CELEX: 52006PC0286
Language: en
Date: 2006-06-14
Title: Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the contained use of genetically modified micro-organisms

COMMISSION OF THE EUROPEAN COMMUNITIES
                                              Brussels, 14.6.2006
                                              COM(2006) 286 final
                                              2006/0100 (COD)
                                 Proposal for a
   DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
         on the contained use of genetically modified micro-organisms
                               (Codified version)
                        (presented by the Commission)
EN                                                                    EN
 ---pagebreak---                              EXPLANATORY MEMORANDUM
   1.  In the context of a people’s Europe, the Commission attaches great importance to
       simplifying and clarifying Community law so as to make it clearer and more
       accessible to the ordinary citizen, thus giving him new opportunities and the chance
       to make use of the specific rights it gives him.
       This aim cannot be achieved so long as numerous provisions that have been amended
       several times, often quite substantially, remain scattered, so that they must be sought
       partly in the original instrument and partly in later amending ones. Considerable
       research work, comparing many different instruments, is thus needed to identify the
       current rules.
       For this reason a codification of rules that have frequently been amended is also
       essential if Community law is to be clear and transparent.
   2.  On 1 April 1987 the Commission therefore decided1 to instruct its staff that all
       legislative acts should be codified after no more than ten amendments, stressing that
       this is a minimum requirement and that departments should endeavour to codify at
       even shorter intervals the texts for which they are responsible, to ensure that the
       Community rules are clear and readily understandable.
   3.  The Conclusions of the Presidency of the Edinburgh European Council
       (December 1992) confirmed this2, stressing the importance of codification as it offers
       certainty as to the law applicable to a given matter at a given time.
       Codification must be undertaken in full compliance with the normal Community
       legislative procedure.
       Given that no changes of substance may be made to the instruments affected by
       codification, the European Parliament, the Council and the Commission have agreed,
       by an interinstitutional agreement dated 20 December 1994, that an accelerated
       procedure may be used for the fast-track adoption of codification instruments.
   4.  The purpose of this proposal is to undertake a codification of Council
       Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified
       micro-organisms3. The new Directive will supersede the various acts incorporated in
       it4; this proposal fully preserves the content of the acts being codified and hence does
       no more than bring them together with only such formal amendments as are required
       by the codification exercise itself.
   5.  The codification proposal was drawn up on the basis of a preliminary consolidation,
       in all official languages, of Directive 90/219/EEC and the instruments amending it,
       carried out by the Office for Official Publications of the European Communities, by
       means of a data-processing system. Where the Articles have been given new
   1
      COM(87) 868 PV.
   2
      See Annex 3 to Part A of the Conclusions.
   3
      Carried out pursuant to the Communication from the Commission to the European Parliament and the
      Council – Codification of the Acquis communautaire, COM(2001) 645 final.
   4
      See Annex VI, Part A of this proposal.
EN                                                2                                                    EN
 ---pagebreak---    numbers, the correlation between the old and the new numbers is shown in a table
   contained in Annex VII to the codified Directive.
EN                                      3                                           EN
 ---pagebreak---                                                                            90/219/EEC (adapted)
                                                                 2006/0100 (COD)
                                                   Proposal for a
        DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
                   on the contained use of genetically modified micro-organisms
                                         (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 Committee5,
   Having regard to the opinion of the Committee of the Regions6,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty7,
   Whereas:
   (1)     Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically
           modified micro-organisms8 has been substantially amended several times9. In the
           interests of clarity and rationality the said Directive should be codified.
                                                                           90/219/EEC Recital 1 (adapted)
   (2)     Under the Treaty, action by the Community relating to the environment shall be based
           on the principle that preventive action shall be taken and shall have as its objective
   5
           OJ C […], […], p. […].
   6
           OJ C […], […], p. […].
   7
           OJ C […], […], p. […].
   8
           OJ L 117, 8.5.1990, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European
           Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
   9
           See Annex VI, Part A.
EN                                                        4                                                    EN
 ---pagebreak---        ⌦ , among other things, ⌫ to preserve, protect and improve the environment and to
       protect human health.
                                                                      90/219/EEC Recital 2 (adapted)
   (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.
