the light of technical progress, changes in international regulations or specifications and new findings in the field of carcinogens or mutagens shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 18 Use of data The Commission shall have access to the use made by the competent national authorities of the information referred to in Article 14(8). Article 19 Notifying the Commission Member States shall communicate to the Commission the provisions of national law which they adopt in the future in the field governed by this Directive. Article 20 Repeal Directive 90/394/EEC, as amended by the Directives referred to in Annex IV, Part A of this Directive is repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition set out in Annex IV, Part B of this Directive. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V. Article 21 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 Union. Article 22 Addressees This Directive is addressed to the Member States.

32004L0050

2004

DIRECTIVE 2004/50/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 amending Council Directive 96/48/EC on the interoperability of the trans-European high-speed rail system and Directive 2001/16/EC of the European Parliament and of the Council on the interoperability of the trans-European conventional rail system Having regard to the Treaty establishing the European Community, and in particular Articles 71 and 156 thereof, Having regard to the Commission proposal (1), Having regard to the Opinion of the European Economic and Social Committee (2), Having regard to the Opinion of the Committee of the Regions (3), Acting in accordance with the procedure referred to in Article 251 of the Treaty (4), in the light of the joint text approved by the Conciliation Committee on 23 March 2004, Whereas: (1) Under Articles 154 and 155 of the Treaty, the Community must contribute to the establishment and development of trans-European networks in the transport sector. In order to achieve these objectives, the Community must take any action necessary to ensure the interoperability of the networks, particularly in the field of technical standardisation. (2) An initial measure was taken in the rail sector with the adoption of Directive 96/48/EC (5). In order to implement the objectives of that Directive, technical specifications for interoperability (TSIs) have been drafted by the European Association for Railway Interoperability (AEIF), which was designated as the joint representative body in the framework of that Directive, and adopted by the Commission on 30 May 2002. (3) On 10 September 1999 the Commission adopted a report to the European Parliament and the Council which gave an initial assessment of progress made in implementing the interoperability of the trans-European high-speed rail system. In its Resolution of 17 May 2000 (6), the European Parliament called on the Commission to submit proposals for amending Directive 96/48/EC on the basis of the model used for Directive 2001/16/EC (7). (4) Directive 2001/16/EC, like Directive 96/48/EC, introduces Community procedures for the preparation and adoption of TSIs, and common rules for assessing conformity with the TSIs. A mandate for the development of the first group of TSIs has been given to the AEIF, also designated as the Joint Representative Body. (5) A number of lessons have been learned from the work on developing TSIs in the high-speed sector, the application of Directive 96/48/EC to specific projects and the work of the committee set up under that Directive, which have led the Commission to propose changes to the two Directives on railway interoperability. (6) The adoption of Regulation (EC) No .../2004 of the European Parliament and of the Council of ... establishing a European Railway Agency (Agency Regulation) (8) and of Directive 2004/.../EC of the European Parliament and of the Council of ... on safety on the Community's railways (Railway Safety Directive) (9) means that certain provisions of Directives 96/48/EC and 2001/16/EC need to be amended. In particular, once the Agency is established, the task of drafting any new or revised TSIs will be entrusted to it by the Commission. (7) The entry into force of Directives 2001/12/EC of the European Parliament and of the Council of 26 February 2001 amending Council Directive 91/440/EEC on the development of the Community's railways (10), 2001/13/EC of the European Parliament and of the Council of 26 February 2001 amending Council Directive 95/18/EC on the licensing of railway undertakings (11) and 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (12) has an impact on the implementation of interoperability. As in the case of other transport modes, the extension of access rights must be accompanied by the requisite harmonisation measures. It is therefore necessary to implement interoperability on the whole network by extending progressively the geographical scope of Directive 2001/16/EC. It is also necessary to extend the legal basis of Directive 2001/16/EC to Article 71 of the Treaty, on which Directive 2001/12/EC is founded. (8) The White Paper on European transport policy announces this Directive, which is part of the Commission's strategy to revitalise rail transport and, consequently, to shift the balance between transport modes, with the ultimate objective of reducing congestion on Europe's roads. (9) The TSIs developed in the framework of Directive 96/48/EC do not explicitly concern the work on renewing infrastructure and rolling stock, or replacements in the context of preventive maintenance. This is the case, however, under Directive 2001/16/EC on the conventional rail system, and the two Directives should be harmonised on this point. (10) The development of TSIs in the high-speed sector has shown the need to clarify the relationship between the essential requirements of Directive 96/48/EC and the TSIs, on the one hand, and the European standards and other documents of a normative nature on the other. In particular, a clear distinction should be drawn between the standards or parts of standards which must be made mandatory in order to achieve the objectives of that Directive, and the "harmonised" standards that have been developed in the spirit of the new approach to technical harmonisation and standardisation. (11) As a rule, the European specifications are developed in the spirit of the new approach to technical harmonisation and standardisation. They enable a presumption to be made of conformity with certain essential requirements of Directive 96/48/EC, particularly in the case of interoperability constituents and interfaces. These European specifications, or the applicable parts thereof, are not mandatory and no explicit reference to these specifications may be made in the TSIs. References to these European specifications are published in the Official Journal of the European Union, and Member States publish the references to the national standards transposing the European standards. (12) TSIs may in certain cases make an explicit reference to European standards or specifications where this is strictly necessary in order to achieve the objectives of this Directive. Such explicit reference has consequences which must be made clear, in particular, these European standards or specifications become mandatory from the moment the TSI is applicable. (13) The TSI sets all the conditions with which an interoperability constituent must conform, and the procedure to be followed in assessing conformity. In addition, it is necessary to specify that every constituent must undergo the procedure for assessing conformity and suitability for the use indicated in the TSIs and have the corresponding certificate. (14) It is necessary for safety reasons to require Member States to assign an identification code to each vehicle placed in service. The vehicle should then be entered in a national vehicle register. The registers must be open to consultation by all Member States and by certain Community economic players. The registers should be consistent as regards the data format. They should therefore be covered by common operational and technical specifications. (15) The procedure to be followed in the case of essential requirements applicable to a subsystem which have not yet been covered by detailed specifications in the corresponding TSI should be specified. In such case, the bodies responsible for the conformity assessment and verification procedures should be those already notified under Article 20 of Directives 96/48/EC and 2001/16/EC. (16) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (13). (17) The definition of rolling stock in Annex I to Directive 96/48/EC should be clarified. The Directive should also concern rolling stock designed to operate only on track upgraded for high speeds, at speeds of the order of 200 km/h. (18) The application of this Directive should, as far as possible, preserve the work already undertaken in the framework of Directives 96/48/EC and 2001/16/EC and the application of these Directives by Member States in the framework of projects which are at an advanced stage of development when this Directive enters into force. (19) Since the objective of the proposed action, namely the interoperability of the trans-European rail system, cannot be sufficiently achieved by the Member States and can therefore, by reason of its trans-European character as recognised by the Treaty, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (20) TSIs applicable to the high-speed rail system concerning infrastructure, rolling stock, energy, control, command and signalling, operation and maintenance were adopted on 30 May 2002 by the Commission. The draft TSIs referred to in Article 1(5) and 2(5) pertain to the revision of these TSIs or to the adoption of new TSIs. (21) Since a draft reference system of technical rules concerning the current degree of interoperability of the trans-European conventional rail system is being developed as provided for in Article 25 of Directive 2001/16/EC, there is a need to update these technical rules in view of the extension of the scope of that Directive and also taking account of the first group of TSIs to be adopted by 2004. (22) Notwithstanding the exemptions from the scope of Directive 2001/16/EC, the voluntary application of the relevant provisions of that Directive by the Member States at national level should be encouraged, with a view to increasing cost efficiency and economies of scale in the manufacturing sector. (23) It is therefore necessary to amend Directives 96/48/EC and 2001/16/EC, Article 1 Directive 96/48/EC is hereby amended as follows: 1) Article 1 shall be replaced by the following: "Article 1 1. The aim of this Directive is to establish the conditions to-be met to achieve interoperability within Community territory of the trans-European high-speed rail system as described in Annex I. These conditions concern the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of this system placed in service after ... (14), as well as the qualifications and health and safety conditions of the staff who contribute to its operation. 2. The pursuit of this objective must lead to the definition of an optimal level of technical harmonisation and make it possible to: (a) facilitate, improve and develop international rail transport services within Community territory and with third countries; (b) contribute to the gradual creation of the internal market in equipment and services for the construction, operation, renewal and upgrading of the trans-European high-speed rail system; (c) contribute to the interoperability of the trans-European high-speed rail system.". 2) the following points shall be added to Article 2: "(j) "basic parameter" means any regulatory, technical or operational condition which is critical to interoperability and requires a decision or recommendation in accordance with the procedure laid down in Article 21(2) before any development of complete draft TSIs; (k) "specific case" means any part of the trans-European high-speed rail system which needs special provisions in the TSIs, either temporary or definitive, because of geographical, topographical or urban environment constraints or those affecting compatibility with the existing system. This may include in particular railway lines and networks isolated from the rest of the Community territory, the loading gauge, the track gauge or space between the tracks; (l) "upgrading" means any major modification work on a subsystem or part subsystem which improves the overall performance of the subsystem; (m) "substitution in the framework of maintenance" means any replacement of components by parts of identical function and performance in the framework of preventive or corrective maintenance; (n) "renewal" means any major substitution work on a subsystem or part subsystem which does not change the overall performance of the subsystem; (o) "existing rail system" means the structure composed of the railway infrastructures, comprising lines and fixed installations of the existing rail system plus the existing rolling stock of all categories and origin travelling on that infrastructure; (p) "placing in service" means all the operations by which a subsystem is put into its design operating state."; 3) Article 2(h) shall be deleted. 4) Article 5 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. Each of the subsystems shall be covered by one TSI. Where necessary, a subsystem may be covered by several TSIs and one TSI may cover several subsystems. The decision to develop and/or to review a TSI and the choice of its technical and geographical scope requires a mandate in accordance with Article 6(1)."; (b) paragraph 3 shall be replaced by the following: "3. To the extent necessary in order to achieve the objectives referred to in Article 1, each TSI shall: (a) indicate its intended scope (part of network or rolling stock referred to in Annex I, subsystem or part of subsystem referred to in Annex II); (b) lay down essential requirements for each subsystem concerned and its interfaces vis-à-vis other subsystems; (c) establish the functional and technical specifications to be met by the subsystem and its interfaces vis-à-vis other subsystems. If need be, these specifications may vary according to the use of the subsystem, for example according to the categories of line and/or rolling stock provided for in Annex I; (d) determine the interoperability constituents and interfaces which must be covered by European specifications, including European standards, which are necessary to achieve interoperability within the trans-European high speed rail system; (e) state, in each case under consideration, which procedures are to be used in order to assess the conformity or the suitability for use of the interoperability constituents, on the one hand, or the EC verification of the subsystems, on the other hand. These procedures shall be based on the modules defined in Decision 93/465/EEC; (f) indicate the strategy for implementing the TSIs. In particular, it is necessary to specify the stages to be completed in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSIs shall be the norm; (g) indicate, for the staff concerned, the professional competences and health and safety conditions at work required for the operation and maintenance of the subsystem, as well as for the implementation of the TSIs."; (c) the following paragraph shall be inserted: "6. TSIs may make an explicit, clearly identified reference to European standards or specifications where this is strictly necessary in order to achieve the objectives of this Directive. In such case, these European standards or specifications (or the relevant parts thereof) shall be regarded as annexes to the TSI concerned and shall become mandatory from the moment the TSI is applicable. In the absence of European standards or specifications and pending their development, reference may be made to other clearly identified normative documents; in such case, this shall concern documents that are easily accessible and in the public domain."; 5) Article 6 shall be replaced by the following: "Article 6 1. Draft TSIs and subsequent amendments to TSIs shall be drafted under a mandate from the Commission in accordance with the procedure set out in Article 21(2). They shall be drafted under the responsibility of the Agency in accordance with Articles 3 and 12 of Regulation (EC) No 2004/ /EC of the European Parliament and of the Council of establishing a European Railway Agency (Agency Regulation) (15) and in cooperation with the Working Parties mentioned in those Articles. TSIs shall be adopted and reviewed in accordance with the procedure set out in Article 21(2). They shall be published by the Commission in the Official Journal of the European Union. 2. The Agency shall be responsible for preparing the review and updating of TSIs and making any recommendations to the Committee referred to in Article 21 in order to take account of developments in technology or social requirements. 3. Each draft TSI shall be drawn up in two stages. First of all, the Agency shall identify the basic parameters for the TSI as well as the interfaces with the other subsystems and any other specific cases that may be necessary. The most viable alternative solutions accompanied by technical and economic justification shall be put forward for each of these parameters and interfaces. A decision shall be taken in accordance with the procedure set out in Article 21(2); if necessary, specific cases shall be cited. The Agency shall then draw up the draft TSI on the basis of these basic parameters. Where appropriate, the Agency shall take account of technical progress, of standardisation work already carried out, of working parties already in place and of acknowledged research work. An overall assessment of the estimated costs and benefits of the implementation of the TSIs shall be attached to the draft TSI; this assessment shall indicate the likely impact for all the operators and economic agents involved. 4. The drafting, adoption and review of each TSI (including the basic parameters) shall take account of the estimated costs and benefits of all the technical solutions considered, together with the interfaces between them, so as to establish and implement the most viable solutions. The Member States shall participate in this assessment by providing the requisite data. 5. The Committee referred to in Article 21 shall be kept regularly informed of the preparatory work on the TSIs. During this work the Committee may formulate any terms of reference or useful recommendations concerning the design of the TSIs and the cost-benefit analysis. In particular, the Committee may, at the request of a Member State, require that alternative solutions be examined and that the assessment of the cost and benefits of these alternative solutions be set out in the report annexed to the draft TSI. 6. On the adoption of each TSI, the date of entry into force of that TSI shall be established in accordance with the procedure set out in Article 21(2). Where different subsystems have to be placed in service simultaneously for reasons of technical compatibility, the dates of entry into force of the corresponding TSIs shall be the same. 7. The drafting, adoption and review of the TSIs shall take account of the opinion of users, as regards the characteristics which have a direct impact on the conditions in which they use the subsystems. To that end the Agency shall consult associations and bodies representing users during the drafting and review phases of the TSIs. They shall enclose with the draft TSI a report on the results of this consultation. The list of associations and bodies to be consulted shall be finalised by the Committee referred to in Article 21 before it adopts the mandate to review the TSIs and may be re-examined and updated at the request of a Member State or the Commission. 8. The drafting, adoption and review of the TSIs shall take account of the opinion of the social partners as regards the conditions referred to in Article 5(3)(g). To this end, the social partners shall be consulted before the draft TSI is submitted, for adoption or review, to the Committee referred to in Article 21. The social partners shall be consulted in the context of the sectoral dialogue committee set up in accordance with Commission Decision 98/500/EC (16). The social partners shall issue their opinion within three months. (15) OJ L" (16) OJ L 225,12.8.1998, p. 27.";" 6) Article 7 shall be replaced by the following: "Article 7 A Member State need not apply one or more TSIs, including those relating to rolling stock, in the following cases and circumstances: (a) for a proposed new line, for the renewal or upgrading of an existing line, or for any element referred to Article 1(1) at an advanced stage of development or the subject of a contract in course of performance when these TSIs are published; (b) for any project concerning the renewal or upgrading of an existing line where the loading gauge, track gauge, space between the tracks, or electrification voltage in these TSIs is not compatible with those of the existing line; (c) for a proposed new line or for the proposed renewal or upgrading of an existing line in the territory of that Member State when its rail network is separated or isolated by the sea from the rail network of the rest of the Community territory; (d) for any proposed renewal, extension or upgrading of an existing line, when the application of these TSIs would compromise the economic viability of the project and/or the compatibility of the rail system in the Member State; (e) where, following an accident or a natural disaster, the conditions for the rapid restoration of the network do not economically or technically allow for partial or total application of the relevant TSIs; In all cases, the Member State concerned shall serve prior notice of its intended derogation to the Commission and shall forward to it a file setting out the TSIs or the parts of TSIs that it does not wish to be applied as well as the corresponding specifications that it does wish to apply. The Commission shall analyse the measures envisaged by the Member State. In cases (b) and (d), the Commission shall take a decision in accordance with the procedure set out in Article 21(2). Where necessary, a recommendation shall be drawn up concerning the specifications to be applied. Nevertheless, in the case of (b) the Commission's decision shall not refer to the loading gauge and the track gauge."; 7) the following subparagraph shall be added to Article 9: "In particular, they may not require checks which have already been carried out as part of the procedure leading to the "EC" declaration of conformity or suitability for use."; 8) Article 10 shall be amended as follows: (a) paragraph 2 shall be replaced by the following: "2. All interoperability constituents shall be subject to the procedure for assessing conformity and suitability for the use indicated in the respective TSI and be accompanied by the corresponding certificate."; (b) paragraph 3 shall be replaced by the following: "3. Member States shall consider that an interoperability constituent meets the essential requirements if it complies with the conditions laid down by the corresponding TSI or the European specifications developed to comply with these conditions."; (c) paragraphs 4 and 5 shall be deleted; 9) Article 11 shall be replaced by the following: "Article 11 Where it appears to a Member State or the Commission that European specifications used directly or indirectly for the purposes of this Directive do not meet the essential requirements, partial or total withdrawal of the specifications concerned from the publications containing them, or their amendment, may be decided upon in accordance with the procedure set out in Article 21(2) after consultation of the Committee set up under Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services (17). (17) OJ L 204,21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18)";" 10) Article 14 shall be replaced by the following: "Article 14 1. Each Member State shall authorise the placing in service of those structural subsystems constituting the trans-European high-speed rail system which are located or operated in its territory. To this end, each Member State shall take all appropriate steps to ensure that these subsystems may be placed in service only if they are designed, constructed and installed in such a way that they do not compromise compliance with the essential requirements concerning them when integrated into the trans-European high-speed rail system. In particular, each Member State shall check the compatibility of these subsystems with the system into which they are being integrated. 2. Each Member State shall check, when the subsystems are placed in service and at regular intervals thereafter, that they are operated and maintained in accordance with the essential requirements concerning them. To that end, the assessment and verification procedures laid down in the respective structural and functional TSIs shall be used. 3. In the event of renewal or upgrading, the infrastructure manager or the railway undertaking shall send the Member State concerned a file describing the project. The Member State shall examine this file and, taking account of the implementation strategy indicated in the applicable TSI, shall decide whether the size of the works means that a new authorisation for placing in service within the meaning of this Directive is needed. Such new authorisation for placing in service shall be required whenever the overall safety level of the subsystem concerned may be affected by the works envisaged. 4. Where Member States authorise the placing in service of rolling stock, they shall be responsible for ensuring that an alphanumeric identification code is assigned to each vehicle. This code must be marked on each vehicle and be entered in a national vehicle register that meets the following criteria: (a) the register shall comply with the common specifications defined in paragraph 5; (b) the register shall be kept and updated by a body independent of any railway undertaking; (c) the register shall be accessible to the safety authorities and the investigating bodies designated in Articles 16 and 21 of Directive 2004/xxx/EC of the European Parliament and of the Council ofon safety on the Community's railways (Railway Safety Directive) (18); it shall also be made accessible, in response to any legitimate request, to the regulatory bodies designated in Article 30 of Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (19), to the Agency, to the railway companies and to the infrastructure managers. In case of rolling stock placed in service for the first time in a third country, Member States may accept vehicles clearly identified according to a different coding system. However, once a Member State has authorised the placing in service of such vehicles on its territory, it must be possible to retrieve the corresponding data, listed below in paragraph 5(c), (d) and (e), through the register. 5. The common specifications for the register shall be adopted in accordance with the procedure set out in Article 21(2), on the basis of the draft specifications prepared by the Agency. These draft specifications shall include: content, data format, functional and technical architecture, operating mode, and rules for data input and consultation. The register shall contain at least the following information: (a) references to the "EC" declaration of verification and the issuing body; (b) references to the register of rolling stock mentioned in Article 22a; (c) identification of the owner of the vehicle or the lessee; (d) any restrictions on how the vehicle may be used; (e) safety-critical data relating to the maintenance schedule of the vehicle. (18) OJ L" (19) OJ L 75,15.3.2001, p. 29. Directive as amended by Commission Decision 2002/844/EC (OJ L 289,26.10.2002, p. 30)";" 11) the following subparagraph shall be added to Article 15: "In particular, they may not require checks which have already been carried out as part of the procedure leading to the "EC" declaration of verification."; 12) Article 16(3) shall be replaced by the following: "3. In the absence of TSIs, and including cases when a derogation has been notified under Article 7, Member States shall send the other Member States and the Commission, for each subsystem, a list of the technical rules in use for implementing the essential requirements. This shall be notified by ... (20) and thereafter each time the list of technical rules is changed. On that occasion, Member States shall also designate the bodies responsible for carrying out, in the case of these technical regulations, the verification procedure referred to in Article 18."; 13) the following subparagraph shall be added to Article 17: "In such a case, the TSIs shall be reviewed in accordance with Article 6(2). If certain technical aspects corresponding to the essential requirements cannot be explicitly covered in a TSI, they shall be clearly identified in an annex to the TSI. Article 16(3) shall apply to these aspects."; 14) the following subparagraph shall be added to Article 18(2): "They shall also cover verification of the interfaces of the subsystem in question in relation to the system in which it is integrated, on the basis of the information available in the respective TSI and the registers defined in Article 22a."; 15) Article 20(5) shall be replaced by the following: "5. The Commission shall set up a notified bodies coordination group (hereinafter the "coordination group") which shall discuss any matter relating to the application of the procedures for assessing conformity or suitability for the use referred to in Article 13 and the verification procedure referred to in Article 18, or to the application of the relevant TSIs. Member States' representatives may take part in the work of the coordination group as observers. The Commission and the observers shall inform the committee referred to in Article 21 of the work carried out in the framework of the coordination group. The Commission, when appropriate, will propose the measures needed to remedy the problems. Where necessary, coordination of the notified bodies shall be implemented in accordance with Article 21."; 16) Article 21 shall be replaced by the following: "Article 21 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (21) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. 4. Should it prove necessary, the Committee may set up working parties to assist it in carrying out its tasks, in particular with a view to coordinating the notified bodies. (21) OJ L 184,17.7.1999, p. 23.";" 17) the following Articles shall be inserted: "Article 21a 1. The Committee may discuss any matter relating to the interoperability of the trans-European high-speed rail system, including questions relating to interoperability between this system and the rail system of third countries. 2. The Committee may discuss any matter relating to the implementation of this Directive. If necessary, the Commission shall adopt an implementing recommendation in accordance with the procedure set out in Article 21(2). Article 21b 1. The Commission may decide, on its own initiative or at the request of a Member State, in accordance with the procedure set out in Article 21(2), to mandate the drafting of a TSI for an additional subject, insofar as it concerns a subsystem mentioned in Annex II. 2. In accordance with the procedure set out in Article 21(2), the Committee shall, on the basis of a proposal by the Commission, adopt a work programme conforming to the objectives of this Directive and Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the trans-European conventional rail system (22). Article 21c Annexes II to VI may be amended in accordance with the procedure set out in Article 21(2). (22) OJ L 110,20.4.2001, p. 1.";" 18) the following Article shall be inserted: "Article 22a 1. Member States shall ensure that a register of infrastructure and a register of rolling stock are published and updated annually. These registers shall indicate the main features of each subsystem or part subsystem involved, e.g. the basic parameters, and their correlation with the features laid down by the applicable TSIs. To that end, each TSI shall indicate precisely which information must be included in the registers of infrastructure and of rolling stock. 2. A copy of those registers shall be sent to the Member States concerned and to the Agency and shall be made available for consultation by interested parties, including at least the professional actors from the sector."; 19) Annex I shall be replaced by the text in Annex I to this Directive; 20) Annex II shall be replaced by the text in Annex II to this Directive; 21) the following point shall be added to Annex III: "2.4.4. Controls Trains must be equipped with a recording device. The data collected by this device and the processing of the information must be harmonised." 22) the following subparagraph shall be added to Annex VII, point 2: "In particular, the body and the staff responsible for the checks must be functionally independent of the authorities designated to issue authorisations for placing in service in the framework of this Directive, licences in the framework of Council Directive 95/18/EC of 19 June 1995 on the licensing of railway undertakings (23) and safety certificates in the framework of Directive 200./../EC (24), and of the bodies in charge of investigations in the event of accidents. (23) OJ L 143, 27.6.1995, p. 70. Directive as amended by Directive 2001/13/EC of the European Parliament and of the Council (OJ L 75, 15.3.2001, p. 26)."" Article 2 Directive 2001/16/EC is hereby amended as follows: 1) the title shall be replaced by the following: "Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the conventional rail system"; 2) Article 1 is hereby amended as follows: (a) Paragraph 1 shall be replaced by the following: "This Directive sets out to establish the conditions to be met to achieve interoperability within the Community territory of the trans-European conventional rail system, as described in Annex I. These conditions concern the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of this system placed in service after the date of entry into force of this Directive, as well as the professional qualifications and health and safety conditions of the staff who contribute to its operation and maintenance."; (b) the introductory part of paragraph 2 shall be replaced by the following: "2. The pursuit of this objective must lead to the definition of an optimal level of technical harmonisation and make it possible to:"; (c) the following paragraph shall be added: "3. The scope of this Directive shall be progressively extended to the whole conventional rail system, including track access to terminals and main port facilities serving or potentially serving more than one user, except for infrastructure and rolling stock reserved for a strictly local, historical or touristic use or infrastructure which is functionally isolated from the rest of the rail system, and without prejudice to the derogations to the application of TSIs as listed in Article 7. This Directive shall be applied to the parts of the network which are not yet covered by paragraph 1 only from the date of entry into force of the corresponding TSIs to be adopted in accordance with the procedure described below and for the fields of application set by them. The Commission shall adopt, following the procedure set out in Article 21(2), by 1 January 2006 a work programme aiming at the development of new TSIs and/or the review of TSIs already adopted with a view to covering the lines and rolling stock not yet covered. This work programme will indicate a first group of new TSIs and/or amendments to TSIs to be developed by January 2009, without prejudice to Article 5(5) as regards the possibility of providing for specific cases and without prejudice to Article 7 allowing for derogations in particular circumstances. The choice of the subjects to be covered by the TSIs will be based on the expected cost-effectiveness of each proposed measure and on the principle of proportionality of measures taken at Community level. To this end, appropriate consideration will be given to Annex I point 4 and the necessary balance between, on one hand, the objectives of uninterrupted movement of trains and of technical harmonisation, and, on the other hand, the trans-European, national, regional or local level of traffic considered. After the development of this first group of TSIs, the identification of the priorities for the development of new TSIs or the revision of existing TSIs will be adopted following the procedure set out in Article 21(2). A Member State need not apply this paragraph in the case of projects at an advanced stage of development or subject to a contract in the course of performance when the relevant group of TSIs are published."; 3) Article 2 shall be amended as follows: (a) point (h) shall be deleted. (b) points (1) and (m) shall be replaced by the following: "(l) "upgrading" means any major modification work on a subsystem or part subsystem which improves the overall performance of the subsystem; (m) "renewal" means any major substitution work on a subsystem or part subsystem which does not change the overall performance of the subsystem;"; (c) the following points shall be added: "(o) "substitution in the framework of maintenance" means any replacement of components by parts of identical function and performance in the framework of preventive or corrective maintenance; (p) "placing in service" means all the operations by which a subsystem is put into its design operating state"; 4) Article 5 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. Each of the subsystems shall be covered by one TSI. Where necessary, a subsystem may be covered by several TSIs and one TSI may cover several subsystems. The decision to develop and/or to review a TSI and the choice of its technical and geographical scope requires a mandate in accordance with Article 6(1)."; (b) point (e) in paragraph 3 shall be replaced by the following: "(e) state, in each case under consideration, which procedures are to be used in order to assess the conformity or the suitability for use of the interoperability constituents, on the one hand, or the "EC" verification of the subsystems, on the other hand. These procedures shall be based on the modules defined in Decision 93/465/EEC;"; (c) the following paragraph shall be added: "7. TSIs may make an explicit, clearly identified reference to European standards or specifications where this is strictly necessary in order to achieve the objectives of this Directive. In such case, these European standards or specifications (or the relevant parts) shall be regarded as annexes to the TSI concerned and shall become mandatory from the moment the TSI is applicable. In the absence of European standards or specifications and pending their development, reference may be made to other clearly identified normative documents; in such case, this shall concern documents that are easily accessible and in the public domain."; 5) Article 6 shall be replaced by the following: "Article 6 1. Draft TSIs and subsequent amendments to TSIs shall be drafted under a mandate from the Commission in accordance with the procedure set out in Article 21(2). They shall be drafted under the responsibility of the Agency, in accordance with Articles 3 and 12 of Regulation(EC) No../2004 of the European Parliament and of the Council of establishing a European Railway Agency (Agency Regulation) (25) and in cooperation with the working parties mentioned in those Articles. TSIs shall be adopted and reviewed in accordance with the procedure set out in Article 21(2). They shall be published by the Commission in the Official Journal of the European Union. 2. The Agency shall be responsible for preparing the review and updating of TSIs and making any recommendations to the Committee referred to in Article 21 in order to take account of developments in technology or social requirements. 3. Each draft TSI shall be drawn up in two stages. First of all, the Agency shall identify the basic parameters for the TSI as well as the interfaces with the other subsystems and any other specific cases that may be necessary. The most viable alternative solutions accompanied by technical and economic justification shall be put forward for each of these parameters and interfaces. A decision shall be taken in accordance with the procedure set out in Article 21 (2); if necessary, specific cases shall be cited. The Agency shall then draw up the draft TSI on the basis of these basic parameters. Where appropriate, the Agency shall take account of technical progress, of standardisation work already carried out, of working parties already in place and of acknowledged research work. An overall assessment of the estimated costs and benefits of the implementation of the TSIs shall be attached to the draft TSI; this assessment shall indicate the likely impact for all the operators and economic agents involved. 4. The drafting, adoption and review of each TSI (including the basic parameters) shall take account of the estimated costs and benefits of all the technical solutions considered, together with the interfaces between them, so as to establish and implement the most viable solutions. The Member States shall participate in this assessment by providing the requisite data. 5. The Committee referred to in Article 21 shall be kept regularly informed of the preparatory work on the TSIs. During this work the Committee may formulate any terms of reference or useful recommendations concerning the design of the TSIs and the cost-benefit analysis. In particular, the Committee may, at the request of a Member State, require that alternative solutions be examined and that the assessment of the cost and benefits of these alternative solutions be set out in the report annexed to the draft TSI. 6. On the adoption of each TSI, the date of entry into force of that TSI shall be established in accordance with the procedure set out in Article 21(2). Where different subsystems have to be placed in service simultaneously for reasons of technical compatibility, the dates of entry into force of the corresponding TSIs shall be the same. 7. The drafting, adoption and review of the TSIs shall take account of the opinions of the users, as regards the characteristics which have a direct impact on the conditions in which they use the subsystems. To that end the Agency shall consult associations and bodies representing users during the drafting and review phases of the TSIs. They shall enclose with the draft TSI a report on the results of this consultation. The list of associations and bodies to be consulted shall be finalised by the Committee referred to in Article 21 before it adopts the mandate of the first TSI and may be re-examined and updated at the request of a Member State or the Commission. 8. The drafting, adoption and review of the TSIs shall take account of the opinion of the social partners as regards the conditions referred to in Article 5(3)(g). To this end, the social partners shall be consulted before the draft TSI is submitted, for adoption or review, to the Committee referred to in Article 21. The social partners shall be consulted in the context of the Sectoral Dialogue Committee set up in accordance with Commission Decision 98/500/EC (26). The social partners shall issue their opinion within three months. (25) OJ L ..." (26) OJ L 225, 12.8.1998, p. 27.";" 6) Article 7(a) shall be replaced by the following: "(a) for a proposed new line, for the renewal or upgrading of an existing line, or for any element referred to Article 1(1) at an advanced stage of development or the subject of a contract in course of performance when these TSIs are published;"; 7) Article 10 shall be amended as follows: (a) paragraph 2 shall be replaced by the following: "2. All interoperability constituents shall be subject to the procedure for assessing conformity and suitability for the use indicated in the respective TSI and shall be accompanied by the corresponding certificate."; (b) paragraph 3 shall be replaced by the following: "3. Member States shall consider that an interoperability constituent meets the essential requirements if it complies with the conditions laid down by the corresponding TSI or the corresponding European specifications developed to comply with these conditions."; (c) paragraphs 4 and 5 shall be deleted; 8) Article 11 shall be replaced by the following: "Article 11 Where it appears to a Member State or the Commission that European specifications used directly or indirectly to achieve the objectives of this Directive do not meet the essential requirements, partial or total withdrawal of the specifications concerned from the publications containing them, or their amendment, may be decided upon in accordance with the procedure set out in Article 21(2) after consultation of the committee set up under Directive 98/34/EC; 9) Article 14 shall be amended as follows: (a) the following subparagraph shall be added to paragraph 2: "To that end, the assessment and verification procedures laid down in the respective structural and functional TSIs shall be used."; (b) paragraph 3 shall be replaced by the following: "3. In the event of renewal or upgrading, the infrastructure manager or the railway undertaking shall send the Member State concerned a file describing the project. The Member State shall examine this file and, taking account of the implementation strategy indicated in the applicable TSI, shall decide whether the size of the works means that a new authorisation for placing in service within the meaning of this Directive is needed. Such new authorisation for placing in service shall be required each time the overall safety level of the subsystem concerned may be affected by the works envisaged. If a new authorisation is needed, the Member State shall decide to what extent the TSIs need to be applied to the project. The Member State shall notify its decision to the Commission and the other Member States."; (c) the following paragraphs shall be inserted: "4. Where Member States authorise the placing in service of rolling stock, they shall be responsible for ensuring that an alphanumeric identification code is assigned to each vehicle. This code must be marked on each vehicle and be entered in a national vehicle register that meets the following criteria: (a) the register shall comply with the common specifications defined in paragraph 5; (b) the register shall be kept and updated by a body independent of any railway undertaking; (c) the register shall be accessible to the safety authorities and investigating bodies designated in Articles 16 and 21 of Directive 2004/xxx/EC of the European Parliament and of the Council Ofon safety on the Community's railways (Railway Safety Directive) (27). It shall also be made accessible, in response to any legitimate request, to the regulatory bodies designated in Article 30 of Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (28), to the Agency, to the railway undertakings and to the infrastructure managers. In case of rolling stock placed in service for the first time in a third country, Member States may accept vehicles clearly identified according to a different coding system. However, once a Member State has authorised the placing in service of such vehicles on its territory, it must be possible to retrieve the corresponding data, listed below in paragraph 5(c), (d) and (e), through the register. 5. The common specifications for the register shall be adopted in accordance with the procedure laid down in Article 21(2), on the basis of the draft specifications prepared by the Agency. These draft specifications shall include: content, data format, functional and technical architecture, operating mode, rules for data input and consultation. The register shall contain at least the following information: (a) references to the "EC" declaration of verification and the issuing body; (b) references to the register of rolling stock mentioned in Article 24; (c) identification of the owner of the vehicle or the lessee; (d) any restrictions on how the vehicle may be used; (e) safety-critical data relating to the maintenance schedule of the vehicle. (27) OJ L ..." (28) OJ L 75, 15.3.2001, p. 29. Directive as amended by Commission Decision 2002/844/EC (OJ L 289, 26.10.2002, p. 30)";" 10) Article 16(3) shall be replaced by the following: "3. In the absence of TSIs, and including cases when a derogation has been notified under Article 7, Member States shall send the other Member States and the Commission, for each subsystem, a list of the technical rules in use for implementing the essential requirements. This shall be notified before (29) and following that, each time the list of technical rules is changed. On that occasion, Member States shall also designate the bodies responsible for carrying out, in the case of these technical regulations, the verification procedure referred to in Article 18.; 11) the following subparagraph shall be added to Article 17: "In such a case, the TSIs shall be reviewed in accordance with the procedure referred to in Article 6(2). If certain technical aspects corresponding to the essential requirements cannot be explicitly covered in a TSI, they shall be clearly identified in an Annex to the TSI. Article 16(3) shall apply to these aspects."; 12) Article 20(5) shall be replaced by the following: "5. The Commission shall set up a notified bodies coordination group (hereinafter referred to as "the coordination group") which shall discuss any matter relating to the application of the procedures for assessing conformity or suitability for the use referred to in Article 13 and the verification procedure referred to in Article 18, or to application of the relevant TSIs. Member States' representatives may take part in the work of the coordination group as observers. The Commission and the observers shall inform the committee referred to in Article 21 of the work carried out in the framework of this coordination group. The Commission, when appropriate, will propose the measures needed to remedy the problems. Where necessary, coordination of the notified bodies shall be implemented in accordance with Article 21."; 13) in Article 21 the following paragraph shall be added: "4. Should it prove necessary, the Committee may set up working parties to assist it in carrying out its tasks, in particular with a view to coordinating the notified bodies."; 14) the following Article shall be inserted: "Article 21a The Commission may submit to the Committee any matter relating to the implementation of this Directive. If necessary, the Commission shall adopt an implementing recommendation in accordance with the procedure set out in Article 21 (2). Article 21b Annexes II to VI may be amended in accordance with the procedure set out in Article 21(2)."; 15) Article 23 shall be replaced by the following: "Article 23 1. The order of priority for the adoption of the TSIs shall be as follows, without prejudice to the order of adoption of the mandates provided for in Article 6(1): (a) the first group of TSIs shall cover control/command and signalling; telematic applications for freight services; traffic operation and management (including staff qualifications for cross-border services respecting the criteria defined in Annexes II and III); freight wagons; noise problems deriving from rolling stock and infrastructure. As regards rolling stock, that intended for international use shall be developed first; (b) the following aspects shall also be discussed in the light of the resources of the Commission and the Agency: telematic applications for passenger services, maintenance, with particular regard to safety, passenger carriages, traction units and locomotives, infrastructure, energy and air pollution. As regards rolling stock, that intended for international use shall be developed first; (c) at the request of the Commission, a Member State or the Agency, the Committee may decide, in accordance with the procedure set out in Article 21(2), to draw up a TSI for an additional subject in so far as it concerns a subsystem mentioned in Annex II. 2. The Commission, in accordance with the procedure set out in Article 21(2), shall draw up a work programme observing the order of priority referred to in paragraph 1 and that of the other tasks entrusted to it by this Directive. The TSIs mentioned in the first work programme referred to in paragraph l(a) shall be drawn up not later than 20 April 2004. 3. The work programme shall consist of the following stages: (a) development on the basis of a draft established by the Agency of a representative architecture of the conventional rail system, based on the list of subsystems (Annex II), to guarantee consistency between TSIs. This architecture must include in particular the various constituents of this system and their interfaces and act as a reference framework for defining the areas of use of each TSI; (b) adoption of a model structure for developing TSIs; (c) adoption of a method of cost-benefit analysis of the solutions set out in the TSIs; (d) adoption of the mandates needed to draw up the TSIs; (e) adoption of the basic parameters for each TSI; (f) approval of draft standardisation programmes; (g) management of the transition period between the date of entry into force of Directive 2004/.../EC (30) of the European Parliament and of the Council amending Council Directive 96/48/EC on the interoperability of the trans-European high-speed rail system and Directive 2001/16/EC of the European Parliament and of the Council on the interoperability of the trans-European conventional rail system and publication of the TSIs, including the adoption of the reference system mentioned in Article 25. (30) OJ L ...";" 16) Article 24(2) shall be replaced by the following: "2. A copy of those registers shall be sent to the Member States concerned and to the Agency and shall be made available for consultation by interested parties, including at least the professional actors from the sector."; 17) Article 25(1) shall be replaced by the following: "1. The Agency shall develop, in accordance with Articles 3 and 12 of Regulation (EC) No xx/2004 (31), on the basis of the information notified by the Member States under Article 16(3), technical documents from the profession and the texts of the relevant international agreements, a draft reference system of technical rules ensuring the current degree of interoperability of the lines and rolling stock that will be brought within the scope of this Directive as defined in Article 1(3). The Commission, following the procedure set out in Article 21(2), shall examine this draft and decide whether it may constitute a reference system pending the adoption of TSIs."; 18) Annex I shall be replaced by the text in Annex III to this Directive; 19) the following point shall be added to Annex III: "2.4.4. Controls Trains must be equipped with a recording device. The data collected by this device and the processing of the information must be harmonised."; 20) the following subparagraph shall be added to Annex VII, point 2: "In particular, the body and the staff responsible for the checks must be functionally independent of the authorities designated to issue authorisations for placing in service in the framework of this Directive, licences in the framework of Council Directive 95/18/EC of 19 June 1995 on the licensing of railway undertakings (32) and safety certificates in the framework of Directive 2004/xx/EC (33), and of the bodies in charge of investigations in the event of accident (32) OJ L 143,27.6.1995, p. 70. Directive as amended by Directive 2001/13/EC of the European Parliament and of the Council (OJ L 75,15.3.2001, p. 26.)"" 21) Annex VIII shall be deleted. Article 3 The Commission shall take all necessary measures to ensure that the application of this Directive preserves as far as possible the TSI development work already mandated in the framework of Directives 96/48/EC and 2001/16/EC and to ensure that projects that are at an advanced stage of development when this Directive enters into force are not affected. Article 4 Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive before ... (34). They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference 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 Union. Article 6 This Directive is addressed to the Member States.

