Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
5. 12. 98 EN Official Journal of the European Communities L 330/13 COUNCIL DIRECTIVE 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 103s(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), (5) Whereas 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 present Directive; other the Community legislation such as Council Directive 90/220/EEC of 23 April 1990 on the deliberate release the environment of genetically modified organisms (4) may apply; scope of into (6) Whereas exemptions pursuant to this Directive do not entail exemptions pursuant to any other Community legislation that may apply, such as Directive 90/220/EEC; (1) Whereas, within the meaning of the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health; (7) Whereas for all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in relevant Community legislation; accordance with (2) Whereas contained uses of genetically modified micro-organisms (GMMs) should be classified in relation to the risks they present for human health and the environment; whereas such classification should be in line with international practice and based on an assessment of the risk; (3) Whereas level of in order to ensure a high protection the containment and other protective measures applied to a contained use must correspond to the classification of the contained use; whereas in case of uncertainty the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data; (4) Whereas appropriate measures should be adopted and used for the control of the disposal of material from contained uses of GMMs; (1) OJ C 356, 22. 11. 1997, p. 14 and OJ C 369, 6. 12. 1997, p. 12. (2) OJ C 295, 7. 10. 1996, p. 52. (3) Opinion of the European Parliament of 12 March 1997 (OJ C 115, 14. 4. 1997, p. 59), Council common position of 16 December 1997 (OJ C 62, 26. 2. 1998, p. 1) and Decision of the European Parliament of 16 June 1998 (OJ C 210, 6. 7. 1998). (8) Whereas the containment and other protective measures applied to contained uses should be reviewed periodically; (9) Whereas people employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Council Directive 90/679/EEC of 26 November 1990 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) (5); (10) Whereas weaknesses have been in Directive the administrative notification requirements should be linked to the risk of the contained uses; 90/219/EEC (6); procedures identified whereas and (4) OJ L 117, 8. 5. 1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27. 6. 1997, p. 72). (5) OJ L 374, 31. 12. 1990, p. 1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15. 10. 1997, p. 33). (6) OJ L 117, 8. 5. 1990, p. 1. Directive as amended by Commission Directive 94/51/EC (OJ L 297, 18. 11. 1994, p. 29). L 330/14 EN Official Journal of the European Communities 5. 12. 98 (11) Whereas Directive 90/219/EEC did not permit sufficient adaptation to technical progress; whereas the technical parts of that Directive need to be adapted to technical progress; transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment; (12) Whereas the of Directive implementation 90/219/EEC could benefit from the addition of a list of GMMs that are safe for human health and the environment; whereas these GMMs should meet certain criteria in order to establish their safety; (13) Whereas, to take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of this list, it is appropriate for the Council to define and revise these criteria; (14) Whereas there is now considerable experience and the the risks associated with knowledge of contained use of GMMs; (15) Whereas Directive 90/219/EEC should therefore be amended accordingly, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 90/219/EEC is hereby amended as follows: 1. Articles 2 to 16 shall be replaced by the following: ‘Article 2 (d) “accident” shall mean 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” shall mean any natural or legal person responsible for the contained use of GMMs; (f) “notification” shall mean the presentation of the requisite information to the competent authorities of a Member State. Article 3 Without prejudice to Article 5(1) this Directive shall not apply: — where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or — for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety to human health and the environment. These types of GMMs shall be listed in Annex II, Part C. For the purposes of this Directive: Article 4 (a) “micro-organism” shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture; (b) “genetically modified micro-organism” (GMM) shall mean 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 genetic to considered result in not modification; (c) “contained use” shall mean any activity in which micro-organisms are genetically modified or in stored, which such GMMs are cultured, Article 5(3) and 5(6) and Articles 6 to 12 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air. 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 Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*) or pursuant to other Community legislation, which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. (*) OJ L 117, 8. 5. 1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27. 6. 1997, p. 72). 5. 12. 98 EN Official Journal of the European Communities L 330/15 Article 5 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 this end the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, 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 6: Class 1: Class 2: Class 3: activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health the environment. as well as activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health as well as the environment. activities of moderate risk, that is to say activities level 3 containment is appropriate to protect the human health environment. for which as well as Class 4: activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health as well as the environment. is doubt as to which class 4. Where there is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority, justifies the application of less stringent measures. 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 7, 9 and 10 or on request. Article 6 1. The user shall apply, except to the extent that paragraph 2 of Annex IV allows other measures to be applied, 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 5(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 7 When premises are to be used for the first time for contained uses, the user shall be required to submit to the competent authorities, before commencing such use, a notification containing at least the information listed in Annex V, Part A. Article 8 Following the notification referred to in Article 7, 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 5(6), which shall be made available to the competent authority on request. Article 9 5. The assessment referred to in paragraph (2) shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment. 1. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part B shall be submitted. L 330/16 EN Official Journal of the European Communities 5. 12. 