EUR-Lex - 32003L0033 - EN Avis juridique important | 32003L0033 Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (Text with EEA relevance) Official Journal L 152 , 20/06/2003 P. 0016 - 0019 Directive 2003/33/EC of the European Parliament and of the Councilof 26 May 2003on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), 55 and 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 consulting the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) There are differences between the Member States' laws, regulations and administrative provisions on the advertising of tobacco products and related sponsorship. Such advertising and sponsorship in certain cases crosses the borders of the Member States or involves events organised on an international level, and are activities to which Article 49 of the Treaty applies. The differences in national legislation are likely to give rise to increasing barriers to the free movement between Member States of the products or services that serve as the support for such advertising and sponsorship. In the case of press advertising, certain obstacles have already been encountered. In the case of sponsorship, distortions of the conditions of competition are likely to increase and have already been noted as regards the organisation of certain major sporting and cultural events.(2) Those barriers should be eliminated and, to this end, the rules relating to the advertising of tobacco products and related sponsorship should in specific cases be approximated. In particular, there is a need to specify the extent to which tobacco advertising in certain categories of publications is allowed.(3) Article 95(3) of the Treaty requires the Commission, in its proposals for the establishment and functioning of the Internal Market concerning health, to take as a base a high level of protection. Within their respective powers, the European Parliament and the Council also seek to achieve this objective. The legislation of the Member States to be approximated is intended to protect public health by regulating the promotion of tobacco, an addictive product responsible for over half a million deaths in the Community annually, thereby avoiding a situation where young people begin smoking at an early age as a result of promotion and become addicted.(4) The circulation in the Internal Market of publications such as periodicals, newspapers and magazines is subject to an appreciable risk of obstacles to free movement as a result of Member States' laws, regulations and administrative provisions which prohibit or regulate tobacco advertising in those media. In order to ensure free circulation throughout the Internal Market for all such media, it is necessary to limit tobacco advertising therein to those magazines and periodicals which are not intended for the general public such as publications intended exclusively for professionals in the tobacco trade and to publications printed and published in third countries, that are not principally intended for the Community market.(5) The laws, regulations and administrative provisions of the Member States relating to certain types of sponsorship for the benefit of tobacco products with cross-border effects give rise to an appreciable risk of distortion of the conditions of competition for this activity within the Internal Market. In order to eliminate these distortions, it is necessary to prohibit such sponsorship only for those activities or events with cross-border effects which otherwise may be a means of circumventing the restrictions placed on direct forms of advertising, without regulating sponsorship on a purely national level.(6) Use of information society services is a means of advertising tobacco products which is increasing as public consumption and access to such services increases. Such services, as well as radio broadcasting, which may also be transmitted via information society services, are particularly attractive and accessible to young consumers. Tobacco advertising by both these media has, by its very nature, a cross-border character, and should be regulated at Community level.(7) Free distribution of tobacco products is subject to restriction in several Member States, given its high potential to create addiction. Cases of free distribution have occurred in the context of the sponsorship of events having cross-border effects and should therefore be prohibited.(8) Internationally applicable standards for the advertising of tobacco products and related sponsorship are the subject of negotiations for the drafting of a World Health Organisation Framework Convention on Tobacco Control. These negotiations are intended to create binding international rules complementary to those contained in this Directive.(9) The Commission should draw up a report on the implementation of this Directive. Provision should be made in the relevant Community programmes to monitor the effects of this Directive on public health.(10) Member States should take adequate and effective steps to ensure control of the implementation of measures adopted pursuant to this Directive in compliance with their national legislation, as provided for in Commission Communication to the European Parliament and the Council on the role of penalties in implementing Community Internal Market legislation and in the Council Resolution of 29 June 1995 on the effective uniform application of Community law and on the penalties applicable for breaches of Community law in the Internal Market(4). Such means should include provision for intervention of persons or organisations with legitimate interest in the suppression of activities that are not in conformity with this Directive.(11) The penalties provided for under this Directive should be without prejudice to any other penalty or remedy provided under national law.(12) This Directive regulates the advertising of tobacco products in the media other than television, i.e. in the press and other printed publications, in radio broadcasting and in information society services. It also regulates the sponsorship, by tobacco companies, of radio programmes and of events or activities involving, or taking place in, several Member States or otherwise having cross-border effects, including the free or discounted distribution of tobacco products. Other forms of advertising, such as indirect advertising, as well as the sponsorship of events or activities without cross-border effects, fall outside the scope of this Directive. Subject to the Treaty, Member States retain the competence to regulate these matters as they deem necessary to guarantee the protection of human health.(13) Advertising relating to medicinal products for human use is 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(5). Advertising relating to products intended for use in overcoming addiction to tobacco does not fall within the scope of this Directive.(14) This Directive should be without prejudice to Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities(6), which prohibits all forms of television advertising for cigarettes and other tobacco products. Directive 89/552/EEC provides that television programmes may not be sponsored by undertakings whose principal activity is the manufacture or sale of cigarettes and other tobacco products, or the provision of services, the advertising of which is prohibited by that Directive. Teleshopping for tobacco products is also prohibited by Directive 89/552/EEC.(15) The transnational character of advertising is recognised by Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising(7). Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products(8), contains provisions on the use of misleading descriptions on the labelling of tobacco products, the cross-border effect of which has also been recognised.(16) Directive 98/43/EC of the European Parliament and of the Council of 6 July 1998 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products(9) was annulled by the Court of Justice in Case C-376/98 Federal Republic of Germany v European Parliament and Council of the European Union(10). References to Directive 98/43/EC should therefore be construed as references to this Directive.(17) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of the proper functioning of the Internal Market to lay down rules on the advertising of tobacco products and related sponsorship. 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.(18) 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 respect for the fundamental right of freedom of expression,HAVE ADOPTED THIS DIRECTIVE:Article 1Subject-matter and scope1. The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to the advertising of tobacco products and their promotion:(a) in the press and other printed publications;(b) in radio broadcasting;(c) in information society services; and(d) through tobacco related sponsorship, including the free distribution of tobacco products.2. This Directive is intended to ensure the free movement of the media concerned and of related services and to eliminate obstacles to the operation of the Internal Market.Article 2DefinitionsFor the purposes of this Directive, the following definitions shall apply:(a) "tobacco products" means all products intended to be smoked, sniffed, sucked or chewed inasmuch as they are made, even partly, of tobacco;(b) "advertising" means any form of commercial communications with the aim or direct or indirect effect of promoting a tobacco product;(c) "sponsorship" means any form of public or private contribution to any event, activity or individual with the aim or direct or indirect effect of promoting a tobacco product;(d) "information society services" means services within the meaning of Article 1(2) of 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(11).Article 3Advertising in printed media and information society services1. Advertising in the press and other printed publications shall be limited to publications intended exclusively for professionals in the tobacco trade and to publications which are printed and published in third countries, where those publications are not principally intended for the Community market.Other advertising in the press and other printed publications shall be prohibited.2. Advertising that is not permitted in the press and other printed publications shall not be permitted in information society services.Article 4Radio advertising and sponsorship1. All forms of radio advertising for tobacco products shall be