32004L0082

2004

COUNCIL DIRECTIVE 2004/82/EC of 29 April 2004 on the obligation of carriers to communicate passenger data Having regard to the Treaty establishing the European Community, and in particular Article 62(2)(a) and Article 63(3)(b) thereof, Having regard to the initiative of the Kingdom of Spain (1), Whereas: (1) In order to combat illegal immigration effectively and to improve border control, it is essential that all Member States introduce provisions laying down obligations on air carriers transporting passengers into the territory of the Member States. In addition, in order to ensure the greater effectiveness of this objective, the financial penalties currently provided for by the Member States for cases where carriers fail to meet their obligations should be harmonised to the extent possible, taking into account the differences in legal systems and practices between the Member States. (2) The European Council of 25 and 26 March 2004 adopted a Declaration on combating terrorism stressing the need to expedite examination of measures in this area and take work forward on the proposed Council Directive on the obligation of carriers to communicate passenger data with a view to an early conclusion on this measure. (3) It is important to avoid a vacuum in the Community's action in combating illegal immigration. (4) As from 1 May 2004 the Council can no longer act on an initiative of a Member State. (5) The Council has exhausted all possibilities to obtain in time the opinion of the European Parliament. (6) Under these exceptional circumstances the Directive should be adopted without the opinion of the European Parliament. (7) The obligations to be imposed on carriers by virtue of this Directive are complementary to those established pursuant to the provisions of Article 26 of the 1990 Schengen Convention implementing the Schengen Agreement of 14 June 1985, as supplemented by Council Directive 2001/51/EC (2), the two types of obligation serving the same objective of curbing migratory flows and combating illegal immigration. (8) Without prejudice to the provisions of 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 (3), the freedom of the Member States to retain or introduce additional obligations for aircarriers or some categories of other carriers, including information or data in relation to return tickets, whether referred to in this Directive or not, should not be affected. (9) In order to combat illegal immigration more effectively and in order to ensure the greater effectiveness of this objective, it is essential that, without prejudice to the provisions of Directive 95/46/EC, account be taken at the earliest opportunity of any technological innovation, especially with reference to the integration and use of biometric features in the information to be provided by the carriers. (10) Member States should ensure that in any proceedings brought against carriers which may result in the application of penalties, the rights of defence and the right of appeal against such decisions can be exercised effectively. (11) These measures take up the control options set out in the Decision of the Executive Committee of Schengen (SCH/Com-ex (94) 17-rev. 4), aimed at enabling border checks to be increased and providing for sufficient time to enable detailed and comprehensive checks to be carried out on all passengers through the transmission of passenger data to the authorities responsible for carrying out such controls. (12) Directive 95/46/EC applies with regard to the processing of personal data by the authorities of the Member States. This means, that whereas it would be legitimate to process the passenger data transmitted for the performance of border checks also for the purposes of allowing their use as evidence in proceedings aiming at the enforcement of the laws and regulations on entry and immigration, including their provisions on the protection of public policy (ordre public) and national security, any further processing in a way incompatible with those purposes would run counter to the principle set out in Article 6(1)(b) of Directive 95/46/EC. Member States should provide for a system of sanctions to be applied in the event of use contrary to the purpose of the present Directive. (13) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark annexed to the Treaty on European Union and the Treaty establishing the European Community, Denmark is not taking part in the adoption of this Directive, and is not bound by it or subject to its application. Given that this Directive builds upon the Schengen acquis under the provisions of Title IV of Part Three of the Treaty establishing the European Community, Denmark shall, in accordance with Article 5 of the said Protocol, decide within a period of six months after the Council has adopted this Directive whether it will implement it in its national law. (14) As regards Iceland and Norway, this Directive constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latter's association with the implementation, application and development of the Schengen acquis (4), which fall within the area referred to in Article 1, point E, of Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of that Agreement (5). (15) The United Kingdom is taking part in this Directive in accordance with Article 5 of the Protocol integrating the Schengen acquis into the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 8(2) of Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (6). (16) Ireland is taking part in this Directive in accordance with Article 5 of the Protocol integrating the Schengen acquis into the framework of the European Union annexed to the Treaty on European Union and the Treaty establishing the European Community, and Article 6(2) of Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (7). (17) This Directive constitutes an act building upon the Schengen acquis or otherwise related to it within the meaning of Article 3(1) of the 2003 Act of Accession, Article 1 Objective This Directive aims at improving border controls and combating illegal immigration by the transmission of advance passenger data by carriers to the competent national authorities. Article 2 Definitions For the purpose of this Directive: (a) ‘carrier’ means any natural or legal person whose occupation it is to provide passenger transport by air; (b) ‘external borders’ means the external borders of the Member States with third countries; (c) ‘border control’ means a check carried out at a border in response exclusively to an intention to cross that border, regardless of any other consideration; (d) ‘border crossing point’ means any crossing point authorised by the competent authorities for crossing external borders; (e) ‘personal data’, ‘processing of personal data’ and ‘personal data filing system’ have the meaning as stipulated under Article 2 of Directive 95/46/EC. Article 3 Data transmission 1. Member States shall take the necessary steps to establish an obligation for carriers to transmit at the request of the authorities responsible for carrying out checks on persons at external borders, by the end of check-in, information concerning the passengers they will carry to an authorised border crossing point through which these persons will enter the territory of a Member State. 2. The information referred to above shall comprise: — the number and type of travel document used, — nationality, — full names, — the date of birth, — the border crossing point of entry into the territory of the Member States, — code of transport, — departure and arrival time of the transportation, — total number of passengers carried on that transport, — the initial point of embarkation. 3. In any case the transmission of the above mentioned data does not discharge the obligations and responsibilities laid down in the provisions of Article 26 of the Schengen Convention for carriers, as supplemented by Directive 2001/51/EC. Article 4 Sanctions 1. Member States shall take the necessary measures to impose sanctions on carriers which, as a result of fault, have not transmitted data or have transmitted incomplete or false data. Member States shall take the necessary measures to ensure that sanctions are dissuasive, effective and proportionate and that either: (a) the maximum amount of such sanctions is not less than EUR 5 000, or than the equivalent national currency at the rate of exchange published in the Official Journal of the European Union on the day on which this Directive enters into force for each journey for which passenger data were not communicated or were communicated incorrectly; or (b) the minimum amount of such sanctions is not less than EUR 3 000, or than the equivalent national currency at the rate of exchange published in the Official Journal of the European Union on the day on which this Directive enters into force for each journey for which passenger data were not communicated or were communicated incorrectly. 2. This Directive shall not prevent Member States from adopting or retaining, for carriers which infringe very seriously the obligations arising from the provisions of this Directive, other sanctions, such as immobilisation, seizure and confiscation of the means of transport, or temporary suspension or withdrawal of the operating licence. Article 5 Proceedings Member States shall ensure that their laws, regulations and administrative provisions stipulate that carriers against which proceedings are brought with a view to imposing penalties have effective rights of defence and appeal. Article 6 Data processing 1. The personal data referred to in Article 3(1) shall be communicated to the authorities responsible for carrying out checks on persons at external borders through which the passenger will enter the territory of a Member State, for the purpose of facilitating the performance of such checks with the objective of combating illegal immigration more effectively. Member States shall ensure that these data are collected by the carriers and transmitted electronically or, in case of failure, by any other appropriate means to the authorities responsible for carrying out border checks at the authorised border crossing point through which the passenger will enter the territory of a Member State. The authorities responsible for carrying out checks on persons at external borders shall save the data in a temporary file. After passengers have entered, these authorities shall delete the data, within 24 hours after transmission, unless the data are needed later for the purposes of exercising the statutory functions of the authorities responsible for carrying out checks on persons at external borders in accordance with national law and subject to data protection provisions under Directive 95/46/EC. Member States shall take the necessary measures to oblige carriers to delete, within 24 hours of the arrival of the means of transportation pursuant to Article 3(1), the personal data they have collected and transmitted to the border authorities for the purposes of this Directive. In accordance with their national law and subject to data protection provisions under Directive 95/46/EC, Member States may also use the personal data referred to in Article 3(1) for law enforcement purposes. 2. Member States shall take the necessary measures to oblige the carriers to inform the passengers in accordance with the provisions laid down in Directive 95/46/EC. This shall also comprise the information referred to in Article 10(c) and Article 11(1)(c) of Directive 95/46/EC. Article 7 Transposal 1. Member States shall take the necessary measures to comply with this Directive not later than 5 September 2006. 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 8 Entry into force This Directive shall enter into force 30 days after its publication in the Official Journal of the European Union. Article 9 Addressees This Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.

32004L0080

2004

COUNCIL DIRECTIVE 2004/80/EC of 29 April 2004 relating to compensation to crime victims Having regard to the Treaty establishing the European Community, and in particular Article 308 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 European Economic and Social Committee (3), Whereas: (1) One of the objectives of the European Community is to abolish, as between Member States, obstacles to the free movement of persons and services. (2) The Court of Justice held in the Cowan (4) Case that, when Community law guarantees to a natural person the freedom to go to another Member State, the protection of that person from harm in the Member State in question, on the same basis as that of nationals and persons residing there, is a corollary of that freedom of movement. Measures to facilitate compensation to victims of crimes should form part of the realisation of this objective. (3) At its meeting in Tampere on 15 and 16 October 1999, the European Council called for the drawing-up of minimum standards on the protection of the victims of crime, in particular on crime victims' access to justice and their rights to compensation for damages, including legal costs. (4) The Brussels European Council, meeting on 25 and 26 March 2004, in the Declaration on Combating Terrorism, called for the adoption of this Directive before 1 May 2004. (5) On 15 March 2001 the Council adopted Framework Decision 2001/220/JHA on the standing of victims in criminal proceedings. (5) This Decision, based on Title VI of the Treaty on the European Union, allows crime victims to claim compensation from the offender in the course of criminal proceedings. (6) Crime victims in the European Union should be entitled to fair and appropriate compensation for the injuries they have suffered, regardless of where in the European Community the crime was committed (7) This Directive sets up a system of cooperation to facilitate access to compensation to victims of crimes in cross-border situations, which should operate on the basis of Member States' schemes on compensation to victims of violent intentional crime, committed in their respective territories. Therefore, a compensation mechanism should be in place in all Member States. (8) Most Member States have already established such compensation schemes, some of them in fulfilment of their obligations under the European Convention of 24 November 1983 on the compensation of victims of violent crimes. (9) Since the measures contained in this Directive are necessary in order to attain objectives of the Community and the Treaty provides for no powers other than those in Article 308 thereof for the adoption of this Directive, that Article should be applied. (10) Crime victims will often not be able to obtain compensation from the offender, since the offender may lack the necessary means to satisfy a judgment on damages or because the offender cannot be identified or prosecuted. (11) A system of cooperation between the authorities of the Member States should be introduced to facilitate access to compensation in cases where the crime was committed in a Member State other than that of the victim's residence. (12) This system should ensure that crime victims could always turn to an authority in their Member State of residence and should ease any practical and linguistic difficulties that occur in a cross-border situation. (13) The system should include the provisions necessary for allowing the crime victim to find the information needed to make the application and for allowing for efficient cooperation between the authorities involved. (14) This Directive respects the fundamental rights and observes the principles reaffirmed in particular by the Charter of Fundamental Rights of the European Union as general principles of Community law. (15) Since the objective of facilitating access to compensation to victims of crimes of cross-border situations cannot be sufficiently achieved by the Member States because of the cross-border elements and can therefore, by reason of the scale or effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (16) The measures necessary for the implementation of the Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6), CHAPTER I ACCESS TO COMPENSATION IN CROSS-BORDER SITUATIONS Article 1 Right to submit an application in the Member State of residence Member States shall ensure that where a violent intentional crime has been committed in a Member State other than the Member State where the applicant for compensation is habitually resident, the applicant shall have the right to submit the application to an authority or any other body in the latter Member State. Article 2 Responsibility for paying compensation Compensation shall be paid by the competent authority of the Member State on whose territory the crime was committed. Article 3 Responsible authorities and administrative procedures 1. Member States shall establish or designate one or several authorities or any other bodies, hereinafter referred to as ‘assisting authority or authorities’, to be responsible for applying Article 1. 2. Member States shall establish or designate one or several authorities or any other bodies to be responsible for deciding upon applications for compensation, hereinafter referred to as ‘deciding authority or authorities’. 3. Member States shall endeavour to keep to a minimum the administrative formalities required of an applicant for compensation. Article 4 Information to potential applicants Member States shall ensure that potential applicants for compensation have access to essential information on the possibilities to apply for compensation, by any means Member States deem appropriate. Article 5 Assistance to the applicant 1. The assisting authority shall provide the applicant with the information referred to in Article 4 and the required application forms, on the basis of the manual drawn up in accordance with Article 13(2). 2. The assisting authority shall, upon the request of the applicant, provide him or her with general guidance and information on how the application should be completed and what supporting documentation may be required. 3. The assisting authority shall not make any assessment of the application. Article 6 Transmission of applications 1. The assisting authority shall transmit the application and any supporting documentation as quickly as possible to the deciding authority. 2. The assisting authority shall transmit the application using the standard form referred to in Article 14. 3. The language of the application and any supporting documentation shall be determined in accordance with Article 11(1). Article 7 Receipt of applications Upon receipt of an application transmitted in accordance with Article 6, the deciding authority shall send the following information as soon as possible to the assisting authority and to the applicant: (a) the contact person or the department responsible for handling the matter; (b) an acknowledgement of receipt of the application; (c) if possible, an indication of the approximate time by which a decision on the application will be made. Article 8 Requests for supplementary information The assisting authority shall if necessary provide general guidance to the applicant in meeting any request for supplementary information from the deciding authority. It shall upon the request of the applicant subsequently transmit it as soon as possible directly to the deciding authority, enclosing, where appropriate, a list of any supporting documentation transmitted. Article 9 Hearing of the applicant 1. If the deciding authority decides, in accordance with the law of its Member State, to hear the applicant or any other person such as a witness or an expert, it may contact the assisting authority for the purpose of arranging for: (a) the person(s) to be heard directly by the deciding authority, in accordance with the law of its Member State, through the use in particular of telephone- or video-conferencing; or (b) the person(s) to be heard by the assisting authority, in accordance with the law of its Member State, which will subsequently transmit a report of the hearing to the deciding authority. 2. The direct hearing in accordance with paragraph 1(a) may only take place in cooperation with the assisting authority and on a voluntary basis without the possibility of coercive measures being imposed by the deciding authority. Article 10 Communication of the decision The deciding authority shall send the decision on the application for compensation, by using the standard form referred to in Article 14, to the applicant and to the assisting authority, as soon as possible, in accordance with national law, after the decision has been taken. Article 11 Other provisions 1. Information transmitted between the authorities pursuant to Articles 6 to 10 shall be expressed in: (a) the official languages or one of the languages of the Member State of the authority to which the information is sent, which corresponds to one of the languages of the Community institutions; or (b) another language of the Community institutions that that Member State has indicated it can accept; with the exception of: (i) the full text of decisions taken by the deciding authority, where the use of languages shall be governed by the law of its Member State; (ii) reports drawn up following a hearing in accordance with Article 9(1)(b), where the use of languages shall be determined by the assisting authority, subject to the requirement that it corresponds to one of the languages of the Community institutions. 2. Services rendered by the assisting authority in accordance with Articles 1 to 10 shall not give rise to a claim for any reimbursement of charges or costs from the applicant or from the deciding authority. 3. Application forms and any other documentation transmitted in accordance with Articles 6 to 10 shall be exempted from authentication or any equivalent formality. CHAPTER II NATIONAL SCHEMES ON COMPENSATION Article 12 1. The rules on access to compensation in cross-border situations drawn up by this Directive shall operate on the basis of Member States' schemes on compensation to victims of violent intentional crime committed in their respective territories. 2. All Member States shall ensure that their national rules provide for the existence of a scheme on compensation to victims of violent intentional crimes committed in their respective territories, which guarantees fair and appropriate compensation to victims. CHAPTER III IMPLEMENTING PROVISIONS Article 13 Information to be sent to the Commission and the manual 1. Member States shall, no later than 1 July 2005, send to the Commission details of: (a) the list of authorities established or designated in accordance with Articles 3(1) and 3(2), including, where appropriate, information on the special and territorial jurisdiction of these authorities; (b) the language(s) referred to in Article 11(1)(a) which the authorities can accept for the purpose of applying Articles 6 to 10 and the official language or languages other than its own which is or are acceptable to it for the transmission of applications in accordance with Article 11(1)(b). (c) the information established in accordance with Article 4; (d) the application forms for compensation; Member States shall inform the Commission of any subsequent changes to this information. 2. The Commission shall, in cooperation with the Member States establish and publish on the internet a manual containing the information provided by the Member States pursuant to paragraph 1. The Commission shall be responsible for arranging the necessary translations of the manual. Article 14 Standard form for transmission of applications and decisions Standard forms shall be established, at the latest by 31 October 2005, for the transmission of applications and decisions in accordance with the procedure referred to in Article 15(2). Article 15 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply. 3. The Committee shall adopt its Rules of Procedure. Article 16 Central contact points Member States shall appoint a central contact point for the purposes of: (a) assisting with the implementation of Article 13(2); (b) furthering close cooperation and exchange of information between the assisting and deciding authorities in the Member States; and (c) giving assistance and seeking solutions to any difficulties that may occur in the application of Articles 1 to 10. The contact points shall meet regularly. Article 17 More favourable provisions This Directive shall not prevent Member States, in so far as such provisions are compatible with this Directive, from: (a) introducing or maintaining more favourable provisions for the benefit of victims of crime or any other persons affected by crime; (b) introducing or retaining provisions for the purpose of compensating victims of crime committed outside their territory, or any other person affected by such a crime, subject to any conditions that Member States may specify for that purpose. Article 18 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2006 at the latest, with the exception of Article 12(2), in which case the date of compliance shall be 1 July 2005. They shall forthwith inform the Commission thereof. 2. Member States may provide that the measures necessary to comply with this Directive shall apply only to applicants whose injuries result from crimes committed after 30 June 2005. 3. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 4. 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 19 Review No later than by 1 January 2009, the Commission shall present to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Directive. Article 20 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 Union. Article 21 Addressees This Directive is addressed to the Member States.

32004L0077

2004

COMMISSION DIRECTIVE 2004/77/EC of 29 April 2004 amending Directive 94/54/EC as regards the labelling of certain foods containing glycyrrhizinic acid and its ammonium salt (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 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, After consulting the Scientific Committee on Food, Whereas: (1) 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 2000/13/EC (2) contains a list of foodstuffs for which the labelling must include one or more additional particulars. (2) The purpose of this Directive is to supplement that list with regard to certain foods containing glycyrrhizinic acid and its ammonium salt. (3) Glycyrrhizinic acid naturally occurs in the liquorice plant Glycyrrhiza glabra while its ammonium salt is manufactured from aqueous extracts of liquorice plant Glycyrrhiza glabra. Glycyrrhizinic acid and its ammonium salt are included in the Community register of flavouring substances laid down by Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 (3). Exposure to glycyrrhizinic acid and its ammonium salt occur mostly via consumption of liquorice confectionery, including chewing gum, herbal teas and other beverages. (4) The Scientific Committee on Food, in its opinion of 4 April 2003 on glycyrrhizinic acid and its ammonium salt, concluded that an upper limit for regular ingestion of 100 mg/day provides a sufficient level of protection for the majority of the population, consumption above this level may give rise to hypertension. However the Committee noted that within the human population there are subgroups for which this upper limit might not offer sufficient protection. These subgroups comprise people with medical conditions related to disturbed water- and electrolyte homeostasis. (5) These findings make it necessary to provide labelling which gives the consumers clear information on the presence of glycyrrhizinic acid or its ammonium salt in confectionery and beverages. In the case of high contents of glycyrrhizinic acid or its ammonium salt in these products, the consumers, and in particular those suffering from hypertension, should in addition be informed that excessive intake should be avoided. To ensure a good understanding of these information by the consumers, the well known term ‘liquorice extracts’ should be preferably used. (6) Directive 94/54/EC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex to Directive 94/54/EC is amended in accordance with the text set out in the Annex to this Directive. Article 2 1. The Member States shall permit trade in products which comply with this Directive from 20 May 2005 at the latest. 2. The Member States shall prohibit trade in products which do not comply with this Directive from 20 May 2006. However, products which do not comply with this Directive and which were labelled before 20 May 2006 shall be authorised while stocks last. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 May 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0052

