21.5.2009 EN Official Journal of the European Union L 125/75 DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (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 Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity. (2) Under the Treaty, action by the Community relating to the environment must be based on the principle that preventive action is to be taken and must have as its objective, among other things, the preservation, protection and improvement of the environment and the protection of human health. (3) Measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate. (4) The development of biotechnology is such as to contribute to the economic expansion of the Member States. This involves the use of genetically modified micro-organisms (GMMs) in operations of various types and scales. (5) The contained use of GMMs should be such as to limit their possible negative consequences for human health and the environment, due attention being given to the prevention of accidents and the control of waste. (6) GMMs which are disposed of without appropriate provisions for specific containment measures to limit their contact with the general population and the environment do not fall within the scope of this Directive. Other Community legislation such as Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (5) may apply. (7) Micro-organisms, if released into the environment in one Member State in the course of their contained use, may reproduce and spread, crossing national frontiers and thereby affecting other Member States. (8) In order to bring about the safe development of biotechnology throughout the Community, it is necessary to establish common measures for the evaluation and reduction of the potential risks arising in the course of all operations involving the contained use of GMMs and to set appropriate conditions of use. (9) The precise nature and scale of risks associated with the contained use of GMMs are not yet fully known and the risk involved must be assessed on a case-by-case basis. In order to evaluate the risk to human health and the environment, it is necessary to lay down requirements for risk assessment. (10) Contained uses of GMMs should be classified in relation to the risks they present to human health and the environment. Such classification should be in line with international practice and based on an assessment of the risk. (11) In order to ensure a high level of protection, the containment and other protective measures applied to a contained use must correspond to the classification of the contained use. Where there is any uncertainty, the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data. (12) For all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation. (13) Appropriate containment measures should be applied at the various stages of an operation to control emissions and the disposal of material from contained uses of GMMs, and to prevent accidents. (14) Any person, before undertaking for the first time the contained use of a GMM in a particular installation, should forward a notification to the competent authority so that the authority may satisfy itself that the proposed installation is appropriate for the purposes of carrying out the activity in a manner that does not present a hazard to human health and the environment. (15) It is also necessary to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of GMMs, taking account of the degree of risk involved. (16) In the case of operations involving high risk, the consent of the competent authority should be given. (17) The containment and other protective measures applied to contained uses should be reviewed periodically. (18) It may be considered appropriate to consult the public on the contained use of GMMs. (19) People employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (6). (20) Appropriate measures should be taken to inform any person liable to be affected by an accident on all matters relating to safety. (21) Emergency plans should be established to deal effectively with accidents. (22) If an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action. (23) It is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such accidents. (24) The contained use of GMMs throughout the Community should be monitored, and to this end Member States should supply certain information to the Commission. (25) In order to be considered safe for human health and the environment, GMMs should meet the list of criteria as defined in Annex II, Part B. To take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of that list, it is appropriate for the Council to revise those criteria, which should, where necessary, be supplemented by guidance notes to facilitate their application. (26) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (27) In particular, the Commission should be empowered to adopt the amendments necessary to adapt Annexes II, III, IV and V to technical progress, and to adapt Annex II, Part C. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (28) The new elements introduced into this Directive concern only the committee procedures. They therefore do not need to be transposed by the Member States. (29) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex VI, Part B, HAVE ADOPTED THIS DIRECTIVE: Article 1 This Directive lays down common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment. Article 2 For the purposes of this Directive the following definitions shall apply: (a) ‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture; (b) ‘genetically modified micro-organism’ (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; within the terms of this definition: (i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A; (ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification; (c) ‘contained use’ means any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment; (d) ‘accident’ means any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment; (e) ‘user’ means any natural or legal person responsible for the contained use of GMMs; (f) ‘notification’ means the presentation of the requisite information to the competent authorities of a Member State. Article 3 1. Without prejudice to Article 4(1), this Directive shall not apply: (a) where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A; or (b) for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety for human health and the environment. These types of GMMs shall be listed in Annex II, Part C. 2. Article 4(3) and (6) and Articles 5 to 11 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air. 3. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Directive 2001/18/EC or pursuant to other Community legislation which provides for a specific environmental risk assessment similar to that laid down in that Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. Article 4 1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs. 2. To that end, the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that those contained uses may pose, using as a minimum the elements of assessment and the procedure set out in Annex III, Sections A and B. 3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 5: Class 1 : activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health and the environment. Class 2 : activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health and the environment. Class 3 : activities of moderate risk, that is to say activities for which level 3 containment is appropriate to protect human health and the environment. Class 4 : activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health and the environment. 4. Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless, by agreement with the competent authority, there is sufficient evidence to justify the application of less stringent measures. 