prohibited.2. Radio programmes shall not be sponsored by undertakings whose principal activity is the manufacture or sale of tobacco products.Article 5Sponsorship of events1. Sponsorship of events or activities involving or taking place in several Member States or otherwise having cross-border effects shall be prohibited.2. Any free distribution of tobacco products in the context of the sponsorship of the events referred to in paragraph 1 having the purpose or the direct or indirect effect of promoting such products shall be prohibited.Article 6ReportNo later than 20 June 2008, the Commission shall submit a report to the European Parliament, the Council and the European Economic and Social Committee on the implementation of this Directive. That report shall be accompanied by any proposals for amendments to this Directive which the Commission deems necessary.Article 7Penalties and enforcementMember 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. The Member States shall notify those rules to the Commission by the date specified in Article 10 at the latest and shall notify it without delay of any subsequent amendment affecting them.Those rules shall include provisions ensuring that persons or organisations which, under national legislation, can justify a legitimate interest in the suppression of advertising, sponsorship or other matters incompatible with this Directive, may take legal action against such advertising or sponsorship or bring such advertising or sponsorship to the attention of an administrative body competent either to pronounce on complaints or to institute the appropriate legal proceedings.Article 8Free movement of products and servicesMember States shall not prohibit or restrict the free movement of products or services which comply with this Directive.Article 9References to Directive 98/43/ECReferences to the annulled Directive 98/43/EC shall be construed as references to this Directive.Article 10Implementation1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2005 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 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 main provisions of national law which they adopt in the field covered by this Directive.Article 11Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 12AddresseesThis Directive is addressed to the Member States.Done at Brussels, 26 May 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 270 E, 25.9.2001, p. 97.(2) OJ C 36, 8.2.2002, p. 104.(3) Opinion of the European Parliament of 20 November 2002 (not yet published in the Official Journal) and Decision of the Council of 27 March 2003.(4) OJ C 188, 22.7.1995, p. 1.(5) OJ L 311, 28.11.2001, p. 67.(6) OJ L 298, 17.10.1989, p. 23. Directive as amended by Directive 97/36/EC of the European Parliament and of the Council (OJ L 202, 30.7.1997, p. 60).(7) OJ L 250, 19.9.1984, p. 17. Directive as amended by Directive 97/55/EC of the European Parliament and of the Council (OJ L 290, 23.10.1997, p. 18).(8) OJ L 194, 18.7.2001, p. 26.(9) OJ L 213, 30.7.1998, p. 9.(10) [2000] ECR I-8419.(11) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).

Summary: Tobacco advertising and sponsorship Tobacco advertising and sponsorship SUMMARY OF: Directive 2003/33/EC on advertising and sponsorship of tobacco products WHAT IS THE AIM OF THIS DIRECTIVE? It regulates tobacco* advertising* and promotion in the printed media, on radio, in information society services and through tobacco-related sponsorship. KEY POINTS Press and printed publications: advertising is banned except for publications intended exclusively for the tobacco trade, or those printed and published outside the EU and not intended for an EU audience. Radio: all forms of advertising are banned. Programmes may not be sponsored by companies whose main activity is the manufacture and sale of tobacco. Sponsorship: this is banned for all events and activities involving or taking place in more than one EU country. The ban extends to the free distribution of tobacco products. The legality of the directive was confirmed by the Court of Justice of the European Union in December 2006. In May 2008, the European Commission published a report on the directive’s implementation. Additional rules for audiovisual media services complement the directive by banning advertising and product placement of tobacco products on television and through on-demand services (e.g. services that allow viewers to watch a programme when they choose because it is, for example, available on the broadcaster’s website). In addition to this, a non-binding Council recommendation urges EU governments to take various measures to limit advertising in their countries, including: banning promotional practices such as offering ashtrays, lighters and price discounts, banning local tobacco advertising on billboards, at points of sale and in cinemas, requiring manufacturers, importers and large-scale traders to provide information on their spending on advertising, marketing, sponsorship and promotion campaigns not banned by EU legislation. Directive 2014/40/EU extended the EU rules on tobacco advertising and promotion to electronic cigarettes. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 20 June 2003. EU countries had to incorporate it into national law by 3 July 2005. * KEY TERMS Tobacco products: all products, even partly containing tobacco, intended to be smoked, sniffed, sucked or chewed. Advertising: any form of commercial communication that aims, directly or indirectly, to promote tobacco products. MAIN DOCUMENT Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (OJ L 152, 20.6.2003, pp. 16-19) Successive amendments and corrections to Directive 2003/33/EC have been incorporated in to the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, pp. 1-24) Consolidated version Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, pp. 1-38) Consolidated version Council Recommendation 2003/54/EC of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control (OJ L 22, 25.1.2003, pp. 31-34) last update 25.07.2016


EUR-Lex - 32002L0098 - EN Avis juridique important | 32002L0098 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 Official Journal L 033 , 08/02/2003 P. 0030 - 0040 Directive 2002/98/EC of the European Parliament and of the Councilof 27 January 2003setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/ECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,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 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 4 November 2002,Whereas:(1) The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order to prevent in particular the transmission of diseases.(2) The availability of blood and blood components used for therapeutic purposes is dependent largely on Community citizens who are prepared to donate. In order to safeguard public health and to prevent the transmission of infectious diseases, all precautionary measures during their collection, processing, distribution and use need to be taken making appropriate use of scientific progress in the detection and inactivation and elimination of transfusion transmissible pathogenic agents.(3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through 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(5). The specific exclusion of whole blood, plasma and blood cells of human origin from that Directive, however, has led to a situation whereby their quality and safety, in so far as they are intended for transfusion and not processed as such, are not subject to any binding Community legislation. It is essential, therefore, that whatever the intended purpose, Community provisions should ensure that blood and its components are of comparable quality and safety throughout the blood transfusion chain in all Member States, bearing in mind the freedom of movement of citizens within Community territory. The establishment of high standards of quality and safety, therefore, will help to reassure the public that human blood and blood components which are derived from donations in another Member State nonetheless meet the same requirements as those in their own country.(4) In respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, Directive 2001/83/EC refers to measures to be taken by Member States to prevent the transmission of infectious diseases, comprising the application of the monographs of the European Pharmacopoeia and the recommendations of the Council of Europe and the World Health Organisation (WHO) as regards in particular the selection and testing of blood and plasma donors. Furthermore, Member States should take measures to promote Community self-sufficiency in human blood or blood components and to encourage voluntary unpaid donations of blood and blood components.(5) In order to ensure that there is an equivalent level of safety and quality of blood components, whatever their intended purpose, technical requirements for the collection and testing of all blood and blood components including starting materials for medicinal products should be established by this Directive. Directive 2001/83/EC should be amended accordingly.(6) The Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community identified the need for a blood strategy in order to reinforce confidence in the safety of the blood transfusion chain and promote Community self-sufficiency.(7) In its Resolution of 2 June 1995, on blood safety and self-sufficiency in the Community(6), the Council invited the Commission to submit appropriate proposals in the framework of the development of a blood strategy.(8) In its Resolution of 12 November 1996 on a strategy towards blood safety and self-sufficiency in the European Community(7), the Council invited the Commission to submit proposals as a matter of urgency with a view to encouraging the development of a coordinated approach to the safety of blood and blood products.(9) In its Resolutions of 14 September 1993(8), 18 November 1993(9), 14 July 1995(10), and 17 April 1996(11) on blood safety and self-sufficiency through voluntary unpaid donations in the European Community, the European Parliament stressed the importance of ensuring the highest level of blood safety and has reiterated its continued support for the objective of Community self-sufficiency.(10) In elaborating the provisions of this Directive account has been taken of the opinion of the Scientific Committee for Medicinal Products and Medical Devices as well as international experience in this field.