2004

DIRECTIVE 2004/52/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the interoperability of electronic road toll systems in the Community (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 7(1) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Having regard to the Opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) By its Resolution of 17 June 1997 on the development of telematics in road transport, in particular with respect to electronic fee collection (EFC) (4) the Council called on the Commission and Member States to develop a strategy for the convergence of EFC systems in order to achieve an appropriate level of interoperability at a European level. The communication of the Commission on interoperable electronic fee collection systems in Europe was the first stage of this strategy. (2) The majority of Member States which have installed electronic toll systems to finance road infrastructure costs or to collect road usage fees (jointly referred to hereinafter as "electronic toll systems") use short-range microwave technology and frequencies close to 5,8 GHz, but these systems are currently not totally compatible. The work on microwave technology undertaken by the European Committee for Standardisation (CEN) resulted in January 2003 in the preparation of technical standards making for the compatibility of 5,8 GHz microwave electronic toll systems, following the adoption of technical pre-standards in 1997. However, these pre-standards do not cover all the Dedicated Short-Range Communications (DSRC) 5,8 GHz systems in operation in the Community and encompass two variants which are not totally compatible. They are based on the Open Systems Interconnection model defined by the International Standardisation Organisation for communication between computer systems. (3) Manufacturers of equipment and infrastructure managers have nonetheless agreed, within the Community, to develop interoperable products based on existing DSRC 5,8 GHz systems. The equipment that will need to be made available to users should accordingly be capable of communicating with the technologies that may only be used in new electronic toll systems to be deployed in the Community after 1 January 2007, namely satellite positioning technology, mobile communications technology using the GSM-GPRS standard and 5,8 GHz microwave technology. (4) It is essential that the standardisation work be completed as quickly as possible to establish technical standards ensuring technical compatibility among electronic toll systems based on 5,8 GHz microwave technology and on satellite positioning and mobile communications technologies, in order to avoid further fragmentation of the market. (5) It is necessary to provide for the widespread deployment of electronic toll systems in the Member States and neighbouring countries, and the need is arising to have interoperable systems suited to the future development of road-charging policy at Community level and to future technical developments. (6) The electronic toll systems should be interoperable and based on open and public standards, available on a non-discriminatory basis to all system suppliers. (7) In introducing new electronic toll systems, sufficient equipment should be made available to avoid discrimination between the undertakings concerned. (8) In particular, owing to their great flexibility and versatility, application of the new satellite positioning (GNSS) and mobile communications (GSM/GPRS) technologies to electronic toll systems may serve to meet the requirements of the new road-charging policies planned at Community and Member State level. These technologies enable the number of kilometres covered per category of road to be counted without requiring costly investment in infrastructure. They also open the door to additional new safety and information services for travellers, such as the automatic alarm triggered by a vehicle involved in an accident and indicating its position, and real-time information on traffic conditions, traffic levels and journey times. With regard to satellite positioning, the Galileo project launched by the Community in 2002 is designed to provide, as of 2008, information services of higher quality than that provided by the current satellite navigation systems and which are optimal for road telematic services. The European geostationary navigation overlay service (EGNOS) precursor system will already be operational in 2004, providing similar results. However, these innovative systems could raise problems concerning the reliability of checks and with regard to fraud prevention. However, owing to the considerable advantages referred to above, the application of satellite positioning and mobile communications technologies is in principle to be recommended in introducing new electronic toll systems. (9) The proliferation of technologies for electronic toll systems already in use or planned in the coming years (mainly 5,8 GHz microwave, satellite positioning and mobile communications) and the proliferation of specifications imposed by the Member States and neighbouring countries for their electronic toll systems may compromise both the smooth operation of the internal market and transport policy objectives. Such a situation is liable to lead to the proliferation of incompatible and expensive electronic boxes in the driving cabs of heavy goods vehicles, and to drivers making mistakes when using them with the result, for example, of unintentionally avoiding payment. Such a proliferation is unacceptable to users and to manufacturers of vehicles for cost, safety and legal reasons. (10) Artificial barriers to the operation of the internal market should be removed, while still allowing the Member States and the Community to implement a variety of road-charging policies for all types of vehicles at local, national or international level. The equipment installed in vehicles should allow such road-charging policies to be implemented in accordance with the principles of non-discrimination between the citizens of all Member States. The interoperability of electronic toll systems at Community level therefore needs to be ensured as soon as possible. (11) Drivers are legitimately concerned to see improved quality of service on the road infrastructure, in particular in terms of safety, as well as a substantial reduction in congestion at toll plazas, especially on busy days and at certain particularly congested points in the road network. The definition of the European electronic toll service needs to address that concern. Provision should, moreover, be made to ensure that the technologies and components provided for can, as far as technically possible, also be combined with other vehicle components, in particular the electronic tachograph and emergency call capabilities. Intermodal systems should not be excluded at a later stage. (12) The option of accessing other, future applications in addition to toll collection should be ensured by fitting appropriate equipment. (13) A European electronic toll service should provide interoperability at technical, contractual and procedural level, covering: (a) a single contract between the clients and the operators offering the service, complying with a contractual set of rules allowing all operators and/or issuers to provide the service, giving access to the whole network; (b) a set of technical standards and requirements allowing the industry to provide the necessary equipment for the provision of the service. (14) Contractual interoperability provides the potential for important facilitation to some road-users and for significant economies in administration for commercial road users. (15) Electronic toll systems contribute significantly to reducing the risk of accidents, thus increasing road safety, to reducing the number of cash transactions and to reducing congestion at toll plazas, especially on busy days. They also reduce the negative environmental impact of waiting and restarting vehicles and congestion, as well as the environmental impact related to the installation of new toll gates or expansion of existing toll stations. (16) The White Paper on European Transport Policy for 2010 contains objectives of safety and fluidity of road traffic. Interoperable Intelligent Transport Services and Systems are a key tool in the achievement of these objectives. (17) The introduction of electronic toll systems will entail the processing of personal data. Such processing needs to be carried out in accordance with Community rules, as set out inter alia in 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 (5) and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (6). The right to protection of personal data is explicitly recognised by Article 8 of the Charter of Fundamental Rights of the European Union. (18) Automatic debiting of toll charges to bank accounts or credit/debit card accounts which are domiciled anywhere, in the Community and beyond, is conditional on a fully operational Community payments area with non-discriminatory service charges. (19) Systems of electronic toll collection which are put in place in the Member States should meet the following fundamental criteria: the system should be amenable to ready incorporation of future technological and systems improvements and developments without costly redundancy of older models and methods, the costs of its adoption by commercial and private road users should be insignificant compared with the benefits to those road users as well as to society as a whole, and its implementation in any Member State should be non-discriminatory in all respects between domestic road users and road users from other Member States. (20) Since the objectives of this Directive, in particular, the interoperability of electronic toll systems in the internal market and the introduction of a European electronic toll service covering the entire Community road network on which tolls are charged, cannot be sufficiently achieved by the Member States and can therefore, by reason of their European dimension, be better achieved at Community level, the Community may take measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (21) The inclusion of interested parties (such as toll-service operators, infrastructure managers, electronics and motor industries and users) in Commission consultations on technical and contractual aspects of creating the European electronic toll service should be provided for. Where appropriate, the Commission should also consult non-governmental organisations active in the field of privacy protection, road safety and the environment. (22) To set up the European electronic toll service it will first be necessary to establish guidelines to be laid down by the Electronic Toll Committee established by this Directive. (23) This Directive does not affect the Member States' freedom to lay down rules governing road infrastructure charging and taxation matters. (24) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7), Article 1 Objective and scope 1. This Directive lays down the conditions necessary to ensure the interoperability of electronic road toll systems in the Community. It applies to the electronic collection of all types of road fees, on the entire Community road network, urban and interurban, motorways, major and minor roads, and various structures such as tunnels, bridges and ferries. 2. This Directive does not apply to: (a) road toll systems for which no electronic means of toll collection exists; (b) electronic road toll systems which do not need the installation of on-board equipment; (c) small, strictly local road toll systems for which the costs of compliance with the requirements of this Directive would be disproportionate to the benefits. 3. To achieve the objective set in paragraph 1, a European electronic toll service shall be created. This service, which is complementary to the national electronic toll services of the Member States, shall ensure the interoperability throughout the Community, for users, of the electronic toll systems that have already been introduced in the Member States and of those to be introduced in the future in the framework of this Directive. Article 2 Technological solutions 1. All new electronic toll systems brought into service on or after 1 January 2007 shall, for carrying out electronic toll transactions, use one or more of the following technologies: (a) satellite positioning; (b) mobile communications using the GSM-GPRS standard (reference GSM TS 03.60/23.060); (c) 5,8 GHz microwave technology 2. The European electronic toll service shall be brought into service pursuant to Article 3(1). Operators shall make available to interested users on-board equipment which is suitable for use with all electronic toll systems in service in the Member States using the technologies referred to in paragraph 1 and which is suitable for use in all types of vehicle, in accordance with the timetable set out in Article 3(4). This equipment shall at least be interoperable and capable of communicating with all the systems operating in the Member States using one or more of the technologies listed in paragraph 1. The detailed arrangements in this respect shall be determined by the Committee referred to in Article 5(1), including arrangements for the availability of on-board equipment to meet the demand of interested users. 3. It is recommended that new electronic toll systems brought into service after the adoption of this Directive use the satellite positioning and mobile communications technologies listed in paragraph 1. In respect of the possible migration to systems using such technologies by systems using other technologies, the Commission, in liaison with the Committee referred to in Article 5(1), shall draw up a report by 31 December 2009. This report shall include a study of use of each of the technologies referred to in paragraph 1, as well as a cost-benefit analysis. If appropriate, the Commission shall accompany the report with a proposal to the European Parliament and the Council for a migration strategy. 4. Without prejudice to paragraph 1, on-board equipment may also be suitable for other technologies, on condition that this does not lead to an additional burden for users or create discrimination between them. Where relevant, on-board equipment may also be linked to the vehicle's electronic tachograph. 5. Where Member States have toll systems, they shall take the necessary measures to increase the use of electronic toll systems. They shall endeavour to ensure that, by 1 January 2007 at the latest, at least 50% of traffic flow in each toll station can use electronic toll systems. Lanes used for electronic toll collection may also be used for toll collection by other means, with due regard to safety. 6. Interoperability work on existing toll technologies undertaken in connection with the European electronic toll service shall ensure the full compatibility and interfacing of those technologies with the technologies referred to in paragraph 1 and of their equipment with each other. 7. Member States shall ensure that processing of personal data necessary for the operation of the European electronic toll service is carried out in accordance with the Community rules protecting the freedoms and fundamental rights of individuals, including their privacy, and that, in particular, the provisions of Directives 95/46/EC and 2002/5 8/EC are complied with. Article 3 Setting-up of a European electronic toll service 1. A European electronic toll service shall be set up which encompasses all the road network in the Community on which tolls or road usage fees are collected electronically. This electronic toll service will be defined by a contractual set of rules allowing all operators and/or issuers to provide the service, a set of technical standards and requirements and a single subscription contract between the clients and the operators and/or issuers offering the service. This contract shall give access to the service on the whole of the network and subscriptions shall be available from the operator of any part of the network and/or from the issuer. 2. The European electronic toll service shall be independent of the fundamental decisions taken by Member States to levy tolls on particular types of vehicles, of the level of charges and of the purpose for which such charges are levied. It shall concern only the method of collecting tolls or fees. The service shall allow for contracts to be concluded irrespective of the place of registration of the vehicle, the nationality of the parties to the contract, and the zone or point on the road network in respect of which the toll is due. 3. The system shall allow intermodality to develop without creating disadvantages for other modes of transport. 4. Where Member States have national systems of electronic toll collection, they shall ensure that operators and/or issuers offer the European electronic toll service to their customers in accordance with the following timetable: (a) for all vehicles exceeding 3,5 tonnes and for all vehicles which are allowed to carry more than nine passengers (driver + 8), at the latest three years after the decisions on the definition of the European electronic toll service, as referred to in Article 4(4), have been taken; (b) for all other types of vehicle, at the latest five years after the decisions on the definition of the European electronic toll service, as referred to in Article 4(4), have been taken. Article 4 Features of the European electronic toll service 1. The European electronic toll service shall be based on the items listed in the Annex to this Directive. 2. Where appropriate, this Annex may be modified for technical reasons in accordance with the procedure referred to in Article 5(2). 3. The European electronic toll service shall employ the technological solutions referred to. in Article 2, using specifications which shall be publicly available. 4. The decisions relating to the definition of the European electronic toll service shall be taken by the Commission in accordance with the procedure referred to in Article 5(2), by 1 July 2006. Such decisions shall only be taken if all the conditions, evaluated on the basis of appropriate studies, are in place to enable interoperability to work from all points of view, including technical, legal and commercial. 5. If the decisions referred to in paragraph 4 are not taken by 1 July 2006, the Commission shall, in accordance with the procedure referred to in Article 5(2), set a new date by which such decisions are to be taken. 6. Technical decisions relating to the realisation of the European electronic toll service shall be taken by the Commission in accordance with the procedure referred to in Article 5(2). 7. The Commission shall ask the relevant standardisation bodies, in particular the CEN, in accordance with the procedure laid down by Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (8), to make every necessary effort rapidly to adopt standards applicable to electronic toll systems with regard to the technologies listed in Article 2(1). 8. Equipment for the European electronic toll service shall comply in particular with the requirements of Directives 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (9) and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (10). Article 5 Committee procedure 1. The Commission shall be assisted by an Electronic Toll Committee (hereinafter "the Committee"). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 6 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before ... (11). They shall immediately forward to the Commission the text of those provisions, together with a table correlating those provisions with this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 7 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 Union. Article 8 Addressees This Directive is addressed to the Member States.

32004L0073

2004

COMMISSION DIRECTIVE 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth 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), and in particular Article 28 thereof, Whereas: (1) Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling of each substance. That list needs to be updated to include further notified new substances and further existing substances as well adapting the existing entries to technical progress such as setting environmental concentration limits for certain substances. Accordingly it is also necessary to delete entries for certain substances and to split some entries because the classification no longer applies to all the substances under those entries. The labelling of substances containing 1,3-butadiene should be changed in order to reflect that that substance will be classified as a mutagen by the present Directive. (2) Annex V to Directive 67/548/EEC lays down the methods for the determination of the physicochemical properties, toxicity and ecotoxicity of substances and preparations. It is appropriate to amend that Annex in order to obtain a reduction to a minimum of the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (2). The methods for sub-chronic oral toxicity in Chapters B.1, B.4, B.5, B.31 and B.35 should be revised accordingly. Furthermore, Chapter B.42 should be added to Annex V in order to make available a refined method on sub-chronic oral toxicity. Finally, Chapter A.21 on physico-chemical properties, Chapter B.43 on sub-chronic oral toxicity and Chapters C.21 to C.24 on environmental toxicity should be added in order to allow for the determination of properties which are not yet sufficiently covered by the methods in Annex V. (3) The measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade with Dangerous Substances and Preparations, Article 1 Directive 67/548/EEC is amended as follows: (1) Annex I is amended as follows: (a) note K in the foreword is replaced by the text set out in Annex 1 A; (b) the entries corresponding to the entries set out in Annex 1B to this Directive are replaced by the text set out in that Annex; (c) the entries set out in Annex 1C to this Directive are inserted in accordance with the order of the entries set out in Annex I to Directive 67/548/EEC; (d) the entries with index numbers 604-050-00-X, 607-050-00-8, 607-171-00-6 and 613-130-00-3 are deleted; (e) the entry with index number 048-002-00-0 is replaced by the entries with index numbers 048-002-00-0 and 048-011-00-X set out in Annex 1D to this Directive; (f) the entry with index number 609-006-00-3 is replaced by the entries with index numbers 609-006-00-3 and 609-065-00-5 set out in Annex 1D to this Directive; (g) the entry with index number 612-039-00-6 is replaced by the entries with index numbers 612-039-00-6 and 612-207-00-9 as set out in Annex 1D. (2) Annex V is amended as follows: (a) the text set out in Annex 2A to this Directive is added as Chapter A.21; (b) chapter B.1bis is replaced by the text set out in Annex 2B to this Directive; (c) chapter B.1tris is replaced by the the text set out in Annex 2C to this Directive; (d) chapter B.4 is replaced by the text set out in Annex 2D to this Directive; (e) chapter B.5 is replaced by the text set out in Annex 2E to this Directive; (f) chapter B.31 is replaced by the text set out in Annex 2F to this Directive; (g) chapter B.35 is replaced by the text set out in Annex 2G to this Directive; (h) the text set out in Annex 2H to this Directive is added as Chapter B.42 and B.43; (i) the text set out in Annex 2I to this Directive is added as Chapter C.21 to C.24. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 October 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0086

2004

COMMISSION DIRECTIVE 2004/86/EC of 5 July 2004 amending, for the purposes of adapting to technical progress, Council Directive 93/93/EEC on the masses and dimensions of two or three-wheel motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/93/EEC of 29 October 1993 on the masses and dimensions of two or three-wheel motor vehicles (1), and in particular Article 3 thereof, Having regard to Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (2), and in particular Article 17 thereof, Whereas: (1) Directive 93/93/EEC is one of the separate directives in the context of the Community type-approval procedure according to Directive 2002/24/EC. The provisions of Directive 2002/24/EC relating to systems, components and separate technical units for vehicles therefore apply to Directive 93/93/EEC. (2) In order to enable the full type-approval system to function properly, it is necessary to clarify and supplement certain requirements in Directive 93/93/EEC. (3) To that end, it is necessary to specify that the masses of exchangeable superstructures for quadricycles of categories L6e and L7e, intended for transportation of goods, have to be considered as part of the payload rather than included in the unladen mass. (4) Directive 93/93/EEC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress set up pursuant to Article 13 of Council Directive 70/156/EEC (3), Article 1 The Annex to Directive 93/93/EEC is amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 January 2005, in the case of two or three-wheel motor vehicles whose masses and dimensions comply with the requirements of Directive 93/93/EEC, as amended by this Directive, Member States shall not, on grounds relating to the masses and dimensions: (a) refuse, in respect of such a vehicle to grant EC type-approval or national type-approval; or (b) prohibit the registration, sale or entry into service of such a vehicle. 2. With effect from 1 July 2005, if the requirements of Directive 93/93/EEC, as amended by this Directive, are not fulfilled for any new type of two or three-wheel motor vehicle, by reason of its masses or dimensions, Member States shall refuse to grant EC type-approval. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0088

2004

COMMISSION DIRECTIVE 2004/88/EC of 7 September 2004 amending Council Directive 76/768/EEC concerning cosmetic products for the purpose of adapting Annex III thereto to technical progress (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), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers, Whereas: (1) As the risk assessment had not been completed in accordance with Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances (2), the period of inclusion in part 2 of Annex III to Directive 76/768/EEC for musk xylene and musk ketone was extended until 30 September 2004. (2) On 8 January 2004, the Scientific Committee on Toxicity, Ecotoxicity and the Environment adopted an opinion on the results of the risk assessment of musk xylene and musk ketone that was carried out in accordance with Regulation (EEC) 793/93. (3) The Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers (SCCNFP) has confirmed that musk xylene can be safely used in cosmetic products, excluding oral care products, up to a maximum concentration in the final product of 1 % in fine fragrance, 0,4 % in eau de toilette and 0,03 % in other products and that musk ketone can be safely used in cosmetic products, excluding oral care products, up to a maximum concentration in the final product of 1,4 % in fine fragrance, 0,56 % in eau de toilette and 0,042 % in other products. (4) It is therefore necessary to include musk xylene and musk ketone in part 1 of Annex III to Directive 76/768/EEC while the corresponding entries in part 2 of that Annex should be deleted. (5) Directive 76/768/EEC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 Annex III to Directive 76/768/EEC 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 to comply with this Directive by 1 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0087

2004

COMMISSION DIRECTIVE 2004/87/EC of 7 September 2004 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress (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), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, Whereas: (1) In April 2002, the Commission included in part 2 of Annex III to Directive 76/768/EEC 60 hair dyes under the reference numbers 1 to 60. Since more information on the safety of those hair dyes was needed in order for the Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) to finish the risk assessment of those substances, those hair dyes have been provisionally allowed to be employed in cosmetic products until 30 September 2004. (2) In December 2002, the SCCNFP set the basic requirements to carry out a modern risk assessment of hair dyes. Following the process of consultation with the Member States and stakeholders it was agreed in December 2003 that the date of July 2005 was appropriate for the presentation to the SCCNFP of the additional information on hair dyes meeting the new requirements. Therefore, the period for which those hair dyes have been included in part 2 of Annex III to Directive 76/768/EEC has to be extended. (3) Directive 76/768/EEC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 In part 2 of Annex III to Directive 76/768/EEC, the date ‘30.9.2004’ in column g for reference numbers 1 to 60 is replaced by ‘31.12.2005’. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0089

2004

COMMISSION DIRECTIVE 2004/89/EC of 13 September 2004 adapting for the fifth time to technical progress Council Directive 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (1), and in particular Article 8 thereof, Whereas: (1) The Annex to Directive 96/49/EC refers to the Regulation concerning the International Carriage of Dangerous Goods by Rail (RID), as applicable with effect from 1 July 2003. (2) The RID is normally updated every two years, the latest update being in force from 1 January 2003, with a transitional period up to 30 June 2003. (3) Exceptionally the RID was updated again after one year so that the amended version entered into force on 1 January 2004. (4) It is therefore necessary to amend the Annex to Directive 96/49/EC. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee on the transport of dangerous goods referred to in Article 9 of Directive 96/49/EC, Article 1 The Annex to Directive 96/49/EC is replaced by the following: ‘Regulation concerning the International Carriage of Dangerous Goods by Rail (RID) appearing in Annex I to Appendix B to the Convention concerning International Carriage by Rail (COTIF), as applicable with effect from 1 January 2004, it being understood that the terms “contracting party” and “the States or the railways” will be replaced by the term “Member State”. The text of the amendments of the 2004 version of the RID will be published as soon as it is available in all official languages of the Community.’ Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0094

2004

COMMISSION DIRECTIVE 2004/94/EC of 15 September 2004 amending Council Directive 76/768/EEC as regards Annex IX (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 approximation of the laws of the Member States relating to cosmetic products (1), in particular the second subparagraph of Article 4a(1) thereof, After consulting the Scientific Committee on Cosmetic products and Non-food Products intended for consumers, Whereas: (1) The contents of Annex IX to Directive 76/768/EEC should be established for the purpose of listing those alternative methods to animal testing that have been validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre and that are not listed in Annex V 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 (2). (2) As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex IX whether the alternative method fully or partially replaces animal testing. (3) Directive 76/768/EEC should therefore be amended accordingly. (4) There are at present, no alternative methods validated by ECVAM, other than those listed in Annex V to Council Directive 67/548/EEC. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 The text in the Annex to this Directive is inserted in the Annex IX to Directive 76/768/EEC. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 September 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 2. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0093

2004

COMMISSION DIRECTIVE 2004/93/EC of 21 September 2004 amending Council Directive 76/768/EEC for the purpose of adapting its Annexes II and III to technical progress (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) and in particular Article 4b and Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP), Whereas: (1) Directive 76/768/EEC, as amended by Directive 2003/15/EC of the European Parliament and of the Council (2), prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1, 2 and 3, under Annex I 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 (3), but allows the use of substances classified in category 3 pursuant to Directive 67/548/EEC subject to evaluation and approval by the SCCNFP; Directive 76/768/EEC requires the Commission to adopt the necessary measures to that end. (2) In so far, as some of the substances classified as CMR of category 1 and 2 under Annex I to Directive 67/548/EEC are not yet listed in Annex II to Directive 76/768/EEC, it is necessary to include them in that Annex. Substances classified as CMR of category 3 under Annex I to Directive 67/548/EEC should also be included in Annex II to Directive 76/768/EEC, except if they have been evaluated by the SCCNFP and found acceptable for use in cosmetic products. (3) Substances classified as CMR of category 1 and 2 listed in Annex III, part 1 to Directive 76/768/EEC should be deleted. (4) Directive 76/768/EEC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 Annex II and Annex III, part 1 to Directive 76/768/EEC are amended in accordance with the text set out in the Annex to this Directive. Article 2 1. Member States shall take all necessary measures to ensure that from three months after the date of entry into force of the national provisions foreseen in Article 3, paragraph 1, cosmetic products which fail to comply with this Directive shall not be placed on the market by Community manufacturers or by importers established within the Community. 2. Member States shall take all necessary measures to ensure that the products referred to in paragraph 1 are not sold or disposed of to the final consumer after six months from the date of entry into force of the national provisions foreseen in Article 3, paragraph 1. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0097

2004

COMMISSION DIRECTIVE 2004/97/EC of 27 September 2004 amending Commission Directive 2004/60/EC as regards time limits (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), and in particular Article 6(1) thereof, Whereas: (1) Commission Directive 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to include quinoxyfen as active substance (2) adds that substance in Annex I to that Directive. (2) After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing that active substance and in particular to review existing provisional authorisations and, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with that Directive 91/414/EEC. (3) The time limits for the implementation provided for in Directive 2004/60/EC are not in line with those for other new active substances. The approach for all new active substances under the current review phase should be harmonised. (4) It is therefore appropriate to amend Directive 2004/60/EC accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Article 3 of Directive 2004/60/EC is amended as follows: Paragraph 2 is replaced by the following: ‘2. For each authorised plant protection product containing quinoxyfen as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2004 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing quinoxyfen as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2006 at the latest; or (b) in the case of a product containing quinoxyfen as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.’ Article 2 This Directive shall enter into force on 1 September 2004. Article 3 This Directive is addressed to the Member States.

32004L0096

2004

COMMISSION DIRECTIVE 2004/96/EC of 27 September 2004 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies for the purpose of adapting its Annex I to technical progress (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and Having regard to Council Directive 76/769/EEC 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 dangerous substances and preparations (1), and in particular Article 2a thereof, Whereas: (1) According to Directive 76/769/EEC as amended by Directive 94/27/EC of the European Parliament and the Council (2), nickel and its compounds are not to be used in certain post assemblies for piercing and certain other products unless they conform to the requirements set out in Directive 76/769/EEC. (2) The risk of sensitisation of humans to nickel by piercing post assemblies has been newly assessed in a targeted risk assessment; the risk assessment concluded that a migration limit for piercing post assemblies would be more appropriate than a content limit. (3) The new rate of nickel release (migration limit) should be adjusted with the multiplication factor specified in EN 1811 to compensate inter-laboratory variations and measuring inaccuracies. The European Committee of Standardisation (CEN) is invited to review EN 1811 in particular regarding the adjustment factor and to prepare a revised standard without adjustment factor, or with a smaller adjustment factor, if appropriate. (4) The risk assessment was referred to the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) for peer review and the CSTEE has confirmed that a nickel migration limit may induce lower risks of sensitisation than a nickel content limit. (5) The provisions laid down by this Directive take into account the current state of knowledge, science and techniques. (6) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, in particular 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 (3), and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (4). (7) 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 amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 1 August 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 September 2005. When Member States adopt those provisions, these shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0098

2004

COMMISSION DIRECTIVE 2004/98/EC of 30 September 2004 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of pentabromodiphenyl ether in aircraft emergency evacuation systems for the purpose of adapting its Annex I to technical progress (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and Having regard to Council Directive 76/769/EEC 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 dangerous substances and preparations (1), and in particular Article 2a thereof, Whereas: (1) Pentabromodiphenyl ether (pentaBDE) is used as a brominated flame retardant in order to protect plastics, fabrics and other articles against fire. (2) On the basis of a risk assessment pursuant to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (2) it was considered necessary to restrict the placing on the market and use of pentaBDE, and the substance was therefore added to Annex I to Directive 76/769/EEC. (3) Recently, new information has become available showing that pentaBDE is used in specific fabrics for aircraft evacuation slides and slide-rafts and cannot be replaced by suitable alternatives due to the extensive safety testing and regulatory requirements. (4) Emissions from such slides into the environment and exposure of humans cannot be expected, except in emergency cases for a few seconds, and only in the rare event that the material is burning. (5) Considering the limited application of pentaBDE in aircraft emergency evacuation systems and the negligible contribution to the overall risks posed by that article to health and the environment, it is justified to permit pentaBDE to be placed on the market and used for that specific purpose. (6) Given the complexity of the substitution process and the authorisation regulations for aircraft emergency systems, and the serious socio-economic implications, a time limited derogation is justified for articles essential for evacuation situations. Permitting the use of pentaBDE in aircraft emergency evacuation systems would maintain aircraft safety by preventing the use of older emergency systems. (7) Directive 76/769/EEC should therefore be amended accordingly. (8) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, in particular 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 (3), and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (4). (9) 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 amended in accordance with the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 1 January 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 January 2005 at the latest. When Member States adopt those provisions, these shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 Union. Article 4 This Directive is addressed to the Member States.

32004L0103

2004

COMMISSION DIRECTIVE 2004/103/EC of 7 October 2004 on identity and plant health checks of plants, plant products or other objects, listed in Part B of Annex V to Council Directive 2000/29/EC, which may be carried out at a place other than the point of entry into the Community or at a place close by and specifying the conditions related to these checks Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular Articles 13c(2)(d) and 13c(2)(e) and the fourth and fifth subparagraphs of Article 13c(4) thereof, Whereas: (1) Pursuant to Directive 2000/29/EC, plants, plant products or other objects listed in Part B of Annex V, thereto, coming from third countries, should in principle be subjected to identity and plant health checks at the point of entry into the Community, or at a place close by. (2) In case of transit of non-Community goods these identity and plant health checks may also be carried out on the premises of the official body of destination or at any other place close by; in certain other cases, these checks may be carried out at the place of destination, such as a place of production, as long as specific guarantees and documents as regards the transport of plants, plant products or other objects are provided. (3) It is necessary to specify the cases in which identity and plant health checks may be carried out at the place of destination. (4) To ensure that there is no risk of harmful organisms spreading during transport, provisions or specific guarantees and documents, as regards the transport, should be laid down. (5) Minimum conditions for the carrying out of the identity and plant health checks should be laid down as regards technical requirements applicable to the responsible official bodies in charge of the inspection at places of destination as well as regards facilities, tools and equipment enabling the said responsible official bodies to carry out identity and plant health checks. (6) It is necessary to lay down detailed rules concerning the cooperation between official responsible bodies and customs offices, including the model forms of documents to be used in that cooperation, the means of transmission of these documents and the procedures for exchange of information. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 1. This Directive shall apply to plants, plant products or other objects coming from third countries, listed in Part B of Annex V to Directive 2000/29/EC (hereinafter referred to as ‘products concerned’). In the cases and circumstances defined by this Directive, Member States may lay down that those inspections referred to in Article 13a(1)(b)(ii) and (iii) of Directive 2000/29/EC on the products concerned may be carried out at another place. In the case of transit of non-Community goods referred to in Article 13c(2)(c) of Directive 2000/29/EC, the inspection may take place at the premises of the official body of destination, or at any place close by, when the conditions referred to in paragraph 2 are met. In cases referred to in Article 13c(2)(d) of Directive 2000/29/EC, the inspection may take place at the place of destination such as a place of production, when the conditions referred to in paragraph 2 are met. 2. The conditions referred to in paragraph 1 shall be: (a) when the official bodies of the point of entry and of destination, decide, where appropriate by agreement between the responsible official bodies of the Member States, that identity checks and plant health checks (hereinafter referred to as ‘checks’) could more meticulously be carried out at a place other than the point of entry into the Community or at a place close by and (b) when any importer or other person responsible for the places or the premises where the checks are to be carried out (hereinafter referred to as ‘the applicant’) of a consignment composed of the products concerned has the approval, through an approval procedure defined in Article 2(2) for checks to be carried out at ‘an approved place of inspection’ which is either: — in the case of transit of non-Community goods referred to in Article 13c(2)(c) of Directive 2000/29/EC, at — the premises of the official body of destination, or — a place close by those premises and designated or approved by the customs authorities and by the responsible official body, or — in the cases referred to in Article 13c(2)(d) of Directive 2000/29/EC, at — a place of destination approved by the official body and the customs authorities responsible for the area where that place of destination is located and (c) when specific guarantees and documents as regards the transport of a consignment composed of the products concerned (hereinafter referred to as ‘the consignment’), to the approved place of inspection are met, and, where appropriate, minimum conditions concerning the storage of these products on these places of inspection are fulfilled. 3. The specific guarantees, documents and minimum conditions referred to in paragraph 2(c) shall be: (a) the packaging of the consignment or the means of transport used for this consignment shall be closed or sealed in such a way that the products concerned cannot cause infestation or infection during their transport to the approved place of inspection and will be such that their identity will remain unchanged. In duly reasoned cases the relevant official bodies of the Member States may allow consignments which are not closed or sealed, provided that the products concerned cannot cause infestation or infection during their transport to the approved place of inspection; (b) the consignment shall be sent to the approved place of inspection. No change of the place of inspection is allowed, except following approval by the relevant official bodies of the point of entry and of the requested destination, and the customs authorities responsible for the area where the requested place of inspection is located; (c) the consignment shall be accompanied by a ‘Plant health movement document’, without prejudice to the certificates prescribed in Article 13(1) of Directive 2000/29/EC, and contain the required information in accordance with the model in the Annex to this Directive; the document shall be completed by typing or in handwritten legible capital letters or by electronic means in agreement with the relevant official bodies of point of entry and of destination and shall be in at least one of the official languages of the Community; (d) the relevant headings of the document referred to in paragraph 3(c) shall be filled in and signed by the importer of the consignment under the supervision of the relevant official body of point of entry; (e) in the cases referred to in paragraph 2(b), second indent, the storage of the consignment at the approved place of inspection shall be such that it is separated from both Community goods and from consignments infested or suspected to be infested by harmful organisms. Article 2 1. Member States shall ensure that an approval procedure be established as specified in paragraphs 2, 3 and 4 to evaluate, and where appropriate to approve, the suitability in phytosanitary terms, of carrying out checks at places proposed as approved places of inspection. 2. The procedure referred to in paragraph 1 shall indicate that, if the checks are to be carried out at approved places of inspection, any applicant shall apply to the responsible official bodies in charge of carrying out such checks, requesting that checks be carried out at places mentioned in the request. 3. The application shall include a technical dossier supplying the information necessary for evaluating the suitability of proposed places as an approved place of inspection, and covering, in particular: (a) information relating to the products concerned intended to be imported and the places in which the imported products concerned will be stored or kept awaiting the final results of the checks, and in particular how separation referred to in Article 1(3)(e) is to be secured, and (b) where appropriate, when the products concerned are intended for a person to whom the status of ‘authorised consignee’ was granted and fulfil the conditions laid down in Article 406 of Commission Regulation (EEC) No 2454/93 (2) or when the places concerned are subject to an authorisation as referred to in Article 497 of the said Regulation, relevant evidence thereof. 4. Member States shall ensure that the application referred to in paragraph 2 shall be recorded and that the responsible official bodies shall: (a) examine the information supplied in the application; (b) evaluate the suitability for carrying out checks at the proposed places of inspection, which should fulfil minimum requirements which are at least those laid down in paragraph 3(b) and (c) of the Annex to Commission Directive 98/22/EC (3), or any further requirements which the Member States may impose in a non-discriminatory manner and which are justified in order to allow efficient inspections; (c) respond to the applicant by either: (i) indicating that the application is acceptable and that the places concerned are designated as approved place of inspection, or (ii) indicating that the application is not acceptable and the reason therefore. 5. Member States shall keep and make available to the Commission and to the Member States on request, the updated list of the approved places of inspection. 6. Member States shall ensure that the responsible official bodies shall take the necessary measures if it is found that there are elements which would militate against the proper functioning of carrying out checks at the approved places of inspection situated in their territory. Member States shall notify the Commission and the Member States concerned of all significant cases of non-compliance with the conditions which apply to an approved place of inspection. Article 3 Member States shall ensure that the importer of the consignments for which it was decided that checks of these consignments may be carried out at an approved place of inspection, shall be subject to the following obligations, without prejudice to those already laid down in Commission Directive 92/90/EEC (4): (a) the importer shall notify the introduction of the products concerned sufficiently in advance to the relevant official body of destination, which notification shall contain in particular: (i) the name, address and the location of the approved place of inspection; (ii) the scheduled date and time of arrival at the approved place of inspection of the products concerned; (iii) if available, the individual serial number of the Plant health movement document referred to in Article 1(3)(c); (iv) if available, the date and place at which the Plant health movement document referred to in Article 1(3)(c) was drawn up; (v) the name, the address and the official registration number of the importer; (vi) the reference number of the phytosanitary certificate and/or phytosanitary certificate for re-export, or any other required phytosanitary document; (b) the importer shall notify to the relevant official body of destination any changes as regards the information supplied pursuant to subparagraph (a). Article 4 Member States shall ensure that the checks of the products concerned carried out at the approved place of inspection satisfy minimum conditions which are at least those laid down in paragraphs 1, 2 and 3(a) of the Annex to Directive 98/22/EC, or any further requirements which the Member States may impose in a non-discriminatory manner and which are justified in order to allow efficient inspections. Article 5 Member States may lay down additional requirements deemed necessary to designate a proposed place as an approved place of inspection. Article 6 1. Member States shall ensure cooperation, where applicable, between: (a) the official body of point of entry and the official body of destination and (b) the official body of point of entry and the customs office of point of entry and (c) the official body of destination and the customs office of destination and (d) the official body of point of entry and the customs office of destination by means of exchange of relevant information on the plants, plant products or other objects intended to be imported, their packaging and means of transport in written or electronic form using the Plant health movement document referred to in Article 1(3)(c). 2. If the point of entry into the Community of the products concerned and the approved place of inspection are situated in different Member States, the consignment may be sent to and the checks may be carried out at an approved place of inspection on the basis of an agreement between the responsible official bodies of the Member States concerned. Evidence of the agreement between the responsible official bodies of the Member States concerned shall be recorded on the Plant health movement document. 3. After the products have been inspected at the approved place of inspection, the official body of destination shall certify on the Plant health movement document, using a service stamp and a date, that the relevant identity and plant health checks referred to in Article 13a(1)(b)(ii) and (iii) of Directive 2000/29/EC have been carried out. The final outcome of these checks shall be shown in the box headed ‘Decision’. This provision applies, mutatis mutandis, if the documentary checks referred to in Article 13c(2)(a) of Directive 2000/29/EC have also been complied with. 4. If the outcome of the checks referred to in paragraph 3 is ‘Release’, the consignment and the accompanying Plant health movement document shall be presented to the customs authorities responsible for the area of the ‘approved place of inspection’ enabling the consignment to be placed under the relevant customs procedure referred to in Article 13(1) of Directive 2000/29/EC. The Plant health movement document shall no longer be required to accompany the consignment and this document or a copy thereof shall be kept for at least one year by the official body of point of destination. 5. If the outcome of the checks referred to in paragraph 3 leads to the obligation to move the products concerned within the Community to a destination outside the Community, they shall remain under Customs supervision until the re-export of the products has taken place. Article 7 This Directive shall be reviewed by 1 January 2007 at the latest. Article 8 1. Member States shall adopt and publish by 31 December 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 January 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 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 9 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 10 This Directive is addressed to the Member States.