5. The assessment referred to in paragraph 2 shall especially take into account the question of disposal of waste and effluents. Where appropriate, the safety measures needed in order to protect human health and the environment shall be implemented. 6. A record of the assessment referred to in paragraph 2 shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 6, 8 and 9 or on request. Article 5 1. Save to the extent that point 2 of Annex IV allows other measures to be applied, the user shall apply the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured. 2. The assessment referred to in Article 4(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if: (a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct; or (b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge. Article 6 When premises are to be used for the first time for contained uses, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A. Article 7 Following the notification referred to in Article 6, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 4(6), which shall be made available to the competent authority on request. Article 8 1. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part B shall be submitted. 2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation. The decision must be made within a maximum of 45 days from the notification. 3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority. Article 9 1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part C shall be submitted. 2. A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority, which shall communicate its decision in writing: (a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed; (b) at the latest 90 days after submission of the notification, in other cases. Article 10 1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 6, 8 and 9. 2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 4(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures. 3. If necessary, the competent authority may: (a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). In this case the competent authority may require that the contained use, if proposed, should not begin, or, if in progress, should be suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use; (b) limit the time for which the contained use should be permitted or subject it to certain specific conditions. 4. For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time during which the competent authority: (a) is awaiting any further information which it may have requested from the notifier in accordance with point (a) of paragraph 3; or (b) is carrying out a public inquiry or consultation in accordance with Article 12; shall not be taken into account. Article 11 1. If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences in terms of the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 6, 8 and 9 shall be modified. 2. If information subsequently becomes available to the competent authority which could have significant consequences in terms of the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use. Article 12 Where a Member State considers it appropriate, it may provide that the public is to be consulted on aspects of the proposed contained use, without prejudice to Article 18. Article 13 1. The competent authorities shall ensure that before a contained use commences: (a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation; (b) information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available. 2. The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals. Article 14 1. Member States shall take the necessary measures to ensure that, in the event of an accident, the user is required immediately to inform the competent authority specified in Article 10 and to provide the following information: (a) the circumstances of the accident; (b) the identity and quantities of the GMMs concerned; (c) any information necessary to assess the effects of the accident on the health of the general population and the environment; (d) the measures taken. 2. Where information is given pursuant to paragraph 1, the Member States shall be required to: (a) ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident; (b) collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof. Article 15 1. Member States shall be required to: (a) consult with other Member States likely to be affected in the event of an accident on the proposed implementation of emergency plans; (b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, the response measures taken and their effectiveness and an analysis of the accident, including recommendations designed to limit its effects and to avoid similar accidents in the future. 2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future. Article 16 Member States shall ensure that the competent authority organises inspections and other control measures to ensure that users comply with this Directive. Article 17 1. Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 9, including the description, purpose and risks of the contained use(s). 2. Every three years, and for the first time on 5 June 2003, Member States shall send the Commission a summary report on their experience with this Directive. 3. Every three years, and for the first time on 5 June 2004, the Commission shall publish a summary based on the reports referred to in paragraph 2. 4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user. Article 18 1. Where its disclosure affects one or more of the items mentioned in Article 4(2) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (8), the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. 2. In no case may the following information, when submitted pursuant to Articles 6, 8 or 9, be kept confidential: (a) the general characteristics of the GMMs, the name and address of the notifier, and the location of use; (b) the class of contained use and the containment measures; (c) the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. 3. The Commission and the competent authorities shall not divulge to third parties any information deemed to be confidential according to the second subparagraph of paragraph 1 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received. 4. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied. Article 19 The measures designed to amend non-essential elements of this Directive relating to adapting Annexes II, III, IV and V to technical progress, and to adapting Annex II, Part C, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(2). Article 20 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. Article 21 Directive 90/219/EEC, as amended by the acts listed in Annex VI, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex VI, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VII. Article 22 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 23 This Directive is addressed to the Member States. Done at Strasbourg, 6 May 2009. For the European Parliament The President H.-G. PÖTTERING For the Council The President J. KOHOUT (1) OJ C 162, 25.6.2008, p. 85. (2) Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 30 March 2009. (3) OJ L 117, 8.5.1990, p. 1. (4) See Annex VI, Part A. (5) OJ L 106, 17.4.2001, p. 1. (6) OJ L 262, 17.10.2000, p. 21. (7) OJ L 184, 17.7.1999, p. 23. (8) OJ L 41, 14.2.2003, p. 26. ANNEX I PART A Techniques of genetic modification referred to in point (b)(i) of Article 2 are, inter alia: 1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation. 2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism, including micro-injection, macro-injection and micro-encapsulation. 3. Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally. PART B Techniques referred to in point (b)(ii) of Article 2 which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than the techniques/methods excluded by Part A of Annex II: 1. in vitro fertilisation; 2. natural processes such as: conjugation, transduction, transformation; 3. polyploidy induction. ANNEX II PART A Techniques or methods of genetic modification yielding micro-organisms to be excluded from this Directive on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below: 1. Mutagenesis. 2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes. 3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions. 4. Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants. Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms. PART B Criteria establishing the safety of GMMs for human health and the environment This Annex describes in general terms the criteria to be met when establishing the safety of types of GMMs for human health and the environment and their suitability for inclusion in Part C. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex. 1. Introduction Types of GMMs listed in Part C in accordance with the regulatory procedure with scrutiny referred to in Article 20(2) are excluded from the scope of this Directive. GMMs will be added to the list on a case-by-case basis and exclusion will relate only to each clearly identified GMM. This exclusion applies only when the GMM is used under conditions of contained use as defined in point (c) of Article 2. It does not apply to the deliberate release of GMMs. For a GMM to be listed in Part C, it must be proved that it meets the criteria given below. 2. General criteria 2.1. Strain verification/authentication Identity of the strain must be precisely established. Modification must be known and verified. 2.2. Documented and established evidence of safety Documented evidence of the safety of the organism must be provided. 2.3. Genetic stability Where any instability could adversely affect safety, evidence of stability is required. 3. Specific criteria 3.1. Non-pathogenic The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore be: 3.1.1. Non-toxigenic The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties. 3.1.2. Non-allergenic The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having, for example, allergenicity comparable in particular with that of the micro-organisms identified in Directive 2000/54/EC. 3.2. No harmful adventitious agents The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or inside the GMM, that could cause harm to human health and the environment. 3.3. Transfer of genetic material The modified genetic material must not give rise to harm if transferred; nor should it be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism. 3.4. Safety for the environment in the event of a significant and unintended release GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur. GMMs that do not meet the above criteria may not be included in Part C. PART C Types of GMMs which meet the criteria listed in Part B: … (to be completed in accordance with the regulatory procedure with scrutiny referred to in Article 20(2)) ANNEX III Principles to be followed for the assessment referred to in Article 4(2) This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 4(2). Technical guidance notes (1) may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex, in particular as regards Section B. A. Elements of assessment 1. The following should be considered as potentially harmful effects: — disease to humans, including allergenic or toxic effects, — disease to animals or plants, — deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis, — deleterious effects due to establishment or dissemination in the environment, — deleterious effects due to the natural transfer of inserted genetic material to other organisms. 2. The assessment referred to in Article 4(2) should be based on the following: (a) the identification of any potentially harmful effects, in particular those associated with: (i) the recipient micro-organism; (ii) the genetic material inserted (originating from the donor organism); (iii) the vector; (iv) the donor micro-organism (as long as the donor micro-organism is used during the operation); (v) the resulting GMM; (b) the characteristics of the activity; (c) the severity of the potentially harmful effects; (d) the likelihood of the potentially harmful effects being realised. B. Procedure 3. The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, and any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties. 4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 4(3): (i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants (2); (ii) the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants (2), or likely to have deleterious effects on the environment; (iii) the GMM is unlikely to cause disease to humans, animals or plants (2) and is unlikely to have deleterious effects on the environment. 5. In order to obtain the necessary information to implement this process the user may firstly take into account relevant Community legislation (in particular Directive 2000/54/EC). International or national classification schemes (e.g. World Health Organisation, National Institutes of Health) and their revisions due to new scientific knowledge and technical progress may also be considered. These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. Directive 2000/54/EC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult. These classes of risk can be used as guidance for the purposes of categorisation of the contained use activities in the four classes of risk referred to in Article 4(3). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures. 6. The hazard identification process carried out in accordance with points 3 to 5 should lead to the identification of the level of risk associated with the GMM. 7. Selection of the containment and other protective measures should then be made on the basis of the level of risk associated with the GMMs together with consideration of: (i) the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity); (ii) the characteristics of the activity (e.g. its scale and/or nature); (iii) any non-standard operations (e.g. the inoculation of animals with GMMs; use of equipment likely to generate aerosols). Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under point 6. 8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 4(3). 9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 4(2). (1) See Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III to Directive 90/219/EEC on the contained use of genetically modified micro-organisms (OJ L 258, 12.10.2000, p. 43). (2) This would only apply to animals and plants in the environment likely to be exposed. ANNEX IV CONTAINMENT AND OTHER PROTECTIVE MEASURES General principles 1. These tables present the normal minimum requirements and measures necessary for each level of containment. Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply: (i) to keep workplace and environmental exposure to any GMM to the lowest practicable level; (ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary; (iii) to test adequately and maintain control measures and equipment; (iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment; (v) to provide appropriate training of personnel; (vi) to establish biological safety committees or subcommittees, if required; (vii) to formulate and implement local codes of practice for the safety of personnel, as required; (viii) where appropriate, to display biohazard signs; (ix) to provide washing and decontamination facilities for personnel; (x) to keep adequate records; (xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area; (xii) to prohibit mouth pipetting; (xiii) to provide written standard operating procedures where appropriate to ensure safety; (xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs; (xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate. 2. The titles of the tables are indicative: Table I A presents minimum requirements for laboratory activities. Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs. Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs. Table II presents minimum requirements for activities other than laboratory activities. In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level. In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels. In these tables ‘optional’ means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 4(2). 3. In implementing this Annex, Member States may in addition incorporate in the following tables the general principles set out in points 1 and 2, with a view to clarifying the requirements. Table I A Containment and other protective measures for laboratory activities Specifications Containment levels 1 2 3 4 1 Laboratory suite: isolation (1) Not required Not required Required Required 2 Laboratory: sealable for fumigation Not required Not required Required Required Equipment 3 Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean Required (bench) Required (bench) Required (bench, floor) Required (bench, floor, ceiling, walls) 4 Entry to lab via airlock (2) Not required Not required Optional Required 5 Negative pressure relative to the pressure of the immediate environment Not required Not required Required except for (3) Required 6 Extract and input air from the laboratory should be HEPA (4)-filtered Not required Not required Required (HEPA — extract air except for (3)) Required (HEPA— input and extract air (5)) 7 Microbiological safety post Not required Optional Required Required 8 Autoclave On site In the building En suite (6) In lab = double-ended System of work 9 Restricted access Not required Required Required Required 10 Biohazard sign on the door Not required Required Required Required 11 Specific measures to control aerosol dissemination Not required Required minimise Required prevent Required prevent 13 Shower Not required Not required Optional Required 14 Protective clothing Suitable protective clothing Suitable protective clothing Suitable protective clothing and (optional) footwear Complete change of clothing and footwear before entry and exit 15 Gloves Not required Optional Required Required 18 Efficient vector control (e.g. for rodents and insects) Optional Required Required Required Waste 19 Inactivation of GMMs in effluent from hand-washing sinks or drains and showers and similar effluents Not required Not required Optional Required 20 Inactivation of GMMs in contaminated material and waste Optional Required Required Required Other measures 21 Laboratory to contain its own equipment Not required Not required Optional Required 23 An observation window or alternative is to be present so that occupants can be seen Optional Optional Optional Required Table I B Containment and other protective measures for glasshouses and growth-rooms The terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment. All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2 3 4 Building 1 Glasshouse: permanent structure (7) Not required Required Required Required Equipment 3 Entry via a separate room with two interlocking doors Not required Optional Optional Required 4 Control of contaminated run-off water Optional Minimise (8) run-off Prevent run-off Prevent run-off System of work 6 Measures to control undesired species such as insects, rodents, arthropods Required Required Required Required 7 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMs Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination Table I C Containment and other protective measures for activities in animal units All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2 3 4 Facilities 1 Isolation of animal unit (9) Optional Required Required Required 2 Animal facilities (10) separated by lockable doors Optional Required Required Required 3 Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.)) Optional Optional Required Required 4 Floor and/or walls easily washable Optional Required (floor) Required (floor and walls) Required (floor and walls) 5 Animals kept in appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional 6 Filters on isolators or isolated room (11) Not required Optional Required Required Table II Containment and other protective measures for other activities Specifications Containment levels 1 2 3 4 General 1 Viable micro-organisms should be contained in a system which separates the process from the environment (closed system) Optional Required Required Required 2 Control of exhaust gases from the closed system Not required Required, minimise dissemination Required, prevent dissemination Required, prevent dissemination 3 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system Optional Required, minimise dissemination Required, prevent dissemination Required, prevent dissemination 4 Inactivation of bulk culture fluids before removal from the closed system Optional Required, by validated means Required, by validated means Required, by validated means 5 Seals should be designed so as to minimise or prevent release No specific requirement Minimise dissemination Prevent dissemination Prevent dissemination 6 The controlled area should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required 7 The controlled area should be sealable to permit fumigation Not required Optional Optional Required Equipment 8 Entry via airlock Not required Not required Optional Required 9 Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean Required (bench if any) Required (bench if any) Required (bench if any, floor) Required (bench, floor, ceiling, walls) 10 Specific measures to adequately ventilate the controlled area in order to minimise air contamination Optional Optional Optional Required 11 The controlled area should be maintained at an air pressure negative to the immediate surroundings Not required Not required Optional Required 12 Extract and input air from the controlled area should be HEPA filtered Not required Not required Required (extract air, optional for input air) Required (input and extract air) System of work 13 Closed systems should be located within a controlled area Not required Optional Required Required 14 Access should be restricted to nominated personnel only Not required Required Required Required 15 Biohazard signs should be posted Not required Required Required Required 17 Personnel should shower before leaving the controlled area Not required Not required Optional Required 18 Personnel should wear protective clothing Required (work clothing) Required (work clothing) Required Complete change before exit and entry Waste 22 Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents Not required Not required Optional Required 23 Inactivation of GMMs in contaminated material and waste, including those in process effluent before final discharge Optional Required, by validated means Required, by validated means Required, by validated means (1) Isolation= the laboratory is separated from other areas in the same building or is in a separate building. (2) Airlock= entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. (3) Activities where transmission does not occur via airborne route. (4) HEPA= High efficiency particulate air. (5) Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air. (6) With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection. (7) The glasshouse shall consist of a permanent structure with a continuous waterproof covering, located on a site graded to prevent entry of surface-water