                                                                      90/219/EEC Recital 3 (adapted)
   (4) The development of biotechnology is such as to contribute to the economic expansion
       of the Member States. This implies that genetically modified micro-organisms
       ⌦ (GMMs) ⌫ will be used in operations of various types and scale.
                                                                      90/219/EEC Recital 4 (adapted)
   (5) The contained use of ⌦ GMMs ⌫ should be carried out in such a way 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.
                                                                      98/81/EC Recital 5 (adapted)
   (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 the present 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
       organisms10 may apply.
                                                                      90/219/EEC Recital 5
   (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.
                                                                      90/219/EEC Recital 6 (adapted)
   (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
   10
       OJ L ⌦ 106, 17.4.2001, p. 1 ⌫. Directive as last amended by ⌦ Regulation (EC) No 1830/2003 of
       the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 24) ⌫.
EN                                                  5                                                EN
 ---pagebreak---         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.
                                                                 90/219/EEC Recital 7 (adapted)
   (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 case by
        case. To evaluate the risk to human health and the environment, it is necessary to lay
        down requirements for risk assessment.
                                                                 98/81/EC Recital 2 (adapted)
   (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.
                                                                 98/81/EC Recital 3
   (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. 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.
                                                                 98/81/EC Recital 7
   (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.
                                                                 90/219/EEC Recital 9 and
                                                              98/81/EC Recital 4 (adapted)
   (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.
                                                                 90/219/EEC Recital 10
                                                              (adapted)
   (14) Any person, before undertaking for the first time the contained use of a ⌦ GMM ⌫
        in a particular installation, should forward to the competent authority a notification so
        that the authority may satisfy itself that the proposed installation is appropriate to carry
EN                                                6                                                  EN
 ---pagebreak---         out the activity in a manner that does not present a hazard to human health and the
        environment.
                                                              90/219/EEC Recital 11
                                                           (adapted)
   (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.
                                                              90/219/EEC Recital 12
   (16) In the case of operations involving high risk, the consent of the competent authority
        should be given.
                                                              98/81/EC Recital 8
   (17) The containment and other protective measures applied to contained uses should be
        reviewed periodically.
                                                              90/219/EEC Recital 13
                                                           (adapted)
   (18) It may be considered appropriate to consult the public on the contained use of
        ⌦ GMMs ⌫.
                                                              98/81/EC Recital 9 (adapted)
   (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)11.
                                                              90/219/EEC Recital 14
   (20) Appropriate measures should be taken to inform any person liable to be affected by an
        accident on all matters relating to safety.
   11
        OJ L ⌦ 262, 17.10.2000, p. 21 ⌫.
EN                                               7                                            EN
 ---pagebreak---                                                                90/219/EEC Recital 15
   (21) Emergency plans should be established to deal effectively with accidents.
                                                               90/219/EEC Recital 16
   (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.
                                                               90/219/EEC Recital 17
   (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.
                                                               90/219/EEC Recital 18
                                                            (adapted)
   (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.
                                                               98/81/EC Recitals 12 and 13
                                                            (adapted) and 2001/204/EC
                                                            Recital 2 (adapted)
   (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 this 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 and for the adaptation to technical
        progress 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 Commission12.
   12
        OJ L 184, 17.7.1999, p. 23.
EN                                               8                                              EN
 ---pagebreak---    (27)   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,
                                                                    90/219/EEC (adapted)
   ⌦ HAVE ⌫ ADOPTED THIS DIRECTIVE:
                                                                    90/219/EEC
                                                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.
                                                                    98/81/EC Art. 1 pt. 1 (adapted)
                                                                    1 Corrigendum, 98/81/EC
                                                                 (OJ L 93, 8.4.1999, p. 27)
                                                                 (adapted)
                                                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,
            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 1 to limit their contact with, and to provide a high level of safety for, the
            general population and the environment;
EN                                                  9                                                  EN
 ---pagebreak---    (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.
                                                                   98/81/EC, Art. 1 pt. 1 (adapted)
   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 the said Directive,
   provided that the contained use is in accordance with the conditions, if any, of the consent for
   placing on the market.
                                                                   98/81/EC, Art. 1 pt. 1
                                               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 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 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:
EN                                                10                                                  EN
 ---pagebreak---    Class 1:      activities of no or negligible risk, that is to say activities for which level 1
                 containment is appropriate to protect human health as well as the environment.