32004L0105

2004

COMMISSION DIRECTIVE 2004/105/EC of 15 October 2004 determining the models of official phytosanitary certificates or phytosanitary certificates for re-export accompanying plants, plant products or other objects from third countries and listed in Council Directive 2000/29/EC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1) and in particular Article 13a(4)(a) thereof, Whereas: (1) Under Directive 2000/29/EC, plants, plant products or other objects listed in that Directive, coming from third countries, are in principle to be accompanied by the original of the required official ‘phytosanitary certificate’ or ‘phytosanitary certificate for re-export’ (certificates). (2) The International Plant Protection Convention (IPPC) of 6 December 1951 concluded at the United Nations Food and Agricultural Organisation (FAO) specifies in its Annex models of certificates providing a standard wording and format that should be followed for the preparation and issue of certificates. (3) The IPPC was significantly amended in 1979 and 1997. As a consequence of those amendments different models of the certificates were approved to accompany plants, plant products and other objects when moving in international traffic. (4) Although the amendments of the IPPC in 1997 have not yet entered into force, Resolution 12/97 of the 29th session of the Conference of the FAO allowed the use of the amended certificates as an alternative and on voluntary basis among Contracting Parties to the IPPC that accept them. It appeared that many Contracting Parties to the IPPC already use the certificates based on the models specified in the Annex to the IPPC, as amended in 1997. (5) The models of certificates to accompany plants, plant products or other objects for entry into the Community should be determined. (6) National plant protection organisations usually stock up certificates in large quantities. It is appropriate to lay down rules for the use of certificates based on the models specified in the Annex to IPPC, as amended in 1979, during a transitional period. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 1. For the purposes of Article 13(1)(ii) of Directive 2000/29/EC, the Member States shall accept official ‘phytosanitary certificates’ or ‘phytosanitary certificates for re-export’ (certificates) accompanying plants, plant products or other objects listed in Part B of Annex V to Directive 2000/29/EC coming from contracting third countries to the International Plant Protection Convention (IPPC) which are issued in accordance with the models as specified in Annex I. 2. Member States shall only accept the certificates referred to in paragraph 1 provided that they have been completed taking into account the FAO International Standard for Phytosanitary Measures No 12 on Guidelines for phytosanitary certificates. Article 2 The Member States shall accept certificates issued in accordance with the models as specified in Annex II, until 31 December 2009. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 4 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32004L0101

2004

DIRECTIVE 2004/101/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 amending Directive 2003/87/EC establishing a scheme for greenhouse gas emission allowance trading within the Community, in respect of the Kyoto Protocol's project mechanisms (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Directive 2003/87/EC (3) establishes a scheme for greenhouse gas emission allowance trading within the Community (the Community scheme) in order to promote reductions of greenhouse gas emissions in a cost-effective and economically efficient manner, recognising that, in the longer-term, global emissions of greenhouse gases will need to be reduced by approximately 70 % compared to 1990 levels. It aims at contributing towards fulfilling the commitments of the Community and its Member States to reduce anthropogenic greenhouse gas emissions under the Kyoto Protocol which was approved by Council Decision 2002/358/EC of 25 April 2002 concerning the approval, on behalf of the European Community, of the Kyoto Protocol to the United Nations Framework Convention on Climate Change and the joint fulfilment of commitments thereunder (4). (2) Directive 2003/87/EC states that the recognition of credits from project-based mechanisms for fulfilling obligations as from 2005 will increase the cost-effectiveness of achieving reductions of global greenhouse gas emissions and shall be provided for by provisions for linking the Kyoto project-based mechanisms, including joint implementation (JI) and the clean development mechanism (CDM), with the Community scheme. (3) Linking the Kyoto project-based mechanisms to the Community scheme, while safeguarding the latter's environmental integrity, gives the opportunity to use emission credits generated through project activities eligible pursuant to Articles 6 and 12 of the Kyoto Protocol in order to fulfil Member States' obligations in accordance with Article 12(3) of Directive 2003/87/EC. As a result, this will increase the diversity of low-cost compliance options within the Community scheme leading to a reduction of the overall costs of compliance with the Kyoto Protocol while improving the liquidity of the Community market in greenhouse gas emission allowances. By stimulating demand for JI credits, Community companies will invest in the development and transfer of advanced environmentally sound technologies and know-how. The demand for CDM credits will also be stimulated and thus developing countries hosting CDM projects will be assisted in achieving their sustainable development goals. (4) In addition to the use of the Kyoto project-based mechanisms by the Community and its Member States, and by companies and individuals outside the Community scheme, those mechanisms should be linked to the Community scheme in such a way as to ensure consistency with the United Nations Framework Convention on Climate Change (UNFCCC) and the Kyoto Protocol and subsequent decisions adopted thereunder as well as with the objectives and architecture of the Community scheme and provisions laid down by Directive 2003/87/EC. (5) Member States may allow operators to use, in the Community scheme, certified emission reductions (CERs) from 2005 and emission reduction units (ERUs) from 2008. The use of CERs and ERUs by operators from 2008 may be allowed up to a percentage of the allocation to each installation, to be specified by each Member State in its national allocation plan. The use will take place through the issue and immediate surrender of one allowance in exchange for one CER or ERU. An allowance issued in exchange for a CER or ERU will correspond to that CER or ERU. (6) The Commission Regulation for a standardised and secured system of registries, to be adopted pursuant to Article 19(3) of Directive 2003/87/EC and Article 6(1) of Decision No 280/2004/EC of the European Parliament and of the Council of 11 February 2004 concerning a mechanism for monitoring Community greenhouse gas emissions and for implementing the Kyoto Protocol (5), will provide for the relevant processes and procedures in the registries system for the use of CERs during the period 2005 to 2007 and subsequent periods, and for the use of ERUs during the period 2008 to 2012 and subsequent periods. (7) Each Member State will decide on the limit for the use of CERs and ERUs from project activities, having due regard to the relevant provisions of the Kyoto Protocol and the Marrakesh Accords, to meet the requirements therein that the use of the mechanisms should be supplemental to domestic action. Domestic action will thus constitute a significant element of the effort made. (8) In accordance with the UNFCCC and the Kyoto Protocol and subsequent decisions adopted thereunder, Member States are to refrain from using CERs and ERUs generated from nuclear facilities to meet their commitments pursuant to Article 3(1) of the Kyoto Protocol and pursuant to Decision 2002/358/EC. (9) Decisions 15/CP.7 and 19/CP.7 adopted pursuant to the UNFCCC and the Kyoto Protocol emphasise that environmental integrity is to be achieved, inter alia, through sound modalities, rules and guidelines for the mechanisms, and through sound and strong principles and rules governing land use, land-use change and forestry activities, and that the issues of non-permanence, additionality, leakage, uncertainties and socioeconomic and environmental impacts, including impacts on biodiversity and natural ecosystems, associated with afforestation and reforestation project activities are to be taken into account. The Commission should consider, in its review of Directive 2003/87/EC in 2006, technical provisions relating to the temporary nature of credits and the limit of 1 % for eligibility for land use, land-use change and forestry project activities as established in Decision 17/CP.7, and also provisions relating to the outcome of the evaluation of potential risks associated with the use of genetically modified organisms and potentially invasive alien species in afforestation and reforestation project activities, to allow operators to use CERs and ERUs resulting from land use, land use change and forestry project activities in the Community scheme from 2008, in accordance with the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol. (10) In order to avoid double counting, CERs and ERUs should not be issued as a result of project activities undertaken within the Community that also lead to a reduction in, or limitation of, emissions from installations covered by Directive 2003/87/EC, unless an equal number of allowances is cancelled from the registry of the Member State of the CERs’ or ERUs’ origin. (11) In accordance with the relevant treaties of accession, the acquis communautaire should be taken into account in the establishment of baselines for project activities undertaken in countries acceding to the Union. (12) Any Member State that authorises private or public entities to participate in project activities remains responsible for the fulfilment of its obligations under the UNFCCC and the Kyoto Protocol and should therefore ensure that such participation is consistent with the relevant guidelines, modalities and procedures adopted pursuant to the UNFCCC or the Kyoto Protocol. (13) In accordance with the UNFCCC, the Kyoto Protocol and subsequent decisions adopted for their implementation, the Commission and the Member States should support capacity building activities in developing countries and countries with economies in transition in order to help them take full advantage of JI and the CDM in a manner that supports their sustainable development strategies. The Commission should review and report on efforts in this regard. (14) Criteria and guidelines that are relevant to considering whether hydroelectric power production projects have negative environmental or social impacts have been identified by the World Commission on Dams in its November 2000 Report ‘Dams and Development — A New Framework for Decision-Making’, by the OECD and by the World Bank. (15) Since participation in JI and CDM project activities is voluntary, corporate environmental and social responsibility and accountability should be enhanced in accordance with paragraph 17 of the Plan of implementation of the world summit on sustainable development. In this connection, companies should be encouraged to improve the social and environmental performance of JI and CDM activities in which they participate. (16) Information on project activities in which a Member State participates or authorises private or public entities to participate should be made available to the public in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (6). (17) The Commission may mention impacts on the electricity market in its reports on emission allowance trading and the use of credits from project activities. (18) Following entry into force of the Kyoto Protocol, the Commission should examine whether it could be possible to conclude agreements with countries listed in Annex B to the Kyoto Protocol which have yet to ratify the Protocol, to provide for the recognition of allowances between the Community scheme and mandatory greenhouse gas emissions trading schemes capping absolute emissions established within those countries. (19) Since the objective of the proposed action, namely the establishment of a link between the Kyoto project-based mechanisms and the Community scheme, cannot be sufficiently achieved by the Member States acting individually, and can therefore by reason of the scale and effects of this action be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (20) Directive 2003/87/EC should therefore be amended accordingly, Article 1 Amendments to Directive 2003/87/EC Directive 2003/87/EC is hereby amended as follows: 1. In Article 3, the following points are added: ‘(k) “Annex I Party” means a Party listed in Annex I to the United Nations Framework Convention on Climate Change (UNFCCC) that has ratified the Kyoto Protocol as specified in Article 1(7) of the Kyoto Protocol; (l) “project activity” means a project activity approved by one or more Annex I Parties in accordance with Article 6 or Article 12 of the Kyoto Protocol and the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol; (m) “emission reduction unit” or “ERU” means a unit issued pursuant to Article 6 of the Kyoto Protocol and the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol; (n) “certified emission reduction” or “CER” means a unit issued pursuant to Article 12 of the Kyoto Protocol and the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol.’ 2. The following Articles are inserted after Article 11: ‘Article 11a Use of CERs and ERUs from project activities in the Community scheme 1. Subject to paragraph 3, during each period referred to in Article 11(2), Member States may allow operators to use CERs and ERUs from project activities in the Community scheme up to a percentage of the allocation of allowances to each installation, to be specified by each Member State in its national allocation plan for that period. This shall take place through the issue and immediate surrender of one allowance by the Member State in exchange for one CER or ERU held by the operator in the national registry of its Member State. 2. Subject to paragraph 3, during the period referred to in Article 11(1), Member States may allow operators to use CERs from project activities in the Community scheme. This shall take place through the issue and immediate surrender of one allowance by the Member State in exchange for one CER. Member States shall cancel CERs that have been used by operators during the period referred to in Article 11(1). 3. All CERs and ERUs that are issued and may be used in accordance with the UNFCCC and the Kyoto Protocol and subsequent decisions adopted thereunder may be used in the Community scheme: (a) except that, in recognition of the fact that, in accordance with the UNFCCC and the Kyoto Protocol and subsequent decisions adopted thereunder, Member States are to refrain from using CERs and ERUs generated from nuclear facilities to meet their commitments pursuant to Article 3(1) of the Kyoto Protocol and in accordance with Decision 2002/358/EC, operators are to refrain from using CERs and ERUs generated from such facilities in the Community scheme during the period referred to in Article 11(1) and the first five-year period referred to in Article 11(2); and (b) except for CERs and ERUs from land use, land use change and forestry activities. Article 11b Project activities 1. Member States shall take all necessary measures to ensure that baselines for project activities, as defined by subsequent decisions adopted under the UNFCCC or the Kyoto Protocol, undertaken in countries having signed a Treaty of Accession with the Union fully comply with the acquis communautaire, including the temporary derogations set out in that Treaty of Accession. 2. Except as provided for in paragraphs 3 and 4, Member States hosting project activities shall ensure that no ERUs or CERs are issued for reductions or limitations of greenhouse gas emissions from installations falling within the scope of this Directive. 3. Until 31 December 2012, for JI and CDM project activities which reduce or limit directly the emissions of an installation falling within the scope of this Directive, ERUs and CERs may be issued only if an equal number of allowances is cancelled by the operator of that installation. 4. Until 31 December 2012, for JI and CDM project activities which reduce or limit indirectly the emission level of installations falling within the scope of this Directive, ERUs and CERs may be issued only if an equal number of allowances is cancelled from the national registry of the Member State of the ERUs’ or CERs’ origin. 5. A Member State that authorises private or public entities to participate in project activities shall remain responsible for the fulfilment of its obligations under the UNFCCC and the Kyoto Protocol and shall ensure that such participation is consistent with the relevant guidelines, modalities and procedures adopted pursuant to the UNFCCC or the Kyoto Protocol. 6. In the case of hydroelectric power production project activities with a generating capacity exceeding 20 MW, Member States shall, when approving such project activities, ensure that relevant international criteria and guidelines, including those contained in the World Commission on Dams November 2000 Report “Dams and Development — A New Framework for Decision-Making”, will be respected during the development of such project activities. 7. Provisions for the implementation of paragraphs 3 and 4, particularly in respect of the avoidance of double counting, and any provisions necessary for the implementation of paragraph 5 where the host party meets all eligibility requirements for JI project activities shall be adopted in accordance with Article 23(2).’ 3. Article 17 is replaced by the following: ‘Article 17 Access to information Decisions relating to the allocation of allowances, information on project activities in which a Member State participates or authorises private or public entities to participate, and the reports of emissions required under the greenhouse gas emissions permit and held by the competent authority, shall be made available to the public in accordance with Directive 2003/4/EC.’ 4. In Article 18 the following subparagraph is added: ‘Member States shall in particular ensure coordination between their designated focal point for approving project activities pursuant to Article 6 (1)(a) of the Kyoto Protocol and their designated national authority for the implementation of Article 12 of the Kyoto Protocol respectively designated in accordance with subsequent decisions adopted under the UNFCCC or the Kyoto Protocol.’ 5. In Article 19(3) the following sentence is added: ‘That Regulation shall also include provisions concerning the use and identification of CERs and ERUs in the Community scheme and the monitoring of the level of such use.’ 6. Article 21 is amended as follows: (a) in paragraph 1 the second sentence is replaced by the following: ‘This report shall pay particular attention to the arrangements for the allocation of allowances, the use of ERUs and CERs in the Community scheme, the operation of registries, the application of the monitoring and reporting guidelines, verification and issues relating to compliance with the Directive and the fiscal treatment of allowances, if any.’ (b) paragraph 3 is replaced by the following: ‘3. The Commission shall organise an exchange of information between the competent authorities of the Member States concerning developments relating to issues of allocation, the use of ERUs and CERs in the Community scheme, the operation of registries, monitoring, reporting, verification and compliance with this Directive.’ 7. The following Article is inserted after Article 21: ‘Article 21a Support of capacity-building activities In accordance with the UNFCCC, the Kyoto Protocol and any subsequent decision adopted for their implementation, the Commission and the Member States shall endeavour to support capacity-building activities in developing countries and countries with economies in transition in order to help them take full advantage of JI and the CDM in a manner that supports their sustainable development strategies and to facilitate the engagement of entities in JI and CDM project development and implementation.’ 8. Article 30 is amended as follows: (a) in paragraph 2, point (d) is replaced by the following: ‘(d) the use of credits from project activities, including the need for harmonisation of the allowed use of ERUs and CERs in the Community scheme;’ (b) in paragraph 2 the following points are added: ‘(l) the impact of project mechanisms on host countries, particularly on their development objectives, whether JI and CDM hydroelectric power production project activities with a generating capacity exceeding 500 MW and having negative environmental or social impacts have been approved, and the future use of CERs or ERUs resulting from any such hydroelectric power production project activities in the Community scheme; (m) the support for capacity-building efforts in developing countries and countries with economies in transition; (n) the modalities and procedures for Member States' approval of domestic project activities and for the issuing of allowances in respect of emission reductions or limitations resulting from such activities from 2008; (o) technical provisions relating to the temporary nature of credits and the limit of 1 % for eligibility for land use, land-use change and forestry project activities as established in Decision 17/CP.7, and provisions relating to the outcome of the evaluation of potential risks associated with the use of genetically modified organisms and potentially invasive alien species by afforestation and reforestation project activities, to allow operators to use CERs and ERUs resulting from land use, land-use change and forestry project activities in the Community scheme from 2008, in accordance with the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol.’ (c) paragraph 3 is replaced by the following: ‘3. In advance of each period referred to in Article 11(2), each Member State shall publish in its national allocation plan its intended use of ERUs and CERs and the percentage of the allocation to each installation up to which operators are allowed to use ERUs and CERs in the Community scheme for that period. The total use of ERUs and CERs shall be consistent with the relevant supplementarity obligations under the Kyoto Protocol and the UNFCCC and the decisions adopted thereunder. Member States shall, in accordance with Article 3 of Decision No 280/2004/EC of the European Parliament and of the Council of 11 February 2004 concerning a mechanism for monitoring Community greenhouse gas emissions and for implementing the Kyoto Protocol (7), report to the Commission every two years on the extent to which domestic action actually constitutes a significant element of the efforts undertaken at national level, as well as the extent to which use of the project mechanisms is actually supplemental to domestic action, and the ratio between them, in accordance with the relevant provisions of the Kyoto Protocol and the decisions adopted thereunder. The Commission shall report on this in accordance with Article 5 of the said Decision. In the light of this report, the Commission shall, if appropriate, make legislative or other proposals to complement provisions adopted by Member States to ensure that use of the mechanisms is supplemental to domestic action within the Community.’ 9. In Annex III the following point is added: ‘12. The plan shall specify the maximum amount of CERs and ERUs which may be used by operators in the Community scheme as a percentage of the allocation of the allowances to each installation. The percentage shall be consistent with the Member State’s supplementarity obligations under the Kyoto Protocol and decisions adopted pursuant to the UNFCCC or the Kyoto Protocol.’ Article 2 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 November 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a 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 provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 3 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 Addressees This Directive is addressed to the Member States.

32004L0113

2004

COUNCIL DIRECTIVE 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services Having regard to the Treaty establishing the European Community and in particular Article 13(1) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Parliament (1), Having regard to the Opinion of the European Economic and Social Committee (2), Having regard to the opinion of the Committee of the Regions (3), Whereas: (1) In accordance with Article 6 of the Treaty on European Union, the Union is founded on the principles of liberty, democracy, respect for human rights and fundamental freedoms and the rule of law, principles which are common to the Member States, and respects fundamental rights as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms and as they result from the constitutional traditions common to the Member States as general principles of Community law. (2) The right to equality before the law and protection against discrimination for all persons constitutes a universal right recognised by the Universal Declaration of Human Rights, the United Nations Convention on the Elimination of all forms of Discrimination Against Women, the International Convention on the Elimination of all forms of Racial Discrimination and the United Nations Covenants on Civil and Political Rights and on Economic, Social and Cultural Rights and by the European Convention for the Protection of Human Rights and Fundamental Freedoms, to which all Member States are signatories. (3) While prohibiting discrimination, it is important to respect other fundamental rights and freedoms, including the protection of private and family life and transactions carried out in that context and the freedom of religion. (4) Equality between men and women is a fundamental principle of the European Union. Articles 21 and 23 of the Charter of Fundamental Rights of the European Union prohibit any discrimination on grounds of sex and require equality between men and women to be ensured in all areas. (5) Article 2 of the Treaty establishing the European Community provides that promoting such equality is one of the Community's essential tasks. Similarly, Article 3(2) of the Treaty requires the Community to aim to eliminate inequalities and to promote equality between men and women in all its activities. (6) The Commission announced its intention of proposing a directive on sex discrimination outside of the labour market in its Communication on the Social Policy Agenda. Such a proposal is fully consistent with Council Decision 2001/51/EC of 20 December 2000 establishing a Programme relating to the Community framework strategy on gender equality (2001-2005) (4) covering all Community policies and aimed at promoting equality for men and women by adjusting these policies and implementing practical measures to improve the situation of men and women in society. (7) At its meeting in Nice of 7 and 9 December 2000, the European Council called on the Commission to reinforce equality-related rights by adopting a proposal for a directive on promoting gender equality in areas other than employment and professional life. (8) The Community has adopted a range of legal instruments to prevent and combat sex discrimination in the labour market. These instruments have demonstrated the value of legislation in the fight against discrimination. (9) Discrimination based on sex, including harassment and sexual harassment, also takes place in areas outside of the labour market. Such discrimination can be equally damaging, acting as a barrier to the full and successful integration of men and women into economic and social life. (10) Problems are particularly apparent in the area of the access to and supply of goods and services. Discrimination based on sex, should therefore be prevented and eliminated in this area. As in the case of Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial and ethnic origin (5), this objective can be better achieved by means of Community legislation. (11) Such legislation should prohibit discrimination based on sex in the access to and supply of goods and services. Goods should be taken to be those within the meaning of the provisions of the Treaty establishing the European Community relating to the free movement of goods. Services should be taken to be those within the meaning of Article 50 of that Treaty. (12) To prevent discrimination based on sex, this Directive should apply to both direct discrimination and indirect discrimination. Direct discrimination occurs only when one person is treated less favourably, on grounds of sex, than another person in a comparable situation. Accordingly, for example, differences between men and women in the provision of healthcare services, which result from the physical differences between men and women, do not relate to comparable situations and therefore, do not constitute discrimination. (13) The prohibition of discrimination should apply to persons providing goods and services, which are available to the public and which are offered outside the area of private and family life and the transactions carried out in this context. It should not apply to the content of media or advertising nor to public or private education. (14) All individuals enjoy the freedom to contract, including the freedom to choose a contractual partner for a transaction. An individual who provides goods or services may have a number of subjective reasons for his or her choice of contractual partner. As long as the choice of partner is not based on that person's sex, this Directive should not prejudice the individual's freedom to choose a contractual partner. (15) There are already a number of existing legal instruments for the implementation of the principle of equal treatment between men and women in matters of employment and occupation. Therefore, this Directive should not apply in this field. The same reasoning applies to matters of self-employment insofar as they are covered by existing legal instruments. The Directive should apply only to insurance and pensions which are private, voluntary and separate from the employment relationship. (16) Differences in treatment may be accepted only if they are justified by a legitimate aim. A legitimate aim may, for example, be the protection of victims of sex-related violence (in cases such as the establishment of single-sex shelters), reasons of privacy and decency (in cases such as the provision of accommodation by a person in a part of that person's home), the promotion of gender equality or of the interests of men or women (for example single-sex voluntary bodies), the freedom of association (in cases of membership of single-sex private clubs), and the organisation of sporting activities (for example single-sex sports events). Any limitation should nevertheless be appropriate and necessary in accordance with the criteria derived from case law of the Court of Justice of the European Communities. (17) The principle of equal treatment in the access to goods and services does not require that facilities should always be provided to men and women on a shared basis, as long as they are not provided more favourably to members of one sex. (18) The use of actuarial factors related to sex is widespread in the provision of insurance and other related financial services. In order to ensure equal treatment between men and women, the use of sex as an actuarial factor should not result in differences in individuals' premiums and benefits. To avoid a sudden readjustment of the market, the implementation of this rule should apply only to new contracts concluded after the date of transposition of this Directive. (19) Certain categories of risks may vary between the sexes. In some cases, sex is one but not necessarily the only determining factor in the assessment of risks insured. For contracts insuring those types of risks, Member States may decide to permit exemptions from the rule of unisex premiums and benefits, as long as they can ensure that underlying actuarial and statistical data on which the calculations are based, are reliable, regularly up-dated and available to the public. Exemptions are allowed only where national legislation has not already applied the unisex rule. Five years after transposition of this Directive, Member States should re-examine the justification for these exemptions, taking into account the most recent actuarial and statistical data and a report by the Commission three years after the date of transposition of this Directive. (20) Less favourable treatment of women for reasons of pregnancy and maternity should be considered a form of direct discrimination based on sex and therefore prohibited in insurance and related financial services. Costs related to risks of pregnancy and maternity should therefore not be attributed to the members of one sex only. (21) Persons who have been subject to discrimination based on sex should have adequate means of legal protection. To provide a more effective level of protection, associations, organisations and other legal entities should also be empowered to engage in proceedings, as the Member States so determine, either on behalf or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts. (22) The rules on the burden of proof should be adapted when there is a prima facie case of discrimination and for the principle of equal treatment to be applied effectively, the burden of proof should shift back to the defendant when evidence of such discrimination is brought. (23) The effective implementation of the principle of equal treatment requires adequate judicial protection against victimisation. (24) With a view to promoting the principle of equal treatment, Member States should encourage dialogue with relevant stakeholders, which have, in accordance with national law and practice, a legitimate interest in contributing to the fight against discrimination on grounds of sex in the area of access to and supply of goods and services. (25) Protection against discrimination based on sex should itself be strengthened by the existence of a body or bodies in each Member State, with competence to analyse the problems involved, to study possible solutions and to provide concrete assistance for the victims. The body or bodies may be the same as those with responsibility at national level for the defence of human rights or the safeguarding of individuals' rights, or the implementation of the principle of equal treatment. (26) This Directive lays down minimum requirements, thus giving the Member States the option of introducing or maintaining more favourable provisions. The implementation of this Directive should not serve to justify any regression in relation to the situation, which already prevails in each Member State. (27) Member States should provide for effective, proportionate and dissuasive penalties in cases of breaches of the obligations under this Directive. (28) Since the objectives of this Directive, namely to ensure a common high level of protection against discrimination in all the Member States, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (29) In accordance with paragraph 34 of the interinstitutional agreement on better law-making (6), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables, which will, as far as possible, illustrate the correlation between the Directive and the transposition measures and to make them public, CHAPTER I GENERAL PROVISIONS Article 1 Purpose The purpose of this Directive is to lay down a framework for combating discrimination based on sex in access to and supply of goods and services, with a view to putting into effect in the Member States the principle of equal treatment between men and women. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: (a) direct discrimination: where one person is treated less favourably, on grounds of sex, than another is, has been or would be treated in a comparable situation; (b) indirect discrimination: where an apparently neutral provision, criterion or practice would put persons of one sex at a particular disadvantage compared with persons of the other sex, unless that provision, criterion or practice is objectively justified by a legitimate aim and the means of achieving that aim are appropriate and necessary; (c) harassment: where an unwanted conduct related to the sex of a person occurs with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading, humiliating or offensive environment; (d) sexual harassment: where any form of unwanted physical, verbal, non-verbal or physical conduct of a sexual nature occurs, with the purpose or effect of violating the dignity of a person, in particular when creating an intimidating, hostile, degrading, humiliating or offensive environment. Article 3 Scope 1. Within the limits of the powers conferred upon the Community, this Directive shall apply to all persons who provide goods and services, which are available to the public irrespective of the person concerned as regards both the public and private sectors, including public bodies, and which are offered outside the area of private and family life and the transactions carried out in this context. 2. This Directive does not prejudice the individual's freedom to choose a contractual partner as long as an individual's choice of contractual partner is not based on that person's sex. 3. This Directive shall not apply to the content of media and advertising nor to education. 4. This Directive shall not apply to matters of employment and occupation. This Directive shall not apply to matters of self-employment, insofar as these matters are covered by other Community legislative acts. Article 4 Principle of equal treatment 1. For the purposes of this Directive, the principle of equal treatment between men and women shall mean that (a) there shall be no direct discrimination based on sex, including less favourable treatment of women for reasons of pregnancy and maternity; (b) there shall be no indirect discrimination based on sex. 2. This Directive shall be without prejudice to more favourable provisions concerning the protection of women as regards pregnancy and maternity. 3. Harassment and sexual harassment within the meaning of this Directive shall be deemed to be discrimination on the grounds of sex and therefore prohibited. A person's rejection of, or submission to, such conduct may not be used as a basis for a decision affecting that person. 4. Instruction to direct or indirect discrimination on the grounds of sex shall be deemed to be discrimination within the meaning of this Directive. 5. This Directive shall not preclude differences in treatment, if the provision of the goods and services exclusively or primarily to members of one sex is justified by a legitimate aim and the means of achieving that aim are appropriate and necessary. Article 5 Actuarial factors 1. Member States shall ensure that in all new contracts concluded after 21 December 2007 at the latest, the use of sex as a factor in the calculation of premiums and benefits for the purposes of insurance and related financial services shall not result in differences in individuals' premiums and benefits. 2. Notwithstanding paragraph 1, Member States may decide before 21 December 2007 to permit proportionate differences in individuals' premiums and benefits where the use of sex is a determining factor in the assessment of risk based on relevant and accurate actuarial and statistical data. The Member States concerned shall inform the Commission and ensure that accurate data relevant to the use of sex as a determining actuarial factor are compiled, published and regularly updated. These Member States shall review their decision five years after 21 December 2007, taking into account the Commission report referred to in Article 16, and shall forward the results of this review to the Commission. 3. In any event, costs related to pregnancy and maternity shall not result in differences in individuals' premiums and benefits. Member States may defer implementation of the measures necessary to comply with this paragraph until two years after 21 December 2007 at the latest. In that case the Member States concerned shall immediately inform the Commission. Article 6 Positive action With a view to ensuring full equality in practice between men and women, the principle of equal treatment shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to sex. Article 7 Minimum requirements 1. Member States may introduce or maintain provisions which are more favourable to the protection of the principle of equal treatment between men and women than those laid down in this Directive. 2. The implementation of this Directive shall in no circumstances constitute grounds for a reduction in the level of protection against discrimination already afforded by Member States in the fields covered by this Directive. CHAPTER II REMEDIES AND ENFORCEMENT Article 8 Defence of rights 1. Member States shall ensure that judicial and/or administrative procedures, including where they deem it appropriate conciliation procedures, for the enforcement of the obligations under this Directive are available to all persons who consider themselves wronged by failure to apply the principle of equal treatment to them, even after the relationship in which the discrimination is alleged to have occurred has ended. 2. Member States shall introduce into their national legal systems such measures as are necessary to ensure real and effective compensation or reparation, as the Member States so determine, for the loss and damage sustained by a person injured as a result of discrimination within the meaning of this Directive, in a way which is dissuasive and proportionate to the damage suffered. The fixing of a prior upper limit shall not restrict such compensation or reparation. 3. Member States shall ensure that associations, organisations or other legal entities, which have, in accordance with the criteria laid down by their national law, a legitimate interest in ensuring that the provisions of this Directive are complied with, may engage, on behalf or in support of the complainant, with his or her approval, in any judicial and/or administrative procedure provided for the enforcement of obligations under this Directive. 4. Paragraphs 1 and 3 shall be without prejudice to national rules on time limits for bringing actions relating to the principle of equal treatment. Article 9 Burden of proof 1. Member States shall take such measures as are necessary, in accordance with their national judicial systems, to ensure that, when persons who consider themselves wronged because the principle of equal treatment has not been applied to them establish, before a court or other competent authority, facts from which it may be presumed that there has been direct or indirect discrimination, it shall be for the respondent to prove that there has been no breach of the principle of equal treatment. 2. Paragraph 1 shall not prevent Member States from introducing rules of evidence, which are more favourable to plaintiffs. 3. Paragraph 1 shall not apply to criminal procedures. 4. Paragraphs 1, 2 and 3 shall also apply to any proceedings brought in accordance with Article 8(3). 5. Member States need not apply paragraph 1 to proceedings in which it is for the court or other competent authority to investigate the facts of the case. Article 10 Victimisation Member States shall introduce into their national legal systems such measures as are necessary to protect persons from any adverse treatment or adverse consequence as a reaction to a complaint or to legal proceedings aimed at enforcing compliance with the principle of equal treatment. Article 11 Dialogue with relevant stakeholders With a view to promoting the principle of equal treatment, Member States shall encourage dialogue with relevant stakeholders which have, in accordance with national law and practice, a legitimate interest in contributing to the fight against discrimination on grounds of sex in the area of access to and supply of goods and services. CHAPTER III BODIES FOR THE PROMOTION OF EQUAL TREATMENT Article 12 1. Member States shall designate and make the necessary arrangements for a body or bodies for the promotion, analysis, monitoring and support of equal treatment of all persons without discrimination on the grounds of sex. These bodies may form part of agencies charged at national level with the defence of human rights or the safeguard of individuals' rights, or the implementation of the principle of equal treatment. 2. Member States shall ensure that the competencies of the bodies referred to in paragraph 1 include: (a) without prejudice to the rights of victims and of associations, organisations or other legal entities referred to in Article 8(3), providing independent assistance to victims of discrimination in pursuing their complaints about discrimination; (b) conducting independent surveys concerning discrimination; (c) publishing independent reports and making recommendations on any issue relating to such discrimination. CHAPTER IV FINAL PROVISIONS Article 13 Compliance Member States shall take the necessary measures to ensure that the principle of equal treatment is respected in relation to the access to and supply of goods and services within the scope of this Directive, and in particular that: (a) any laws, regulations and administrative provisions contrary to the principle of equal treatment are abolished; (b) any contractual provisions, internal rules of undertakings, and rules governing profit-making or non-profit-making associations contrary to the principle of equal treatment are, or may be, declared null and void or are amended. Article 14 Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are applied. The penalties, which may comprise the payment of compensation to the victim, shall be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 21 December 2007 at the latest and shall notify it without delay of any subsequent amendment affecting them. Article 15 Dissemination of information Member States shall take care that the provisions adopted pursuant to this Directive, together with the relevant provisions already in force, are brought to the attention of the persons concerned by all appropriate means throughout their territory. Article 16 Reports 1. Member States shall communicate all available information concerning the application of this Directive to the Commission, by 21 December 2009. and every five years thereafter. The Commission shall draw up a summary report, which shall include a review of the current practices of Member States in relation to Article 5 with regard to the use of sex as a factor in the calculation of premiums and benefits. It shall submit this report to the European Parliament and to the Council no later 21 December 2010. Where appropriate, the Commission shall accompany its report with proposals to modify the Directive. 2. The Commission's report shall take into account the viewpoints of relevant stakeholders. Article 17 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 December 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such publication of 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 18 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 19 Addressees This Directive is addressed to the Member States.