98 2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. associated and any The applicant can, however, himself request a the decision on a competent authority. The decision must be made within a maximum of 45 days from the notification. formal authorisation from 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 in the notification paragraph 1, or earlier with the agreement of the competent authority. referred to Article 10 1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 7, 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 11 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 7, 9 and 10. information given, 2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the the assessment referred to in Article 5(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, response and measures. the correctness of emergency 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, does not begin, or, if in progress, is 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 9 and 10, any period of time during which the competent authority: — is awaiting any further information which it may have requested from the notifier in accordance with paragraph 3(a), or — is carrying out a public inquiry or consultation in accordance with Article 13 shall not be taken into account. Article 12 the user becomes aware of If relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 7, 9 and 10 shall be modified. If information subsequently becomes available to the competent authority which could have significant consequences for 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 13 Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use, without prejudice to Article 19. 5. 12. 98 EN Official Journal of the European Communities L 330/17 Article 14 Article 16 The competent authorities shall ensure that before a contained use commences: 1. Member States shall be required to: (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 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. to request it, 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 15 1. Member States shall take the necessary measures to ensure that, in the event of an accident, the user immediately shall be the required in Article 11 and competent authority specified provide the following information: inform to — the circumstances of the accident, — the identity and quantities of the GMMs concerned, — any information necessary to assess the effects of the general the health of the accident on population and the environment, — the measures taken. 2. Where information is given pursuant to paragraph 1, the Member States shall be required to: — ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident, (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 their effectiveness and an analysis of the accident, including recommendations to limit its effects and avoid similar accidents in the future. response measures taken and in consultation with 2. The Commission, 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. ’ 2. Articles 18, 19 and 20 shall be replaced by the following: ‘Article 18 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 10 including the description, purpose and risks of the contained use(s). 2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on 5 June 2003. 3. Every three years, the Commission shall publish a in to summary based on paragraph 2, the first time being on 5 June 2004. the reports referred — 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. 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. L 330/18 EN Official Journal of the European Communities 5. 12. 98 Article 19 3. The following Article shall be inserted: 1. Where its disclosure affects one or more of the items in Article 3(2) of Council Directive mentioned 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (*), 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. competent after authority 2. The consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. shall decide, 3. In no case may the following information, when submitted according to Articles 7, 9 or 10, be kept confidential: — the general characteristics of the GMMs, name and address of the notifier, and location of use, — class of contained use and measures of containment, — the evaluation of foreseeable effects, in particular any the effects on human health and harmful environment. 4. The Commission and the competent authorities shall not divulge to third parties any information decided to be confidential according to paragraph 2 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received. 5. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied. ‘Article 20a Before 5 December 2000 Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part C, shall be adopted by the Council acting by qualified majority on a proposal the Commission. Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. ’ from 4. The Annexes are replaced by the Annexes shown in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 months after the date of its entry into force. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive enters into force on the day of its publication in the Official Journal of the European Communities. Article 4 (*) OJ L 158, 23. 6. 1990, p. 56. This Directive is addressed to the Member States. Article 20 Done at Luxembourg, 26 October 1998. Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress and to adapt Annex II, Part C, shall be decided in accordance with the procedure laid down in Article 21. ’ For the Council The President W. SCHÜSSEL 5. 12. 98 EN Official Journal of the European Communities L 330/19 ANNEX ‘ANNEX I PART A Techniques of genetic modification referred to in Article 2(b)(i) 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 Article 2(b)(ii) 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 techniques/methods excluded by Annex II, PART A: (1) in vitro fertilisation; (2) natural processes such as: conjugation, transduction, transformation; (3) polyploidy induction. L 330/20 EN Official Journal of the European Communities 5. 12. 98 ANNEX II PART A Techniques or methods of genetic modification yielding micro-organisms to be excluded from the Directive on the 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 to human health and the environment:. (to be completed in accordance with the procedures in Article 20a) PART C Types of GMMs which meet the criteria listed in Part B:. (to be completed in accordance with the procedure in Article 21) 5. 12. 98 EN Official Journal of the European Communities L 330/21 ANNEX III PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(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 5(2). It will be supplemented, as regards in particular section B, by guidance notes to be developed by the Commission in accordance with the procedure set out in Article 21. These guidance notes shall be completed no later than 5 June 2000. 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 5(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, 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 5: (i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants (1); (1) This would only apply to animals and plants in the environment likely to be exposed. L 330/22 EN Official Journal of the European Communities 5. 12. 98 (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 (1), or likely to cause deleterious effects in the environment; (iii) the GMM is unlikely to cause disease to humans, animals or plants (1) 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 Council Directive 90/679/EEC (2)). International or national classification schemes (e. g. WHO, NIH, etc. ) 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 90/679/EEC 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 to the categorisation of the contained use activities in the four classes of risk referred to in Article 5(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 paragraphs 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 or 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; nature); (iii) any non-standard operations (e. g. the inoculation of animals with GMMs; 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 paragraph 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 5(3). 