(11) The nature of autologous transfusion necessitates a specific consideration in respect of how and when to apply the different provisions of this Directive.(12) Hospital blood banks are hospital units which perform a limited number of activities, storage, distribution, and compatibility tests. In order to ensure that the quality and safety of blood and blood components are preserved during the whole transfusion chain, while taking account of the specific nature and functions of hospital blood banks, only provisions relevant to these activities should apply to hospital blood banks.(13) Member States should ensure that an appropriate mechanism for designating, authorising, accrediting or licensing exists to ensure that the activities of blood establishments are performed in accordance with the requirements of this Directive.(14) Member States should organise inspection and control measures, to be carried out by officials representing the competent authority, to ensure the compliance of the blood establishment with the provisions of this Directive.(15) Personnel directly involved in the collection, testing, processing, storage and distribution of blood and blood components need to be appropriately qualified and provided with timely and relevant training, without prejudice to existing Community legislation on the recognition of professional qualifications and on the protection of workers.(16) Blood establishments should establish and maintain quality systems involving all activities that determine the quality policy objectives and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system.(17) An adequate system to ensure traceability of whole blood and blood components should be established. Traceability should be enforced through accurate donor, patient, and laboratory identification procedures, through record maintenance, and through an appropriate identification and labelling system. It is desirable that a system is developed in order to enable the unique and unmistakable identification of donations of blood and blood components in the Community. In the case of blood and blood components imported from third countries, it is important that an equivalent level of traceability be ensured by the blood establishments in the stages preceding importation into the Community. The same requirements of traceability which apply to blood and blood components collected in the Community should be ensured in the stages following importation.(18) It is important to introduce a set of organised surveillance procedures to collect and evaluate information on the adverse or unexpected events or reactions resulting from the collection of blood or blood components in order to prevent similar or equivalent events or reactions from occurring thereby improving the security of transfusion by adequate measures. To this end a common system of notification of serious adverse events and reactions linked to the collection, processing, testing, storage, and distribution of blood and blood components should be established in Member States.(19) It is important that when abnormal findings are reported to the donor, relevant counselling is also provided.(20) Modern blood-transfusion practice has been founded on the principles of voluntary donor services, anonymity of both donor and recipient, benevolence of the donor, and absence of profit on the part of the establishments involved in blood transfusion services.(21) All necessary measures need to be taken in order to provide prospective donors of blood or blood components with assurances regarding the confidentiality of any health-related information provided to the authorised personnel, the results of the tests on their donations as well as any future traceability of their donation.(22) According to Article 152(5) of the Treaty, the provisions of this Directive cannot affect national provisions on the donations of blood. Article 152(4)(a) of the Treaty states that Member States cannot be prevented from maintaining or introducing more stringent protective measures as regards standards of quality and safety of blood and blood components.(23) Voluntary and unpaid blood donations are a factor which can contribute to high safety standards for blood and blood components and therefore to the protection of human health. The efforts of the Council of Europe in this area should be supported and all necessary measures should be taken to encourage voluntary and unpaid donations through appropriate measures and initiatives and through ensuring that donors gain greater public recognition, thereby also increasing self-sufficiency. The definition of voluntary and unpaid donation of the Council of Europe should be taken into account.(24) Blood and blood components used for therapeutic purposes or for use in medical devices should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation and that any risk of transmission of infectious diseases is minimised; each and every blood donation should be tested in accordance with rules which provide assurances that all necessary measures have been taken to safeguard the health of individuals who are the recipients of blood and blood components.(25) Directive 95/46/EC of the European Parliament and 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(12) requires that data related to the health of an individual be subject to reinforced protection. However, it covers only personal data and not that rendered anonymous. This Directive should therefore introduce additional safeguards to prevent any unauthorised changes to donation registries, or processing records, or the unauthorised disclosure of information.(26) The Commission should be empowered to establish technical requirements and adopt any necessary changes thereto and to the Annexes in order to take into account scientific and technical progress.(27) Setting of technical requirements and adaptation to progress should take into account the Council recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the EC(13), relevant recommendations of the Council of Europe and the WHO as well as indications of relevant European institutions and organisations such as the monographs of the European Pharmacopoeia.(28) It is necessary that the best possible scientific advice is available to the Community in relation to the safety of blood and blood components, in particular as regards adapting the provisions of this Directive to scientific and technical progress.(29) Tests should be carried out in conformity with the latest scientific and technical procedures that reflect current best practice as defined by, and regularly reviewed and updated through, an appropriate expert consultation process. This review process should also take due account of scientific advances in the detection, inactivation and elimination of pathogens which can be transmitted via transfusion.(30) 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(14).(31) In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalties to be applied by Member States.(32) Since the objectives of this Directive, namely to contribute to general confidence both in the quality of donated blood and blood components and in the health protection of donors, to attain self-sufficiency at a Community level and to enhance confidence in the safety of the transfusion chain among the Member States, cannot be sufficiently achieved by the 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 those objectives.(33) Responsibility for the organisation of health services and the provision of medical care should remain the responsibility of each Member State,HAVE ADOPTED THIS DIRECTIVE:CHAPTER IGENERAL PROVISIONSArticle 1ObjectivesThis Directive lays down standards of quality and safety of human blood and of blood components, in order to ensure a high level of human health protection.Article 2Scope1. This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.2. Where blood and blood components are collected and tested for the sole purpose and exclusive use in autologous transfusion and are clearly identified as such, the requirements to be complied with in respect thereof shall be in accordance with those referred to in Article 29(g).3. This Directive shall apply without prejudice to Directives 93/42/EEC(15), 95/46/EC or 98/79/EC(16).4. This Directive does not apply to blood stem cells.Article 3DefinitionsFor the purposes of this Directive:(a) "blood" shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing;(b) "blood component" shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods;(c) "blood product" shall mean any therapeutic product derived from human blood or plasma;(d) "autologous transfusion" shall mean transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used;(e) "blood establishment" shall mean any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks;(f) "hospital blood bank" shall mean a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities;(g) "serious adverse event" shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;(h) "serious adverse reaction" shall mean an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;(i) "blood component release" shall mean a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification;(j) "deferral" shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary;(k) "distribution" shall mean the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.(l) "haemovigilance" shall mean a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors;(m) "inspection" shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.Article 4Implementation1. 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 in its territory more stringent protective measures which comply with the provisions of the Treaty.In particular, a Member State may introduce requirements for voluntary and unpaid donations, which include the prohibition or restriction of imports of blood and blood components, to ensure a high level of health protection and to achieve the objective set out in Article 20(1), provided that the conditions of the Treaty are met.3. 