   Class 2:      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.
   Class 3:      activities of moderate risk, that is to say activities for which level 3 containment
                 is appropriate to protect human health as well as the environment.
   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.
   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 sufficient evidence, in agreement
   with the competent authority, justifies 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 necessary safety measures shall be
   implemented in order to protect human health and the environment.
   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. The user shall apply, except to the extent that point 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 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
   to submit to the competent authorities, before commencing such use, a notification containing
   at least the information listed in Annex V, Part A.
EN                                                   11                                               EN
 ---pagebreak---                                                  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.
   The applicant can, however, himself request a decision on a formal authorisation from the
   competent authority. 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.
EN                                                  12                                               EN
 ---pagebreak---                                                                     98/81/EC, Art. 1 pt. 1
                                                 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, 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 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 paragraph 3(a), 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 for 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 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.
EN                                                   13                                               EN
 ---pagebreak---                                                  Article 12
   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 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 shall be required to inform immediately the competent authority specified in
   Article 10 and 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.
EN                                                   14                                             EN
 ---pagebreak---                                                 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 to limit its
            effects and 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.
                                                                   90/219/EEC
                                                Article 16
   Member States shall ensure that the competent authority organises inspections and other
   control measures to ensure user compliance with this Directive.
                                                                   98/81/EC, Art. 1 pt. 2
                                                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, 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 summary based on the reports referred to
   in paragraph 2, the first time being on 5 June 2004.
   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.
EN                                                  15                                              EN
 ---pagebreak---                                                 Article 18
                                                                    98/81/EC, Art. 1 pt. 2 (adapted)
   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 ⌫13, the notifier may indicate
   the information in the notifications submitted pursuant to this Directive that should be treated
   as confidential. Verifiable justification should be given in such cases.
                                                                    98/81/EC, Art. 1 pt. 2
   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 according to Articles 6, 8 or 9,
   be kept confidential:
   (a)       the general characteristics of the GMMs, name and address of the notifier, and
             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.
                                                                    98/81/EC Art. 1 pt. 2 (adapted)
   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
   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 ⌦ referred
   to ⌫ in Article 21 ⌦ (2) ⌫.
   13
           OJ L ⌦ 41, 14.2.2003, p. 26 ⌫.
EN                                                  16                                               EN
 ---pagebreak---                                                                    98/81/EC Art. 1 pt. 3 (adapted)
                                               Article 20
   Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority
   on a proposal from the Commission.
                                                                   1882/2003, Art. 3, Annex III,
                                                                pt. 19
                                               Article 21
   1. The Commission shall be assisted by a committee.
   2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall
   apply, having regard to the provisions of Article 8 thereof.
   The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3. The Committee shall adopt its rules of procedure.
                                               Article 22
   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 23
   This Directive shall enter into force on the twentieth day following that of its publication in
   the Official Journal of the European Union.
                                                                   90/219/EEC
                                               Article 24
   This Directive is addressed to the Member States.
EN                                                 17                                              EN
 ---pagebreak---    Done at Brussels,
   For the European Parliament For the Council
   The President               The President
EN                              18             EN
 ---pagebreak---                                                                  98/81/EC Art. 1 pt. 4
                                             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 the techniques/methods
   excluded by Annex II, PART A:
   (1)     in vitro fertilisation;
   (2)     natural processes such as: conjugation, transduction, transformation;
   (3)     polyploidy induction.
                                         _______________
EN                                               19                                              EN
 ---pagebreak---                                                ANNEX II
                                                PART A
   Techniques or methods of genetic modification yielding micro-organisms to be excluded from
   the 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.
                                                                    2001/204/EC Art. 1 (adapted)
                                                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. It will be supplemented by guidance notes for the easy application of such criteria,
   such notes being developed and, if necessary, amended by the Commission in accordance
   with the procedure referred to in Article 21 ⌦ (2) ⌫.
   1.        INTRODUCTION
             Types of GMMs listed in Part C in accordance with the procedure referred to in
             Article 21 ⌦ (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 Article 2(c). 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.
EN                                                 20                                                 EN
 ---pagebreak---                                                                 2001/204/EC Art. 1
   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.