32004L0107

2004

DIRECTIVE 2004/107/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) On the basis of principles enshrined in Article 175(3) of the Treaty, the Sixth Community Environment Action Programme, adopted by Decision No 1600/2002/EC of the European Parliament and of the Council (3), establishes the need to reduce pollution to levels which minimise harmful effects on human health, paying particular attention to sensitive populations, and the environment as a whole, to improve the monitoring and assessment of air quality including the deposition of pollutants and to provide information to the public. (2) Article 4(1) of Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management (4) requires the Commission to submit proposals for regulating the pollutants listed in Annex I to that Directive taking into account the provisions laid down in paragraphs 3 and 4 of that Article. (3) Scientific evidence shows that arsenic, cadmium, nickel and some polycyclic aromatic hydrocarbons are human genotoxic carcinogens and that there is no identifiable threshold below which these substances do not pose a risk to human health. Impact on human health and the environment occurs via concentrations in ambient air and via deposition. With a view to cost-effectiveness, ambient air concentrations of arsenic, cadmium, nickel and polycyclic aromatic hydrocarbons, which would not pose a significant risk to human health, cannot be achieved in specific areas. (4) With the aim of minimising harmful effects on human health, paying particular attention to sensitive populations, and the environment as a whole, of airborne arsenic, cadmium and nickel and polycyclic aromatic hydrocarbons, target values should be set, to be attained as far as possible. Benzo(a)pyrene should be used as a marker for the carcinogenic risk of polycyclic aromatic hydrocarbons in ambient air. (5) The target values would not require any measures entailing disproportionate costs. Regarding industrial installations, they would not involve measures beyond the application of best available techniques (BAT) as required by Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (5) and in particular would not lead to the closure of installations. However, they would require Member States to take all cost-effective abatement measures in the relevant sectors. (6) In particular, the target values of this Directive are not to be considered as environmental quality standards as defined in Article 2(7) of Directive 96/61/EC and which, according to Article 10 of that Directive, require stricter conditions than those achievable by the use of BAT. (7) In accordance with Article 176 of the Treaty, Member States may maintain or introduce more stringent protective measures relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons provided that they are compatible with the Treaty and that they are notified to the Commission. (8) Where concentrations exceed certain assessment thresholds, monitoring of arsenic, cadmium, nickel and benzo(a)pyrene should be mandatory. Supplementary means of assessment may reduce the required number of sampling points for fixed measurements. Further monitoring of background ambient air concentrations and deposition is foreseen. (9) Mercury is a very hazardous substance for human health and the environment. It is present throughout the environment and, in the form of methylmercury, has the capacity to accumulate in organisms, and in particular to concentrate in organisms higher up the food chain. Mercury released into the atmosphere is capable of being transported over long distances. (10) The Commission intends to come forward in 2005 with a coherent strategy containing measures to protect human health and the environment from the release of mercury, based on a life-cycle approach, and taking into account production, use, waste treatment and emissions. In this context, the Commission should consider all appropriate measures with a view to reducing the quantity of mercury in terrestrial and aquatic ecosystems, and thereby the ingestion of mercury via food, and avoiding mercury in certain products. (11) The effects of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons on human health, including via the food chain, and the environment as a whole, occur through concentrations in ambient air and via deposition; the accumulation of these substances in soils and the protection of ground water should be taken into account. In order to facilitate review of this Directive in 2010, the Commission and the Member States should consider promoting research into the effects of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons on human health and the environment, particularly via deposition. (12) Standardised accurate measurement techniques and common criteria for the location of measuring stations are important elements in assessing ambient air quality so that the information obtained is comparable throughout the Community. Providing reference measurement methods is acknowledged to be an important issue. The Commission has already mandated work on the preparation of CEN standards for the measurement of those constituents in ambient air where target values are defined (arsenic, cadmium, nickel and benzo(a)pyrene) as well as for the deposition of heavy metals with a view to their early development and adoption. In the absence of CEN standard methods, the use of international or national standard reference measurement methods should be permitted. (13) Information on the concentrations and the deposition of the regulated pollutants should be forwarded to the Commission as a basis for regular reports. (14) Up-to-date information on ambient air concentrations and deposition of regulated pollutants should be readily available to the public. (15) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. (16) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (17) The amendments necessary for adaptation of this Directive to scientific and technical progress should relate solely to criteria and techniques for the assessment of concentrations and deposition of regulated pollutants or detailed arrangements for forwarding information to the Commission. They should not have the effect of modifying the target values either directly or indirectly, Article 1 Objectives The objectives of this Directive shall be to: (a) establish a target value for the concentration of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air so as to avoid, prevent or reduce harmful effects of arsenic, cadmium, nickel and polycyclic aromatic hydrocarbons on human health and the environment as a whole; (b) ensure, with respect to arsenic, cadmium, nickel and polycyclic aromatic hydrocarbons, that ambient air quality is maintained where it is good and that it is improved in other cases; (c) determine common methods and criteria for the assessment of concentrations of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air as well as of the deposition of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons; (d) ensure that adequate information on concentrations of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air as well as on the deposition of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons is obtained and ensure that it is made available to the public. Article 2 Definitions For the purposes of this Directive the definitions in Article 2 of Directive 96/62/EC, with the exception of the definition of ‘target value’, shall apply. The objectives of this Directive shall be to: (a) ‘target value’ means a concentration in the ambient air fixed with the aim of avoiding, preventing or reducing harmful effects on human health and the environment as a whole, to be attained where possible over a given period; (b) ‘total or bulk deposition’ means the total mass of pollutants which is transferred from the atmosphere to surfaces (e.g. soil, vegetation, water, buildings, etc.) in a given area within a given time; (c) ‘upper assessment threshold’ means a level specified in Annex II below which a combination of measurements and modelling techniques may be used to assess ambient air quality, in accordance with Article 6(3) of Directive 96/62/EC; (d) ‘lower assessment threshold’ means a level specified in Annex II below which the sole use of modelling or objective estimation techniques shall be possible to assess ambient air quality, in accordance with Article 6(4) of Directive 96/62/EC; (e) ‘fixed measurements’ means measurements taken at fixed sites either continuously or by random sampling, in accordance with Article 6(5) of Directive 96/62/EC; (f) ‘arsenic’, ‘cadmium’, ‘nickel’ and ‘benzo(a)pyrene’ mean the total content of these elements and compounds in the PM10 fraction; (g) ‘PM10’ means particulate matter, which passes through a size-selective inlet as defined in EN 12341 with a 50 % efficiency cut-off at 10 μm aerodynamic diameter; (h) ‘polycyclic aromatic hydrocarbons’ means those organic compounds, composed of at least two fused aromatic rings made entirely from carbon and hydrogen; (i) ‘total gaseous mercury’ means elemental mercury vapour (Hg0) and reactive gaseous mercury, i.e. water-soluble mercury species with sufficiently high vapour pressure to exist in the gas phase. Article 3 Target values 1. Member States shall take all necessary measures not entailing disproportionate costs to ensure that, as from 31 December 2012, concentrations of arsenic, cadmium, nickel and benzo(a)pyrene, used as a marker for the carcinogenic risk of polycyclic aromatic hydrocarbons, in ambient air, as assessed in accordance with Article 4, do not exceed the target values laid down in Annex I. 2. Member States shall draw up a list of zones and agglomerations in which the levels of arsenic, cadmium, nickel, and benzo(a)pyrene are below the respective target values. Member States shall maintain the levels of these pollutants in these zones and agglomerations below the respective target values and shall endeavour to preserve the best ambient air quality, compatible with sustainable development. 3. Member States shall draw up a list of the zones and agglomerations where the target values laid down in Annex I are exceeded. For such zones and agglomerations, Member States shall specify the areas of exceedance and the sources contributing thereto. In the areas concerned, Member States shall demonstrate the application of all necessary measures not entailing disproportionate costs, directed in particular at the predominant emission sources, in order to attain the target values. In the case of industrial installations covered by Directive 96/61/EC this means the application of BAT as defined by Article 2(11) of that Directive. Article 4 Assessment of ambient air concentrations and deposition rates 1. Ambient air quality with respect to arsenic, cadmium, nickel and benzo(a)pyrene shall be assessed throughout the territory of the Member States. 2. In accordance with the criteria referred to in paragraph 7, measurement is mandatory in the following zones: (a) zones and agglomerations in which levels are between the upper and the lower assessment threshold, and (b) other zones and agglomerations where levels exceed the upper assessment threshold. The measurements provided for may be supplemented by modelling techniques to provide an adequate level of information on ambient air quality. 3. A combination of measurements, including indicative measurements as referred to in Annex IV, Section I, and modelling techniques may be used to assess ambient air quality in zones and agglomerations where the levels over a representative period are between the upper and lower assessment thresholds, to be determined pursuant to Annex II, Section II. 4. In zones and agglomerations where the levels are below the lower assessment threshold, to be determined pursuant to Annex II, Section II, the sole use of modelling or objective estimation techniques for assessing levels shall be possible. 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 sufficient to enable the levels to be determined. 6. The upper and lower assessment thresholds for arsenic, cadmium, nickel and benzo(a)pyrene in ambient air shall be those laid down in Section I of Annex II. The classification of each zone or agglomeration for the purposes of this Article shall be reviewed at least every five years in accordance with the procedure laid down in Section II of Annex II. Classification shall be reviewed earlier in the event of significant change in activities relevant to concentrations of arsenic, cadmium, nickel and benzo(a)pyrene, in ambient air. 7. The criteria for determining the location of sampling points for the measurement of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air in order to assess compliance with the target values shall be those listed in Sections I and II of Annex III. The minimum number of sampling points for fixed measurements of concentrations of each pollutant shall be as laid down in Section IV of Annex III, and they shall be installed in each zone or agglomeration within which measurement is required if fixed measurement is the sole source of data on concentrations within it. 8. To assess the contribution of benzo(a)pyrene in ambient air, each Member State shall monitor other relevant polycyclic aromatic hydrocarbons at a limited number of measurement sites. These compounds shall include at least: benzo(a)anthracene, benzo(b)fluoranthene, benzo(j)fluoranthene, benzo(k)fluoranthene, indeno(1,2,3-cd)pyrene, and dibenz(a,h)anthracene. Monitoring sites for these polycyclic aromatic hydrocarbons shall be co-located with sampling sites for benzo(a)pyrene and shall be selected in such a way that geographical variation and long-term trends can be identified. Sections I, II and III of Annex III shall apply. 9. Irrespective of concentration levels, one background sampling point shall be installed every 100 000 km2 for the indicative measurement, in ambient air, of arsenic, cadmium, nickel, total gaseous mercury, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8 and of the total deposition of arsenic, cadmium, mercury, nickel, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8. Each Member State shall set up at least one measuring station; however, Member States may, by agreement, and in accordance with guidelines to be drawn up under the procedure laid down in Article 6, set up one or several common measuring stations, covering neighbouring zones in adjoining Member States, to achieve the necessary spatial resolution. Measurement of particulate and gaseous divalent mercury is also recommended. Where appropriate, monitoring shall be coordinated with the European Monitoring and Evaluation of Pollutants (EMEP) monitoring strategy and measurement programme. The sampling sites for these pollutants shall be selected in such a way that geographical variation and long-term trends can be identified. Sections I, II and III of Annex III shall apply. 10. The use of bio indicators may be considered where regional patterns of the impact on ecosystems are to be assessed. 11. For zones and agglomerations within which information from fixed measurement stations is supplemented by information from other sources, such as emission inventories, indicative measurement methods and air quality modelling, the number of fixed measuring stations to be installed and the spatial resolution of other techniques shall be sufficient for the concentrations of air pollutants to be established in accordance with Section I of Annex III and Section I of Annex IV. 12. Data quality objectives are laid down in Section I of Annex IV. Where air quality models are used for assessment, Section II of Annex IV shall apply. 13. The reference methods for the sampling and analysis of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air shall be as laid down in Sections I, II and III of Annex V. Section IV of Annex V sets out reference techniques for measuring the total deposition of arsenic, cadmium, mercury, nickel and the polycyclic aromatic hydrocarbons and Section V of Annex V refers to reference air quality modelling techniques when such techniques are available. 14. The date by which Member States shall inform the Commission of the methods used for the preliminary assessment of air quality under Article 11(1)(d) of Directive 96/62/EC shall be the date referred to in Article 10 of this Directive. 15. Any amendments necessary to adapt the provisions of this Article and of Section II of Annex II and of Annexes III to V to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 6 but may not result in any direct or indirect changes to target values. Article 5 Transmission of information and reporting 1. With regard to the zones and agglomerations where any of the target values laid down in Annex I is exceeded, Member States shall forward the following information to the Commission: (a) the lists of the zones and agglomerations concerned, (b) the areas of exceedance, (c) the concentration values assessed, (d) the reasons for exceedance, and in particular any sources contributing to it, (e) the population exposed to such exceedance. Member States shall also report all data assessed in accordance with Article 4, unless already reported under Council Decision 97/101/EC of 27 January 1997 establishing a reciprocal exchange of information and data from networks and individual stations measuring ambient air pollution within the Member States (7). The information shall be transmitted for each calendar year, by no later than 30 September of the following year, and for the first time for the calendar year following 15 February 2007. 2. In addition to the requirements laid down in paragraph 1, Member States shall also report any measures taken pursuant to Article 3. 3. The Commission shall ensure that all information submitted pursuant to paragraph 1 is promptly made available to the public by appropriate means, such as Internet, press and other easily accessible media. 4. The Commission shall adopt, in accordance with the procedure referred to in Article 6, any detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article. Article 6 Committee 1. The Commission shall be assisted by the committee established by Article 12(2) of Directive 96/62/EC. 2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 7 Public information 1. Member States shall ensure that clear and comprehensible information is accessible and is routinely made available to the public as well as to appropriate organisations, such as environmental organisations, consumer organisations, organisations representing the interests of sensitive populations and other relevant healthcare bodies, on ambient air concentrations of arsenic, cadmium, mercury, nickel and benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in Article 4(8) as well as on deposition rates of arsenic, cadmium, mercury, nickel and benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in Article 4(8). 2. The information shall also indicate any annual exceedance of the target values for arsenic, cadmium, nickel and benzo(a)pyrene laid down in Annex I. The information shall give the reasons for the exceedance and the area to which it applies. It shall also provide a short assessment in relation to the target value and appropriate information regarding effects on health and impact on the environment. Information on any measures taken pursuant to Article 3 shall be made available to the organisations referred to in paragraph 1 of this Article. 3. The information shall be made available by means of, for example, Internet, press and other easily accessible media. Article 8 Report and review 1. The Commission shall, by 31 December 2010 at the latest, submit to the European Parliament and the Council a report based on: (a) the experience acquired in the application of this Directive, (b) in particular, the results of the most recent scientific research concerning the effects on human health, paying particular attention to sensitive populations, and on the environment as a whole, of exposure to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons, and (c) technological developments including the progress achieved in methods of measuring and otherwise assessing concentrations of these pollutants in ambient air as well as their deposition. 2. The report referred to in paragraph 1 shall take into account: (a) current air quality, trends and projections up to and beyond 2015; (b) the scope for making further reductions in polluting emissions from all relevant sources, and the possible merit in introducing limit values aimed at reducing the risk to human health, for the pollutants listed in Annex I, taking account of technical feasibility and cost-effectiveness and any significant additional health and environmental protection that this would provide; (c) the relationships between pollutants and opportunities for combined strategies for improving Community air quality and related objectives; (d) current and future requirements for informing the public and for the exchange of information between Member States and Commission; (e) the experience acquired in the application of this Directive in Member States, and in particular the conditions under which measurement has been carried out as laid down in Annex III; (f) secondary economic benefits for the environment and health in reducing the emissions of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons to the extent that these can be assessed; (g) the adequacy of the particle size fraction used for sampling in view of general particulate matter measurement requirements; (h) the suitability of benzo(a)pyrene as a marker for the total carcinogenic activity of polycyclic aromatic hydrocarbons, having regard to predominantly gaseous forms of polycyclic aromatic hydrocarbons such as fluoranthene. In the light of the latest scientific and technological developments the Commission shall also examine the effect of arsenic, cadmium and nickel on human health with a view to quantifying their genotoxic carcinogenicity. Taking account of measures adopted pursuant to the mercury strategy the Commission shall also consider whether there would be merit in taking further action in relation to mercury, taking account of technical feasibility and cost-effectiveness and any significant additional health and environmental protection that this would provide. 3. With a view to achieving levels of ambient air concentrations that would further reduce harmful effects on human health and would lead to a high level of protection of the environment as a whole, taking into account the technical feasibility and cost-effectiveness of further action, the report referred to in paragraph 1 may be accompanied, if appropriate, by proposals for amendments to this Directive, particularly taking into account the results obtained in accordance with paragraph 2. In addition the Commission shall consider regulating the deposition of arsenic, cadmium, mercury, nickel and specific polycyclic aromatic hydrocarbons. Article 9 Penalties Member States shall determine the penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Article 10 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2007 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 be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive. Article 11 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 Union. Article 12 Addressees This Directive is addressed to the Member States.

32004L0115

2004

COMMISSION DIRECTIVE 2004/115/EC of 15 December 2004 amending Council Directive 90/642/EEC as regards the maximum levels for certain pesticide residues fixed therein (Text with EEA relevance) 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 for pesticide residues in and on certain products of plant origin including fruit and vegetables (1), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), and in particular Article 4(1)(f) thereof, Whereas: (1) In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations are required to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops. (2) Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake. (3) MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data. (4) MRLs for pesticides should be kept under review. They may be changed to take account of new uses, new information and data. (5) Information on new or changed uses of certain pesticides covered by Directive 90/642/EEC have been notified to the Commission. (6) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides, has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (3). It has been calculated that the MRLs concerned will ensure that the acceptable daily intakes are not exceeded. (7) Where appropriate, the acute exposure of consumers to these pesticides via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices currently used within the European Community, taking account of guidelines published by the World Health Organisation. The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. (8) Therefore it is appropriate to fix new maximum levels for residues of those pesticides. (9) Directive 90/642/EEC should therefore be amended accordingly. (10) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The maximum pesticide residue levels for methomyl, thiodicarb, myclobutanil, maneb group, fenpropimorph, metalaxyl, metalaxyl-m, penconazole, iprovalicarb, azoxystrobin and fenhexamid in Annex II to Directive 90/642/EEC are replaced by those in the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 22 June 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply these provisions from 23 June 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32004L0109