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 IIOBLIGATIONS ON MEMBER STATES AUTHORITIESArticle 5Designation, authorisation, accreditation or licensing of blood establishments1. Member States shall ensure that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose.2. For the purpose of paragraph 1, the blood establishment shall submit the information listed in Annex I to the competent authority.3. The competent authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply.4. No substantial change in activities shall be undertaken by the blood establishment without prior written approval by the competent authority.5. The competent authority may suspend or revoke the designation, authorisation, accreditation or licence of a blood establishment if inspection or control measures demonstrate that the blood establishment does not comply with the requirements of this Directive.Article 6Hospital blood banksArticles 7, 10, 11(1), 12(1), 14, 15, 22 and 24 shall apply to hospital blood banks.Article 7Provisions for existing establishmentsMember States may decide to maintain national provisions for nine months after the date laid down in Article 32 so as to enable blood establishments operating under their legislation to comply with the requirements of this Directive.Article 8Inspection and control measures1. Member States shall ensure that the competent authority organise inspections and appropriate control measures in blood establishments to ensure that the requirements of this Directive are complied with.2. Inspection and control measures shall be organised by the competent authority on a regular basis. The interval between two inspections and control measures shall not exceed two years.3. Such inspection and control measures shall be carried out by officials representing the competent authority who must be empowered to:(a) inspect blood establishments as well as facilities of any third parties on its own territory entrusted by the holder of the designation, authorisation, accreditation or licence referred to in Article 5 with the task of carrying out evaluation and testing procedures pursuant to Article 18;(b) take samples for examination and analysis;(c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of the entry into force of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation.4. The competent authority shall organise inspection and other control measures as appropriate in the event of any serious adverse event or reaction or suspicion thereof in accordance with Article 15.CHAPTER IIIPROVISIONS FOR BLOOD ESTABLISHMENTSArticle 9Responsible person1. Blood establishments shall designate a person (responsible person), responsible for:- ensuring that every unit of blood or blood components has been collected and tested, whatever its intended purpose, and processed, stored, and distributed, when intended for transfusion, in compliance with the laws in force in the Member State,- providing information to the competent authority in the designation, authorisation, accreditation or licensing procedures as required in Article 5,- the implementation of the requirements of Articles 10, 11, 12, 13, 14 and 15 in the blood establishment.2. The responsible person shall fulfil the following minimum conditions of qualification:(a) he/she shall possess 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) he/she shall have practical post-graduate experience in relevant areas for at least two years, in one or more establishments which are authorised to undertake activities related to collection and/or testing of human blood and blood components, or to their preparation, storage, and distribution.3. The tasks specified in paragraph 1 may be delegated to other persons who shall be qualified by training and experience to perform such tasks.4. Blood establishments shall notify the competent authority of the name of the responsible person referred to in paragraph 1 and other persons referred to in paragraph 3 together with information on the specific tasks for which they are responsible.5. Where the responsible person or such other persons referred to in paragraph 3 are permanently or temporarily replaced, the blood establishment shall provide immediately the name of the new responsible person and his or her date of commencement to the competent authority.Article 10PersonnelPersonnel directly involved in collection, testing, processing, storage, and distribution of human blood and blood components shall be qualified to perform those tasks and be provided with timely, relevant and regularly updated training.CHAPTER IVQUALITY MANAGEMENTArticle 11Quality system for blood establishments1. Member States shall take all necessary measures to ensure that each blood establishment establishes and maintains a quality system for blood establishments based on the principles of good practice.2. The Commission shall establish the Community standards and specifications referred to in Article 29(h) for the activities relating to a quality system to be carried out by a blood establishment.Article 12Documentation1. Member States shall take all necessary measures in order to ensure that blood establishments maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms.2. Member States shall take all necessary measures in order to ensure that access is provided to these documents for officials entrusted with inspection and control measures referred to in Article 8.Article 13Record keeping1. Member States shall take all necessary measures to ensure that blood establishments maintain records of the information required in Annexes II and IV and under Article 29(b), (c) and (d). The records shall be kept for a minimum of 15 years.2. The competent authority shall keep records of the data received from the blood establishments according to Articles 5, 7, 8, 9 and 15.CHAPTER VHAEMOVIGILANCEArticle 14Traceability1. Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored, released and/or distributed on their territory can be traced from donor to recipient and vice versa.To this end, Member States shall ensure that blood establishments implement a system for identification of each single blood donation and each single blood unit and components thereof enabling full traceability to the donor as well as to the transfusion and the recipient thereof. The system must unmistakably identify each unique donation and type of blood component. This system shall be established in accordance with the requirements referred to in Article 29(a).With regard to blood and blood components imported from third countries, Member States shall ensure that the donor identification system to be implemented by blood establishments permits an equivalent level of traceability.2. Member States shall take all necessary measures in order to ensure that the system used for the labelling of blood and blood components collected, tested, processed, stored, released and/or distributed on their territory complies with the identification system referred to in paragraph 1 and the labelling requirements listed in Annex III.3. Data needed for full traceability in accordance with this Article shall be kept for at least 30 years.Article 15Notification of serious adverse events and reactions1. Member States shall ensure that:- any serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components are notified to the competent authority,- blood establishments have in place a procedure accurately, efficiently and verifiably to withdraw from distribution blood or blood components associated with the notification referred to above.2. These serious adverse events and reactions shall be notified in accordance with the procedure and notification format referred to in Article 29(i).CHAPTER VIPROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTSArticle 16Provision of information to prospective donorsMember States shall ensure that all prospective donors of blood or blood components in the Community are provided with information referred to in Article 29(b).Article 17Information required from donorsMember States shall take all necessary measures to ensure that, upon agreement of a willingness to commence the donation of blood or blood components, all donors in the Community provide the information referred to in Article 29(c) to the blood establishment.Article 18Eligibility of donors1. Blood establishments shall ensure that there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation referred to in Article 29(d) are met.2. The results of the donor evaluation and testing procedures shall be documented and any relevant abnormal findings shall be reported to the donor.Article 19Examination of donorsAn examination of the donor, including an interview, shall be carried out before any donation of blood or blood components. A qualified health professional shall be responsible, in particular, for giving to and gathering from donors the information which is necessary to assess their eligibility to donate and shall, on the basis thereof, assess the eligibility of donors.Article 20Voluntary and unpaid blood donation1. Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations.2. Member States shall submit reports to the Commission on these measures two years after the entry into force of this Directive, 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 measure it intends to take at Community level.Article 21Testing of donationsBlood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV.Member States shall ensure that blood and blood components imported into the Community are tested in conformity with requirements listed in Annex IV.Article 22Storage, transport and distribution conditionsBlood establishments shall ensure that the storage, transport and distribution conditions of blood and blood components comply with the requirements referred to in Article 29(e).Article 23Quality and safety requirements for blood and blood componentsBlood establishments shall ensure that quality and safety requirements for blood and blood components meet the high standards in compliance with the requirements referred to in Article 29(f).CHAPTER VIIDATA PROTECTIONArticle 24Data protection and confidentialityMember States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive to which third parties have access have been rendered anonymous so that the donor is no longer identifiable.For that purpose, they shall ensure:(a) that data security measures are in place as well as safeguards against unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information;(b) that procedures are in place to resolve data discrepancies;(c) that no unauthorised disclosure of such information occurs, whilst guaranteeing the traceability of donations.CHAPTER VIIIEXCHANGE OF INFORMATION, REPORTS AND PENALTIESArticle 25Information exchangeThe Commission shall hold regular meetings with the competent authorities designated by the Member States, delegations of experts from blood establishments and other relevant parties to exchange information on the experience acquired with regard to the implementation of this Directive.Article 26Reports1. Member States shall send to the Commission, commencing on 31 December 2003 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 Economic and Social Committee and the Committee of the Regions, the reports submitted by the Member States on the experience gained in implementing this Directive.3. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, commencing on 1 July 2004 and every three years thereafter, a report on the implementation of the requirements in this Directive, and in particular those relating to inspection and control.Article 27PenaltiesMember 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 the date specified in Article 32 at the latest and shall notify it without delay of any subsequent amendments affecting them.CHAPTER IXCOMMITTEESArticle 28Regulatory procedure1. 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 29Technical requirements and their adaptation to technical and scientific progressThe adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2).The following technical requirements and their adaptation to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2):(a) traceability requirements;(b) information to be provided to donors;(c) information to be obtained from donors including the identification, health history, and the signature of the donor;(d) requirements concerning the suitability of blood and plasma donors and the screening of donated blood including- permanent deferral criteria and possible exemption thereto- temporary deferral criteria;(e) storage, transport and distribution requirements;(f) quality and safety requirements for blood and blood components;(g) requirements applicable to autologous transfusions;(h) Community standards and specifications relating to a quality system for blood establishments;(i) Community procedure for notifying serious adverse reactions and events and notification format.Article 30Consultation of scientific committee(s)The Commission may consult the relevant scientific committee(s) when establishing the technical requirements referred to in Article 29 and when adapting the technical requirements set out in Annexes I to IV to scientific and technical progress, in particular with a view to ensuring an equivalent level of quality and safety of blood and blood components used for transfusion and blood and blood components used as a starting material for the manufacture of medicinal products.CHAPTER XFINAL PROVISIONSArticle 31Amendment of Directive 2001/83/ECArticle 109 of Directive 2001/83/EC shall be replaced by the following:"Article 109For the collection and testing of human blood and human plasma, 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(17) shall apply."Article 32Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 8 February 2005. 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. 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 that they have already adopted or which they adopt in the field governed by this Directive.Article 33Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 34AddresseesThis Directive is addressed to the Member States.Done at Brussels, 27 January 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 154 E, 29.5.2001, p. 141 andOJ C 75 E, 26.3.2002, p. 104.(2) OJ C 221, 7.8.2001, p. 106.(3) OJ C 19, 22.1.2002, p. 6.(4) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 289), Council Common Position of 14 February 2002 (OJ C 113 E, 14.5.2002, p. 93) and Decision of the European Parliament of 12 June 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.(5) OJ L 311, 28.11.2001, p. 67.(6) OJ C 164, 30.6.1995, p. 1.(7) OJ C 374, 11.12.1996, p. 1.(8) OJ C 268, 4.10.1993, p. 29.(9) OJ C 329, 6.12.1993, p. 268.(10) OJ C 249, 25.9.1995, p. 231.(11) OJ C 141, 13.5.1996, p. 131.(12) OJ L 281, 23.11.1995, p. 31.(13) OJ L 203, 21.7.1998, p. 14.(14) OJ L 184, 17.7.1999, p. 23.(15) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by Directive 2001/104/EC of the European Parliament and of the Council (OJ L 6, 10.1.2002, p. 50).(16) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).(17) OJ L 33, 8.2.2003, p. 30.ANNEX IINFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)Part A: General information:- identification of the blood establishment- name, qualification and contact details of responsible persons- a list of hospital blood banks which it supplies.Part B: A description of the quality system, to include:- documentation, such as an organisation chart, including responsibilities of responsible persons and reporting relationships- documentation such as site master file or quality manual describing the quality system in accordance with Article 11(1)- number and qualifications of personnel- hygiene provisions- premises and equipment- list of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall of blood and blood components and for the reporting and recording of serious adverse reactions and events.ANNEX IIREPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITYThis annual report will include:- total number of donors who give blood and blood components- total number of donations- an updated list of the hospital blood banks which it supplies- total number of whole donations not used- number of each component produced and distributed- incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components- number of product recalls- number of serious adverse events and reactions reported.ANNEX IIILABELLING REQUIREMENTSThe label on the component must contain the following information:- the official name of the component- the volume or weight or number of cells in the component (as appropriate)- the unique numeric or alphanumeric donation identification- the name of producing blood establishment- the ABO Group (not required for plasma intended only for fractionation)- the Rh D Group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation)- the date or time of expiry (as appropriate)- the temperature of storage- the name, composition and volume of anticoagulant and/or additive solution (if any).ANNEX IVBASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONSThe following tests must be performed for whole blood and apheresis donations, including autologous predeposit donations:- ABO Group (not required for plasma intended only for fractionation)- Rh D Group (not required for plasma intended only for fractionation)- testing for the following infections in the donors:- Hepatitis B (HBs-Ag)- Hepatitis C (Anti-HCV)- HIV 1/2 (Anti-HIV 1/2)Additional tests may be required for specific components or donors or epidemiological situations.

Summary: Human blood and blood components - maintaining standards Human blood and blood components - maintaining standards SUMMARY OF: Directive 2002/98/EC – quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components SUMMARY Donations of human blood and plasma provide the basis for a wide range of essential, often life-saving, therapies. Blood and its components are also used for routine surgery to prolong a patient's life. Their quality and safety must be guaranteed to prevent any transmission of infection or disease. WHAT DOES THE DIRECTIVE DO? — It lays down quality and safety standards for human blood and its components to ensure a high level of health protection. — It covers blood collection and testing and its processing, storage and distribution when used in transfusions. KEY POINTS EU countries must ensure that: — blood is collected and tested only by designated, authorised, accredited or licensed establishments with suitably qualified personnel. — the establishments have quality systems in place, maintain the necessary documentation on operational procedures and guidelines and are inspected at least once every 2 years. — blood and blood components can be traced from donor to recipient and vice- versa and the data are kept for at least 30 years. — any serious adverse events arising from accidents or errors are notified to the competent authority. — prospective blood donors are given suitable information, such as details of the procedure involved and the opportunity to change their mind, and must provide personal data, such as their health history. — the necessary measures are taken to encourage voluntary and unpaid blood donations. — the data collected, including genetic information, are rendered anonymous so the donor cannot be identified. — a blood donation report is sent to the Commission every 3 years. Lastly, blood establishments must evaluate all blood donors, test each donation (to check if a donor has hepatitis B or C, for instance) and ensure proper storage, transport and distribution of the donated blood. WHEN DOES THE DIRECTIVE APPLY? It entered into force on 8 February 2003. EU countries had to incorporate it in their national law by 8 February 2005. BACKGROUND Blood, tissues and organs on the European Commission's website. ACT 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 (OJ L 33, 8.2.2003, pp. 30–40) RELATED ACTS 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 (OJ L 91, 30.3.2004, pp. 25–39). Successive amendments to Directive 2004/33/EC have been incorporated into the original text. This consolidated version is of documentary value only. Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (OJ L 256, 1.10.2005, pp. 32–40) Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256, 1.10.2005, pp. 41–48) last update 24.11.2015