                                                                2001/204/EC Art. 1 (adapted)
   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 ⌫.
                                                                2001/204/EC Art. 1
   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.
EN                                              21                                                EN
 ---pagebreak---    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.
                                                                98/81/EC, Art. 1 pt. 4 (adapted)
                                             PART C
   Types of GMMs which meet the criteria listed in Part B:
   … (to be completed in accordance with the procedure ⌦ referred to ⌫ in Article 21
   ⌦ (2) ⌫)
                                        _______________
EN                                              22                                               EN
 ---pagebreak---                                              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). It will be supplemented, as
   regards in particular section B, by guidance notes to be developed by the Commission in
   accordance with the procedure ⌦ referred to ⌫ in Article 21 ⌦ (2) ⌫.
                                                                   98/81/EC, Art. 1 pt. 4
   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.
EN                                                 23                                               EN
 ---pagebreak---    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 4(3):
       (i)    the recipient or parental micro-organism is unlikely to cause disease to humans,
              animals or plants14;
       (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 plants15, or
              likely to cause deleterious effects in the environment;
       (iii) the GMM is unlikely to cause disease to humans, animals or plants16 and is
              unlikely to have deleterious effects on the environment.
                                                                      98/81/EC, Art. 1 pt. 4 (adapted)
   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. 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
       ⌦ 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 to the 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.
                                                                      98/81/EC, Art. 1 pt. 4
   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.
   14
      This would only apply to animals and plants in the environment likely to be exposed.
   15
      This would only apply to animals and plants in the environment likely to be exposed.
   16
      This would only apply to animals and plants in the environment likely to be exposed.
EN                                                 24                                                  EN
 ---pagebreak---    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; 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 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).
                                      _______________
EN                                             25                                             EN
 ---pagebreak---                                         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.
EN                                           26                                             EN
 ---pagebreak---    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.    Member States may, in implementing this Annex, incorporate in addition the general
         principles in points 1 and 2 in the following tables for the sake of clarity of the
         requirements.
                                              Table I A
           Containment and other protective measures for laboratory activities
          Specifications                                  Containment levels
                                          1              2              3              4
       1 Laboratory suite:          Not             Not          Required       Required
         isolation1                 required        required
       2 Laboratory: sealable       Not             Not          Required       Required
         for fumigation             required        required
   Equipment
       3 Surfaces resistant to      Required        Required     Required       Required
         water, acids, alkalis,     (bench)         (bench)      (bench, floor) (bench, floor,
         solvents, disinfectants,                                               ceiling, walls)
         decontamination
         agents and easy to
         clean
EN                                                27                                            EN
 ---pagebreak---         4 Entry to lab via         Not          Not           Optional         Required
          airlock2                 required     required
        5 Negative pressure        Not          Not           Required         Required
          relative to the pressure required     required      except for3
          of the immediate
          environment
        6 Extract and input air    Not          Not           Required         Required
          from the laboratory      required     required      (HEPA)4 —        (HEPA)5 —
          should be HEPA-                                     extract air      input and
          filtered                                            except for3      extract air
        7 Microbiological safety Not            Optional      Required         Required
          post                     required
        8 Autoclave                On site      In the        En suite6        In lab =
                                                building                       double-ended
   System of work
        9 Restricted access        Not          Required      Required         Required
                                   required
      10 Biohazard sign on the     Not          Required      Required         Required
          door                     required
      11 Specific measures to      Not          Required      Required         Required
          control aerosol          required     minimise      prevent          prevent
          dissemination
      13 Shower                    Not          Not           Optional         Required
                                   required     required
                                                             Corrigendum, 98/81/EC
                                                           (OJ L 93, 8.4.1999, p. 27)
      14 Protective clothing       Suitable     Suitable      Suitable         Complete
                                   protective   protective    protective       change of
                                   clothing     clothing      clothing and     clothing and
                                                              (optional)       footwear
                                                              footwear         before entry
                                                                               and exit
EN                                            28                                            EN
 ---pagebreak---                                                                           98/81/EC Art. 1 pt. 4
      15 Gloves                           Not              Optional        Required           Required
                                          required
      18 Efficient vector                 Optional         Required        Required           Required
          control (e.g. for
          rodents and insects)
   Waste
      19 Inactivation of GMMs             Not              Not             Optional           Required
          in effluent from hand-          required         required
          washing sinks or
          drains and showers
          and similar effluents
      20 Inactivation of GMMs             Optional         Required        Required           Required
          in contamined
          material and waste
   Other measures
      21 Laboratory to contain            Not              Not             Optional           Required
          its own equipment               required         required
      23 An observation                   Optional         Optional        Optional           Required
          window or alternative
          is to be present so that
          occupants can be seen
    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.