2004

DIRECTIVE 2004/109/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC Having regard to the Treaty establishing the European Community, and in particular Articles 44 and 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the European Central Bank (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Efficient, transparent and integrated securities markets contribute to a genuine single market in the Community and foster growth and job creation by better allocation of capital and by reducing costs. The disclosure of accurate, comprehensive and timely information about security issuers builds sustained investor confidence and allows an informed assessment of their business performance and assets. This enhances both investor protection and market efficiency. (2) To that end, security issuers should ensure appropriate transparency for investors through a regular flow of information. To the same end, shareholders, or natural persons or legal entities holding voting rights or financial instruments that result in an entitlement to acquire existing shares with voting rights, should also inform issuers of the acquisition of or other changes in major holdings in companies so that the latter are in a position to keep the public informed. (3) The Commission Communication of 11 May 1999, entitled ‘Implementing the framework for financial markets: Action Plan’, identifies a series of actions that are needed in order to complete the single market for financial services. The Lisbon European Council of March 2000 calls for the implementation of that Action Plan by 2005. The Action Plan stresses the need to draw up a Directive upgrading transparency requirements. That need was confirmed by the Barcelona European Council of March 2002. (4) This Directive should be compatible with the tasks and duties conferred upon the European System of Central Banks (ESCB) and the Member States' central banks by the Treaty and the Statute of the European System of Central Banks and of the European Central Bank; particular attention in this regard needs to be given to the Member States' central banks whose shares are currently admitted to trading on a regulated market, in order to guarantee the pursuit of primary Community law objectives. (5) Greater harmonisation of provisions of national law on periodic and ongoing information requirements for security issuers should lead to a high level of investor protection throughout the Community. However, this Directive does not affect existing Community legislation on units issued by collective investment undertakings other than the closed-end type, or on units acquired or disposed of in such undertakings. (6) Supervision of an issuer of shares, or of debt securities the denomination per unit of which is less than EUR 1 000, for the purposes of this Directive, would be best effected by the Member State in which the issuer has its registered office. In that respect, it is vital to ensure consistency with Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading. (4) Along the same lines, some flexibility should be introduced allowing third country issuers and Community companies issuing only securities other than those mentioned above a choice of home Member State. (7) A high level of investor protection throughout the Community would enable barriers to the admission of securities to regulated markets situated or operating within a Member State to be removed. Member States other than the home Member State should no longer be allowed to restrict admission of securities to their regulated markets by imposing more stringent requirements on periodic and ongoing information about issuers whose securities are admitted to trading on a regulated market. (8) The removal of barriers on the basis of the home Member State principle under this Directive should not affect areas not covered by this Directive, such as rights of shareholders to intervene in the management of an issuer. Nor should it affect the home Member State's right to request the issuer to publish, in addition, parts of or all regulated information through newspapers. (9) Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (5) has already paved the way for a convergence of financial reporting standards throughout the Community for issuers whose securities are admitted to trading on a regulated market and who are required to prepare consolidated accounts. Thus, a specific regime for security issuers beyond the general system for all companies, as laid down in the Company Law Directives, is already established. This Directive builds on this approach with regard to annual and interim financial reporting, including the principle of providing a true and fair view of an issuer's assets, liabilities, financial position and profit or loss. A condensed set of financial statements, as part of a half-yearly financial report, also represents a sufficient basis for giving such a true and fair view of the first six months of an issuer's financial year. (10) An annual financial report should ensure information over the years once the issuer's securities have been admitted to a regulated market. Making it easier to compare annual financial reports is only of use to investors in securities markets if they can be sure that this information will be published within a certain time after the end of the financial year. As regards debt securities admitted to trading on a regulated market prior to 1 January 2005 and issued by issuers incorporated in a third country, the home Member State may under certain conditions allow issuers not to prepare annual financial reports in accordance with the standards required under this Directive. (11) This Directive introduces more comprehensive half-yearly financial reports for issuers of shares admitted to trading on a regulated market. This should allow investors to make a more informed assessment of the issuer's situation. (12) A home Member State may provide for exemptions from half-yearly reporting by issuers of debt securities in the case of: — credit institutions acting as small-size issuers of debt securities, or — issuers already existing on the date of the entry into force of this Directive who exclusively issue debt securities unconditionally and irrevocably guaranteed by the home Member State or by one of its regional or local authorities, or — during a transitional period of ten years, only in respect of those debt securities admitted to trading on a regulated market prior to 1 January 2005 which may be purchased by professional investors only. If such an exemption is given by the home Member State, it may not be extended in respect of any debt securities admitted to a regulated market thereafter. (13) The European Parliament and the Council welcome the Commission's commitment rapidly to consider enhancing the transparency of the remuneration policies, total remuneration paid, including any contingent or deferred compensation, and benefits in kind granted to each member of administrative, management or supervisory bodies under its Action Plan for ‘Modernising Company Law and Enhancing Corporate Governance in the European Union’ of 21 May 2003 and the Commission's intention to make a Recommendation on this topic in the near future. (14) The home Member State should encourage issuers whose shares are admitted to trading on a regulated market and whose principal activities lie in the extractive industry to disclose payments to governments in their annual financial report. The home Member State should also encourage an increase in the transparency of such payments within the framework established at various international financial fora. (15) This Directive will also make half-yearly reporting mandatory for issuers of only debt securities on regulated markets. Exemptions should only be provided for wholesale markets on the basis of a denomination per unit starting at EUR 50 000, as under Directive 2003/71/EC. Where debt securities are issued in another currency, exemptions should only be possible where the denomination per unit in such a currency is, at the date of the issue, at least equivalent to EUR 50 000. (16) More timely and more reliable information about the share issuer's performance over the financial year also requires a higher frequency of interim information. A requirement should therefore be introduced to publish an interim management statement during the first six months and a second interim management statement during the second six months of a financial year. Share issuers who already publish quarterly financial reports should not be required to publish interim management statements. (17) Appropriate liability rules, as laid down by each Member State under its national law or regulations, should be applicable to the issuer, its administrative, management or supervisory bodies, or persons responsible within the issuer. Member States should remain free to determine the extent of the liability. (18) The public should be informed of changes to major holdings in issuers whose shares are traded on a regulated market situated or operating within the Community. This information should enable investors to acquire or dispose of shares in full knowledge of changes in the voting structure; it should also enhance effective control of share issuers and overall market transparency of important capital movements. Information about shares or financial instruments as determined by Article 13, lodged as collateral, should be provided in certain circumstances. (19) Articles 9 and 10(c) should not apply to shares provided to or by the members of the ESCB in carrying out their functions as monetary authorities provided that the voting rights attached to such shares are not exercised; the reference to a ‘short period’ in Article 11 should be understood with reference to credit operations carried out in accordance with the Treaty and the European Central Bank (ECB) legal acts, in particular the ECB Guidelines on monetary policy instruments and procedures and TARGET, and to credit operations for the purpose of performing equivalent functions in accordance with national provisions. (20) In order to avoid unnecessary burdens for certain market participants and to clarify who actually exercises influence over an issuer, there is no need to require notification of major holdings of shares, or other financial instruments as determined by Article 13 that result in an entitlement to acquire shares with regard to market makers or custodians, or of holdings of shares or such financial instruments acquired solely for clearing and settlement purposes, within limits and guarantees to be applied throughout the Community. The home Member State should be allowed to provide limited exemptions as regards holdings of shares in trading books of credit institutions and investment firms. (21) In order to clarify who is actually a major holder of shares or other financial instruments in the same issuer throughout the Community, parent undertakings should not be required to aggregate their own holdings with those managed by undertakings for collective investment in transferable securities (UCITS) or investment firms, provided that such undertakings or firms exercise voting rights independently from their parent undertakings and fulfil certain further conditions. (22) Ongoing information to holders of securities admitted to trading on a regulated market should continue to be based on the principle of equal treatment. Such equal treatment only relates to shareholders in the same position and does not therefore prejudice the issue of how many voting rights may be attached to a particular share. By the same token, holders of debt securities ranking pari passu should continue to benefit from equal treatment, even in the case of sovereign debt. Information to holders of shares and/or debt securities in general meetings should be facilitated. In particular, holders of shares and/or debt securities situated abroad should be more actively involved in that they should be able to mandate proxies to act on their behalf. For the same reasons, it should be decided in a general meeting of holders of shares and/or debt securities whether the use of modern information and communication technologies should become a reality. In that case, issuers should put in place arrangements in order effectively to inform holders of their shares and/or debt securities, insofar as it is possible for them to identify those holders. (23) Removal of barriers and effective enforcement of new Community information requirements also require adequate control by the competent authority of the home Member State. This Directive should at least provide for a minimum guarantee for the timely availability of such information. For this reason, at least one filing and storage system should exist in each Member State. (24) Any obligation for an issuer to translate all ongoing and periodic information into all the relevant languages in all the Member States where its securities are admitted to trading does not foster integration of securities markets, but has deterrent effects on cross-border admission of securities to trading on regulated markets. Therefore, the issuer should in certain cases be entitled to provide information drawn up in a language that is customary in the sphere of international finance. Since a particular effort is needed to attract investors from other Member States and third countries, Member States should no longer prevent shareholders, persons exercising voting rights, or holders of financial instruments, from making the required notifications to the issuer in a language that is customary in the sphere of international finance. (25) Access for investors to information about issuers should be more organised at a Community level in order to actively promote integration of European capital markets. Investors who are not situated in the issuer's home Member State should be put on an equal footing with investors situated in the issuer's home Member State, when seeking access to such information. This could be achieved if the home Member State ensures compliance with minimum quality standards for disseminating information throughout the Community, in a fast manner on a non-discriminatory basis and depending on the type of regulated information in question. In addition, information which has been disseminated should be available in the home Member State in a centralised way allowing a European network to be built up, accessible at affordable prices for retail investors, while not leading to unnecessary duplication of filing requirements for issuers. Issuers should benefit from free competition when choosing the media or operators for disseminating information under this Directive. (26) In order to further simplify investor access to corporate information across Member States, it should be left to the national supervisory authorities to formulate guidelines for setting up electronic networks, in close consultation with the other parties concerned, in particular security issuers, investors, market participants, operators of regulated markets and financial information providers. (27) So as to ensure the effective protection of investors and the proper operation of regulated markets, the rules relating to information to be published by issuers whose securities are admitted to trading on a regulated market should also apply to issuers which do not have a registered office in a Member State and which do not fall within the scope of Article 48 of the Treaty. It should also be ensured that any additional relevant information about Community issuers or third country issuers, disclosure of which is required in a third country but not in a Member State, is made available to the public in the Community. (28) A single competent authority should be designated in each Member State to assume final responsibility for supervising compliance with the provisions adopted pursuant to this Directive, as well as for international cooperation. Such an authority should be of an administrative nature, and its independence from economic players should be ensured in order to avoid conflicts of interest. Member States may however designate another competent authority for examining that information referred to in this Directive is drawn up in accordance with the relevant reporting framework and taking appropriate measures in case of discovered infringements; such an authority need not be of an administrative nature. (29) Increasing cross-border activities require improved cooperation between national competent authorities, including a comprehensive set of provisions for the exchange of information and for precautionary measures. The organisation of the regulatory and supervisory tasks in each Member State should not hinder efficient cooperation between the competent national authorities. (30) At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European securities markets. In its final report, that Committee proposed the introduction of new legislative techniques based on a four-level approach, namely essential principles, technical implementing measures, cooperation amongst national securities regulators, and enforcement of Community law. This Directive should confine itself to broad ‘framework’ principles, while implementing measures to be adopted by the Commission with the assistance of the European Securities Committee established by Commission Decision 2001/528/EC (6) should lay down the technical details. (31) The Resolution adopted by the Stockholm European Council of March 2001 endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent. (32) According to that Resolution, implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of implementing rules. (33) The Resolution of the European Parliament of 5 February 2002 on the implementation of financial services legislation also endorsed the Committee of Wise Men's report, on the basis of the solemn declaration made before the European Parliament the same day by the President of the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the Chairman of the Parliament's Committee on Economic and Monetary Affairs with regard to safeguards for the European Parliament's role in this process. (34) The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, that period may be shortened. If, within that period, a Resolution is passed by the European Parliament, the Commission should re-examine the draft measures. (35) Technical implementing measures for the rules laid down in this Directive may be necessary to take account of new developments on securities markets. The Commission should accordingly be empowered to adopt implementing measures, provided that they do not modify the essential elements of this Directive and provided that the Commission acts in accordance with the principles set out therein, after consulting the European Securities Committee. (36) In exercising its implementing powers in accordance with this Directive, the Commission should respect the following principles: — the need to ensure confidence in financial markets among investors by promoting high standards of transparency in financial markets; — the need to provide investors with a wide range of competing investments and a level of disclosure and protection tailored to their circumstances; — the need to ensure that independent regulatory authorities enforce the rules consistently, especially as regards the fight against economic crime; — the need for high levels of transparency and consultation with all market participants and with the European Parliament and the Council; — the need to encourage innovation in financial markets if they are to be dynamic and efficient; — the need to ensure market integrity by close and reactive monitoring of financial innovation; — the importance of reducing the cost of, and increasing access to, capital; — the balance of costs and benefits to market participants on a long-term basis, including small and medium-sized businesses and small investors, in any implementing measures; — the need to foster the international competitiveness of Community financial markets without prejudice to a much-needed extension of international cooperation; — the need to achieve a level playing field for all market participants by establishing Community-wide regulations wherever appropriate; — the need to respect differences in national markets where these do not unduly impinge on the coherence of the single market; — the need to ensure coherence with other Community legislation in this area, as imbalances in information and a lack of transparency may jeopardise the operation of the markets and above all harm consumers and small investors. (37) In order to ensure that the requirements set out in this Directive or the measures implementing this Directive are fulfilled, any infringement of those requirements or measures should be promptly detected and, if necessary, subject to penalties. To that end, measures and penalties should be sufficiently dissuasive, proportionate and consistently enforced. Member States should ensure that decisions taken by the competent national authorities are subject to the right of appeal to the courts. (38) This Directive aims to upgrade the current transparency requirements for security issuers and investors acquiring or disposing of major holdings in issuers whose shares are admitted to trading on a regulated market. This Directive replaces some of the requirements set out in Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities. (7) In order to gather transparency requirements in a single act it is necessary to amend it accordingly. Such an amendment however should not affect the ability of Member States to impose additional requirements under Articles 42 to 63 of Directive 2001/34/EC, which remain valid. (39) This Directive is in line with 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 (8). (40) This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of the Fundamental Rights of the European Union. (41) Since the objectives of this Directive, namely to ensure investor confidence through equivalent transparency throughout the Community and thereby to complete the internal market, cannot be sufficiently achieved by the Member States on the basis of the existing Community legislation and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve these objectives. (42) The measures necessary for implementing this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9), CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Directive establishes requirements in relation to the disclosure of periodic and ongoing information about issuers whose securities are already admitted to trading on a regulated market situated or operating within a Member State. 2. This Directive shall not apply to units issued by collective investment undertakings other than the closed-end type, or to units acquired or disposed of in such collective investment undertakings. 3. Member States may decide not to apply the provisions mentioned in Article 16(3) and in paragraphs 2, 3 and 4 of Article 18 to securities which are admitted to trading on a regulated market issued by them or their regional or local authorities. 4. Member States may decide not to apply Article 17 to their national central banks in their capacity as issuers of shares admitted to trading on a regulated market if this admission took place before 20 January 2005. Article 2 Definitions 1. For the purposes of this Directive the following definitions shall apply: (a) ‘securities’ means transferable securities as defined in Article 4(1), point 18, of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (10) with the exception of money-market instruments, as defined in Article 4(1), point 19, of that Directive having a maturity of less than 12 months, for which national legislation may be applicable; (b) ‘debt securities’ means bonds or other forms of transferable securitised debts, with the exception of securities which are equivalent to shares in companies or which, if converted or if the rights conferred by them are exercised, give rise to a right to acquire shares or securities equivalent to shares; (c) ‘regulated market’ means a market as defined in Article 4(1), point 14, of Directive 2004/39/EC; (d) ‘issuer’ means a legal entity governed by private or public law, including a State, whose securities are admitted to trading on a regulated market, the issuer being, in the case of depository receipts representing securities, the issuer of the securities represented; (e) ‘shareholder’ means any natural person or legal entity governed by private or public law, who holds, directly or indirectly: (i) shares of the issuer in its own name and on its own account; (ii) shares of the issuer in its own name, but on behalf of another natural person or legal entity; (iii) depository receipts, in which case the holder of the depository receipt shall be considered as the shareholder of the underlying shares represented by the depository receipts; (f) ‘controlled undertaking’ means any undertaking (i) in which a natural person or legal entity has a majority of the voting rights; or (ii) of which a natural person or legal entity has the right to appoint or remove a majority of the members of the administrative, management or supervisory body and is at the same time a shareholder in, or member of, the undertaking in question; or (iii) of which a natural person or legal entity is a shareholder or member and alone controls a majority of the shareholders' or members' voting rights, respectively, pursuant to an agreement entered into with other shareholders or members of the undertaking in question; or (iv) over which a natural person or legal entity has the power to exercise, or actually exercises, dominant influence or control; (g) ‘collective investment undertaking other than the closed-end type’ means unit trusts and investment companies: (i) the object of which is the collective investment of capital provided by the public, and which operate on the principle of risk spreading; and (ii) the units of which are, at the request of the holder of such units, repurchased or redeemed, directly or indirectly, out of the assets of those undertakings; (h) ‘units of a collective investment undertaking’ means securities issued by a collective investment undertaking and representing rights of the participants in such an undertaking over its assets; (i) ‘home Member State’ means (i) in the case of an issuer of debt securities the denomination per unit of which is less than EUR 1 000 or an issuer of shares: — where the issuer is incorporated in the Community, the Member State in which it has its registered office; — where the issuer is incorporated in a third country, the Member State in which it is required to file the annual information with the competent authority in accordance with Article 10 of Directive 2003/71/EC. The definition of ‘home’ Member State shall be applicable to debt securities in a currency other than Euro, provided that the value of such denomination per unit is, at the date of the issue, less than EUR 1 000, unless it is nearly equivalent to EUR 1 000; (ii) for any issuer not covered by (i), the Member State chosen by the issuer from among the Member State in which the issuer has its registered office and those Member States which have admitted its securities to trading on a regulated market on their territory. The issuer may choose only one Member State as its home Member State. Its choice shall remain valid for at least three years unless its securities are no longer admitted to trading on any regulated market in the Community; (j) ‘host Member State’ means a Member State in which securities are admitted to trading on a regulated market, if different from the home Member State; (k) ‘regulated information’ means all information which the issuer, or any other person who has applied for the admission of securities to trading on a regulated market without the issuer's consent, is required to disclose under this Directive, under Article 6 of Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) (11), or under the laws, regulations or administrative provisions of a Member State adopted under Article 3(1) of this Directive; (l) ‘electronic means’ are means of electronic equipment for the processing (including digital compression), storage and transmission of data, employing wires, radio, optical technologies, or any other electromagnetic means; (m) ‘management company’ means a company as defined in Article 1a(2) of Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (12); (n) ‘market maker’ means a person who holds himself out on the financial markets on a continuous basis as being willing to deal on own account by buying and selling financial instruments against his proprietary capital at prices defined by him; (o) ‘credit institution’ means an undertaking as defined in Article 1(1)(a) of Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions (13); (p) ‘securities issued in a continuous or repeated manner’ means debt securities of the same issuer on tap or at least two separate issues of securities of a similar type and/or class. 2. For the purposes of the definition of ‘controlled undertaking’ in paragraph 1(f)(ii), the holder's rights in relation to voting, appointment and removal shall include the rights of any other undertaking controlled by the shareholder and those of any natural person or legal entity acting, albeit in its own name, on behalf of the shareholder or of any other undertaking controlled by the shareholder. 3. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 1, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures concerning the definitions set out in paragraph 1. The Commission shall, in particular: (a) establish, for the purposes of paragraph 1(i)(ii), the procedural arrangements in accordance with which an issuer may make the choice of the home Member State; (b) adjust, where appropriate for the purposes of the choice of the home Member State referred to in paragraph 1(i)(ii), the three-year period in relation to the issuer's track record in the light of any new requirement under Community law concerning admission to trading on a regulated market; (c) establish, for the purposes of paragraph 1(l), an indicative list of means which are not to be considered as electronic means, thereby taking into account Annex V to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (14). Article 3 Integration of securities markets 1. The home Member State may make an issuer subject to requirements more stringent than those laid down in this Directive. The home Member State may also make a holder of shares, or a natural person or legal entity referred to in Articles 10 or 13, subject to requirements more stringent than those laid down in this Directive. 2. A host Member State may not: (a) as regards the admission of securities to a regulated market in its territory, impose disclosure requirements more stringent than those laid down in this Directive or in Article 6 of Directive 2003/6/EC; (b) as regards the notification of information, make a holder of shares, or a natural person or legal entity referred to in Articles 10 or 13, subject to requirements more stringent than those laid down in this Directive. CHAPTER II PERIODIC INFORMATION Article 4 Annual financial reports 1. The issuer shall make public its annual financial report at the latest four months after the end of each financial year and shall ensure that it remains publicly available for at least five years. 2. The annual financial report shall comprise: (a) the audited financial statements; (b) the management report; and (c) statements made by the persons responsible within the issuer, whose names and functions shall be clearly indicated, to the effect that, to the best of their knowledge, the financial statements prepared in accordance with the applicable set of accounting standards give a true and fair view of the assets, liabilities, financial position and profit or loss of the issuer and the undertakings included in the consolidation taken as a whole and that the management report includes a fair review of the development and performance of the business and the position of the issuer and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face. 3. Where the issuer is required to prepare consolidated accounts according to the Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts (15), the audited financial statements shall comprise such consolidated accounts drawn up in accordance with Regulation (EC) No 1606/2002 and the annual accounts of the parent company drawn up in accordance with the national law of the Member State in which the parent company is incorporated. Where the issuer is not required to prepare consolidated accounts, the audited financial statements shall comprise the accounts prepared in accordance with the national law of the Member State in which the company is incorporated. 4. The financial statements shall be audited in accordance with Articles 51 and 51a of the Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (16) and, if the issuer is required to prepare consolidated accounts, in accordance with Article 37 of Directive 83/349/EEC. The audit report, signed by the person or persons responsible for auditing the financial statements, shall be disclosed in full to the public together with the annual financial report. 5. The management report shall be drawn up in accordance with Article 46 of Directive 78/660/EEC and, if the issuer is required to prepare consolidated accounts, in accordance with Article 36 of Directive 83/349/EEC. 6. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments in financial markets and to ensure the uniform application of paragraph 1. The Commission shall in particular specify the technical conditions under which a published annual financial report, including the audit report, is to remain available to the public. Where appropriate, the Commission may also adapt the five-year period referred to in paragraph 1. Article 5 Half-yearly financial reports 1. The issuer of shares or debt securities shall make public a half-yearly financial report covering the first six months of the financial year as soon as possible after the end of the relevant period, but at the latest two months thereafter. The issuer shall ensure that the half-yearly financial report remains available to the public for at least five years. 2. The half-yearly financial report shall comprise: (a) the condensed set of financial statements; (b) an interim management report; and (c) statements made by the persons responsible within the issuer, whose names and functions shall be clearly indicated, to the effect that, to the best of their knowledge, the condensed set of financial statements which has been prepared in accordance with the applicable set of accounting standards gives a true and fair view of the assets, liabilities, financial position and profit or loss of the issuer, or the undertakings included in the consolidation as a whole as required under paragraph 3, and that the interim management report includes a fair review of the information required under paragraph 4. 3. Where the issuer is required to prepare consolidated accounts, the condensed set of financial statements shall be prepared in accordance with the international accounting standard applicable to the interim financial reporting adopted pursuant to the procedure provided for under Article 6 of Regulation (EC) No 1606/2002. Where the issuer is not required to prepare consolidated accounts, the condensed set of financial statements shall at least contain a condensed balance sheet, a condensed profit and loss account and explanatory notes on these accounts. In preparing the condensed balance sheet and the condensed profit and loss account, the issuer shall follow the same principles for recognising and measuring as when preparing annual financial reports. 4. The interim management report shall include at least an indication of important events that have occurred during the first six months of the financial year, and their impact on the condensed set of financial statements, together with a description of the principal risks and uncertainties for the remaining six months of the financial year. For issuers of shares, the interim management report shall also include major related parties transactions. 5. If the half-yearly financial report has been audited, the audit report shall be reproduced in full. The same shall apply in the case of an auditors' review. If the half-yearly financial report has not been audited or reviewed by auditors, the issuer shall make a statement to that effect in its report. 6. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 1 to 5 of this Article. The Commission shall, in particular: (a) specify the technical conditions under which a published half-yearly financial report, including the auditors' review, is to remain available to the public; (b) clarify the nature of the auditors' review; (c) specify the minimum content of the condensed balance sheet and profit and loss accounts and explanatory notes on these accounts, where they are not prepared in accordance with the international accounting standards adopted pursuant to the procedure provided for under Article 6 of Regulation (EC) No 1606/2002. Where appropriate, the Commission may also adapt the five-year period referred to in paragraph 1. Article 6 Interim management statements 1. Without prejudice to Article 6 of Directive 2003/6/EC, an issuer whose shares are admitted to trading on a regulated market shall make public a statement by its management during the first six-month period of the financial year and another statement by its management during the second six-month period of the financial year. Such statement shall be made in a period between ten weeks after the beginning and six weeks before the end of the relevant six-month period. It shall contain information covering the period between the beginning of the relevant six-month period and the date of publication of the statement. Such a statement shall provide: — an explanation of material events and transactions that have taken place during the relevant period and their impact on the financial position of the issuer and its controlled undertakings, and — a general description of the financial position and performance of the issuer and its controlled undertakings during the relevant period. 2. Issuers which, under either national legislation or the rules of the regulated market or of their own initiative, publish quarterly financial reports in accordance with such legislation or rules shall not be required to make public statements by the management provided for in paragraph 1. 3. The Commission shall provide a report to the European Parliament and the Council by 20 January 2010 on the transparency of quarterly financial reporting and statements by the management of issuers to examine whether the information provided meets the objective of allowing investors to make an informed assessment of the financial position of the issuer. Such a report shall include an impact assessment on areas where the Commission considers proposing amendments to this Article. Article 7 Responsibility and liability Member States shall ensure that responsibility for the information to be drawn up and made public in accordance with Articles 4, 5, 6 and 16 lies at least with the issuer or its administrative, management or supervisory bodies and shall ensure that their laws, regulations and administrative provisions on liability apply to the issuers, the bodies referred to in this Article or the persons responsible within the issuers. Article 8 Exemptions 1. Articles 4, 5 and 6 shall not apply to the following issuers: (a) a State, a regional or local authority of a State, a public international body of which at least one Member State is a member, the ECB, and Member States' national central banks whether or not they issue shares or other securities; and (b) an issuer exclusively of debt securities admitted to trading on a regulated market, the denomination per unit of which is at least EUR 50 000 or, in the case of debt securities denominated in a currency other than Euro, the value of such denomination per unit is, at the date of the issue, equivalent to at least EUR 50 000. 2. The home Member State may choose not to apply Article 5 to credit institutions whose shares are not admitted to trading on a regulated market and which have, in a continuous or repeated manner, only issued debt securities provided that the total nominal amount of all such debt securities remains below EUR 100 000 000 and that they have not published a prospectus under Directive 2003/71/EC. 3. The home Member State may choose not to apply Article 5 to issuers already existing at the date of the entry into force of Directive 2003/71/EC which exclusively issue debt securities unconditionally and irrevocably guaranteed by the home Member State or by one of its regional or local authorities, on a regulated market. CHAPTER III ONGOING INFORMATION SECTION I Information about major holdings Article 9 Notification of the acquisition or disposal of major holdings 1. The home Member State shall ensure that, where a shareholder acquires or disposes of shares of an issuer whose shares are admitted to trading on a regulated market and to which voting rights are attached, such shareholder notifies the issuer of the proportion of voting rights of the issuer held by the shareholder as a result of the acquisition or disposal where that proportion reaches, exceeds or falls below the thresholds of 5 %, 10 %, 15 %, 20 %, 25 %, 30 %, 50 % and 75 %. The voting rights shall be calculated on the basis of all the shares to which voting rights are attached even if the exercise thereof is suspended. Moreover this information shall also be given in respect of all the shares which are in the same class and to which voting rights are attached. 2. The home Member States shall ensure that the shareholders notify the issuer of the proportion of voting rights, where that proportion reaches, exceeds or falls below the thresholds provided for in paragraph 1, as a result of events changing the breakdown of voting rights, and on the basis of the information disclosed pursuant to Article 15. Where the issuer is incorporated in a third country, the notification shall be made for equivalent events. 3. The home Member State need not apply: (a) the 30 % threshold, where it applies a threshold of one-third; (b) the 75 % threshold, where it applies a threshold of two-thirds. 4. This Article shall not apply to shares acquired for the sole purpose of clearing and settling within the usual short settlement cycle, or to custodians holding shares in their custodian capacity provided such custodians can only exercise the voting rights attached to such shares under instructions given in writing or by electronic means. 5. This Article shall not apply to the acquisition or disposal of a major holding reaching or crossing the 5 % threshold by a market maker acting in its capacity of a market maker, provided that: (a) it is authorised by its home Member State under Directive 2004/39/EC; and (b) it neither intervenes in the management of the issuer concerned nor exerts any influence on the issuer to buy such shares or back the share price. 6. Home Member States under Article 2(1)(i) may provide that voting rights held in the trading book, as defined in Article 2(6) of Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (17), of a credit institution or investment firm shall not be counted for the purposes of this Article provided that: (a) the voting rights held in the trading book do not exceed 5 %, and (b) the credit institution or investment firm ensures that the voting rights attaching to shares held in the trading book are not exercised nor otherwise used to intervene in the management of the issuer. 7. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 2, 4 and 5 of this Article. The Commission shall in particular specify the maximum length of the ‘short settlement cycle’ referred to in paragraph 4, as well as the appropriate control mechanisms by the competent authority of the home Member State. In addition, the Commission may draw up a list of the events referred to in paragraph 2. Article 10 Acquisition or disposal of major proportions of voting rights The notification requirements defined in paragraphs 1 and 2 of Article 9 shall also apply to a natural person or legal entity to the extent it is entitled to acquire, to dispose of, or to exercise voting rights in any of the following cases or a combination of them: (a) voting rights held by a third party with whom that person or entity has concluded an agreement, which obliges them to adopt, by concerted exercise of the voting rights they hold, a lasting common policy towards the management of the issuer in question; (b) voting rights held by a third party under an agreement concluded with that person or entity providing for the temporary transfer for consideration of the voting rights in question; (c) voting rights attaching to shares which are lodged as collateral with that person or entity, provided the person or entity controls the voting rights and declares its intention of exercising them; (d) voting rights attaching to shares in which that person or entity has the life interest; (e) voting rights which are held, or may be exercised within the meaning of points (a) to (d), by an undertaking controlled by that person or entity; (f) voting rights attaching to shares deposited with that person or entity which the person or entity can exercise at its discretion in the absence of specific instructions from the shareholders; (g) voting rights held by a third party in its own name on behalf of that person or entity; (h) voting rights which that person or entity may exercise as a proxy where the person or entity can exercise the voting rights at its discretion in the absence of specific instructions from the shareholders. Article 11 1. Articles 9 and 10(c) shall not apply to shares provided to or by the members of the ESCB in carrying out their functions as monetary authorities, including shares provided to or by members of the ESCB under a pledge or repurchase or similar agreement for liquidity granted for monetary policy purposes or within a payment system. 2. The exemption shall apply to the above transactions lasting for a short period and provided that the voting rights attaching to such shares are not exercised. Article 12 Procedures on the notification and disclosure of major holdings 1. The notification required under Articles 9 and 10 shall include the following information: (a) the resulting situation in terms of voting rights; (b) the chain of controlled undertakings through which voting rights are effectively held, if applicable; (c) the date on which the threshold was reached or crossed; and (d) the identity of the shareholder, even if that shareholder is not entitled to exercise voting rights under the conditions laid down in Article 10, and of the natural person or legal entity entitled to exercise voting rights on behalf of that shareholder. 2. The notification to the issuer shall be effected as soon as possible, but not later than four trading days, the first of which shall be the day after the date on which the shareholder, or the natural person or legal entity referred to in Article 10, (a) learns of the acquisition or disposal or of the possibility of exercising voting rights, or on which, having regard to the circumstances, should have learned of it, regardless of the date on which the acquisition, disposal or possibility of exercising voting rights takes effect; or (b) is informed about the event mentioned in Article 9(2). 3. An undertaking shall be exempted from making the required notification in accordance with paragraph 1 if the notification is made by the parent undertaking or, where the parent undertaking is itself a controlled undertaking, by its own parent undertaking. 4. The parent undertaking of a management company shall not be required to aggregate its holdings under Articles 9 and 10 with the holdings managed by the management company under the conditions laid down in Directive 85/611/EEC, provided such management company exercises its voting rights independently from the parent undertaking. However, Articles 9 and 10 shall apply where the parent undertaking, or another controlled undertaking of the parent undertaking, has invested in holdings managed by such management company and the management company has no discretion to exercise the voting rights attached to such holdings and may only exercise such voting rights under direct or indirect instructions from the parent or another controlled undertaking of the parent undertaking. 5. The parent undertaking of an investment firm authorised under Directive 2004/39/EC shall not be required to aggregate its holdings under Articles 9 and 10 with the holdings which such investment firm manages on a client-by-client basis within the meaning of Article 4(1), point 9, of Directive 2004/39/EC, provided that: — the investment firm is authorised to provide such portfolio management under point 4 of Section A of Annex I to Directive 2004/39/EC; — it may only exercise the voting rights attached to such shares under instructions given in writing or by electronic means or it ensures that individual portfolio management services are conducted independently of any other services under conditions equivalent to those provided for under Directive 85/611/EEC by putting into place appropriate mechanisms; and — the investment firm exercises its voting rights independently from the parent undertaking. However, Articles 9 and 10 shall apply where the parent undertaking, or another controlled undertaking of the parent undertaking, has invested in holdings managed by such investment firm and the investment firm has no discretion to exercise the voting rights attached to such holdings and may only exercise such voting rights under direct or indirect instructions from the parent or another controlled undertaking of the parent undertaking. 6. Upon receipt of the notification under paragraph 1, but no later than three trading days thereafter, the issuer shall make public all the information contained in the notification. 7. A home Member State may exempt issuers from the requirement in paragraph 6 if the information contained in the notification is made public by its competent authority, under the conditions laid down in Article 21, upon receipt of the notification, but no later than three trading days thereafter. 8. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 1, 2, 4, 5 and 6 of this Article, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures: (a) to establish a standard form to be used throughout the Community when notifying the required information to the issuer under paragraph 1 or when filing information under Article 19(3); (b) to determine a calendar of ‘trading days’ for all Member States; (c) to establish in which cases the shareholder, or the natural person or legal entity referred to in Article 10, or both, shall effect the necessary notification to the issuer; (d) to clarify the circumstances under which the shareholder, or the natural person or legal entity referred to in Article 10, should have learned of the acquisition or disposal; (e) to clarify the conditions of independence to be complied with by management companies and their parent undertakings or by investment firms and their parent undertakings to benefit from the exemptions in paragraphs 4 and 5. Article 13 1. The notification requirements laid down in Article 9 shall also apply to a natural person or legal entity who holds, directly or indirectly, financial instruments that result in an entitlement to acquire, on such holder's own initiative alone, under a formal agreement, shares to which voting rights are attached, already issued, of an issuer whose shares are admitted to trading on a regulated market. 2. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments in financial markets and to ensure the uniform application of paragraph 1. It shall in particular determine: (a) the types of financial instruments referred to in paragraph 1 and their aggregation; (b) the nature of the formal agreement referred to in paragraph 1; (c) the contents of the notification to be made, establishing a standard form to be used throughout the Community for that purpose; (d) the notification period; (e) to whom the notification is to be made. Article 14 1. Where an issuer of shares admitted to trading on a regulated market acquires or disposes of its own shares, either itself or through a person acting in his own name but on the issuer's behalf, the home Member State shall ensure that the issuer makes public the proportion of its own shares as soon as possible, but not later than four trading days following such acquisition or disposal where that proportion reaches, exceeds or falls below the thresholds of 5 % or 10 % of the voting rights. The proportion shall be calculated on the basis of the total number of shares to which voting rights are attached. 2. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments in financial markets and to ensure the uniform application of paragraph 1. Article 15 For the purpose of calculating the thresholds provided for in Article 9, the home Member State shall at least require the disclosure to the public by the issuer of the total number of voting rights and capital at the end of each calendar month during which an increase or decrease of such total number has occurred. Article 16 Additional information 1. The issuer of shares admitted to trading on a regulated market shall make public without delay any change in the rights attaching to the various classes of shares, including changes in the rights attaching to derivative securities issued by the issuer itself and giving access to the shares of that issuer. 2. The issuer of securities, other than shares admitted to trading on a regulated market, shall make public without delay any changes in the rights of holders of securities other than shares, including changes in the terms and conditions of these securities which could indirectly affect those rights, resulting in particular from a change in loan terms or in interest rates. 3. The issuer of securities admitted to trading on a regulated market shall make public without delay of new loan issues and in particular of any guarantee or security in respect thereof. Without prejudice to Directive 2003/6/EC, this paragraph shall not apply to a public international body of which at least one Member State is member. SECTION II Information for holders of securities admitted to trading on a regulated market Article 17 Information requirements for issuers whose shares are admitted to trading on a regulated market 1. The issuer of shares admitted to trading on a regulated market shall ensure equal treatment for all holders of shares who are in the same position. 2. The issuer shall ensure that all the facilities and information necessary to enable holders of shares to exercise their rights are available in the home Member State and that the integrity of data is preserved. Shareholders shall not be prevented from exercising their rights by proxy, subject to the law of the country in which the issuer is incorporated. In particular, the issuer shall: (a) provide information on the place, time and agenda of meetings, the total number of shares and voting rights and the rights of holders to participate in meetings; (b) make available a proxy form, on paper or, where applicable, by electronic means, to each person entitled to vote at a shareholders' meeting, together with the notice concerning the meeting or, on request, after an announcement of the meeting; (c) designate as its agent a financial institution through which shareholders may exercise their financial rights; and (d) publish notices or distribute circulars concerning the allocation and payment of dividends and the issue of new shares, including information on any arrangements for allotment, subscription, cancellation or conversion. 3. For the purposes of conveying information to shareholders, the home Member State shall allow issuers the use of electronic means, provided such a decision is taken in a general meeting and meets at least the following conditions: (a) the use of electronic means shall in no way depend upon the location of the seat or residence of the shareholder or, in the cases referred to in Article 10(a) to (h), of the natural persons or legal entities; (b) identification arrangements shall be put in place so that the shareholders, or the natural persons or legal entities entitled to exercise or to direct the exercise of voting rights, are effectively informed; (c) shareholders, or in the cases referred to in Article 10(a) to (e) the natural persons or legal entities entitled to acquire, dispose of or exercise voting rights, shall be contacted in writing to request their consent for the use of electronic means for conveying information and, if they do not object within a reasonable period of time, their consent shall be deemed to be given. They shall be able to request, at any time in the future, that information be conveyed in writing, and (d) any apportionment of the costs entailed in the conveyance of such information by electronic means shall be determined by the issuer in compliance with the principle of equal treatment laid down in paragraph 1. 4. The Commission shall, in accordance with the procedure provided for in Article 27(2), adopt implementing measures in order to take account of technical developments in financial markets, to take account of developments in information and communication technology and to ensure the uniform application of paragraphs 1, 2 and 3. It shall, in particular, specify the types of financial institution through which a shareholder may exercise the financial rights provided for in paragraph 2(c). Article 18 Information requirements for issuers whose debt securities are admitted to trading on a regulated market 1. The issuer of debt securities admitted to trading on a regulated market shall ensure that all holders of debt securities ranking pari passu are given equal treatment in respect of all the rights attaching to those debt securities. 2. The issuer shall ensure that all the facilities and information necessary to enable debt securities holders to exercise their rights are publicly available in the home Member State and that the integrity of data is preserved. Debt securities holders shall not be prevented from exercising their rights by proxy, subject to the law of country in which the issuer is incorporated. In particular, the issuer shall: (a) publish notices, or distribute circulars, concerning the place, time and agenda of meetings of debt securities holders, the payment of interest, the exercise of any conversion, exchange, subscription or cancellation rights, and repayment, as well as the right of those holders to participate therein; (b) make available a proxy form on paper or, where applicable, by electronic means, to each person entitled to vote at a meeting of debt securities holders, together with the notice concerning the meeting or, on request, after an announcement of the meeting; and (c) designate as its agent a financial institution through which debt securities holders may exercise their financial rights. 3. If only holders of debt securities whose denomination per unit amounts to at least EUR 50 000 or, in the case of debt securities denominated in a currency other than Euro whose denomination per unit is, at the date of the issue, equivalent to at least EUR 50 000, are to be invited to a meeting, the issuer may choose as venue any Member State, provided that all the facilities and information necessary to enable such holders to exercise their rights are made available in that Member State. 4. For the purposes of conveying information to debt securities holders, the home Member State, or the Member State chosen by the issuer pursuant to paragraph 3, shall allow issuers the use of electronic means, provided such a decision is taken in a general meeting and meets at least the following conditions: (a) the use of electronic means shall in no way depend upon the location of the seat or residence of the debt security holder or of a proxy representing that holder; (b) identification arrangements shall be put in place so that debt securities holders are effectively informed; (c) debt securities holders shall be contacted in writing to request their consent for the use of electronic means for conveying information and if they do not object within a reasonable period of time, their consent shall be deemed to be given. They shall be able to request, at any time in the future, that information be conveyed in writing; and (d) any apportionment of the costs entailed in the conveyance of information by electronic means shall be determined by the issuer in compliance with the principle of equal treatment laid down in paragraph 1. 5. The Commission shall, in accordance with the procedure provided for in Article 27(2), adopt implementing measures in order to take account of technical developments in financial markets, to take account of developments in information and communication technology and to ensure the uniform application of paragraphs 1 to 4. It shall, in particular, specify the types of financial institution through which a debt security holder may exercise the financial rights provided for in paragraph 2(c). CHAPTER IV GENERAL OBLIGATIONS Article 19 Home Member State control 1. Whenever the issuer, or any person having requested, without the issuer's consent, the admission of its securities to trading on a regulated market, discloses regulated information, it shall at the same time file that information with the competent authority of its home Member State. That competent authority may decide to publish such filed information on its Internet site. Where an issuer proposes to amend its instrument of incorporation or statutes, it shall communicate the draft amendment to the competent authority of the home Member State and to the regulated market to which its securities have been admitted to trading. Such communication shall be effected without delay, but at the latest on the date of calling the general meeting which is to vote on, or be informed of, the amendment. 2. The home Member State may exempt an issuer from the requirement under paragraph 1 in respect of information disclosed in accordance with Article 6 of Directive 2003/6/EC or Article 12(6) of this Directive. 3. Information to be notified to the issuer in accordance with Articles 9, 10, 12 and 13 shall at the same time be filed with the competent authority of the home Member State. 4. In order to ensure the uniform application of paragraphs 1, 2 and 3, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures. The Commission shall, in particular, specify the procedure in accordance with which an issuer, a holder of shares or other financial instruments, or a person or entity referred to in Article 10, is to file information with the competent authority of the home Member State under paragraphs 1 or 3, respectively, in order to: (a) enable filing by electronic means in the home Member State; (b) coordinate the filing of the annual financial report referred to in Article 4 of this Directive with the filing of the annual information referred to in Article 10 of Directive 2003/71/EC. Article 20 Languages 1. Where securities are admitted to trading on a regulated market only in the home Member State, regulated information shall be disclosed in a language accepted by the competent authority in the home Member State. 2. Where securities are admitted to trading on a regulated market both in the home Member State and in one or more host Member States, regulated information shall be disclosed: (a) in a language accepted by the competent authority in the home Member State; and (b) depending on the choice of the issuer, either in a language accepted by the competent authorities of those host Member States or in a language customary in the sphere of international finance. 3. Where securities are admitted to trading on a regulated market in one or more host Member States, but not in the home Member State, regulated information shall, depending on the choice of the issuer, be disclosed either in a language accepted by the competent authorities of those host Member States or in a language customary in the sphere of international finance. In addition, the home Member State may lay down in its law, regulations or administrative provisions that the regulated information shall, depending on the choice of the issuer, be disclosed either in a language accepted by its competent authority or in a language customary in the sphere of international finance. 4. Where securities are admitted to trading on a regulated market without the issuer's consent, the obligations under paragraphs 1, 2 and 3 shall be incumbent not upon the issuer, but upon the person who, without the issuer's consent, has requested such admission. 5. Member States shall allow shareholders and the natural person or legal entity referred to in Articles 9, 10 and 13 to notify information to an issuer under this Directive only in a language customary in the sphere of international finance. If the issuer receives such a notification, Member States may not require the issuer to provide a translation into a language accepted by the competent authorities. 6. By way of derogation from paragraphs 1 to 4, where securities whose denomination per unit amounts to at least EUR 50 000 or, in the case of debt securities denominated in a currency other than Euro equivalent to at least EUR 50 000 at the date of the issue, are admitted to trading on a regulated market in one or more Member States, regulated information shall be disclosed to the public either in a language accepted by the competent authorities of the home and host Member States or in a language customary in the sphere of international finance, at the choice of the issuer or of the person who, without the issuer's consent, has requested such admission. 7. If an action concerning the content of regulated information is brought before a court or tribunal in a Member State, responsibility for the payment of costs incurred in the translation of that information for the purposes of the proceedings shall be decided in accordance with the law of that Member State. Article 21 Access to regulated information 1. The home Member State shall ensure that the issuer, or the person who has applied for admission to trading on a regulated market without the issuer's consent, discloses regulated information in a manner ensuring fast access to such information on a non-discriminatory basis and makes it available to the officially appointed mechanism referred to in paragraph 2. The issuer, or the person who has applied for admission to trading on a regulated market without the issuer's consent, may not charge investors any specific cost for providing the information. The home Member State shall require the issuer to use such media as may reasonably be relied upon for the effective dissemination of information to the public throughout the Community. The home Member State may not impose an obligation to use only media whose operators are established on its territory. 2. The home Member State shall ensure that there is at least one officially appointed mechanism for the central storage of regulated information. These mechanisms should comply with minimum quality standards of security, certainty as to the information source, time recording and easy access by end users and shall be aligned with the filing procedure under Article 19(1). 3. Where securities are admitted to trading on a regulated market in only one host Member State and not in the home Member State, the host Member State shall ensure disclosure of regulated information in accordance with the requirements referred to in paragraph 1. 4. In order to take account of technical developments in financial markets, to take account of developments in information and communication technology and to ensure the uniform application of paragraphs 1, 2 and 3, the Commission shall adopt implementing measures in accordance with the procedure referred to in Article 27(2). The Commission shall in particular specify: (a) minimum standards for the dissemination of regulated information, as referred to in paragraph 1; (b) minimum standards for the central storage mechanism as referred to in paragraph 2. The Commission may also specify and update a list of media for the dissemination of information to the public. Article 22 Guidelines 1. The competent authorities of the Member States shall draw up appropriate guidelines with a view to further facilitating public access to information to be disclosed under Directive 2003/6/EC, Directive 2003/71/EC and this Directive. The aim of those guidelines shall be the creation of: (a) an electronic network to be set up at national level between national securities regulators, operators of regulated markets and national company registers covered by the First Council Directive 68/151/EEC of 9 March 1968 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 48 (18) of the Treaty, with a view to making such safeguards equivalent throughout the Community (19); and (b) a single electronic network, or a platform of electronic networks across Member States. 2. The Commission shall review the results achieved under paragraph 1 by 31 December 2006 and may, in accordance with the procedure referred to in Article 27(2), adopt implementing measures to facilitate compliance with Articles 19 and 21. Article 23 Third countries 1. Where the registered office of an issuer is in a third country, the competent authority of the home Member State may exempt that issuer from requirements under Articles 4 to 7 and Articles 12(6), 14, 15 and 16 to 18, provided that the law of the third country in question lays down equivalent requirements or such an issuer complies with requirements of the law of a third country that the competent authority of the home Member State considers as equivalent. However, the information covered by the requirements laid down in the third country shall be filed in accordance with Article 19 and disclosed in accordance with Articles 20 and 21. 2. By way of derogation from paragraph 1, an issuer whose registered office is in a third country shall be exempted from preparing its financial statement in accordance with Article 4 or Article 5 prior to the financial year starting on or after 1 January 2007, provided such issuer prepares its financial statements in accordance with internationally accepted standards referred to in Article 9 of Regulation (EC) No 1606/2002. 3. The competent authority of the home Member State shall ensure that information disclosed in a third country which may be of importance for the public in the Community is disclosed in accordance with Articles 20 and 21, even if such information is not regulated information within the meaning of Article 2(1)(k). 4. In order to ensure the uniform application of paragraph 1, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures (i) setting up a mechanism ensuring the establishment of equivalence of information required under this Directive, including financial statements and information, including financial statements, required under the law, regulations or administrative provisions of a third country; (ii) stating that, by reason of its domestic law, regulations, administrative provisions, or of the practices or procedures based on the international standards set by international organisations, the third country where the issuer is registered ensures the equivalence of the information requirements provided for in this Directive. The Commission shall, in accordance with the procedure referred to in Article 27(2), take the necessary decisions on the equivalence of accounting standards which are used by third country issuers under the conditions set out in Article 30(3) at the latest five years following the date referred to in Article 31. If the Commission decides that the accounting standards of a third country are not equivalent, it may allow the issuers concerned to continue using such accounting standards during an appropriate transitional period. 5. In order to ensure uniform application of paragraph 2, the Commission may, in accordance with the procedure referred to in Article 27(2), adopt implementing measures defining the type of information disclosed in a third country that is of importance to the public in the Community. 6. Undertakings whose registered office is in a third country which would have required an authorisation in accordance with Article 5(1) of Directive 85/611/EEC or, with regard to portfolio management under point 4 of section A of Annex I to Directive 2004/39/EC if it had its registered office or, only in the case of an investment firm, its head office within the Community, shall also be exempted from aggregating holdings with the holdings of its parent undertaking under the requirements laid down in Article 12(4) and (5) provided that they comply with equivalent conditions of independence as management companies or investment firms. 7. In order to take account of technical developments in financial markets and to ensure the uniform application of paragraph 6, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures stating that, by reason of its domestic law, regulations, or administrative provisions, a third country ensures the equivalence of the independence requirements provided for under this Directive and its implementing measures. CHAPTER V COMPETENT AUTHORITIES Article 24 Competent authorities and their powers 1. Each Member State shall designate the central authority referred to in Article 21(1) of Directive 2003/71/EC as central competent administrative authority responsible for carrying out the obligations provided for in this Directive and for ensuring that the provisions adopted pursuant to this Directive are applied. Member States shall inform the Commission accordingly. However, for the purpose of paragraph 4(h) Member States may designate a competent authority other than the central competent authority referred to in the first subparagraph. 2. Member States may allow their central competent authority to delegate tasks. Except for the tasks referred to in paragraph 4(h), any delegation of tasks relating to the obligations provided for in this Directive and in its implementing measures shall be reviewed five years after the entry into force of this Directive and shall end eight years after the entry into force of this Directive. Any delegation of tasks shall be made in a specific manner stating the tasks to be undertaken and the conditions under which they are to be carried out. Those conditions shall include a clause requiring the entity in question to be organised in a manner such that conflicts of interest are avoided and information obtained from carrying out the delegated tasks is not used unfairly or to prevent competition. In any case, the final responsibility for supervising compliance with the provisions of this Directive and implementing measures adopted pursuant thereto shall lie with the competent authority designated in accordance with paragraph 1. 3. Member States shall inform the Commission and competent authorities of other Member States of any arrangements entered into with regard to the delegation of tasks, including the precise conditions for regulating the delegations. 4. Each competent authority shall have all the powers necessary for the performance of its functions. It shall at least be empowered to: (a) require auditors, issuers, holders of shares or other financial instruments, or persons or entities referred to in Articles 10 or 13, and the persons that control them or are controlled by them, to provide information and documents; (b) require the issuer to disclose the information required under point (a) to the public by the means and within the time limits the authority considers necessary. It may publish such information on its own initiative in the event that the issuer, or the persons that control it or are controlled by it, fail to do so and after having heard the issuer; (c) require managers of the issuers and of the holders of shares or other financial instruments, or of persons or entities referred to in Articles 10 or 13, to notify the information required under this Directive, or under national law adopted in accordance with this Directive, and, if necessary, to provide further information and documents; (d) suspend, or request the relevant regulated market to suspend, trading in securities for a maximum of ten days at a time if it has reasonable grounds for suspecting that the provisions of this Directive, or of national law adopted in accordance with this Directive, have been infringed by the issuer; (e) prohibit trading on a regulated market if it finds that the provisions of this Directive, or of national law adopted in accordance with this Directive, have been infringed, or if it has reasonable grounds for suspecting that the provisions of this Directive have been infringed; (f) monitor that the issuer discloses timely information with the objective of ensuring effective and equal access to the public in all Member States where the securities are traded and take appropriate action if that is not the case; (g) make public the fact that an issuer, or a holder of shares or other financial instruments, or a person or entity referred to in Articles 10 or 13, is failing to comply with its obligations; (h) examine that information referred to in this Directive is drawn up in accordance with the relevant reporting framework and take appropriate measures in case of discovered infringements; and (i) carry out on-site inspections in its territory in accordance with national law, in order to verify compliance with the provisions of this Directive and its implementing measures. Where necessary under national law, the competent authority or authorities may use this power by applying to the relevant judicial authority and/or in cooperation with other authorities. 5. Paragraphs 1 to 4 shall be without prejudice to the possibility for a Member State to make separate legal and administrative arrangements for overseas European territories for whose external relations that Member State is responsible. 6. The disclosure to competent authorities by the auditors of any fact or decision related to the requests made by the competent authority under paragraph (4)(a) shall not constitute a breach of any restriction on disclosure of information imposed by contract or by any law, regulation or administrative provision and shall not involve such auditors in liability of any kind. Article 25 Professional secrecy and cooperation between Member States 1. The obligation of professional secrecy shall apply to all persons who work or who have worked for the competent authority and for entities to which competent authorities may have delegated certain tasks. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of the laws, regulations or administrative provisions of a Member State. 2. Competent authorities of the Member States shall cooperate with each other, whenever necessary, for the purpose of carrying out their duties and making use of their powers, whether set out in this Directive or in national law adopted pursuant to this Directive. Competent authorities shall render assistance to competent authorities of other Member States. 3. Paragraph 1 shall not prevent the competent authorities from exchanging confidential information. Information thus exchanged shall be covered by the obligation of professional secrecy to which the persons employed or formerly employed by the competent authorities receiving the information are subject. 4. Member States may conclude cooperation agreements providing for the exchange of information with the competent authorities or bodies of third countries enabled by their respective legislation to carry out any of the tasks assigned by this Directive to the competent authorities in accordance with Article 24. Such an exchange of information is subject to guarantees of professional secrecy at least equivalent to those referred to in this Article. Such exchange of information shall be intended for the performance of the supervisory task of the authorities or bodies mentioned. 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. Article 26 Precautionary measures 1. Where the competent authority of a host Member State finds that the issuer or the holder of shares or other financial instruments, or the person or entity referred to in Article 10, has committed irregularities or infringed its obligations, it shall refer its findings to the competent authority of the home Member State. 2. If, despite the measures taken by the competent authority of the home Member State, or because such measures prove inadequate, the issuer or the security holder persists in infringing the relevant legal or regulatory provisions, the competent authority of the host Member State shall, after informing the competent authority of the home Member State, take, in accordance with Article 3(2), all the appropriate measures in order to protect investors. The Commission shall be informed of such measures at the earliest opportunity. CHAPTER VI IMPLEMENTING MEASURES Article 27 Committee procedure 1. The Commission shall be assisted by the European Securities Committee, instituted by Article 1 of Decision 2001/528/EC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof, provided that the implementing measures adopted in accordance with that procedure do not modify the essential provisions of this Directive. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. 4. Without prejudice to the implementing measures already adopted by 20 January 2009 the application of the provisions of this Directive concerning the adoption of technical rules and decisions in accordance with the procedure referred to in paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, shall review them prior to the expiry of the four-year period. Article 28 Penalties 1. Without prejudice to the right of Member States to impose criminal penalties, Member States shall ensure, in conformity with their national law, that at least the appropriate administrative measures may be taken or civil and/or administrative penalties imposed in respect of the persons responsible, where the provisions adopted in accordance with this Directive have not been complied with. Member States shall ensure that those measures are effective, proportionate and dissuasive. 2. Member States shall provide that the competent authority may disclose to the public every measure taken or penalty imposed for infringement of the provisions adopted in accordance with this Directive, save where such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved. Article 29 Right of appeal Member States shall ensure that decisions taken under laws, regulations, and administrative provisions adopted in accordance with this Directive are subject to the right of appeal to the courts. CHAPTER VII TRANSITIONAL AND FINAL PROVISIONS Article 30 Transitional provisions 1. By way of derogation from Article 5(3) of this Directive, the home Member State may exempt from disclosing financial statements in accordance with Regulation (EC) No 1606/2002 issuers referred to in Article 9 of that Regulation for the financial year starting on or after 1 January 2006. 2. Notwithstanding Article 12(2), a shareholder shall notify the issuer at the latest two months after the date in Article 31(1) of the proportion of voting rights and capital it holds, in accordance with Articles 9, 10 and 13, with issuers at that date, unless it has already made a notification containing equivalent information before that date. Notwithstanding Article 12(6), an issuer shall in turn disclose the information received in those notifications no later than three months after the date in Article 31(1). 3. Where an issuer is incorporated in a third country, the home Member State may exempt such issuer only in respect of those debt securities which have already been admitted to trading on a regulated market in the Community prior to 1 January 2005 from drawing up its financial statements in accordance with Article 4(3) and its management report in accordance with Article 4(5) as long as (a) the competent authority of the home Member State acknowledges that annual financial statements prepared by issuers from such a third country give a true and fair view of the issuer's assets and liabilities, financial position and results; (b) the third country where the issuer is incorporated has not made mandatory the application of international accounting standards referred to in Article 2 of Regulation (EC) No 1606/2002; and (c) the Commission has not taken any decision in accordance with Article 23(4)(ii) as to whether there is an equivalence between the abovementioned accounting standards and — the accounting standards laid down in the law, regulations or administrative provisions of the third country where the issuer is incorporated, or — the accounting standards of a third country such an issuer has elected to comply with. 4. The home Member State may exempt issuers only in respect of those debt securities which have already been admitted to trading on a regulated market in the Community prior to 1 January 2005 from disclosing half-yearly financial report in accordance with Article 5 for 10 years following 1 January 2005, provided that the home Member State had decided to allow such issuers to benefit from the provisions of Article 27 of Directive 2001/34/EC at the point of admission of those debt securities. Article 31 Transposition 1. Member States shall take the necessary measures to comply with this Directive by 20 January 2007. 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. Where Member States adopt measures pursuant to Articles 3(1), 8(2), 8(3), 9(6) or 30, they shall immediately communicate those measures to the Commission and to the other Member States. Article 32 Amendments With effect from the date specified in Article 31(1), Directive 2001/34/EC shall be amended as follows: (1) In Article 1, points (g) and (h) shall be deleted; (2) Article 4 shall be deleted; (3) In Article 6, paragraph 2 shall be deleted; (4) In Article 8, paragraph 2 shall be replaced by the following: ‘2. Member States may make the issuers of securities admitted to official listing subject to additional obligations, provided that those additional obligations apply generally for all issuers or for individual classes of issuers’; (5) Articles 65 to 97 shall be deleted; (6) Articles 102 and 103 shall be deleted; (7) In Article 107(3), the second subparagraph shall be deleted; (8) In Article 108, paragraph 2 shall be amended as follows: (a) in point (a), the words ‘periodic information to be published by the companies of which shares are admitted’ shall be deleted; (b) point (b) shall be deleted; (c) point (c)(iii) shall be deleted; (d) point (d) shall be deleted. References made to the repealed provisions shall be construed as being made to the provisions of this Directive. Article 33 Review The Commission shall by 30 June 2009 report on the operation of this Directive to the European Parliament and to the Council including the appropriateness of ending the exemption for existing debt securities after the 10-year period as provided for by Article 30(4) and its potential impact on the European financial markets. 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 Union. Article 35 Addressees This Directive is addressed to the Member States.