EUR-Lex - 32003L0004 - EN Avis juridique important | 32003L0004 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC Official Journal L 041 , 14/02/2003 P. 0026 - 0032 Directive 2003/4/EC of the European Parliament and of the Councilof 28 January 2003on public access to environmental information and repealing Council Directive 90/313/EECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,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) in the light of the joint text approved by the Conciliation Committee on 8 November 2002,Whereas:(1) Increased public access to environmental information and the dissemination of such information contribute to a greater awareness of environmental matters, a free exchange of views, more effective participation by the public in environmental decision-making and, eventually, to a better environment.(2) Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(5) initiated a process of change in the manner in which public authorities approach the issue of openness and transparency, establishing measures for the exercise of the right of public access to environmental information which should be developed and continued. This Directive expands the existing access granted under Directive 90/313/EEC.(3) Article 8 of that Directive requires Member States to report to the Commission on the experience gained, in the light of which the Commission is required to make a report to the European Parliament and to the Council together with any proposal for revision of the Directive which it may consider appropriate.(4) The report produced under Article 8 of that Directive identifies concrete problems encountered in the practical application of the Directive.(5) On 25 June 1998 the European Community signed the UN/ECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters ("the Aarhus Convention"). Provisions of Community law must be consistent with that Convention with a view to its conclusion by the European Community.(6) It is appropriate in the interest of increased transparency to replace Directive 90/313/EEC rather than to amend it, so as to provide interested parties with a single, clear and coherent legislative text.(7) Disparities between the laws in force in the Member States concerning access to environmental information held by public authorities can create inequality within the Community as regards access to such information or as regards conditions of competition.(8) It is necessary to ensure that any natural and legal person has a right of access to environmental information held by or for public authorities without his having to state an interest.(9) It is also necessary that public authorities make available and disseminate environmental information to the general public to the widest extent possible, in particular by using information and communication technologies. The future development of these technologies should be taken into account in the reporting on, and reviewing of, this Directive.(10) The definition of environmental information should be clarified so as to encompass information in any form on the state of the environment, on factors, measures or activities affecting or likely to affect the environment or designed to protect it, on cost-benefit and economic analyses used within the framework of such measures or activities and also information on the state of human health and safety, including the contamination of the food chain, conditions of human life, cultural sites and built structures in as much as they are, or may be, affected by any of those matters.(11) To take account of the principle in Article 6 of the Treaty, that environmental protection requirements should be integrated into the definition and implementation of Community policies and activities, the definition of public authorities should be expanded so as to encompass government or other public administration at national, regional or local level whether or not they have specific responsibilities for the environment. The definition should likewise be expanded to include other persons or bodies performing public administrative functions in relation to the environment under national law, as well as other persons or bodies acting under their control and having public responsibilities or functions in relation to the environment.(12) Environmental information which is physically held by other bodies on behalf of public authorities should also fall within the scope of this Directive.(13) Environmental information should be made available to applicants as soon as possible and within a reasonable time and having regard to any timescale specified by the applicant.(14) Public authorities should make environmental information available in the form or format requested by an applicant unless it is already publicly available in another form or format or it is reasonable to make it available in another form or format. In addition, public authorities should be required to make all reasonable efforts to maintain the environmental information held by or for them in forms or formats that are readily reproducible and accessible by electronic means.(15) Member States should determine the practical arrangements under which such information is effectively made available. These arrangements shall guarantee that the information is effectively and easily accessible and progressively becomes available to the public through public telecommunications networks, including publicly accessible lists of public authorities and registers or lists of environmental information held by or for public authorities.(16) The right to information means that the disclosure of information should be the general rule and that public authorities should be permitted to refuse a request for environmental information in specific and clearly defined cases. Grounds for refusal should be interpreted in a restrictive way, whereby the public interest served by disclosure should be weighed against the interest served by the refusal. The reasons for a refusal should be provided to the applicant within the time limit laid down in this Directive.(17) Public authorities should make environmental information available in part where it is possible to separate out any information falling within the scope of the exceptions from the rest of the information requested.(18) Public authorities should be able to make a charge for supplying environmental information but such a charge should be reasonable. This implies that, as a general rule, charges may not exceed actual costs of producing the material in question. Instances where advance payment will be required should be limited. In particular cases, where public authorities make available environmental information on a commercial basis, and where this is necessary in order to guarantee the continuation of collecting and publishing such information, a market-based charge is considered to be reasonable; an advance payment may be required. A schedule of charges should be published and made available to applicants together with information on the circumstances in which a charge may be levied or waived.(19) Applicants should be able to seek an administrative or judicial review of the acts or omissions of a public authority in relation to a request.(20) Public authorities should seek to guarantee that when environmental information is compiled by them or on their behalf, the information is comprehensible, accurate and comparable. As this is an important factor in assessing the quality of the information supplied the method used in compiling the information should also be disclosed upon request.(21) In order to increase public awareness in environmental matters and to improve environmental protection, public authorities should, as appropriate, make available and disseminate information on the environment which is relevant to their functions, in particular by means of computer telecommunication and/or electronic technology, where available.(22) This Directive should be evaluated every four years, after its entry into force, in the light of experience and after submission of the relevant reports by the Member States, and be subject to revision on that basis. The Commission should submit an evaluation report to the European Parliament and the Council.(23) Since the objectives of the proposed Directive cannot be sufficiently achieved by the Member States 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 those objectives.(24) The provisions of this Directive shall not affect the right of a Member State to maintain or introduce measures providing for broader access to information than required by this Directive,HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe objectives of this Directive are:(a) to guarantee the right of access to environmental information held by or for public authorities and to set out the basic terms and conditions of, and practical arrangements for, its exercise; and(b) to ensure that, as a matter of course, environmental information is progressively made available and disseminated to the public in order to achieve the widest possible systematic availability and dissemination to the public of environmental information. To this end the use, in particular, of computer telecommunication and/or electronic technology, where available, shall be promoted.Article 2DefinitionsFor the purposes of this Directive:1. "Environmental information" shall mean any information in written, visual, aural, electronic or any other material form on:(a) the state of the elements of the environment, such as air and atmosphere, water, soil, land, landscape and natural sites including wetlands, coastal and marine areas, biological diversity and its components, including genetically modified organisms, and the interaction among these elements;(b) factors, such as substances, energy, noise, radiation or waste, including radioactive waste, emissions, discharges and other releases into the environment, affecting or likely to affect the elements of the environment referred to in (a);(c) measures (including administrative measures), such as policies, legislation, plans, programmes, environmental agreements, and activities affecting or likely to affect the elements and factors referred to in (a) and (b) as well as measures or activities designed to protect those elements;(d) reports on the implementation of environmental legislation;(e) cost-benefit and other economic analyses and assumptions used within the framework of the measures and activities referred to in (c); and(f) the state of human health and safety, including the contamination of the food chain, where relevant, conditions of human life, cultural sites and built structures inasmuch as they are or may be affected by the state of the elements of the environment referred to in (a) or, through those elements, by any of the matters referred to in (b) and (c).2. "Public authority" shall mean:(a) government or other public administration, including public advisory bodies, at national, regional or local level;(b) any natural or legal person performing public administrative functions under national law, including specific duties, activities or services in relation to the environment; and(c) any natural or legal person having public responsibilities or functions, or providing public services, relating to the environment under the control of a body or person falling within (a) or (b).Member States may provide that this definition shall not include