9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 5(2). (1) This would only apply to animals and plants in the environment likely to be exposed. (2) OJ L 374, 31. 12. 1990, p. 1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15. 10. 1997, p. 33). 5. 12. 98 EN Official Journal of the European Communities L 330/23 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 5(2). 3. Member states may, in implementing this Annex, incorporate in addition the general principles in paragraphs 1 and 2 in the following tables for the sake of clarity of the requirements. L 330/24 EN Official Journal of the European Communities 5. 12. 98 Table I A Containment and other protective measures for laboratory activities Specifications Containment levels 1 2 3 4 Laboratory suite: isolation (1) Not required Not required Required Required Laboratory: sealable for fumigation Not required Not required Required Required 1 2 Equipment 3 4 5 6 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench) Required (bench) Required (bench, floor) Required (bench, floor, ceiling, walls) Entry to lab via airlock (2) Not required Not required Optional Required Negative pressure relative to the pressure of the immediate environment Not required Not required Required except for (3) Required Extract and input air from the laboratory should be HEPA-filtered Not required Not required Required (HEPA) (4) — extract air except for (3) Required (HEPA) (5) — input and extract air 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 and (optional) footwear Suitable protective clothing Complete change of clothing and footwear before entry and exit 5. 12. 98 EN Official Journal of the European Communities L 330/25 Specifications Containment levels 1 2 3 4 15 Gloves Not required Optional Required Required 18 Efficient vector control (e. g. for rodents and insects) Optional Required Required Required Waste 19 from Inactivation of GMMs hand-washing sinks or drains and showers and similar effluents effluent in Not required Not required Optional Required 20 Inactivation of GMMs in contamined 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 Optional Optional Optional Required present so that occupants can be seen (1) Isolation = the laboratory is separated from other areas in the same building or is in a separated 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. L 330/26 EN Official Journal of the European Communities 5. 12. 98 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 Greenhouse: permanent structure (1) Not required Required Required Required Equipment 3 Entry via a separated room with two interlocking doors Not required Optional Optional Required 4 Control of contaminated run-off water Optional Minimise (2) run-off Prevent run-off Prevent run-off System of work 6 Measures to control undesired species such as Required Required Required Required insects, rodents, arthropods 7 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of genetically modified micro-organisms Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination (1) The glasshouse shall consist of a permanent structure with a continuous waterproofed covering, located on a site graded to prevent entry of surface-water run-off having self-closing lockable doors. (2) Where transmission can occur through the ground. 5. 12. 98 EN Official Journal of the European Communities L 330/27 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 2 3 Isolation of animal unit (1) Optional Required Required Required Animal facilities (2) separated by lockable doors Optional Required Required Required facilities Animal facilitate decontamination (waterproof and easily washable material (cages, etc. )) designed to Optional Optional Required Required 4 Floor and/or walls easily washable Optional Required (floor) Required (floor and walls) Required (floor and walls) 5 6 Animals kept in appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional Filters on isolators or isolated room (3) Not required Optional Required Required (1) 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. (2) 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. (3) Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. L 330/28 EN Official Journal of the European Communities 5. 12. 98 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 4 5 6 7 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 Inactivation of bulk culture fluids before removal from the closed system Optional Required, by validated means Required, by validated means Required, by validated means Seals should be designed so as to minimise or prevent release No sepecific requirement Minimise dissemination Prevent dissemination Prevent dissemination The controlled area should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required The controlled area should be sealable to permit fumigation Not required Optional Optional Required Equipment 8 9 Entry via airlock Not required Not required Optional Required Surfaces resistant to water, acids, alkalis, solvents, disinfectants, 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 to minimise air in order contamination Optional Optional Optional Required 11 The controlled area should be maintained at an air Not required Not required Optional Required pressure negative to the immediate surroundings 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) 5. 12. 98 EN Official Journal of the European Communities L 330/29 Specifications Containment levels 1 2 3 4 System of work 13 Closed systems should be located within a Not required Optional Required Required controlled area 14 Access should be restricted to nominated personnel Not required Required Required Required only 15 Biohazard signs should be posted Not required Required Required Required 17 Personnel should shower before controlled area leaving the 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 23 Inactivation of GMMs handwashing sinks and effluents in effluent showers or from similar Not required Not required Optional Required 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 L 330/30 EN Official Journal of the European Communities 5. 12. 98 ANNEX V PART A Information required for the notification referred to in Article 7: — 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 5(2) and information on waste management. PART B Information required for the notification referred to in Article 9: — the date of submission of the notification referred to in Article 7, — the name of the persons responsible for supervision and safety and information on the 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), — identity and characteristics of the GMM, — the purpose of the contained use including the expected results, — approximate culture volumes to be used, — 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 5(2), — the information necessary for the competent authority to evaluate any emergency response plans if required under Article 14. PART C Information required for the notification referred to in Article 10: (a) — the date of submission of the notification referred to in Article 7, — the name of the persons responsible for supervision and safety and information on the 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 functions(s) of the genetic material(s) involved in the modification(s), — identity and characteristics of the GMM, — the culture volumes to be used; 5. 12. 98 EN Official Journal of the European Communities L 330/31 (c) — 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, — 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, — 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 14; (e) a copy of the assessment referred to in Article 5(2). ’