32004L0108

2004

DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure referred to in Article 251 of the Treaty (2), Whereas: (1) Council Directive 89/336/EEC of 3 May 1989 on the approximation of laws of the Member States relating to electromagnetic compatibility (3) has been the subject of a review under the initiative known as Simpler Legislation for the Internal Market (SLIM). Both the SLIM process and a subsequent in-depth consultation have revealed the need to complete, reinforce and clarify the framework established by Directive 89/336/EEC. (2) Member States are responsible for ensuring that radiocommunications, including radio broadcast reception and the amateur radio service operating in accordance with International Telecommunication Union (ITU) radio regulations, electrical supply networks and telecommunications networks, as well as equipment connected thereto, are protected against electromagnetic disturbance. (3) Provisions of national law ensuring protection against electromagnetic disturbance should be harmonised in order to guarantee the free movement of electrical and electronic apparatus without lowering justified levels of protection in the Member States. (4) Protection against electromagnetic disturbance requires obligations to be imposed on the various economic operators. Those obligations should be applied in a fair and effective way in order to achieve such protection. (5) The electromagnetic compatibility of equipment should be regulated with a view to ensuring the functioning of the internal market, that is to say, of an area without internal frontiers in which the free movement of goods, persons, services and capital is assured. (6) The equipment covered by this Directive should include both apparatus and fixed installations. However, separate provision should be made for each. This is so because, whereas apparatus as such may move freely within the Community, fixed installations on the other hand are installed for permanent use at a predefined location, as assemblies of various types of apparatus and, where appropriate, other devices. The composition and function of such installations correspond in most cases to the particular needs of their operators. (7) Radio equipment and telecommunications terminal equipment should not be covered by this Directive since they are already regulated by Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (4). The electromagnetic compatibility requirements in both Directives achieve the same level of protection. (8) Aircraft or equipment intended to be fitted into aircraft should not be covered by this Directive, since they are already subject to special Community or international rules governing electromagnetic compatibility. (9) This Directive need not regulate equipment which is inherently benign in terms of electromagnetic compatibility. (10) This Directive should not deal with the safety of equipment, since that is dealt with by separate Community or national legislation. (11) Where this Directive regulates apparatus, it should refer to finished apparatus commercially available for the first time on the Community market. Certain components or sub-assemblies should, under certain conditions, be considered to be apparatus if they are made available to the end-user. (12) The principles on which this Directive is based are those set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (5). In accordance with that approach, the design and manufacture of equipment is subject to essential requirements in relation to electromagnetic compatibility. Those requirements are given technical expression by harmonised European standards, to be adopted by the various European standardisation bodies, European Committee for Standardisation (CEN), European Committee for Electro-technical Standardisation (CENELEC) and European Telecommunications Standards Institute (ETSI). CEN, CENELEC and ETSI are recognised as the competent institutions in the field of this Directive for the adoption of harmonised standards, which they draw up in accordance with the general guidelines for cooperation between themselves and the Commission, and with the procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (6). (13) Harmonised standards reflect the generally acknowledged state of the art as regards electromagnetic compatibility matters in the European Union. It is thus in the interest of the functioning of the internal market to have standards for the electromagnetic compatibility of equipment which have been harmonised at Community level. Once the reference to such a standard has been published in the Official Journal of the European Union, compliance with it should raise a presumption of conformity with the relevant essential requirements, although other means of demonstrating such conformity should be permitted. Compliance with a harmonised standard means conformity with its provisions and demonstration thereof by the methods the harmonised standard describes or refers to. (14) Manufacturers of equipment intended to be connected to networks should construct such equipment in a way that prevents networks from suffering unacceptable degradation of service when used under normal operating conditions. Network operators should construct their networks in such a way that manufacturers of equipment liable to be connected to networks do not suffer a disproportionate burden in order to prevent networks from suffering an unacceptable degradation of service. The European standardisation organisations should take due account of that objective (including the cumulative effects of the relevant types of electromagnetic phenomena) when developing harmonised standards. (15) It should be possible to place apparatus on the market or put it into service only if the manufacturers concerned have established that such apparatus has been designed and manufactured in conformity with the requirements of this Directive. Apparatus placed on the market should bear the ‘CE’ marking attesting to compliance with this Directive. Although conformity assessment should be the responsibility of the manufacturer, without any need to involve an independent conformity assessment body, manufacturers should be free to use the services of such a body. (16) The conformity assessment obligation should require the manufacturer to perform an electromagnetic compatibility assessment of apparatus, based on relevant phenomena, in order to determine whether or not it meets the protection requirements under this Directive. (17) Where apparatus is capable of taking different configurations, the electromagnetic compatibility assessment should confirm whether the apparatus meets the protection requirements in the configurations foreseeable by the manufacturer as representative of normal use in the intended applications; in such cases it should be sufficient to perform an assessment on the basis of the configuration most likely to cause maximum disturbance and the configuration most susceptible to disturbance. (18) Fixed installations, including large machines and networks, may generate electromagnetic disturbance, or be affected by it. There may be an interface between fixed installations and apparatus, and the electromagnetic disturbances produced by fixed installations may affect apparatus, and vice versa. In terms of electromagnetic compatibility, it is irrelevant whether the electromagnetic disturbance is produced by apparatus or by a fixed installation. Accordingly, fixed installations and apparatus should be subject to a coherent and comprehensive regime of essential requirements. It should be possible to use harmonised standards for fixed installations in order to demonstrate conformity with the essential requirements covered by such standards. (19) Due to their specific characteristics, fixed installations need not be subject to the affixation of the ‘CE’ marking or to the declaration of conformity. (20) It is not pertinent to carry out the conformity assessment of apparatus placed on the market for incorporation into a given fixed installation, and otherwise not commercially available, in isolation from the fixed installation into which it is to be incorporated. Such apparatus should therefore be exempted from the conformity assessment procedures normally applicable to apparatus. However, such apparatus should not be permitted to compromise the conformity of the fixed installation into which it is incorporated. Should apparatus be incorporated into more than one identical fixed installation, identifying the electromagnetic compatibility characteristics of these installations should be sufficient to ensure exemption from the conformity assessment procedure. (21) A transitional period is necessary in order to ensure that manufacturers and other concerned parties are able to adapt to the new regulatory regime. (22) Since the objective of this Directive, namely to ensure the functioning of the internal market by requiring equipment to comply with an adequate level of electromagnetic compatibility, cannot be sufficiently achieved by Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (23) Directive 89/336/EEC should therefore be repealed, CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Directive regulates the electromagnetic compatibility of equipment. It aims to ensure the functioning of the internal market by requiring equipment to comply with an adequate level of electromagnetic compatibility. This Directive applies to equipment as defined in Article 2. 2. This Directive shall not apply to: (a) equipment covered by Directive 1999/5/EC; (b) aeronautical products, parts and appliances as referred to in Regulation (EC) No 1592/2002 of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency (7); (c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution and Convention of the ITU (8), unless the equipment is available commercially. Kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment. 3. This Directive shall not apply to equipment the inherent nature of the physical characteristics of which is such that: (a) it is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunication equipment and other equipment to operate as intended; and (b) it will operate without unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon its intended use. 4. Where, for the equipment referred to in paragraph 1, the essential requirements referred to in Annex I are wholly or partly laid down more specifically by other Community directives, this Directive shall not apply, or shall cease to apply, to that equipment in respect of such requirements from the date of implementation of those directives. 5. This Directive shall not affect the application of Community or national legislation regulating the safety of equipment. Article 2 Definitions 1. For the purposes of this Directive, the following definitions shall apply: (a) ‘equipment’ means any apparatus or fixed installation; (b) ‘apparatus’ means any finished appliance or combination thereof made commercially available as a single functional unit, intended for the end user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; (c) ‘fixed installation’ means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location; (d) ‘electromagnetic compatibility’ means the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment; (e) ‘electromagnetic disturbance’ means any electromagnetic phenomenon which may degrade the performance of equipment. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself; (f) ‘immunity’ means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance; (g) ‘safety purposes’ means the purposes of safeguarding human life or property; (h) ‘electromagnetic environment’ means all electromagnetic phenomena observable in a given location. 2. For the purposes of this Directive the following shall be deemed to be an apparatus within the meaning of paragraph 1(b): (a) ‘components’ or ‘sub-assemblies’ intended for incorporation into an apparatus by the end user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; (b) ‘mobile installations’ defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations. Article 3 Placing on the market and/or putting into service Member States shall take all appropriate measures to ensure that equipment is placed on the market and/or put into service only if it complies with the requirements of this Directive when properly installed, maintained and used for its intended purpose. Article 4 Free movement of equipment 1. Member States shall not impede, for reasons relating to electromagnetic compatibility, the placing on the market and/or the putting into service in their territory of equipment which complies with this Directive. 2. The requirements of this Directive shall not prevent the application in any Member State of the following special measures concerning the putting into service or use of equipment: (a) measures to overcome an existing or predicted electromagnetic compatibility problem at a specific site; (b) measures taken for safety reasons to protect public telecommunications networks or receiving or transmitting stations when used for safety purposes in well-defined spectrum situations. Without prejudice to Directive 98/34/EC, Member States shall notify those special measures to the Commission and to the other Member States. The special measures which have been accepted shall be published by the Commission in the Official Journal of the European Union. 3. Member States shall not create any obstacles to the display and/or demonstration at trade fairs, exhibitions or similar events of equipment which does not comply with this Directive, provided that a visible sign clearly indicates that such equipment may not be placed on the market and/or put into service until it has been brought into conformity with this Directive. Demonstration may only take place provided that adequate measures are taken to avoid electromagnetic disturbances. Article 5 Essential requirements The equipment referred to in Article 1 shall meet the essential requirements set out in Annex I. Article 6 Harmonised standards 1. ‘Harmonised standard’ means a technical specification adopted by a recognised European standardisation body under a mandate from the Commission in conformity with the procedures laid down in Directive 98/34/EC for the purpose of establishing a European requirement. Compliance with a ‘harmonised standard’ is not compulsory. 2. The compliance of equipment with the relevant harmonised standards whose references have been published in the Official Journal of the European Union shall raise a presumption, on the part of the Member States, of conformity with the essential requirements referred to in Annex I to which such standards relate. This presumption of conformity is limited to the scope of the harmonised standard(s) applied and the relevant essential requirements covered by such harmonised standard(s). 3. Where a Member State or the Commission considers that a harmonised standard does not entirely satisfy the essential requirements referred to in Annex I, it shall bring the matter before the Standing Committee set up by Directive 98/34/EC (hereinafter ‘the Committee’), stating its reasons. The Committee shall deliver an opinion without delay. 4. Upon receipt of the Committee's opinion, the Commission shall take one of the following decisions with regard to the references to the harmonised standard concerned: (a) not to publish; (b) to publish with restrictions; (c) to maintain the reference in the Official Journal of the European Union; (d) to withdraw the reference from the Official Journal of the European Union. The Commission shall inform the Member States of its decision without delay. CHAPTER II APPARATUS Article 7 Conformity assessment procedure for apparatus Compliance of apparatus with the essential requirements referred to in Annex I shall be demonstrated by means of the procedure described in Annex II (internal production control). However, at the discretion of the manufacturer or of his authorised representative in the Community, the procedure described in Annex III may also be followed. Article 8 ‘CE’ marking 1. Apparatus whose compliance with this Directive has been established by means of the procedure laid down in Article 7 shall bear the ‘CE’ marking which attests to that fact. The affixing of the ‘CE’ marking shall be the responsibility of the manufacturer or his authorised representative in the Community. The ‘CE’ marking shall be affixed in accordance with Annex V. 2. Member States shall take the necessary measures to prohibit the affixing to the apparatus, or to its packaging, or to the instructions for its use, of marks which are likely to mislead third parties in relation to the meaning and/or graphic form of the ‘CE’ marking. 3. Any other mark may be affixed to the apparatus, its packaging, or the instructions for its use, provided that neither the visibility nor the legibility of the ‘CE’ marking is thereby impaired. 4. Without prejudice to Article 10, if a competent authority establishes that the ‘CE’ marking has been unduly affixed, the manufacturer or his authorised representative in the Community shall bring the apparatus into conformity with the provisions concerning the ‘CE’ marking under conditions imposed by the Member State concerned. Article 9 Other marks and information 1. Each apparatus shall be identified in terms of type, batch, serial number or any other information allowing for the identification of the apparatus. 2. Each apparatus shall be accompanied by the name and address of the manufacturer and, if he is not established within the Community, the name and address of his authorised representative or of the person in the Community responsible for placing the apparatus on the Community market. 3. The manufacturer shall provide information on any specific precautions that must be taken when the apparatus is assembled, installed, maintained or used, in order to ensure that, when put into service, the apparatus is in conformity with the protection requirements set out in Annex I, point 1. 4. Apparatus for which compliance with the protection requirements is not ensured in residential areas shall be accompanied by a clear indication of this restriction of use, where appropriate also on the packaging. 5. The information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be contained in the instructions accompanying the apparatus. Article 10 Safeguards 1. Where a Member State ascertains that apparatus bearing the ‘CE’ marking does not comply with the requirements of this Directive, it shall take all appropriate measures to withdraw the apparatus from the market, to prohibit its placing on the market or its putting into service, or to restrict the free movement thereof. 2. The Member State concerned shall immediately inform the Commission and the other Member States of any such measure, indicating the reasons and specifying, in particular, whether non-compliance is due to: (a) failure to satisfy the essential requirements referred to in Annex I, where the apparatus does not comply with the harmonised standards referred to in Article 6; (b) incorrect application of the harmonised standards referred to in Article 6; (c) shortcomings in the harmonised standards referred to in Article 6. 3. The Commission shall consult the parties concerned as soon as possible, following which it shall inform the Member States whether or not it finds the measure to be justified. 4. Where the measure referred to in paragraph 1 is attributed to a shortcoming in harmonised standards, the Commission, after consulting the parties, shall, if the Member State concerned intends to uphold the measure, bring the matter before the Committee and initiate the procedure laid down in Article 6(3) and (4). 5. Where the non-compliant apparatus has been subject to the conformity assessment procedure referred to in Annex III, the Member State concerned shall take appropriate action in respect of the author of the statement referred to in Annex III, point 3, and shall inform the Commission and the other Member States accordingly. Article 11 Decisions to withdraw, prohibit or restrict the free movement of apparatus 1. Any decision taken pursuant to this Directive to withdraw apparatus from the market, prohibit or restrict its placing on the market or its putting into service, or restrict the free movement thereof, shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject. 2. In the event of a decision as referred to in paragraph 1, the manufacturer, his authorised representative, or any other interested party shall have the opportunity to put forward his point of view in advance, unless such consultation is not possible because of the urgency of the measure to be taken as justified in particular with respect to public interest requirements. Article 12 Notified bodies 1. Member States shall notify the Commission of the bodies which they have designated to carry out the tasks referred to in Annex III. When determining the bodies to be designated, Member States shall apply the criteria laid down in Annex VI. Such notification shall state whether the bodies are designated to carry out the tasks referred to in Annex III for all apparatus covered by this Directive, and/or the essential requirements referred to in Annex I or whether the scope of designation is limited to certain specific aspects and/or categories of apparatus. 2. Bodies which comply with the assessment criteria established by the relevant harmonised standards shall be presumed to comply with the criteria set out in Annex VI covered by such harmonised standards. The Commission shall publish in the Official Journal of the European Union the references of those standards. 3. The Commission shall publish in the Official Journal of the European Union a list of notified bodies. The Commission shall ensure that the list is kept up to date. 4. If a Member State finds that a notified body no longer meets the criteria listed in Annex VI, it shall inform the Commission and the other Member States accordingly. The Commission shall withdraw the reference to that body from the list referred to in paragraph 3. CHAPTER III FIXED INSTALLATIONS Article 13 Fixed installations 1. Apparatus which has been placed on the market and which may be incorporated into a fixed installation is subject to all relevant provisions for apparatus set out in this Directive. However, the provisions of Articles 5, 7, 8 and 9 shall not be compulsory in the case of apparatus which is intended for incorporation into a given fixed installation and is otherwise not commercially available. In such cases, the accompanying documentation shall identify the fixed installation and its electromagnetic compatibility characteristics and shall indicate the precautions to be taken for the incorporation of the apparatus into the fixed installation in order not to compromise the conformity of that installation. It shall furthermore include the information referred to in Article 9(1) and (2). 2. Where there are indications of non-compliance of the fixed installation, in particular, where there are complaints about disturbances being generated by the installation, the competent authorities of the Member State concerned may request evidence of compliance of the fixed installation, and, when appropriate, initiate an assessment. Where non-compliance is established, the competent authorities may impose appropriate measures to bring the fixed installation into compliance with the protection requirements set out in Annex I, point 1. 3. Member States shall set out the necessary provisions for identifying the person or persons responsible for the establishment of compliance of a fixed installation with the relevant essential requirements. CHAPTER IV FINAL PROVISIONS Article 14 Repeal Directive 89/336/EEC is hereby repealed as from 20 July 2007. References to Directive 89/336/EEC shall be construed as references to this Directive and should be read in accordance with the correlation table set out in Annex VII. Article 15 Transitional provisions Member States shall not impede the placing on the market and/or the putting into service of equipment which is in compliance with the provisions of Directive 89/336/EEC and which was placed on the market before 20 July 2009. Article 16 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 20 January 2007. They shall forthwith inform the Commission thereof. They shall apply those provisions as from 20 July 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be 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 covered by this Directive. Article 17 Entry into force This Directive shall enter into force on the twentieth day after its publication in the Official Journal of the European Union. Article 18 Addressees This Directive is addressed to the Member States.