bodies or institutions when acting in a judicial or legislative capacity. If their constitutional provisions at the date of adoption of this Directive make no provision for a review procedure within the meaning of Article 6, Member States may exclude those bodies or institutions from that definition.3. "Information held by a public authority" shall mean environmental information in its possession which has been produced or received by that authority.4. "Information held for a public authority" shall mean environmental information which is physically held by a natural or legal person on behalf of a public authority.5. "Applicant" shall mean any natural or legal person requesting environmental information.6. "Public" shall mean one or more natural or legal persons, and, in accordance with national legislation or practice, their associations, organisations or groups.Article 3Access to environmental information upon request1. Member States shall ensure that public authorities are required, in accordance with the provisions of this Directive, to make available environmental information held by or for them to any applicant at his request and without his having to state an interest.2. Subject to Article 4 and having regard to any timescale specified by the applicant, environmental information shall be made available to an applicant:(a) as soon as possible or, at the latest, within one month after the receipt by the public authority referred to in paragraph 1 of the applicant's request; or(b) within two months after the receipt of the request by the public authority if the volume and the complexity of the information is such that the one-month period referred to in (a) cannot be complied with. In such cases, the applicant shall be informed as soon as possible, and in any case before the end of that one-month period, of any such extension and of the reasons for it.3. If a request is formulated in too general a manner, the public authority shall as soon as possible, and at the latest within the timeframe laid down in paragraph 2(a), ask the applicant to specify the request and shall assist the applicant in doing so, e.g. by providing information on the use of the public registers referred to in paragraph 5(c). The public authorities may, where they deem it appropriate, refuse the request under Article 4(1)(c).4. Where an applicant requests a public authority to make environmental information available in a specific form or format (including in the form of copies), the public authority shall make it so available unless:(a) it is already publicly available in another form or format, in particular under Article 7, which is easily accessible by applicants; or(b) it is reasonable for the public authority to make it available in another form or format, in which case reasons shall be given for making it available in that form or format.For the purposes of this paragraph, public authorities shall make all reasonable efforts to maintain environmental information held by or for them in forms or formats that are readily reproducible and accessible by computer telecommunications or by other electronic means.The reasons for a refusal to make information available, in full or in part, in the form or format requested shall be provided to the applicant within the time limit referred to in paragraph 2(a).5. For the purposes of this Article, Member States shall ensure that:(a) officials are required to support the public in seeking access to information;(b) lists of public authorities are publicly accessible; and(c) the practical arrangements are defined for ensuring that the right of access to environmental information can be effectively exercised, such as:- the designation of information officers;- the establishment and maintenance of facilities for the examination of the information required,- registers or lists of the environmental information held by public authorities or information points, with clear indications of where such information can be found.Member States shall ensure that public authorities inform the public adequately of the rights they enjoy as a result of this Directive and to an appropriate extent provide information, guidance and advice to this end.Article 4Exceptions1. Member States may provide for a request for environmental information to be refused if:(a) the information requested is not held by or for the public authority to which the request is addressed. In such a case, where that public authority is aware that the information is held by or for another public authority, it shall, as soon as possible, transfer the request to that other authority and inform the applicant accordingly or inform the applicant of the public authority to which it believes it is possible to apply for the information requested;(b) the request is manifestly unreasonable;(c) the request is formulated in too general a manner, taking into account Article 3(3);(d) the request concerns material in the course of completion or unfinished documents or data;(e) the request concerns internal communications, taking into account the public interest served by disclosure.Where a request is refused on the basis that it concerns material in the course of completion, the public authority shall state the name of the authority preparing the material and the estimated time needed for completion.2. Member States may provide for a request for environmental information to be refused if disclosure of the information would adversely affect:(a) the confidentiality of the proceedings of public authorities, where such confidentiality is provided for by law;(b) international relations, public security or national defence;(c) the course of justice, the ability of any person to receive a fair trial or the ability of a public authority to conduct an enquiry of a criminal or disciplinary nature;(d) the confidentiality of commercial or industrial information where such confidentiality is provided for by national or Community law to protect a legitimate economic interest, including the public interest in maintaining statistical confidentiality and tax secrecy;(e) intellectual property rights;(f) the confidentiality of personal data and/or files relating to a natural person where that person has not consented to the disclosure of the information to the public, where such confidentiality is provided for by national or Community law;(g) the interests or protection of any person who supplied the information requested on a voluntary basis without being under, or capable of being put under, a legal obligation to do so, unless that person has consented to the release of the information concerned;(h) the protection of the environment to which such information relates, such as the location of rare species.The grounds for refusal mentioned in paragraphs 1 and 2 shall be interpreted in a restrictive way, taking into account for the particular case the public interest served by disclosure. In every particular case, the public interest served by disclosure shall be weighed against the interest served by the refusal. Member States may not, by virtue of paragraph 2(a), (d), (f), (g) and (h), provide for a request to be refused where the request relates to information on emissions into the environment.Within this framework, and for the purposes of the application of subparagraph (f), Member States shall ensure that the requirements 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 are complied with(6).3. Where a Member State provides for exceptions, it may draw up a publicly accessible list of criteria on the basis of which the authority concerned may decide how to handle requests.4. Environmental information held by or for public authorities which has been requested by an applicant shall be made available in part where it is possible to separate out any information falling within the scope of paragraphs 1(d) and (e) or 2 from the rest of the information requested.5. A refusal to make available all or part of the information requested shall be notified to the applicant in writing or electronically, if the request was in writing or if the applicant so requests, within the time limits referred to in Article 3(2)(a) or, as the case may be, (b). The notification shall state the reasons for the refusal and include information on the review procedure provided for in accordance with Article 6.Article 5Charges1. Access to any public registers or lists established and maintained as mentioned in Article 3(5) and examination in situ of the information requested shall be free of charge.2. Public authorities may make a charge for supplying any environmental information but such charge shall not exceed a reasonable amount.3. Where charges are made, public authorities shall publish and make available to applicants a schedule of such charges as well as information on the circumstances in which a charge may be levied or waived.Article 6Access to justice1. Member States shall ensure that any applicant who considers that his request for information has been ignored, wrongfully refused (whether in full or in part), inadequately answered or otherwise not dealt with in accordance with the provisions of Articles 3, 4 or 5, has access to a procedure in which the acts or omissions of the public authority concerned can be reconsidered by that or another public authority or reviewed administratively by an independent and impartial body established by law. Any such procedure shall be expeditious and either free of charge or inexpensive.2. In addition to the review procedure referred to in paragraph 1, Member States shall ensure that an applicant has access to a review procedure before a court of law or another independent and impartial body established by law, in which the acts or omissions of the public authority concerned can be reviewed and whose decisions may become final. Member States may furthermore provide that third parties incriminated by the disclosure of information may also have access to legal recourse.3. Final decisions under paragraph 2 shall be binding on the public authority holding the information. Reasons shall be stated in writing, at least where access to information is refused under this Article.Article 7Dissemination of environmental information1. Member States shall take the necessary measures to ensure that public authorities organise the environmental information which is relevant to their functions and which is held by or for them, with a view to its active and systematic dissemination