EN                                                      29                                                       EN
 ---pagebreak---                                               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.
                                                                 98/81/EC (adapted)
   All provisions of Table I A shall apply with the following additions/modifications:
            Specifications                                Containment levels
                                          1                 2                3            4
   Building
        1 ⌦ Glasshouse ⌫:            Not           Required             Required     Required
           permanent structure1      required
   Equipment
        3 Entry via a separate       Not           Optional             Optional     Required
           room with two             required
           interlocking doors
        4 Control of                 Optional      Minimise2 run-off    Prevent      Prevent
           contaminated run-off                                         run-off      run-off
           water
   System of work
        6 Measures to control        Required        Required         Required       Required
           undesired species
           such as insects,
           rodents, arthropods
EN                                                30                                            EN
 ---pagebreak---      7 Procedures for               Minimise          Minimise              Prevent           Prevent
       transfer of living           dissemination     dissemination         dissemination     dissemination
       material between the
       glasshouse/growth-
       room, protective
       structure and
       laboratory shall
       control dissemination
       of ⌦ GMMs ⌫
   1
         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.
   2
         Where transmission can occur through the ground.
EN                                                 31                                                         EN
 ---pagebreak---                                                                             98/81/EC Art. 1 pt. 4
                                                     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 unit1          Optional        Required          Required           Required
         2 Animal facilities2                 Optional        Required          Required           Required
              separated by lockable
              doors
         3 Animal facilities                  Optional        Optional          Required           Required
              designed to facilitate
              decontamination
              (waterproof and easily
              washable material
              (cages, etc.))
         4 Floor and/or walls easily Optional                 Required          Required           Required
              washable                                        (floor)           (floor and         (floor and
                                                                                walls)             walls)
         5 Animals kept in                    Optional        Optional          Optional           Optional
              appropriate containment
              facilities such as cages,
              pens or tanks
         6 Filters on isolators or            Not             Optional          Required           Required
              isolated room3                  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.
EN                                                       32                                                          EN
 ---pagebreak---                                              Table II
                Containment and other protective measures for other activities
            Specifications                              Containment levels
                                        1              2              3             4
   General
       1 Viable micro-             Optional      Required      Required      Required
           organisms should be
           contained in a system
           which separates the
           process from the
           environment (closed
           system)
       2 Control of exhaust        Not           Required,     Required,     Required,
           gases from the closed   required      minimise      prevent       prevent
           system                                dissemination dissemination dissemination
       3 Control of aerosols       Optional      Required,     Required,     Required,
           during sample                         minimise      prevent       prevent
           collection, addition of               dissemination dissemination dissemination
           material to a closed
           system or transfer of
           material to another
           closed system
       4 Inactivation of bulk      Optional      Required, by  Required, by  Required, by
           culture fluids before                 validated     validated     validated
           removal from the                      means         means         means
           closed system
       5 Seals should be           No            Minimise      Prevent       Prevent
           designed so as to       sepecific     dissemination dissemination dissemination
           minimise or prevent     requirement
           release
       6 The controlled area       Optional      Optional      Required      Required
           should be designed to
           contain spillage of the
           entire contents of the
           closed system
       7 The controlled area       Not           Optional      Optional      Required
           should be sealable to   required
           permit fumigation
EN                                             33                                          EN
 ---pagebreak---    Equipment
        8 Entry via airlock        Not         Not required Optional       Required
                                   required
        9 Surfaces resistant to    Required    Required     Required       Required
          water, acids, alkalis,   (bench if   (bench if    (bench if any, (bench, floor,
          solvents, disinfectants, any)        any)         floor)         ceiling, walls)
          decontamination agents
          and easy to clean
      10 Specific measures to      Optional    Optional     Optional       Required
          adequately ventilate the
          controlled area in order
          to minimise air
          contamination