32004L0117

2004

COUNCIL DIRECTIVE 2004/117/EC of 22 December 2004 amending Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC as regards examinations carried out under official supervision and equivalence of seed produced in third countries Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the European Economic and Social Committee (2), Whereas: (1) Pursuant to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (3), Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (4), Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (5), Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (6) and Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (7), seed can be officially certified only where the conditions to be satisfied by the seed have been established in official seed testing on samples of seed drawn officially for the purpose of seed testing. (2) Commission Decision 98/320/EC of 27 April 1998 on the organisation of a temporary experiment on seed sampling and seed testing pursuant to Council Directives 66/400/EEC, 66/401/EEC, 66/402/EEC and 69/208/EEC (8), provides for the organisation at Community level of a temporary experiment, with the aim of assessing whether seed sampling and seed testing under official supervision may constitute improved alternatives to the procedures for official seed certification, without a significant decline in the quality of the seed. (3) The results of the experiment have shown that under specified conditions the procedures for official seed certification could be simplified without any significant decline in the quality of the seed compared with that achieved under the system of official seed sampling and seed testing. It is therefore appropriate to provide that those simplified procedures should apply on a long-term basis and should be extended to vegetable crops. (4) Council Directive 98/96/EC (9), amending, inter alia, as regards unofficial field inspections Directives 66/400/EEC, 66/401/EEC, 66/402/EEC and 69/208/EEC lays down rules on certification procedures for field inspections under official supervision. A detailed evaluation of those procedures has shown that the field inspections under official supervision should be extended to all the crops for the production of certified seed. The evaluation has also shown that the proportion of the areas entered for official certification to be checked and inspected by official inspectors should be reduced. (5) It is appropriate to align Directive 2002/54/EC to the other seeds Directives in relation to the possibility to grant derogations to Member States in which the growing of beet and the marketing of beet seed are of minimum economic importance. (6) The scope of the Community seed equivalence in respect of seed harvested in third countries is currently restricted to certain categories of seed. In view in particular of developments at international level, the equivalence regime should be extended to all the various kinds of seed meeting the characteristics, the examination requirements, the marking and sealing conditions laid down in Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC. (7) Decision 98/320/EC expires on 27 April 2005. It is therefore appropriate to keep the Community conditions concerning the marketing of seed produced pursuant to that Decision, pending the application of the new provisions. (8) Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC should therefore be amended accordingly, Article 1 Directive 66/401/EEC is hereby amended as follows: 1. Article 2(1) shall be amended as follows: (a) in (B)(1), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision, to satisfy the conditions set out in (a), (b) and (c).’; (b) in (B)(2), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision, to satisfy the conditions set out in (a), (b) and (c).’; (c) in (C), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (d) in (Ca), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (e) in (Cb), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (f) in (D), point (c) shall be replaced by the following: ‘(c) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a) and (b).’; 2. Article 2(3) shall be replaced by the following: ‘3. When the examination under official supervision set out in paragraphs (1)(B)(1)(d), (1)(B)(2)(d), (1)(C)(d), (1)(Ca)(d), (1)(Cb)(d) and (1)(D)(c) is carried out, the following requirements shall be complied with: A. Field inspection (a) The inspectors shall: (i) have the necessary technical qualifications; (ii) derive no private gain in connection with the carrying out of the inspections; (iii) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations; (iv) carry out inspections under official supervision in accordance with the rules applicable to official inspections. (b) The seed crop to be inspected shall be grown from seed, which has undergone official post-control, the results of which have been satisfactory. (c) A proportion of the seed crops shall be checked by official inspectors. That proportion shall be at least 5 %. (d) A proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. (e) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the licence provided for in (a)(iii) from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. B. Seed testing (a) Seed testing shall be carried out by seed-testing laboratories which have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b) to (d). (b) The seed-testing laboratory shall have a seed analyst-in-charge who has direct responsibility for the technical operations of the laboratory and has the necessary qualifications for technical management of a seed-testing laboratory. Its seed analysts shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed analysts and confirmed by official examinations. The laboratory shall be maintained in premises and with equipment officially considered by the seed certification authority to be satisfactory for the purpose of seed testing, within the scope of the authorisation. It shall carry out seed testing in accordance with current international methods. (c) The seed-testing laboratory shall be: (i) an independent laboratory; or (ii) a laboratory belonging to a seed company. In the case referred to in (ii), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed company to which it belongs, unless it has been otherwise agreed between that seed company, the applicant for certification and the seed certification authority. (d) The seed-testing laboratory’s performance of seed testing shall be subject to appropriate supervision by the seed certification authority. (e) For the purposes of the supervision referred to in (d) a proportion of the seed lots entered for the official certification shall be check-tested by official seed testing. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification, and the species entered, but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. (f) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed-testing laboratories which are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.’; 3. in Article 2(4), the second subparagraph shall be deleted; 4. Article 7 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: ‘1. Member States shall require that, for the checking of varieties, the examination of seed for certification and the examination of commercial seed, samples are drawn officially or under official supervision in accordance with appropriate methods. However seed sampling with a view to controls pursuant to Article 19 shall be carried out officially.’; (b) the following paragraphs shall be inserted: ‘1a. When the seed sampling under official supervision provided for in paragraph 1 is carried out, the following requirements shall be complied with: (a) seed sampling shall be carried out by seed samplers who have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b), (c), and (d); (b) seed samplers shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed samplers and confirmed by official examinations. They shall carry out seed sampling in accordance with current international methods; (c) seed samplers shall be: (i) independent natural persons; (ii) persons employed by natural or legal persons whose activities do not involve seed production, seed growing, seed processing or seed trade; or (iii) persons employed by natural or legal persons whose activities involve seed production, seed growing, seed processing or seed trade. In the case referred to in (iii), a seed sampler may carry out seed sampling only on seed lots produced on behalf of his employer, unless it has been otherwise agreed between his employer, the applicant for certification and the seed certification authority; (d) the performance of the seed samplers shall be subject to proper supervision by the seed certification authority. When automatic sampling is in operation appropriate procedures must be adhered to and officially supervised; (e) for the purposes of the supervision referred to in (d) a proportion of the seed lots entered for official certification shall be check-sampled by official seed samplers. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification, and the species entered, but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. This check sampling does not apply to automatic sampling. The Member States shall compare the seed samples drawn officially with those of the same seed lot drawn under official supervision; (f) the Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed samplers who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed sampled is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. 1b. Further measures applicable to the carrying out of seed sampling under official supervision may be adopted in accordance with the procedure laid down in Article 21(2).’; 5. Article 15(3) shall be replaced by the following: ‘3. The Member States shall also provide that fodder plant seed harvested in a third country shall, on request, be officially certified if: (a) it has been produced directly from: (i) basic seed or certified seed officially certified either in one or more Member States or in a third country which has been granted equivalence under Article 16(1)(b); or (ii) the crossing of basic seed officially certified in a Member State with basic seed officially certified in a third country referred to in (i); (b) it has undergone field inspection satisfying the conditions laid down in an equivalence decision made under Article 16(1)(a) for the relevant category; (c) official examination has shown that the conditions laid down in Annex II for the same category are satisfied.’; 6. in Article 16(1), point b shall be replaced by the following: ‘(b) fodder plant seed harvested in a third country and affording the same assurances as regards its characteristics and the arrangements for its examination, for ensuring identity, for marking and for control is equivalent in these respects to seed harvested within the Community and complying with the provisions of this Directive.’ Article 2 Directive 66/402/EEC is hereby amended as follows: 1. Article 2(1) shall be amended as follows: (a) in (C), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (b) in (Ca), point (c) shall be replaced by the following: ‘(c) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a) and (b).’; (c) in (D)(1), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (d) in (D)(2), point (b) shall be replaced by the following: ‘(b) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a).’; (e) in (D)(3), point (c) shall be replaced by the following: ‘(c) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a) and (b).’; (f) in (E), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (g) in (F), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; (h) in (G), point (d) shall be replaced by the following: ‘(d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c).’; 2. Article 2(3) shall be replaced by the following: ‘3. When the examination under official supervision set out in paragraphs (1)(C)(d), (1)(Ca)(c), (1)(D)(1)(d), (1)(D)(2)(b), (1)(D)(3)(c), (1)(E)(d), (1) (F)(d) and (1)(G)(d) is carried out, the following requirements shall be complied with: A. Field inspection (a) The inspectors shall: (i) have the necessary technical qualifications; (ii) derive no private gain in connection with the carrying out of the inspections; (iii) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations; (iv) carry out inspections under official supervision in accordance with the rules applicable to official inspections. (b) The seed crop to be inspected shall be grown from seed, which has undergone official post-control, the results of which have been satisfactory. (c) A proportion of the seed crops shall be checked by official inspectors. That proportion shall be at least 5 %. (d) A proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. (e) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the licence provided for in (a)(iii), from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. B. Seed testing (a) Seed testing shall be carried out by seed-testing laboratories which have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b) to (d). (b) The seed-testing laboratory shall have a seed analyst-in-charge who has direct responsibility for the technical operations of the laboratory and has the necessary qualifications for technical management of a seed-testing laboratory. Its seed analysts shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed analysts and confirmed by official examinations. The laboratory shall be maintained in premises and with equipment officially considered by the seed certification authority to be satisfactory for the purpose of seed testing, within the scope of the authorisation. It shall carry out seed testing in accordance with current international methods. (c) The seed-testing laboratory shall be: (i) an independent laboratory; or (ii) a laboratory belonging to a seed company. In the case referred to in (ii), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed company to which it belongs, unless it has been otherwise agreed between that seed company, the applicant for certification and the competent seed certification authority. (d) The seed-testing laboratory’s performance of seed testing shall be subject to appropriate supervision by the seed certification authority. (e) For the purposes of the supervision referred to in (d) a proportion of the seed lots entered for the official certification shall be check-tested by official seed testing. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification, and the species entered, but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. (f) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed-testing laboratories which are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.’; 3. in Article 2(4), the second subparagraph shall be deleted; 4. Article 7 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: ‘1. Member States shall require that, for the checking of varieties, and for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods. However, seed sampling with a view to controls pursuant to Article 19 shall be carried out officially.’; (b) the following paragraphs 1a and 1b shall be inserted: ‘1a. When the seed sampling under official supervision provided for in paragraph 1 is carried out, the following requirements shall be complied with: (a) seed sampling shall be carried out by seed samplers who have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b), (c), and (d); (b) seed samplers shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed samplers and confirmed by official examinations. They shall carry out seed sampling in accordance with current international methods; (c) seed samplers shall be: (i) independent natural persons; (ii) persons employed by natural or legal persons whose activities do not involve seed production, seed growing, seed processing or seed trade; or (iii) persons employed by natural or legal persons whose activities involve seed production, seed growing, seed processing or seed trade. In the case referred to in (iii), a seed sampler may carry out seed sampling only on seed lots produced on behalf of his employer, unless it has been otherwise agreed between his employer, the applicant for certification and the seed certification authority; (d) the performance of the seed samplers shall be subject to appropriate supervision by the seed certification authority. When automatic sampling is in operation appropriate procedures must be adhered to and officially supervised; (e) for the purposes of the supervision referred to in (d) a proportion of the seed lots entered for official certification shall be check-sampled by official seed samplers. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification, and the species entered but may also be oriented to eliminate specific doubts. That proportion shall be at least 5%. This check sampling does not apply to automatic sampling. The Member States shall compare the seed samples drawn officially with those of the same seed lot drawn under official supervision; (f) the Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed samplers who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed sampled is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. 1b. Further measures applicable to the carrying out of seed sampling under official supervision may be adopted in accordance with the procedure laid down in Article 21(2).’; 5. Article 15(3) shall be replaced by the following: ‘3. The Member States shall also provide that cereal seed harvested in a third country shall, on request, be officially certified if: (a) it has been produced directly from: (i) basic seed or certified seed of the first generation officially certified either in one or more Member States or in a third country which has been granted equivalence under Article 16(1)(b); or (ii) the crossing of basic seed officially certified in a Member State with basic seed officially certified in a third country referred to in (i); (b) it has undergone field inspection satisfying the conditions laid down in an equivalence decision made under Article 16(1)(a) for the relevant category; (c) official examination has shown that the conditions laid down in Annex II for the same category are satisfied.’; 6. in Article 16(1), point b shall be replaced by the following: ‘(b) cereal seed harvested in a third country and affording the same assurances as regards its characteristics and the arrangements for its examination, for ensuring identity, for marking and for control is equivalent in these respects to seed harvested within the Community and complying with the provisions of this Directive.’ Article 3 Directive 2002/54/EC is hereby amended as follows: 1. Article 2(1) shall be amended as follows: (a) in (c), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or, in the case of the conditions laid down in Annex IB, either by official examination or examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (b) in (d), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ 2. Article 2(3) shall be replaced by the following: ‘3. When the examinations under official supervision referred to in paragraph (1)(c)(iv) and (1)(d)(iv) is carried out, the following requirements shall be complied with: A. Field inspection (a) The inspectors shall: (i) have the necessary technical qualifications; (ii) derive no private gain in connection with the carrying out of the inspections; (iii) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations; (iv) carry out inspections under official supervision in accordance with the rules applicable to official inspections. (b) The seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory. (c) A proportion of the seed crops shall be checked by official inspectors. That proportion shall be at least 5 %. (d) A proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. (e) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the licence provided for in (a)(iii), from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. B. Seed testing (a) Seed testing shall be carried out by seed-testing laboratories which have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b) to (d). (b) The seed-testing laboratory shall have a seed analyst-in-charge who has direct responsibility for the technical operations of the laboratory and has the necessary qualifications for technical management of a seed-testing laboratory. Its seed analysts shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed analysts and confirmed by official examinations. The laboratory shall be maintained in premises and with equipment officially considered by the seed certification authority to be satisfactory for the purpose of seed testing, within the scope of the authorisation. It shall carry out seed testing in accordance with current international methods. (c) The seed-testing laboratory shall be: (i) an independent laboratory; or (ii) a laboratory belonging to a seed company. In the case referred to in (ii), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed company to which it belongs, unless it has been otherwise agreed between that seed-company, the applicant for certification and the seed certification authority. (d) The seed-testing laboratory’s performance of seed testing shall be subject to appropriate supervision by the seed certification authority. (e) For the purposes of the supervision referred to in (d) a proportion of the seed lots entered for the official certification shall be check-tested by official seed testing. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification, and the species entered but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. (f) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed-testing laboratories who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.’; 3. in Article 2(4), the second subparagraph shall be deleted; 4. Article 9 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: ‘1. Member States shall require that, for the checking of varieties, and for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods. However seed sampling with a view to controls pursuant to Article 25 shall be carried out officially.’; (b) the following paragraphs shall be inserted: ‘1a. When the seed sampling under official supervision provided for in paragraph 1 is carried out, the following requirements shall be complied with: (a) seed sampling shall be carried out by seed samplers who have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b), (c), and (d); (b) seed samplers shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed samplers and confirmed by official examinations. They shall carry out seed sampling in accordance with current international methods; (c) seed samplers shall be: (i) independent natural persons; (ii) persons employed by natural or legal persons whose activities do not involve seed production, seed growing, seed processing or seed trade; or (iii) persons employed by natural or legal persons whose activities involve seed production, seed growing, seed processing or seed trade. In the case referred to in (iii), a seed sampler may carry out seed sampling only on seed lots produced on behalf of his employer, unless it has been otherwise agreed between his employer, the applicant for certification and the seed certification authority; (d) the performance of the seed samplers shall be subject to proper supervision by the seed certification authority. When automatic sampling is in operation appropriate procedures must be adhered to and officially supervised; (e) for the purposes of the supervision referred to in (d) a proportion of the seed lots entered for official certification shall be check-sampled by official seed samplers. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. This check sampling does not apply to automatic sampling. The Member States shall compare the seed samples drawn officially with those of the same seed lot drawn under official supervision; (f) the Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed samplers who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed sampled is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. 1b. Further measures applicable to the carrying out of seed sampling under official supervision may be adopted in accordance with the procedure laid down in Article 28(2).’; 5. Article 22(3) shall be replaced by the following: ‘3. The Member States shall also provide that beet seed harvested in a third country shall, on request, be officially certified if: (a) it has been produced directly from basic seed officially certified in one or more Member States or in a third country which has been granted equivalence under Article 23(1)(b); (b) it has undergone field inspection satisfying the conditions laid down in an equivalence decision made under Article 23(1)(a) for the relevant category; (c) official examination has shown that the conditions laid down in Annex I, part B for the same category are satisfied.’; 6. in Article 23(1), point b shall be replaced by the following: ‘(b) beet seed harvested in a third country and affording the same assurances as regards its characteristics and the arrangements for its examination, for ensuring its identity, for marking and for control is equivalent in these respects to seed harvested within the Community and complying with the provisions of this Directive.’; 7. the following Article shall be inserted after Article 30: ‘Article 30A In accordance with the procedure laid down in Article 28(2), a Member State may, if it so requests, be wholly or partially released from the obligation to apply the provisions of this Directive, with the exception of Article 20, in so far the growing of beets and the marketing of beet seed are of minimal economic importance in its territory.’ Article 4 Directive 2002/57/EC is hereby amended as follows: 1. Article 2(1) shall be amended as follows: (a) in (c), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (b) in (d)(1), point (ii) shall be replaced by the following: ‘(ii) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i);’ (c) in (d)(2), point (iii) shall be replaced by the following: ‘(iii) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i) and (ii);’ (d) in (e), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (e) in (f), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (f) in (g), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (g) in (h), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (h) in (i), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (i) in (j), point (iii) shall be replaced by the following: ‘(iii) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i) and (ii);’ 2. Article 2(5) shall be replaced by the following: ‘5. When the examinations under official supervision referred to in paragraphs (1)(c)(iv), (1)(d)(1)(ii), (1)(d)(2)(iii), (1)(e)(iv), (1)(f)(iv), (1)(g)(iv), (1)(h)(iv), (1)(i)(iv) and (1)(j)(iii) are carried out, the following requirements shall be complied with: A. Field inspection (a) The inspectors shall: (i) have the necessary technical qualifications; (ii) derive no private gain in connection with the carrying out of the inspections; (iii) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations; (iv) carry out inspections under official supervision in accordance with the rules applicable to official inspections. (b) The seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory. (c) A proportion of the seed crops shall be checked by official inspectors. That proportion shall be at least 5 %. (d) A proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. (e) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the licence provided for in (a)(iii), from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. B. Seed testing (a) Seed testing shall be carried out by seed-testing laboratories which have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b) to (d). (b) The seed-testing laboratory shall have a seed analyst-in-charge who has direct responsibility for the technical operations of the laboratory and has the necessary qualifications for technical management of a seed-testing laboratory. Its seed analysts shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed analysts and confirmed by official examinations. The laboratory shall be maintained in premises and with equipment officially considered by the seed certification authority to be satisfactory for the purpose of seed testing, within the scope of the authorisation. It shall carry out seed testing in accordance with current international methods. (c) The seed-testing laboratory shall be: (i) an independent laboratory; or (ii) a laboratory belonging to a seed-company. In the case referred to in (ii), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed-company to which it belongs, unless it has been otherwise agreed between that seed-company, the applicant for certification and the seed certification authority. (d) The seed-testing laboratory’s performance of seed testing shall be subject to appropriate supervision by the seed certification authority. (e) For the purposes of the supervision referred to in (d) a proportion of the seed lots entered for the official certification shall be check-tested by official seed testing. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification, and the species entered, but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. (f) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed-testing laboratories which are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.’; 3. in Article 2(6), the second subparagraph shall be deleted; 4. Article 9 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: ‘1. Member States shall require that, for the checking of varieties, the examination of seed for certification and the examination of commercial seed, samples are drawn officially or under official supervision in accordance with appropriate methods. However seed sampling with a view to controls pursuant to Article 22 shall be carried out officially.’; (b) the following paragraphs shall be inserted: ‘1a. When the seed sampling under official supervision provided for in paragraph 1 is carried out, the following requirements shall be complied with: (a) seed sampling shall be carried out by seed samplers who have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b), (c), and (d); (b) seed samplers shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed samplers and confirmed by official examinations. They shall carry out seed sampling in accordance with current international methods; (c) seed samplers shall be: (i) independent natural persons; (ii) persons employed by natural or legal persons whose activities do not involve seed production, seed growing, seed processing or seed trade; or (iii) persons employed by natural or legal persons whose activities involve seed production, seed growing, seed processing or seed trade. In the case referred to in (iii), a seed sampler may carry out seed sampling only on seed lots produced on behalf of his employer, unless it has been otherwise agreed between his employer, the applicant for certification and the seed certification authority; (d) the performance of the seed samplers shall be subject to appropriate supervision by the seed certification authority. When automatic sampling is in operation appropriate procedures must be adhered to and officially supervised; (e) for the purposes of the supervision referred to in (d) a proportion of the seed lots entered for official certification shall be check-sampled by official seed samplers. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification and the species entered but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. This check sampling does not apply to automatic sampling. The Member States shall compare the seed samples drawn officially with those of the same seed lot drawn under official supervision; (f) the Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed samplers who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed sampled is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. 1b. Further measures applicable to the carrying out of seed sampling under official supervision may be adopted in accordance with the procedure laid down in Article 25(2).’; 5. Article 19(3) shall be replaced by the following: ‘3. The Member States shall also provide that seed of oil and fibre plants harvested in a third country shall, on request, be officially certified if: (a) the seed has been produced directly from: (i) basic seed or certified seed of the first generation officially certified either in one or more Member States or in a third country which has been granted equivalence under Article 20(1)(b); or (ii) the crossing of basic seed officially certified in a Member State with basic seed officially certified in a third country referred to in (i); (b) it has undergone field inspection satisfying the conditions laid down in an equivalence decision made under Article 20(1)(a) for the relevant category; (c) official examination has shown that the conditions laid down in Annex II for the same category are satisfied.’; 6. in Article 20(1), point (b) shall be replaced by the following: ‘(b) seed of oil and fibre plants which has been harvested in a third country and affords the same assurances as regards its characteristics and the arrangements for its examination, for ensuring its identity, for marking and for control is equivalent in these respects to seed harvested within the Community and complying with the provisions of this Directive.’ Article 5 Directive 2002/55/EC is hereby amended as follows: 1. Article 2(1) shall be amended as follows: (a) in (c), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ (b) in (d), point (iv) shall be replaced by the following: ‘(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);’ 2. the following paragraph 4 shall be added to Article 2: ‘4. When the examinations under official supervision referred to in paragraph (1)(c)(iv) and (1)(d)(iv) are carried out, the following requirements shall be complied with: A. Field inspection (a) The inspectors shall: (i) have the necessary technical qualifications; (ii) derive no private gain in connection with the carrying out of the inspections; (iii) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations; (iv) carry out inspections under official supervision in accordance with the rules applicable to official inspections. (b) The seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory. (c) A proportion of the seed crops shall be checked by official inspectors. That proportion shall be at least 5 %. (d) A proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. (e) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the licence provided for in (a)(iii), from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. B. Seed testing (a) Seed testing shall be carried out by seed-testing laboratories which have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b) to (d). (b) The seed-testing laboratory shall have a seed analyst-in-charge who has direct responsibility for the technical operations of the laboratory and has the necessary qualifications for technical management of a seed-testing laboratory. Its seed analysts shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed analysts and confirmed by official examinations. The laboratory shall be maintained in premises and with equipment officially considered by the competent seed certification authority to be satisfactory for the purpose of seed testing, within the scope of the authorisation. It shall carry out seed testing in accordance with current international methods. (c) The seed-testing laboratory shall be: (i) an independent laboratory; or (ii) a laboratory belonging to a seed company. In the case referred to in (ii), the laboratory may carry out seed testing only on seed lots produced on behalf of the seed company to which it belongs, unless it has been otherwise agreed between that company, the applicant for certification and the seed certification authority. (d) The seed-testing laboratory’s performance of seed testing shall be subject to appropriate supervision by the seed certification authority. (e) For the purposes of the supervision referred to in (d) a proportion of the seed lots entered for the official certification shall be check-tested by official seed testing. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification and the species entered but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. (f) The Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed-testing laboratories who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed examined is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.’; 3. Article 25 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: ‘1. Member States shall require that, for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods. However seed sampling with a view to controls pursuant to Article 39 shall be carried out officially. These provisions shall also apply where samples of standard seed are drawn for post-control tests.’; (b) the following paragraphs shall be inserted: ‘1a. When the seed sampling under official supervision provided for in paragraph 1 is carried out, the following requirements shall be complied with: (a) seed sampling shall be carried out by seed samplers who have been authorised for that purpose by the seed certification authority of the Member State concerned under the conditions set out in (b), (c), and (d); (b) seed samplers shall have the necessary technical qualifications obtained in training courses organised under conditions applicable to official seed samplers and confirmed by official examinations. They shall carry out seed sampling in accordance with current international methods; (c) seed samplers shall be: (i) independent natural persons; (ii) persons employed by natural or legal persons whose activities do not involve seed production, seed growing, seed processing or seed trade; or (iii) persons employed by natural or legal persons whose activities involve seed production, seed growing, seed processing or seed trade. In the case referred to in (iii), a seed sampler may carry out seed sampling only on seed lots produced on behalf of his employer, unless it has been otherwise agreed between his employer, the applicant for certification and the competent seed certification authority; (d) the performance of the seed samplers shall be subject to proper supervision by the competent seed certification authority. When automatic sampling is in operation appropriate procedures must be adhered to and officially supervised; (e) for the purposes of the supervision referred to in (d) a proportion of the seed lots entered for official certification shall be check-sampled by official seed samplers. That proportion shall in principle be as evenly spread as possible over natural and legal persons entering seed for certification but may also be oriented to eliminate specific doubts. That proportion shall be at least 5 %. This check sampling does not apply to automatic sampling. The Member States shall compare the seed samples drawn officially with those of the same seed lot drawn under official supervision; (f) the Member States shall lay down the rules on penalties applicable to infringements of the national provisions governing examination under official supervision, adopted pursuant to this Directive. The penalties provided for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the authorisation provided for in (a), from officially authorised seed samplers who are found guilty of deliberately or negligently contravening the rules governing official examinations. The Member States shall ensure that any certification of the seed sampled is annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements. 1b. Further measures applicable to the carrying out of seed sampling under official supervision may be adopted in accordance with the procedure laid down in Article 46(2).’ Article 6 In Article 4 of Decision 98/320/EC the date ‘27 April 2005’ shall be replaced by ‘30 September 2005’. Article 7 By 1 October 2010, the Commission shall submit a detailed evaluation of the simplification of the certification procedures introduced by this Directive. This evaluation shall focus in particular on the performance of supervisory systems in terms of possible effects on the quality of seed. Article 8 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 2005. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or 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 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 9 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union. Article 10 This Directive is addressed to the Member States.

32004L0116

2004

COMMISSION DIRECTIVE 2004/116/EC of 23 December 2004 amending the Annex to Council Directive 82/471/EEC as regards the inclusion of Candida guilliermondii (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 82/471/EEC concerning certain products used in animal nutrition (1), and in particular Article 6 thereof, Whereas: (1) An application for authorisation has been submitted for Candida guilliermondii, cultivated on substrates of vegetable origin, which belongs to the product group ‘1.2.1. yeasts cultivated on substrates of animal or vegetable origin’ set out in the Annex to Directive 82/471/EEC. This feed is a microbial product based on the spent cells remaining after the industrial production of citric acid by fermentation. (2) The Scientific Panel on additives and products or substances used in animal feed of the European Food Safety Authority has delivered an opinion on the use of this product in feedingstuffs on 7 of June 2004, which concludes that the use of Candida guilliermondii cultivated on a substrate of vegetable origin (sugar cane molasses) does not present a risk to human health, animal health or the environment. (3) The assessment of the request for authorisation submitted in respect of Candida guilliermondii cultivated on substrates of vegetable origin shows that this product meets the requirements laid down in Article 6(2) of Directive 82/471/EEC, under the conditions set out in the Annex. (4) Directive 82/471/EEC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 82/471/EC is amended as set out 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 by 30 June 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 seventh day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0004

2005

COMMISSION DIRECTIVE 2005/4/EC of 19 January 2005 amending Directive 2001/22/EC laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption (1), and in particular Article 1 thereof, Whereas: (1) Commission Directive 2001/22/EC of 8 March 2001 lays down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs (2). (2) It is necessary to include updated standard information for contaminants in food, in particular to take into account the measurement uncertainty for analysis. (3) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the European Union. (4) Directive 2001/22/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2001/22/EC is amended as set out in Annex I to this Directive. Annex II to Directive 2001/22/EC is amended as set out in Annex II to this Directive Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive within twelve months after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 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 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Directive is addressed to the Member States.

32005L0006

2005

COMMISSION DIRECTIVE 2005/6/EC of 26 January 2005 amending Directive 71/250/EEC as regards reporting and interpretation of analytical results required under Directive 2002/32/EC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to the Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feeding-stuffs (1), and in particular Article 2 thereof, Whereas: (1) Commission Directive 71/250/EEC of 15 June 1971 establishing Community methods of analysis for the official control of feeding-stuffs (2) includes provisions concerning the expression of results. (2) To ensure a harmonised implementation approach to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (3) in all Member States, it is of major importance that analytical results are reported and interpreted in a uniform way. (3) Directive 71/250/EEC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 71/250/EEC is amended as follows: 1. In Article 1 the following paragraph is added after the second paragraph: ‘As regards undesirable substances within the meaning of Directive 2002/32/EC of the European Parliament and of the Council (4) including dioxins and dioxin-like PCBs, point C(3) of Part 1 of the Annex to this Directive shall apply.’ 2. The Annex 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 to comply with this Directive twelve months after the entry into force. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0005

2005

COMMISSION DIRECTIVE 2005/5/EC of 26 January 2005 amending Directive 2002/26/EC as regards sampling methods and methods of analysis for the official control of the levels of ochratoxin A in certain foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption (1), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (2), fixes maximum limits for ochratoxin A in roasted coffee beans, ground roasted coffee, soluble coffee, wine and grape juice. (2) Sampling plays a crucial part in the precision of the determination of the levels of ochratoxin A. Commission Directive 2002/26/EC of 13 March 2002 laying down the sampling methods and methods of analysis for the official control of the levels of ochratoxin A in foodstuffs (3), should include provisions related to roasted coffee beans, ground roasted coffee, soluble coffee, wine and grape juice. (3) Directive 2002/26/EC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/26/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 to comply with this Directive 12 months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.