run-off, and with self-closing lockable doors. (8) Where transmission can occur through the ground. (9) Animal unit: a building or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc. (10) Animal facility: a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures. (11) Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. ANNEX V Information required for the notification referred to in Articles 6, 8 and 9 PART A Information required for the notification referred to in Article 6: — name of user(s), including those responsible for supervision and safety, — information on the training and qualifications of the persons responsible for supervision and safety, — details of any biological committees or subcommittees, — address and general description of the premises, — a description of the nature of the work which will be undertaken, — the class of the contained uses, — only for class 1 contained uses, a summary of the assessment referred to in Article 4(2) and information on waste management. PART B Information required for the notification referred to in Article 8: — the date of submission of the notification referred to in Article 6, — the names of the persons responsible for supervision and safety and information on their training and qualification, — the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used, — the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s), — the identity and characteristics of the GMM, — the purpose of the contained use, including the expected results, — the approximate culture volumes to be used, — a description of the containment and other protective measures to be applied, including information about waste management, including the wastes to be generated, their treatment, final form and destination, — a summary of the assessment referred to in Article 4(2), — the information necessary for the competent authority to evaluate any emergency response plans, if required under Article 13(1). PART C Information required for the notification referred to in Article 9: (a) — the date of submission of the notification referred to in Article 6, — the names of the persons responsible for supervision and safety and information on their training and qualification; (b) — the recipient or parental micro-organism(s) to be used, — the host-vector system(s) to be used (where applicable), — the source(s) and intended function(s) of the genetic material(s) involved in the modification(s), — the identity and characteristics of the GMM, — the culture volumes to be used; (c) — a description of the containment and other protective measures to be applied, including information about waste management, including the type and form of wastes to be generated, their treatment, final form and destination, — the purpose of the contained use, including the expected results, — a description of the parts of the installation; (d) information about accident prevention and emergency response plans, if any: — any specific hazards arising from the location of the installation, — the preventive measures applied, such as safety equipment, alarm systems and containment methods, — the procedures and plans for verifying the continuing effectiveness of the containment measures, — a description of information provided to workers, — the information necessary for the competent authority to evaluate any emergency response plans, if required under Article 13(1); (e) a copy of the assessment referred to in Article 4(2). ANNEX VI PART A Repealed Directive with list of its successive amendments (referred to in Article 21) Council Directive 90/219/EEC (OJ L 117, 8.5.1990, p. 1) Commission Directive 94/51/EC (OJ L 297, 18.11.1994, p. 29) Council Directive 98/81/EC (OJ L 330, 5.12.1998, p. 13) Council Decision 2001/204/EC (OJ L 73, 15.3.2001, p. 32) Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) Annex III, point 19, only PART B Time limits for transposition into national law (referred to in Article 21) Directive Time limit for transposition 90/219/EEC 23 October 1991 94/51/EC 30 April 1995 98/81/EC 5 June 2000 ANNEX VII CORRELATION TABLE Directive 90/219/EEC This Directive Article 1 Article 1 Article 2 Article 2 Article 3, introductory wording Article 3(1), introductory wording Article 3, first indent Article 3(1), point (a) Article 3, second indent Article 3(1), point (b) Article 4, first paragraph Article 3(2) Article 4, second paragraph Article 3(3) Article 5 Article 4 Article 6 Article 5 Article 7 Article 6 Article 8 Article 7 Article 9 Article 8 Article 10 Article 9 Article 11(1), (2) and (3) Article 10(1), (2) and (3) Article 11(4), introductory wording Article 10(4), introductory wording Article 11(4), first indent Article 10(4), point (a) Article 11(4), second indent Article 10(4), point (b) Article 12, first paragraph Article 11(1) Article 12, second paragraph Article 11(2) Article 13 Article 12 Article 14, first paragraph Article 13(1) Article 14, second paragraph Article 13(2) Article 15(1), introductory wording Article 14(1), introductory wording Article 15(1), first indent Article 14(1), point (a) Article 15(1), second indent Article 14(1), point (b) Article 15(1), third indent Article 14(1), point (c) Article 15(1), fourth indent Article 14(1), point (d) Article 15(2), introductory wording Article 14(2), introductory wording Article 15(2), first indent Article 14(2), point (a) Article 15(2), second indent Article 14(2), point (b) Article 16 Article 15 Article 17 Article 16 Article 18 Article 17 Article 19(1) Article 18(1), first subparagraph Article 19(2) Article 18(1), second subparagraph Article 19(3), introductory wording Article 18(2), introductory wording Article 19(3), first indent Article 18(2), point (a) Article 19(3), second indent Article 18(2), point (b) Article 19(3), third indent Article 18(2), point (c) Article 19(4) Article 18(3) Article 19(5) Article 18(4) Article 20 Article 19 Article 20a — Article 21(1) Article 20(1) Article 21(2), first subparagraph Article 20(2) and (3), first subparagraph Article 21(2), second subparagraph Article 20(3), second subparagraph Article 21(3) — Article 22 — — Article 21 — Article 22 Article 23 Article 23 Annexes I-V Annexes I-V — Annex VI — Annex VII

Summary: Contained use of genetically modified microorganisms Contained use of genetically modified microorganisms SUMMARY OF: Directive 2009/41/EC on the contained use of genetically modified microorganisms WHAT IS THE AIM OF THE DIRECTIVE? It lays down rules for the contained use* of genetically modified microorganisms (GMMs)* in order to protect human health and the environment in the EU. KEY POINTS Classifications and notifications Users of GMMs must assess the contained uses regarding the risk to human health and the environment. The assessment results in one of the following classes. Class 1: for activities with no or negligible risk. Class 2: for activities with low risk. Class 3: for activities with moderate risk. Class 4: for activities with high risk. When a contained use of a GMM is to be carried out for the first time, the user must submit a notification containing information (listed in Annex V of the directive) to the competent authority of their EU country. This is to satisfy them that the proposed installation is appropriate for the purposes of the activity so that there is no risk to human health and the environment. Following the notification to the competent authorities, class 1 contained use may proceed without further notification. Class 2 contained use can proceed immediately after notification provided the premises were the subject of previous notification to carry out class 2 or higher. However, if this is not the case and in the absence of a refusal from the competent authority, class 2 contained