      11 The controlled area       Not         Not required Optional       Required
          should be maintained at required
          an air pressure negative
          to the immediate
          surroundings
      12 Extract and input air     Not         Not required Required       Required
          from the controlled      required                 (extract air,  (input and
          area should be HEPA                               optional for   extract air)
          filtered                                          input air)
   System of work
      13 Closed systems should     Not         Optional     Required       Required
          be located within a      required
          controlled area
      14 Access should be          Not         Required     Required       Required
          restricted to nominated  required
          personnel only
      15 Biohazard signs should    Not         Required     Required       Required
          be posted                required
      17 Personnel should          Not         Not required Optional       Required
          shower before leaving    required
          the controlled area
      18 Personnel should wear     Required    Required     Required       Complete
          protective clothing      (work       (work                       change before
                                   clothing)   clothing)                   exit and entry
EN                                           34                                            EN
 ---pagebreak---    Waste
     22 Inactivation of GMMs     Not         Not required Optional     Required
         in effluent from        required
         handwashing sinks and
         showers or similar
         effluents
     23 Inactivation of GMMs     Optional    Required, by Required, by Required, by
         in contaminated                     validated    validated    validated
         material and waste                  means        means        means
         including those in
         process effluent before
         final discharge
                                    _______________
EN                                         35                                       EN
 ---pagebreak---                                               ANNEX V
                                                                    98/81/EC, Art. 1 pt. 4 (adapted)
     ⌦ INFORMATION REQUIRED FOR THE NOTIFICATION REFERRED TO IN
                                    ARTICLES 6, 8 AND 9 ⌫
                                                                    98/81/EC Art. 1 pt. 4
                                               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,
EN                                                36                                                 EN
 ---pagebreak---    –       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);
EN                                                37                                               EN
 ---pagebreak---    (e) a copy of the assessment referred to in Article 4(2).
                                    _______________
EN                                           38              EN
 ---pagebreak---                                             ANNEX VI
                                               Part A
                       Repealed Directive with its successive amendments
                                     (referred to in Article 22)
   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               Annex III, point 19, only
      Parliament and of the Council
      (OJ L 284, 31.10.2003, p. 1)
                                               Part B
                      List of time-limits for transposition into national law
                                     (referred to in Article 22)
                   Directive                               Time-limit for transposition
   90/219/EEC                                    23 October 1991
   94/51/EC                                      30 April 1995
   98/81/EC                                      5 June 2000
                                          _____________
EN                                               39                                        EN
 ---pagebreak---                                          ANNEX VII
                                      CORRELATION TABLE
                 Directive 90/219/EEC                            This Directive
   Article 1                                    Article 1
   Article 2                                    Article 2
   Article 3, introductory phrase               Article 3(1), introductory phrase
   Article 3, first indent                      Article 3(1)(a)
   Article 3, second indent                     Article 3(1)(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 phrase           Article 10(4), introductory phrase
   Article 11(4), first indent                  Article 10(4)(a)
   Article 11(4), second indent                 Article 10(4)(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 phrase           Article 14(1), introductory phrase
EN                                           40                                    EN
 ---pagebreak---    Article 15(1), first indent           Article 14(1)(a)
   Article 15(1), second indent          Article 14(1)(b)
   Article 15(1), third indent           Article 14(1)(c)
   Article 15(1), fourth indent          Article 14(1)(d)
   Article 15(2), introductory phrase    Article 14(2), introductory phrase
   Article 15(2), first indent           Article 14(2)(a)
   Article 15(2), second indent          Article 14(2)(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 phrase    Article 18(2), introductory phrase
   Article 19(3), first indent           Article 18(2)(a)
   Article 19(3), second indent          Article 18(2)(b)
   Article 19(3), third indent           Article 18(2)(c)
   Article 19(4)                         Article 18(3)
   Article 19(5)                         Article 18(4)
   Article 20                            Article 19
   Article 20a                           Article 20
   Article 21                            Article 21
   Article 22                            _________
   _________                             Article 22
   _________                             Article 23
   Article 23                            Article 24
EN                                    41                                    EN
 ---pagebreak---    Annexes I-V          Annexes I-V
   _________            Annex VI
   _________            Annex VII
               _____________
EN                   42             EN