to the public, in particular by means of computer telecommunication and/or electronic technology, where available.The information made available by means of computer telecommunication and/or electronic technology need not include information collected before the entry into force of this Directive unless it is already available in electronic form.Member States shall ensure that environmental information progressively becomes available in electronic databases which are easily accessible to the public through public telecommunication networks.2. The information to be made available and disseminated shall be updated as appropriate and shall include at least:(a) texts of international treaties, conventions or agreements, and of Community, national, regional or local legislation, on the environment or relating to it;(b) policies, plans and programmes relating to the environment;(c) progress reports on the implementation of the items referred to in (a) and (b) when prepared or held in electronic form by public authorities;(d) the reports on the state of the environment referred to in paragraph 3;(e) data or summaries of data derived from the monitoring of activities affecting, or likely to affect, the environment;(f) authorisations with a significant impact on the environment and environmental agreements or a reference to the place where such information can be requested or found in the framework of Article 3;(g) environmental impact studies and risk assessments concerning the environmental elements referred to in Article 2(1)(a) or a reference to the place where the information can be requested or found in the framework of Article 3.3. Without prejudice to any specific reporting obligations laid down by Community legislation, Member States shall take the necessary measures to ensure that national, and, where appropriate, regional or local reports on the state of the environment are published at regular intervals not exceeding four years; such reports shall include information on the quality of, and pressures on, the environment.4. Without prejudice to any specific obligation laid down by Community legislation, Member States shall take the necessary measures to ensure that, in the event of an imminent threat to human health or the environment, whether caused by human activities or due to natural causes, all information held by or for public authorities which could enable the public likely to be affected to take measures to prevent or mitigate harm arising from the threat is disseminated, immediately and without delay.5. The exceptions in Article 4(1) and (2) may apply in relation to the duties imposed by this Article.6. Member States may satisfy the requirements of this Article by creating links to Internet sites where the information can be found.Article 8Quality of environmental information1. Member States shall, so far as is within their power, ensure that any information that is compiled by them or on their behalf is up to date, accurate and comparable.2. Upon request, public authorities shall reply to requests for information pursuant to Article 2(1)b, reporting to the applicant on the place where information, if available, can be found on the measurement procedures, including methods of analysis, sampling, and pre-treatment of samples, used in compiling the information, or referring to a standardised procedure used.Article 9Review procedure1. Not later than 14 February 2009, Member States shall report on the experience gained in the application of this Directive.They shall communicate the report to the Commission not later than 14 August 2009.No later than 14 February 2004, the Commission shall forward to the Member States a guidance document setting out clearly the manner in which it wishes the Member States to report.2. In the light of experience and taking into account developments in computer telecommunication and/or electronic technology, the Commission shall make a report to the European Parliament and to the Council together with any proposal for revision, which it may consider appropriate.Article 10ImplementationMember States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 February 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 reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.Article 11RepealDirective 90/313/EEC is hereby repealed with effect from 14 February 2005.References to the repealed Directive shall be construed as referring to this Directive and shall be read in accordance with the correlation table in the Annex.Article 12Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 13AddresseesThis Directive is addressed to the Member States.Done at Brussels, 28 January 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Papandreou(1) OJ C 337 E, 28.11.2000, p. 156 and OJ C 240 E, 28.8.2001, p. 289.(2) OJ C 116, 20.4.2001, p. 43.(3) OJ C 148, 18.5.2001, p. 9.(4) Opinion of the European Parliament of 14 March 2001 (OJ C 343, 5.12.2001, p. 165), Council Common Position of 28 January 2002 (OJ C 113 E, 14.5.2002, p. 1) and Decision of the European Parliament of 30 May 2002 (not yet published in the Official Journal). Decision of the Council of 16 December 2002 and decision the European Parliament of 18 December 2002.(5) OJ L 158, 23.6.1990, p. 56.(6) OJ L 281, 23.11.1995, p. 31.ANNEXCORRELATION TABLE>TABLE>

Summary: Public access to environmental information Public access to environmental information SUMMARY OF: Directive 2003/4/EC on public access to environmental information WHAT IS THE AIM OF THE DIRECTIVE? It fully adapts European Union (EU) countries’ national laws to the 1998 Aarhus Convention on access to information, public participation and access to justice in environmental matters. It guarantees the public access to environmental information* held by, or for, public authorities*, both upon request and through active dissemination. It sets out the basic terms, conditions and practical arrangements that a member of the public must respect when granted access to the requested environmental information. KEY POINTS Access upon request Public authorities must make available any environmental information they possess to an applicant without the person having to state a reason. The information should be provided at the latest 1 month after the request is received. This may be extended to 2 months for voluminous and complex requests. Public authorities must make every reasonable effort to ensure the information they have can be readily reproduced and accessed electronically. The information should be supplied in the form or format the applicant specifies unless it is already publicly available in another format. EU countries must ensure civil servants help the public seeking access to information and maintain a list of accessible public authorities. Practical arrangements for dealing with requests include: appointment of information officers; facilities for examining the information; and registers or lists of the information held and details of information points. Requests may be refused if they are: manifestly unreasonable; too general; relate to unfinished material; or concern internal communications. They may also be refused, in full or in part, if the disclosure could be damaging to one of the exhaustive grounds envisaged, for instance: international relations; the course of justice; intellectual property rights; or commercial or industrial confidentiality. Access to public registers or lists should be free of charge. Public authorities may charge for the environmental information they make available upon request, but the amount should be reasonable. Applicants who consider their request has been ignored or wrongfully refused may have access to remedies, including a court of law or another independent body. Active dissemination Electronically accessible environmental information must contain at least: texts of international treaties, conventions or agreements, policies, plans and programmes relating to the environment; progress reports on implementation of the above items; reports on the state of the environment; monitoring data of activities that could affect the environment; authorisations which could have a significant impact on the environment; impact studies and risk assessments. For items other than those above, active dissemination may be done progressively taking account of the human, financial and technical resources required. EU countries must ensure any information compiled by them or on their behalf is up-to-date, accurate and comparable. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 14 February 2003. EU countries had to incorporate it into national law by 14 February 2005. BACKGROUND The Århus Convention has been in force since 2001. It is based on the premise that greater public awareness of and involvement in environmental matters will improve environmental protection. It is designed to help protect the right of every person of present and future generations to live in an environment adequate to his or her health and well-being. To this end, the Convention provides for action in 3 areas: ensuring public access to environmental information held by or for the public authorities; fostering public participation in decision-making which affects the environment; extending the conditions of access to justice in environmental matters. For more information, see: ‘The Aarhus Convention’ on the European Commission's website. * KEY TERMS Environmental information: any written, visual, aural, electronic or other form of information on issues set out in Article 2(1) of Directive 2003/4/EC. Public authority: in particular, government or other national, regional or local public administration, including public advisory bodies and individuals covered by the legislation. EU governments may decide that this definition does not include bodies when acting in a judicial or legislative capacity. MAIN DOCUMENT Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, pp. 26-32) RELATED DOCUMENTS 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 (OJ L 145, 31.5.2001, pp. 43-48) Council Decision 2005/370/EC of 17 February 2005 on the conclusion, on behalf of the European Community, of the Convention on access to information, public participation in decision-making and access to justice in environmental matters (OJ L 124, 17.5.2005, pp. 1-3) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, pp. 13-19) Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, pp. 1-14) last update 26.01.2017