use may proceed 45 days after the submission of the notification (or earlier with the agreement of the authority). A class 3 or 4 contained use may not proceed without the prior consent of the competent authority, which must communicate its decision in writing. Accidents * Before a contained use begins, EU countries must ensure that: in order to react in the case of an accident, an emergency plan is drawn up for cases where failure of the containment measures could lead to serious danger; and persons at risk of being affected by an accident are informed of all aspects related to their safety. Should an accident occur, the respective EU country must ensure that the GMM user informs the competent authorities and communicates the information necessary for assessing the situation and taking action. FROM WHEN DOES THE DIRECTIVE APPLY? It applies from 10 June 2009. BACKGROUND This directive repeals and consolidates Directive 90/219/EEC and its successive amendments into a single act. It lays down minimal standards applicable to the contained use of GMMs. EU countries are permitted to take stronger measures. * KEY TERMS Contained use: Any activity in which microorganisms are genetically modified, cultured, stored, transported, destroyed, disposed of or used in any other way and for which containment/safety measures are used to limit their contact with the general population and the environment. GMMs: Micro-organisms, such as bacteria, viruses or fungi, that have had their genetic material altered in a way that does not occur naturally by mating and/or natural recombination. Accidents: In the context of this directive, these refer to any incident involving a significant and unintended release of GMMs in the course of their contained use that could be hazardous to human health or the environment. MAIN DOCUMENT Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, pp. 75-97) last update 07.07.2016


1.5.2009 EN Official Journal of the European Union L 110/30 DIRECTIVE 2009/22/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2009 on injunctions for the protection of consumers' interests (Codified version) (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 Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers' interests (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified. (2) Certain Directives, listed in Annex I to this Directive, lay down rules with regard to the protection of consumers' interests. (3) Current mechanisms available for ensuring compliance with those Directives, both at national and at Community level, do not always allow infringements harmful to the collective interests of consumers to be terminated in good time. Collective interests means interests which do not include the cumulation of interests of individuals who have been harmed by an infringement. This is without prejudice to individual actions brought by individuals who have been harmed by an infringement. (4) As far as the purpose of bringing about the cessation of practices that are unlawful under the national provisions applicable is concerned, the effectiveness of national measures transposing the Directives in question, including protective measures that go beyond the level required by those Directives, provided they are compatible with the Treaty and allowed by those Directives, may be thwarted where those practices produce effects in a Member State other than that in which they originate. (5) Those difficulties can disrupt the smooth functioning of the internal market, their consequence being that it is sufficient to move the source of an unlawful practice to another country in order to place it out of reach of all forms of enforcement. This constitutes a distortion of competition. (6) Those difficulties are likely to diminish consumer confidence in the internal market and may limit the scope for action by organisations representing the collective interests of consumers or independent public bodies responsible for protecting the collective interests of consumers, adversely affected by practices that infringe Community law. (7) Those practices often extend beyond the frontiers between the Member States. There is an urgent need for some degree of approximation of national provisions designed to enjoin the cessation of the unlawful practices irrespective of the Member State in which the unlawful practice has produced its effects. With regard to jurisdiction, this is without prejudice to the rules of private international law and the Conventions in force between Member States, while respecting the general obligations of the Member States deriving from the Treaty, in particular those related to the smooth functioning of the internal market. (8) The objective of the action envisaged can only be attained by the Community. It is therefore incumbent on the Community to act. (9) The third paragraph of Article 5 of the Treaty makes it incumbent on the Community not to go beyond what is necessary to achieve the objectives of the Treaty. In accordance with that Article, the specific features of national legal systems must be taken into account to every extent possible by leaving Member States free to choose between different options having equivalent effect. The courts or administrative authorities competent to rule on the proceedings referred to in this Directive should have the right to examine the effects of previous decisions. (10) One option should consist in requiring one or more independent public bodies, specifically responsible for the protection of the collective interests of consumers, to exercise the rights of action set out in this Directive. Another option should provide for the exercise of those rights by organisations whose purpose is to protect the collective interests of consumers, in accordance with criteria laid down by national law. (11) Member States should be able to choose between or combine these two options in designating at national level the bodies and/or organisations qualified for the purposes of this Directive. (12) For the purposes of intra-Community infringements the principle of mutual recognition should apply to these bodies and/or organisations. The Member States should, at the request of their national entities, communicate to the Commission the name and purpose of their national entities which are qualified to bring an action in their own country according to the provisions of this Directive. (13) It is the business of the Commission to ensure the publication of a list of these qualified entities in the Official Journal of the European Union. Until a statement to the contrary is published, a qualified entity is assumed to have legal capacity if its name is included in that list. (14) Member States should be able to require that a prior consultation be undertaken by the party that intends to bring an action for an injunction, in order to give the defendant an opportunity to bring the contested infringement to an end. Member States should be able to require that this prior consultation take place jointly with an independent public body designated by those Member States. (15) Where the Member States have established that there should be prior consultation, a deadline of two weeks after the request for consultation is received should be set after which, should the cessation of the infringement not be achieved, the applicant shall be entitled to bring an action, without any further delay, before the competent court or administrative authority. (16) It is appropriate that the Commission report on the functioning of this Directive and in particular on its scope and on the operation of prior consultation. (17) The application of this Directive should not prejudice the application of Community competition rules. (18) This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition and application in national law of the Directives set out in Annex II, Part B, HAVE ADOPTED THIS DIRECTIVE: Article 1 Scope 1. The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to actions for an injunction referred to in Article 2 aimed at the protection of the collective interests of consumers included in the Directives listed in Annex I, with a view to ensuring the smooth functioning of the internal market. 2. For the purposes of this Directive, an infringement means any act contrary to the Directives listed in Annex I as transposed into the internal legal order of the Member States which harms the collective interests referred to in paragraph 1. Article 2 Actions for an injunction 1. Member States shall designate the courts or administrative authorities competent to rule on proceedings commenced by qualified entities within the meaning of Article 3 seeking: (a) an order with all due expediency, where appropriate by way of summary procedure, requiring the cessation or prohibition of any infringement; (b) where appropriate, measures such as the publication of the decision, in full or in part, in such form as deemed adequate and/or the publication of a corrective statement with a view to eliminating the continuing effects of the infringement; (c) in so far as the legal system of the Member State concerned so permits, an order against the losing defendant for payments into the public purse or to any beneficiary designated in or under national legislation, in the event of failure to comply with the decision within a time limit specified by the courts or administrative authorities, of a fixed amount for each day’s delay or any other amount provided for in national legislation, with a view to ensuring compliance with the decisions. 2. This Directive shall be without prejudice to the rules of private international law with respect to the applicable law, that is, normally, either the law of the Member State where the infringement originated or the law of the Member State where the infringement has its effects. Article 3 Entities qualified to bring an action For the purposes of this Directive, a ‘qualified entity’ means any body or organisation which, being properly constituted according to the law of a Member State, has a legitimate interest in ensuring that the provisions referred to in Article 1 are complied with, in particular: (a) one or more independent public bodies, specifically responsible for protecting the interests referred to in Article 1, in Member States in which such bodies exist; and/or (b) organisations whose purpose is to protect the interests referred to in Article 1, in accordance with the criteria laid down by the national law. Article 4 Intra-Community infringements 1. Each Member State shall take the measures necessary to ensure that, in the event of an infringement originating in that Member State, any qualified entity from another Member State where the interests protected by that qualified entity are affected by the infringement, may apply to the court or administrative authority referred to in Article 2, on presentation of the list provided for in paragraph 3 of this Article. The courts or administrative authorities shall accept this list as proof of the legal capacity of the qualified entity without prejudice to their right to examine whether the purpose of the qualified entity justifies its taking action in a specific case. 2. For the purposes of intra-Community infringements, and without prejudice to the rights granted to other entities under national legislation, the Member States shall, at the request of their qualified entities, communicate to the Commission that these entities are qualified to bring an action under Article 2. The Member States shall inform the Commission of the name and purpose of these qualified entities. 3. The Commission shall draw up a list of the qualified entities referred to in paragraph 2, with the specification of their purpose. This list shall be published in the Official Journal of the European Union; changes to this list shall be published without delay and the updated list shall be published every six months. Article 5 Prior consultation 1. Member States may introduce or maintain in force provisions whereby the party that intends to seek an injunction can only start this procedure after it has tried to achieve the cessation of the infringement in consultation either with the defendant or with both the defendant and a qualified entity within the meaning of Article 3(a) of the Member State in which the injunction is sought. It shall be for the Member State to decide whether the party seeking the injunction must consult the qualified entity. If the cessation of the infringement is not achieved within two weeks after the request for consultation is received, the party concerned may bring an action for an injunction without any further delay. 2. The rules governing prior consultation adopted by Member States shall be notified to the Commission and shall be published in the Official Journal of the European Union. Article 6 Reports 1. Every three years and for the first time no later than 2 July 2003 the Commission shall submit to the European Parliament and to the Council a report on the application of this Directive. 2. In its first report the Commission shall examine in particular: (a) the scope of this Directive in relation to the protection of the collective interests of persons exercising a commercial, industrial, craft or professional activity; (b) the scope of this Directive as determined by the Directives listed in Annex I; (c) whether the prior consultation provided for in Article 5 has contributed to the effective protection of consumers. Where appropriate, this report shall be accompanied by proposals with a view to amending this Directive. Article 7 Provisions for wider action This Directive shall not prevent Member States from adopting or maintaining in force provisions designed to grant qualified entities and any other person concerned more extensive rights to bring action at national level. Article 8 Implementation Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 9 Repeal Directive 98/27/EC, as amended by the Directives set out in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition into national law and application of the Directives set out in Annex II, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III. Article 10 Entry into force This Directive shall enter into force on 29 December 2009. Article 11 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 23 April 2009. For the European Parliament The President H.-G. PÖTTERING For the Council The President P. NEČAS (1) OJ C 161, 13.7.2007, p. 39. (2) Opinion of the European Parliament of 19 June 2007 (OJ C 146 E, 12.6.2008, p. 73) and Council Decision of 23 March 2009. (3) OJ L 166, 11.6.1998, p. 51. (4) See Annex II, Part A. ANNEX I LIST OF DIRECTIVES REFERRED TO IN ARTICLE 1 (1) 1. Council Directive 85/577/EEC of 20 December 1985 to protect the consumer in respect of contracts negotiated away from business premises (OJ L 372, 31.12.1985, p. 31). 2. Council Directive 87/102/EEC of 22 December 1986 for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit (OJ L 42, 12.2.1987, p. 48) (2). 3. 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: Articles 10 to 21 (OJ L 298, 17.10.1989, p. 23). 4. Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (OJ L 158, 23.6.1990, p. 59). 5. Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). 6. Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (OJ L 144, 4.6.1997, p. 19). 7. Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12). 8. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects on information society services, in particular electronic commerce, in the internal market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). 9. 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: Articles 86 to 100 (OJ L 311, 28.11.2001, p. 67). 10. Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services (OJ L 271, 9.10.2002, p. 16). 11. Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (OJ L 149, 11.6.2005, p. 22). 12. Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36). 13. Directive 2008/122/EC of the European Parliament and of the Council of 14 January 2009 on the protection of consumers in respect of certain aspects of timeshare, long-term holiday product, resale and exchange contracts (OJ L 33, 3.2.2009, p. 10). (1) The Directives referred to in points 5, 6, 9 and 11 contain specific provisions concerning injunctions. (2) The said Directive was repealed and replaced, with effect from 12 May 2010, by Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers (OJ L 133, 22.5.2008, p. 66). ANNEX II PART A Repealed Directive and its amendments (referred to in Article 9) Directive 98/27/EC of the European Parliament and of the Council (OJ L 166, 11.6.1998, p. 51). Directive 1999/44/EC of the European Parliament and of the Council (OJ L 171, 7.7.1999, p. 12). Article 10 only Directive 2000/31/EC of the European Parliament and of the Council (OJ L 178, 17.7.2000, p. 1). Article 18(2) only Directive 2002/65/EC of the European Parliament and of the Council (OJ L 271, 9.10.2002, p. 16). Article 19 only Directive 2005/29/EC of the European Parliament and of the Council (OJ L 149, 11.6.2005, p. 22). Article 16(1) only Directive 2006/123/EC of the European Parliament and of the Council (OJ L 376, 27.12.2006, p. 36). Article 42 only PART B List of time limits for transposition into national law and application (referred to in Article 9) Directive Time limit for transposition Date of application 98/27/EC 1 January 2001 — 1999/44/EC 1 January 2002 — 2000/31/EC 16 January 2002 — 2002/65/EC 9 October 2004 — 2005/29/EC 12 June 2007 12 December 2007 2006/123/EC 28 December 2009 — ANNEX III CORRELATION TABLE Directive 98/27/EC This Directive Articles 1 to 5 Articles 1 to 5 Article 6(1) Article 6(1) Article 6(2), first subparagraph, first indent Article 6(2), first subparagraph, point (a) Article 6(2), first subparagraph, second indent Article 6(2), first subparagraph, point (b) Article 6(2), first subparagraph, third indent Article 6(2), first subparagraph, point (c) Article 6(2), second subparagraph Article 6(2), second subparagraph Article 7 Article 7 Article 8(1) — Article 8(2) Article 8 — Article 9 Article 9 Article 10 Article 10 Article 11 Annex Annex I — Annex II — Annex III

Summary: Injunctions protecting the collective interests of consumers (until 2023) Injunctions protecting the collective interests of consumers (until 2023) SUMMARY OF: Directive 2009/22/EC – injunctions for the protection of consumers’ interests WHAT IS THE AIM OF THE DIRECTIVE? It introduces European Union (EU) rules to ensure that injunctions are effective enough to terminate infringements that are harmful to the collective interests of consumers. The directive will be repealed and replaced by Directive (EU) 2020/1828 (see summary) as of 25 June 2023. KEY POINTS Injunctions aim to terminate or prohibit infringements that are contrary to the collective interests of consumers. The alignment of legislation in accordance with this directive allows these injunctions to be more effective and enables the EU’s internal market to function more smoothly. The infringements concerned include those relating to consumer credit, package travel, unfair terms in contracts concluded with consumers, distance contracts and unfair commercial practices. A full list of the directives concerned can be found in Annex I to Directive 2009/22/EC. Recourse to injunctions may result in: the cessation or prohibition of an infringement, where appropriate by way of summary procedure*;the elimination of the continuing effects of an infringement, particularly through the publication of the decision;the sentencing of defendants to comply with a decision by requiring them to pay a fine. Bodies qualified to bring an action must have a legitimate interest in ensuring that the collective interests of consumers and the smooth running of the internal market are complied with. This is the case, in particular, for independent public bodies specifically responsible for protecting the collective interests of consumers, or for consumer protection organisations. A list of the qualified authorities that may bring action in the event of infringements within the EU is established by the European Commission and published in the Official Journal of the European Union. For the list of qualified bodies that are able to act in the case of infringements within the EU, please see here. The EU Member State in which an action is to be brought may decide whether there should be prior consultation between the parties, in the presence or not of a qualified body from that country. If the infringement continues for more than 2 weeks after the request for consultation has been received, the action for an injunction may be brought immediately. A study on the application of Directive 2009/22/EC was undertaken in 2011 and was used in the preparation of a Commission report published in 2012. The directive was evaluated in 2017 within the fitness check of EU consumer and marketing law. Repeal Directive 2009/22/EC will be repealed and replaced by Directive (EU) 2020/1828 as of 25 June 2023. The latter was adopted following the Commission’s ‘new deal for consumers’ initiative. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 29 December 2009. Directive 2009/22/EC codified and replaced Directive 98/27/EC and its subsequent amendments. The original Directive 98/27/EC had to become law in the Member States by 2001. BACKGROUND For further information, see: Injunctions (European Commission). KEY TERMS Summary procedure. A special procedure enabling the arbitral tribunal to discard ineligible, abusive claims at the preliminary stage of an arbitration proceeding. MAIN DOCUMENT Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers’ interests (codified version) (OJ L 110, 1.5.2009, pp. 30–36). Successive amendments to Directive 2009/22/EC have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Report on the fitness check of consumer and marketing law of 25 May 2017 (SWD(2017) 209 final). Report from the Commission to the European Parliament and the Council concerning the application of Directive 2009/22/EC of the European Parliament and of the Council on injunctions for the protection of consumers’ interest (COM(2012) 635 final, 6.11.2012). Commission Recommendation 2013/396/EU of 11 June 2013 on common principles for injunctive and compensatory collective redress mechanisms in the Member States concerning violations of rights granted under Union Law (OJ L 201, 26.7.2013, pp. 60–65). Notification from the Commission concerning Article 4(3) of Directive 2009/22/EC of the European Parliament and of the Council on injunctions for the protection of consumers’ interests, which codifies Directive 98/27/EC, concerning the entities qualified to bring an action under Article 2 of this Directive (OJ C 361, 30.9.2016, pp. 1–55). Corrigendum to Notification from the Commission concerning Article 4(3) of Directive 2009/22/EC of the European Parliament and of the Council on injunctions for the protection of consumers’ interests, which codifies Directive 98/27/EC, concerning the entities qualified to bring an action under Article 2 of this Directive (OJ C 367, 6.10.2016, p. 6). last update 03.02.2022